false FY 0001624326 0001624326 2024-01-01 2024-12-31 0001624326 PAVM:CommonStock0.001ParValuePerShareMember 2024-01-01 2024-12-31 0001624326 PAVM:SeriesZWarrantsEachToPurchase115thOfOneShareOfCommonStockMember 2024-01-01 2024-12-31 0001624326 2024-06-30 0001624326 2024-12-31 0001624326 2025-03-20 0001624326 2024-10-01 2024-12-31 0001624326 2023-12-31 0001624326 PAVM:SeriesBConvertiblePreferredStockMember 2024-12-31 0001624326 PAVM:SeriesBConvertiblePreferredStockMember 2023-12-31 0001624326 2023-01-01 2023-12-31 0001624326 us-gaap:PreferredStockMember PAVM:SeriesBConvertiblePreferredStockMember 2023-12-31 0001624326 us-gaap:CommonStockMember 2023-12-31 0001624326 us-gaap:AdditionalPaidInCapitalMember 2023-12-31 0001624326 us-gaap:RetainedEarningsMember 2023-12-31 0001624326 us-gaap:TreasuryStockCommonMember 2023-12-31 0001624326 us-gaap:NoncontrollingInterestMember 2023-12-31 0001624326 us-gaap:PreferredStockMember PAVM:SeriesBConvertiblePreferredStockMember 2022-12-31 0001624326 us-gaap:CommonStockMember 2022-12-31 0001624326 us-gaap:AdditionalPaidInCapitalMember 2022-12-31 0001624326 us-gaap:RetainedEarningsMember 2022-12-31 0001624326 us-gaap:TreasuryStockCommonMember 2022-12-31 0001624326 us-gaap:NoncontrollingInterestMember 2022-12-31 0001624326 2022-12-31 0001624326 us-gaap:PreferredStockMember PAVM:SeriesBConvertiblePreferredStockMember 2024-01-01 2024-12-31 0001624326 us-gaap:CommonStockMember 2024-01-01 2024-12-31 0001624326 us-gaap:AdditionalPaidInCapitalMember 2024-01-01 2024-12-31 0001624326 us-gaap:RetainedEarningsMember 2024-01-01 2024-12-31 0001624326 us-gaap:TreasuryStockCommonMember 2024-01-01 2024-12-31 0001624326 us-gaap:NoncontrollingInterestMember 2024-01-01 2024-12-31 0001624326 us-gaap:PreferredStockMember PAVM:SeriesBConvertiblePreferredStockMember 2023-01-01 2023-12-31 0001624326 us-gaap:CommonStockMember 2023-01-01 2023-12-31 0001624326 us-gaap:AdditionalPaidInCapitalMember 2023-01-01 2023-12-31 0001624326 us-gaap:RetainedEarningsMember 2023-01-01 2023-12-31 0001624326 us-gaap:TreasuryStockCommonMember 2023-01-01 2023-12-31 0001624326 us-gaap:NoncontrollingInterestMember 2023-01-01 2023-12-31 0001624326 us-gaap:PreferredStockMember PAVM:SeriesBConvertiblePreferredStockMember 2024-12-31 0001624326 us-gaap:CommonStockMember 2024-12-31 0001624326 us-gaap:AdditionalPaidInCapitalMember 2024-12-31 0001624326 us-gaap:RetainedEarningsMember 2024-12-31 0001624326 us-gaap:TreasuryStockCommonMember 2024-12-31 0001624326 us-gaap:NoncontrollingInterestMember 2024-12-31 0001624326 srt:MinimumMember 2023-02-01 2023-02-28 0001624326 srt:MaximumMember 2023-02-01 2023-02-28 0001624326 srt:MaximumMember 2023-02-28 0001624326 srt:MinimumMember 2023-02-28 0001624326 2023-11-28 2023-11-28 0001624326 2023-12-07 2023-12-07 0001624326 us-gaap:LetterOfCreditMember 2024-12-31 0001624326 us-gaap:LetterOfCreditMember 2023-12-31 0001624326 PAVM:TwoThousandEighteenEquityPlanMember 2024-01-01 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncMember srt:MinimumMember 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncMember srt:MaximumMember 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncMember srt:MaximumMember 2024-09-10 0001624326 PAVM:LucidDiagnosticsIncMember 2024-09-10 2024-09-10 0001624326 PAVM:LucidDiagnosticsIncMember 2024-01-01 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncMember 2024-09-10 0001624326 PAVM:LucidDiagnosticsIncMember 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncMember us-gaap:CommonStockMember 2024-09-10 0001624326 PAVM:LucidDiagnosticsIncMember us-gaap:CommonStockMember 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncMember us-gaap:CommonStockMember 2024-09-10 0001624326 PAVM:LucidDiagnosticsIncMember us-gaap:CommonStockMember 2024-12-31 0001624326 PAVM:ManagementServicesAgreementMember srt:BoardOfDirectorsChairmanMember PAVM:LucidDiagnosticsIncMember 2024-01-01 2024-01-01 0001624326 PAVM:ManagementServicesAgreementMember srt:BoardOfDirectorsChairmanMember PAVM:LucidDiagnosticsIncMember 2024-07-01 2024-07-01 0001624326 PAVM:ManagementServicesAgreementMember srt:BoardOfDirectorsChairmanMember PAVM:LucidDiagnosticsIncMember 2024-09-11 2024-12-31 0001624326 us-gaap:IntellectualPropertyMember 2024-09-27 2024-09-27 0001624326 PAVM:LucidDiagnosticsIncMember PAVM:JanuaryOneTwoThousandTwentyFourToSeptemberTenTwoThousandTwentyFourMember 2024-01-01 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncMember PAVM:SeptemberElevenTwoThousandTwentyFourToSeptemberThirtyTwoThousandTwentyFourMember 2024-01-01 2024-12-31 0001624326 PAVM:ComputerAndOfficeEquipmentMember 2024-12-31 0001624326 PAVM:ComputerAndOfficeEquipmentMember 2023-12-31 0001624326 PAVM:ComputerAndOfficeEquipmentMember srt:MinimumMember 2024-12-31 0001624326 PAVM:ComputerAndOfficeEquipmentMember srt:MaximumMember 2024-12-31 0001624326 PAVM:LaboratoryEquipmentMember 2024-12-31 0001624326 PAVM:LaboratoryEquipmentMember 2023-12-31 0001624326 PAVM:LaboratoryEquipmentMember srt:MinimumMember 2024-12-31 0001624326 PAVM:LaboratoryEquipmentMember srt:MaximumMember 2024-12-31 0001624326 us-gaap:FurnitureAndFixturesMember 2024-12-31 0001624326 us-gaap:FurnitureAndFixturesMember 2023-12-31 0001624326 us-gaap:FurnitureAndFixturesMember srt:MinimumMember 2024-12-31 0001624326 us-gaap:FurnitureAndFixturesMember srt:MaximumMember 2024-12-31 0001624326 us-gaap:LeaseholdImprovementsMember 2024-12-31 0001624326 us-gaap:LeaseholdImprovementsMember 2023-12-31 0001624326 us-gaap:AssetUnderConstructionMember 2024-12-31 0001624326 us-gaap:AssetUnderConstructionMember 2023-12-31 0001624326 PAVM:DefensiveAssetMember 2024-12-31 0001624326 PAVM:DefensiveAssetMember 2023-12-31 0001624326 PAVM:LaboratoryInformationManagementSoftwareMember 2024-12-31 0001624326 PAVM:LaboratoryInformationManagementSoftwareMember 2023-12-31 0001624326 PAVM:OtherInfiniteLivedIntangibleAssetMember 2024-12-31 0001624326 PAVM:OtherInfiniteLivedIntangibleAssetMember 2023-12-31 0001624326 PAVM:LucidCommonStockMember us-gaap:FairValueInputsLevel1Member 2024-12-31 0001624326 PAVM:LucidCommonStockMember us-gaap:FairValueInputsLevel2Member 2024-12-31 0001624326 PAVM:LucidCommonStockMember us-gaap:FairValueInputsLevel3Member 2024-12-31 0001624326 PAVM:LucidCommonStockMember 2024-12-31 0001624326 us-gaap:FairValueInputsLevel1Member 2024-12-31 0001624326 us-gaap:FairValueInputsLevel2Member 2024-12-31 0001624326 us-gaap:FairValueInputsLevel3Member 2024-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:FairValueInputsLevel1Member 2024-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:FairValueInputsLevel2Member 2024-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:FairValueInputsLevel3Member 2024-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember 2024-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:FairValueInputsLevel1Member 2024-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:FairValueInputsLevel2Member 2024-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:FairValueInputsLevel3Member 2024-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2024-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:FairValueInputsLevel1Member 2023-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:FairValueInputsLevel2Member 2023-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:FairValueInputsLevel3Member 2023-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember 2023-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:FairValueInputsLevel1Member 2023-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:FairValueInputsLevel2Member 2023-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:FairValueInputsLevel3Member 2023-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2023-12-31 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember us-gaap:FairValueInputsLevel1Member 2023-12-31 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember us-gaap:FairValueInputsLevel2Member 2023-12-31 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember us-gaap:FairValueInputsLevel3Member 2023-12-31 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2023-12-31 0001624326 us-gaap:FairValueInputsLevel1Member 2023-12-31 0001624326 us-gaap:FairValueInputsLevel2Member 2023-12-31 0001624326 us-gaap:FairValueInputsLevel3Member 2023-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember 2022-04-04 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2022-09-08 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2023-03-21 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2024-09-10 0001624326 PAVM:MeasurementInputRequiredRateOfReturnMember PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember 2024-12-31 0001624326 PAVM:MeasurementInputRequiredRateOfReturnMember PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2024-12-31 0001624326 PAVM:MeasurementInputRequiredRateOfReturnMember PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2024-09-10 0001624326 us-gaap:MeasurementInputConversionPriceMember PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember 2024-12-31 0001624326 us-gaap:MeasurementInputConversionPriceMember PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2024-12-31 0001624326 us-gaap:MeasurementInputConversionPriceMember PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2024-09-10 0001624326 us-gaap:MeasurementInputSharePriceMember PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember 2024-12-31 0001624326 us-gaap:MeasurementInputSharePriceMember PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2024-12-31 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember us-gaap:MeasurementInputSharePriceMember 2024-09-10 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:MeasurementInputExpectedTermMember srt:MinimumMember 2024-01-01 2024-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:MeasurementInputExpectedTermMember srt:MaximumMember 2024-01-01 2024-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:MeasurementInputExpectedTermMember 2024-01-01 2024-12-31 0001624326 us-gaap:MeasurementInputExpectedTermMember PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2024-01-01 2024-09-10 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:MeasurementInputPriceVolatilityMember 2024-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:MeasurementInputPriceVolatilityMember 2024-12-31 0001624326 us-gaap:MeasurementInputPriceVolatilityMember PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2024-09-10 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MinimumMember 2024-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MaximumMember 2024-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:MeasurementInputRiskFreeInterestRateMember 2024-12-31 0001624326 us-gaap:MeasurementInputRiskFreeInterestRateMember PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2024-09-10 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:MeasurementInputExpectedDividendRateMember 2024-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:MeasurementInputExpectedDividendRateMember 2024-12-31 0001624326 us-gaap:MeasurementInputExpectedDividendRateMember PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2024-09-10 0001624326 PAVM:MeasurementInputRequiredRateOfReturnMember PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember srt:MinimumMember 2023-12-31 0001624326 PAVM:MeasurementInputRequiredRateOfReturnMember PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember srt:MaximumMember 2023-12-31 0001624326 PAVM:MeasurementInputRequiredRateOfReturnMember PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember srt:MinimumMember 2023-12-31 0001624326 PAVM:MeasurementInputRequiredRateOfReturnMember PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember srt:MaximumMember 2023-12-31 0001624326 PAVM:MeasurementInputRequiredRateOfReturnMember PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2023-12-31 0001624326 us-gaap:MeasurementInputConversionPriceMember PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember 2023-12-31 0001624326 us-gaap:MeasurementInputConversionPriceMember PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2023-12-31 0001624326 us-gaap:MeasurementInputConversionPriceMember PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2023-12-31 0001624326 us-gaap:MeasurementInputSharePriceMember PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember 2023-12-31 0001624326 us-gaap:MeasurementInputSharePriceMember PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2023-12-31 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember us-gaap:MeasurementInputSharePriceMember 2023-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:MeasurementInputExpectedTermMember srt:MinimumMember 2023-01-01 2023-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:MeasurementInputExpectedTermMember srt:MaximumMember 2023-01-01 2023-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:MeasurementInputExpectedTermMember srt:MinimumMember 2023-01-01 2023-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:MeasurementInputExpectedTermMember srt:MaximumMember 2023-01-01 2023-12-31 0001624326 us-gaap:MeasurementInputExpectedTermMember PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2023-01-01 2023-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:MeasurementInputPriceVolatilityMember 2023-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:MeasurementInputPriceVolatilityMember 2023-12-31 0001624326 us-gaap:MeasurementInputPriceVolatilityMember PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2023-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MinimumMember 2023-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MaximumMember 2023-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MinimumMember 2023-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MaximumMember 2023-12-31 0001624326 us-gaap:MeasurementInputRiskFreeInterestRateMember PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2023-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember us-gaap:MeasurementInputExpectedDividendRateMember 2023-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:MeasurementInputExpectedDividendRateMember 2023-12-31 0001624326 us-gaap:MeasurementInputExpectedDividendRateMember PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2023-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember 2024-01-01 2024-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2024-01-01 2024-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember 2023-01-01 2023-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2023-01-01 2023-12-31 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2023-01-01 2023-12-31 0001624326 PAVM:OtherIncomeExpenseMember 2023-12-31 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2024-01-01 2024-12-31 0001624326 PAVM:OtherIncomeExpenseMember 2024-01-01 2024-12-31 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2024-12-31 0001624326 PAVM:OtherIncomeExpenseMember 2024-12-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember 2022-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2022-12-31 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2022-12-31 0001624326 PAVM:OtherIncomeExpenseMember 2022-12-31 0001624326 PAVM:OtherIncomeExpenseMember 2023-01-01 2023-12-31 0001624326 PAVM:SecuritiesPurchaseAgreementMember PAVM:AccreditedInstitutionalInvestorMember 2022-03-31 0001624326 PAVM:SecuritiesPurchaseAgreementMember PAVM:AccreditedInstitutionalInvestorMember PAVM:InitialIssuanceMember 2022-03-31 0001624326 PAVM:SecuritiesPurchaseAgreementMember PAVM:AccreditedInstitutionalInvestorMember PAVM:AdditionalIssuanceMember 2022-03-31 0001624326 PAVM:AprilTwoThousandTwentyTwoSeniorConvertibleNotesMember 2022-04-02 2022-04-04 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2022-09-07 2022-09-08 0001624326 us-gaap:CashMember 2024-12-31 0001624326 PAVM:AprilAndSeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2024-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:InvestorMember 2024-01-01 2024-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:InterestRateFloorMember 2024-01-01 2024-12-31 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:InterestRateFloorMember 2024-12-31 0001624326 PAVM:AprilAndSeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember PAVM:DecemberThirtyOneTwentyFourThroughJanuaryFifteenTwentyTwentyFourMember 2024-12-31 0001624326 PAVM:AprilAndSeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember PAVM:DecemberThirtyOneTwentyFourThroughJanuaryFifteenTwentyTwentyFourMember 2024-01-01 2024-12-31 0001624326 PAVM:DebtExchangeAgreementMember us-gaap:SubsequentEventMember 2025-01-17 2025-01-17 0001624326 PAVM:DebtExchangeAgreementMember PAVM:AprilAndSeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2024-11-15 2024-11-15 0001624326 PAVM:DebtExchangeAgreementMember us-gaap:SeriesCPreferredStockMember PAVM:AprilAndSeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2024-11-15 0001624326 PAVM:AprilAndSeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:SubsequentEventMember 2025-01-17 0001624326 PAVM:AprilAndSeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:SubsequentEventMember 2025-01-17 2025-01-17 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember 2024-01-01 2024-09-10 0001624326 PAVM:LucidMarchTwoThousandTwentyThreeSeniorConvertibleNoteMember us-gaap:InvestorMember 2024-01-01 2024-09-10 0001624326 PAVM:TwoThousandAndFourteenEquityPlanMember 2024-12-31 0001624326 PAVM:TwoThousandAndFourteenEquityPlanMember us-gaap:SubsequentEventMember 2025-01-31 0001624326 PAVM:TwoThousandAndFourteenEquityPlanMember srt:ParentCompanyMember 2024-02-22 2024-02-22 0001624326 PAVM:TwoThousandAndFourteenEquityPlanMember us-gaap:RestrictedStockMember srt:ParentCompanyMember 2024-02-22 2024-02-22 0001624326 srt:ParentCompanyMember us-gaap:SubsequentEventMember 2025-01-01 2025-01-31 0001624326 srt:ParentCompanyMember us-gaap:SubsequentEventMember srt:MinimumMember 2025-01-01 2025-01-31 0001624326 srt:ParentCompanyMember us-gaap:SubsequentEventMember srt:MaximumMember 2025-01-01 2025-01-31 0001624326 PAVM:LucidDiagnosticsIncMember PAVM:TwoThousandEighteenEquityPlanMember 2024-02-22 2024-02-22 0001624326 PAVM:TwoThousandEighteenEquityPlanMember PAVM:LucidDiagnosticsIncMember us-gaap:RestrictedStockMember 2024-05-01 2024-05-31 0001624326 PAVM:TwoThousandAndFourteenEquityPlanMember 2024-01-01 2024-12-31 0001624326 PAVM:TwoThousandAndFourteenEquityPlanMember 2023-01-01 2023-12-31 0001624326 PAVM:TwoThousandEighteenEquityPlanMember 2023-01-01 2023-12-31 0001624326 PAVM:EmployeeStockPurchasePlanMember 2024-01-01 2024-03-31 0001624326 PAVM:EmployeeStockPurchasePlanMember 2023-01-01 2023-03-31 0001624326 PAVM:EmployeeStockPurchasePlanMember 2023-01-01 2023-09-30 0001624326 PAVM:EmployeeStockPurchasePlanMember 2024-12-31 0001624326 PAVM:EmployeeStockPurchasePlanMember us-gaap:SubsequentEventMember 2025-01-01 2025-01-31 0001624326 PAVM:EmployeeStockPurchasePlanMember PAVM:LucidDiagnosticsIncMember 2024-01-01 2024-03-31 0001624326 PAVM:EmployeeStockPurchasePlanMember PAVM:LucidDiagnosticsIncMember 2023-01-01 2023-03-31 0001624326 PAVM:EmployeeStockPurchasePlanMember PAVM:LucidDiagnosticsIncMember 2023-01-01 2023-09-30 0001624326 PAVM:TwoThousandAndFourteenEquityPlanMember 2022-12-31 0001624326 PAVM:TwoThousandAndFourteenEquityPlanMember 2021-12-31 0001624326 PAVM:TwoThousandAndFourteenEquityPlanMember 2023-12-31 0001624326 PAVM:TwoThousandEighteenEquityPlanMember 2022-12-31 0001624326 PAVM:TwoThousandEighteenEquityPlanMember 2022-01-01 2022-12-31 0001624326 PAVM:TwoThousandEighteenEquityPlanMember 2023-12-31 0001624326 PAVM:TwoThousandEighteenEquityPlanMember 2024-12-31 0001624326 srt:ParentCompanyMember PAVM:TwoThousandAndFourteenEquityPlanMember 2024-01-01 2024-12-31 0001624326 srt:ParentCompanyMember PAVM:TwoThousandAndFourteenEquityPlanMember 2023-01-01 2023-12-31 0001624326 PAVM:LucidDiagnosticsIncMember PAVM:TwoThousandEighteenEquityPlanMember 2024-09-10 2024-09-10 0001624326 PAVM:LucidDiagnosticsIncMember PAVM:TwoThousandEighteenEquityPlanMember 2023-12-31 2023-12-31 0001624326 us-gaap:RestrictedStockUnitsRSUMember PAVM:TwoThousandAndFourteenEquityPlanMember 2022-12-31 0001624326 us-gaap:RestrictedStockUnitsRSUMember PAVM:TwoThousandAndFourteenEquityPlanMember 2023-01-01 2023-12-31 0001624326 us-gaap:RestrictedStockUnitsRSUMember PAVM:TwoThousandAndFourteenEquityPlanMember 2023-12-31 0001624326 us-gaap:RestrictedStockUnitsRSUMember PAVM:TwoThousandAndFourteenEquityPlanMember 2024-01-01 2024-12-31 0001624326 us-gaap:RestrictedStockUnitsRSUMember PAVM:TwoThousandAndFourteenEquityPlanMember 2024-12-31 0001624326 us-gaap:RestrictedStockUnitsRSUMember PAVM:TwoThousandEighteenEquityPlanMember 2022-12-31 0001624326 us-gaap:RestrictedStockUnitsRSUMember PAVM:TwoThousandEighteenEquityPlanMember 2023-01-01 2023-12-31 0001624326 us-gaap:RestrictedStockUnitsRSUMember PAVM:TwoThousandEighteenEquityPlanMember 2023-12-31 0001624326 us-gaap:RestrictedStockUnitsRSUMember PAVM:TwoThousandEighteenEquityPlanMember 2024-01-01 2024-12-31 0001624326 us-gaap:RestrictedStockUnitsRSUMember PAVM:TwoThousandEighteenEquityPlanMember 2024-12-31 0001624326 PAVM:CostOfRevenueMember 2024-01-01 2024-12-31 0001624326 PAVM:CostOfRevenueMember 2023-01-01 2023-12-31 0001624326 us-gaap:SellingAndMarketingExpenseMember 2024-01-01 2024-12-31 0001624326 us-gaap:SellingAndMarketingExpenseMember 2023-01-01 2023-12-31 0001624326 us-gaap:GeneralAndAdministrativeExpenseMember 2024-01-01 2024-12-31 0001624326 us-gaap:GeneralAndAdministrativeExpenseMember 2023-01-01 2023-12-31 0001624326 us-gaap:ResearchAndDevelopmentExpenseMember 2024-01-01 2024-12-31 0001624326 us-gaap:ResearchAndDevelopmentExpenseMember 2023-01-01 2023-12-31 0001624326 PAVM:LucidDiagnosticsIncTwoThousandEighteenEquityPlanMember PAVM:CostOfRevenueMember 2024-01-01 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncTwoThousandEighteenEquityPlanMember PAVM:CostOfRevenueMember 2023-01-01 2023-12-31 0001624326 PAVM:LucidDiagnosticsIncTwoThousandEighteenEquityPlanMember us-gaap:SellingAndMarketingExpenseMember 2024-01-01 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncTwoThousandEighteenEquityPlanMember us-gaap:SellingAndMarketingExpenseMember 2023-01-01 2023-12-31 0001624326 PAVM:LucidDiagnosticsIncTwoThousandEighteenEquityPlanMember us-gaap:GeneralAndAdministrativeExpenseMember 2024-01-01 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncTwoThousandEighteenEquityPlanMember us-gaap:GeneralAndAdministrativeExpenseMember 2023-01-01 2023-12-31 0001624326 PAVM:LucidDiagnosticsIncTwoThousandEighteenEquityPlanMember us-gaap:ResearchAndDevelopmentExpenseMember 2024-01-01 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncTwoThousandEighteenEquityPlanMember us-gaap:ResearchAndDevelopmentExpenseMember 2023-01-01 2023-12-31 0001624326 PAVM:PAVmedIncTwoThousandFourteenEquityPlanMember PAVM:CostOfRevenueMember 2024-01-01 2024-12-31 0001624326 PAVM:PAVmedIncTwoThousandFourteenEquityPlanMember PAVM:CostOfRevenueMember 2023-01-01 2023-12-31 0001624326 PAVM:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:SellingAndMarketingExpenseMember 2024-01-01 2024-12-31 0001624326 PAVM:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:SellingAndMarketingExpenseMember 2023-01-01 2023-12-31 0001624326 PAVM:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:GeneralAndAdministrativeExpenseMember 2024-01-01 2024-12-31 0001624326 PAVM:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:GeneralAndAdministrativeExpenseMember 2023-01-01 2023-12-31 0001624326 PAVM:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:ResearchAndDevelopmentExpenseMember 2024-01-01 2024-12-31 0001624326 PAVM:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:ResearchAndDevelopmentExpenseMember 2023-01-01 2023-12-31 0001624326 PAVM:LucidDiagnosticsIncMember 2024-01-01 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncMember 2023-01-01 2023-12-31 0001624326 us-gaap:StockOptionMember PAVM:PAVmedIncTwoThousandFourteenEquityPlanMember 2024-12-31 0001624326 PAVM:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:StockOptionMember 2024-01-01 2024-12-31 0001624326 us-gaap:RestrictedStockMember PAVM:PAVmedIncTwoThousandFourteenEquityPlanMember 2024-12-31 0001624326 PAVM:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:RestrictedStockMember 2024-01-01 2024-12-31 0001624326 PAVM:SeriesBConvertiblePreferredStockMember 2024-01-01 2024-12-31 0001624326 PAVM:SeriesBConvertiblePreferredStockMember 2023-01-01 2023-12-31 0001624326 us-gaap:PreferredStockMember PAVM:SeriesBConvertiblePreferredStockMember us-gaap:SubsequentEventMember 2025-01-01 2025-01-31 0001624326 PAVM:SeriesCConvertiblePreferredStockMember us-gaap:SubsequentEventMember 2025-01-01 2025-01-17 0001624326 PAVM:SeriesCConvertiblePreferredStockMember us-gaap:SubsequentEventMember 2025-01-17 0001624326 2025-01-01 2025-03-31 0001624326 2024-03-07 2024-03-07 0001624326 PAVM:EmployeeStockPurchasePlanMember 2024-01-01 2024-12-31 0001624326 PAVM:AprilAndSeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember 2024-01-01 2024-12-31 0001624326 PAVM:AprilAndSeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:SubsequentEventMember 2025-03-20 0001624326 PAVM:SeptemberTwoThousandTwentyTwoSeniorConvertibleNoteMember us-gaap:SubsequentEventMember 2025-03-20 2025-03-20 0001624326 2025-03-20 2025-03-20 0001624326 2025-03-31 2025-03-31 0001624326 PAVM:VendorsMember 2024-01-01 2024-12-31 0001624326 PAVM:VendorsMember 2025-03-20 2025-03-20 0001624326 us-gaap:CommonStockMember us-gaap:SubsequentEventMember 2025-02-18 2025-02-18 0001624326 us-gaap:SubsequentEventMember 2025-02-18 0001624326 us-gaap:SubsequentEventMember PAVM:VerisHealthIncMember 2025-02-18 0001624326 us-gaap:CommonStockMember us-gaap:SubsequentEventMember PAVM:VerisHealthIncMember 2025-02-18 2025-02-18 0001624326 us-gaap:SubsequentEventMember 2025-02-21 2025-02-21 0001624326 srt:ScenarioForecastMember 2030-02-18 0001624326 us-gaap:SubsequentEventMember srt:MaximumMember 2025-01-31 0001624326 us-gaap:SubsequentEventMember srt:MinimumMember 2025-01-31 0001624326 us-gaap:SubsequentEventMember 2025-01-31 0001624326 PAVM:LucidDiagnosticsIncMember 2024-02-14 2024-02-15 0001624326 PAVM:LucidDiagnosticsIncMember 2024-01-14 2024-01-15 0001624326 PAVM:LucidDiagnosticsIncMember us-gaap:CommonStockMember 2024-01-14 2024-01-15 0001624326 2024-02-14 2024-02-15 0001624326 2024-02-15 0001624326 PAVM:SeriesZWarrantsMember 2024-12-31 0001624326 PAVM:SeriesZWarrantsMember 2023-12-31 0001624326 PAVM:SeriesZWarrantsMember 2024-02-15 0001624326 PAVM:SeriesZWarrantsMember srt:MinimumMember 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncMember 2024-12-31 0001624326 PAVM:LucidDiagnosticsIncMember 2024-09-10 2024-09-10 0001624326 PAVM:LucidDiagnosticsIncMember 2024-01-26 2024-01-26 0001624326 PAVM:SeriesAConvertiblePreferredStockMember 2023-03-05 2023-03-07 0001624326 PAVM:SeriesAConvertiblePreferredStockMember 2023-03-07 0001624326 PAVM:SeriesAOnePreferredStockMember 2024-03-12 2024-03-13 0001624326 PAVM:SeriesBConvertiblePreferredStockMember 2024-03-12 2024-03-13 0001624326 PAVM:SeriesBConvertiblePreferredStockMember 2024-03-13 0001624326 PAVM:LucidSeriesAAndLucidSeriesAOnePreferredStockMember 2024-03-12 2024-03-13 0001624326 PAVM:SeriesBOnePreferredStockMember 2024-05-06 2024-05-06 0001624326 PAVM:SeriesBOnePreferredStockMember 2024-05-06 0001624326 PAVM:VerisHealthIncMember 2024-12-31 0001624326 PAVM:VerisHealthIncMember srt:ParentCompanyMember 2024-12-31 0001624326 PAVM:VerisHealthIncMember PAVM:UnrelatedThirdPartiesMember 2024-12-31 0001624326 2024-03-13 2024-03-13 0001624326 2024-09-10 0001624326 srt:MinimumMember 2024-12-31 0001624326 srt:MaximumMember 2023-12-31 0001624326 srt:MinimumMember 2024-09-10 2024-09-10 0001624326 srt:MaximumMember 2024-09-10 2024-09-10 0001624326 us-gaap:ResearchMember 2024-12-31 0001624326 PAVM:StockOptionsMember 2024-01-01 2024-12-31 0001624326 PAVM:StockOptionsMember 2023-01-01 2023-12-31 0001624326 us-gaap:RestrictedStockMember 2024-01-01 2024-12-31 0001624326 us-gaap:RestrictedStockMember 2023-01-01 2023-12-31 0001624326 PAVM:SeriesZWarrantsMember 2024-01-01 2024-12-31 0001624326 PAVM:SeriesZWarrantsMember 2023-01-01 2023-12-31 0001624326 PAVM:SeriesBConvertiblePreferredStockMember 2024-01-01 2024-12-31 0001624326 PAVM:SeriesBConvertiblePreferredStockMember 2023-01-01 2023-12-31 iso4217:USD xbrli:shares iso4217:USD xbrli:shares xbrli:pure PAVM:Segment

0001624326 PAVmed Inc. false --12-31 FY 2025 Our board administers its cybersecurity risk oversight function directly through our audit committee. Our audit committee has primary responsibility for overseeing our risk assessment and risk management policies (including with respect to cybersecurity matters). Our audit committee regularly discusses with management, counsel, and auditors the Company’s major risk exposures. This includes potential financial impact on the Company and the steps taken to monitor and control those risks. Additionally, our board is informed regarding the risks facing the Company and coordinates with management and our cybersecurity team to ensure our board receives regular risk assessment updates from management. Our board administers its cybersecurity risk oversight function directly through our audit committee. Our audit committee has primary responsibility for overseeing our risk assessment and risk management policies (including with respect to cybersecurity matters). Our audit committee regularly discusses with management, counsel, and auditors the Company’s major risk exposures. This includes potential financial impact on the Company and the steps taken to monitor and control those risks. Additionally, our board is informed regarding the risks facing the Company and coordinates with management and our cybersecurity team to ensure our board receives regular risk assessment updates from management. Our board administers its cybersecurity risk oversight function directly through our audit committee. Our audit committee has primary responsibility for overseeing our risk assessment and risk management policies (including with respect to cybersecurity matters). Our audit committee regularly discusses with management, counsel, and auditors the Company’s major risk exposures. This includes potential financial impact on the Company and the steps taken to monitor and control those risks. Additionally, our board is informed regarding the risks facing the Company and coordinates with management and our cybersecurity team to ensure our board receives regular risk assessment updates from management. Our board administers its cybersecurity risk oversight function directly through our audit committee. Our audit committee has primary responsibility for overseeing our risk assessment and risk management policies (including with respect to cybersecurity matters). Our audit committee regularly discusses with management, counsel, and auditors the Company’s major risk exposures. This includes potential financial impact on the Company and the steps taken to monitor and control those risks. Additionally, our board is informed regarding the risks facing the Company and coordinates with management and our cybersecurity team to ensure our board receives regular risk assessment updates from management. true true true true true false false false false false true false 0.001 0.001 20,000,000 20,000,000 0.001 0.001 1,529,389 1,529,389 1,412,865 1,412,865 0.001 20,000,000 20,000,000 1,080 19,457 19,457 0 0 0.001 0.001 25,000,000 25,000,000 927,934 927,934 373,300 373,300 299 0 0 0 10 33.33 66.67 1 2 10 33.33 66.67 1 2 33.33 66.67 1 2 10 523,300 1,529,389 1,412,865 0 10,763,186 0 2022 2023 2024 2025 Share activity and weighted average grant date fair values include immaterial rounding due to the Company's 1-for-30 reverse stock split. The intrinsic value is computed as the difference between the quoted price of the Lucid Diagnostics common stock on each of September 10, 2024 and December 31, 2023 and the exercise price of the underlying Lucid Diagnostics stock options, to the extent such quoted price is greater than the exercise price. Stock options granted under the Lucid Diagnostics 2018 Equity Plan and those granted outside such plan generally vest one-third in one year then ratably over the next eight quarters, and have a ten-year contractual term from date-of-grant. Convertible preferred stock and restricted stock awards would potentially be considered a participating security under the two-class method of calculating net income (loss) per share. For periods where losses are presented, such holders are not contractually obligated to share in the losses, there is no impact on the Company’s net income (loss) per share calculation for the periods indicated. Lesser of remaining lease term or estimated useful life. The outstanding stock options presented in the table above are inclusive of 1,816 and 2,001 stock options granted outside the PAVmed 2014 Equity Plan, as of December 31, 2025 and December 31, 2024, respectively. 00016243262025-01-012025-12-31 iso4217:USD 00016243262024-06-30 xbrli:shares 00016243262026-03-27 thunderdome:item 00016243262025-12-31 00016243262024-12-31 iso4217:USDxbrli:shares 0001624326us-gaap:SeriesBPreferredStockMember2025-12-31 0001624326us-gaap:SeriesBPreferredStockMember2024-12-31 0001624326us-gaap:SeriesCPreferredStockMember2025-12-31 0001624326us-gaap:SeriesCPreferredStockMember2024-12-31 00016243262024-01-012024-12-31 0001624326us-gaap:SeriesBPreferredStockMember2025-01-012025-12-31 0001624326us-gaap:SeriesBPreferredStockMember2024-01-012024-12-31 0001624326us-gaap:SeriesCPreferredStockMember2025-01-012025-12-31 0001624326us-gaap:SeriesCPreferredStockMember2024-01-012024-12-31 0001624326pavm:SubsidiaryPreferredStockMember2025-01-012025-12-31 0001624326pavm:SubsidiaryPreferredStockMember2024-01-012024-12-31 0001624326us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2024-12-31 0001624326us-gaap:SeriesCPreferredStockMemberus-gaap:PreferredStockMember2024-12-31 0001624326us-gaap:CommonStockMember2024-12-31 0001624326us-gaap:AdditionalPaidInCapitalMember2024-12-31 0001624326us-gaap:RetainedEarningsMember2024-12-31 0001624326us-gaap:NoncontrollingInterestMember2024-12-31 0001624326pavm:SeriesBDividendsMemberus-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326pavm:SeriesBDividendsMemberus-gaap:SeriesCPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326pavm:SeriesBDividendsMemberus-gaap:CommonStockMember2025-01-012025-12-31 0001624326pavm:SeriesBDividendsMemberus-gaap:AdditionalPaidInCapitalMember2025-01-012025-12-31 0001624326pavm:SeriesBDividendsMemberus-gaap:RetainedEarningsMember2025-01-012025-12-31 0001624326pavm:SeriesBDividendsMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:SeriesBDividendsMember2025-01-012025-12-31 0001624326us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMemberpavm:PavmedAtmFacilityMember2025-01-012025-12-31 0001624326us-gaap:SeriesCPreferredStockMemberus-gaap:PreferredStockMemberpavm:PavmedAtmFacilityMember2025-01-012025-12-31 0001624326us-gaap:CommonStockMemberpavm:PavmedAtmFacilityMember2025-01-012025-12-31 0001624326us-gaap:AdditionalPaidInCapitalMemberpavm:PavmedAtmFacilityMember2025-01-012025-12-31 0001624326us-gaap:RetainedEarningsMemberpavm:PavmedAtmFacilityMember2025-01-012025-12-31 0001624326us-gaap:NoncontrollingInterestMemberpavm:PavmedAtmFacilityMember2025-01-012025-12-31 0001624326pavm:PavmedAtmFacilityMember2025-01-012025-12-31 0001624326us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326us-gaap:CommonStockMember2025-01-012025-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteMemberus-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteMemberus-gaap:SeriesCPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteMemberus-gaap:CommonStockMember2025-01-012025-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteMemberus-gaap:AdditionalPaidInCapitalMember2025-01-012025-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteMemberus-gaap:RetainedEarningsMember2025-01-012025-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteMember2025-01-012025-12-31 0001624326us-gaap:SeriesCPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326us-gaap:AdditionalPaidInCapitalMember2025-01-012025-12-31 0001624326us-gaap:RetainedEarningsMember2025-01-012025-12-31 0001624326us-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMemberus-gaap:PrivatePlacementMember2025-01-012025-12-31 0001624326us-gaap:SeriesCPreferredStockMemberus-gaap:PreferredStockMemberus-gaap:PrivatePlacementMember2025-01-012025-12-31 0001624326us-gaap:CommonStockMemberus-gaap:PrivatePlacementMember2025-01-012025-12-31 0001624326us-gaap:AdditionalPaidInCapitalMemberus-gaap:PrivatePlacementMember2025-01-012025-12-31 0001624326us-gaap:RetainedEarningsMemberus-gaap:PrivatePlacementMember2025-01-012025-12-31 0001624326us-gaap:NoncontrollingInterestMemberus-gaap:PrivatePlacementMember2025-01-012025-12-31 0001624326us-gaap:PrivatePlacementMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughDebtExchangeSeriesCConvertiblePreferredStockNetOfFinancingFeesMemberus-gaap:SeriesCPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughDebtExchangeSeriesCConvertiblePreferredStockNetOfFinancingFeesMemberus-gaap:CommonStockMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughDebtExchangeSeriesCConvertiblePreferredStockNetOfFinancingFeesMemberus-gaap:AdditionalPaidInCapitalMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughDebtExchangeSeriesCConvertiblePreferredStockNetOfFinancingFeesMemberus-gaap:RetainedEarningsMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughDebtExchangeSeriesCConvertiblePreferredStockNetOfFinancingFeesMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughDebtExchangeSeriesCConvertiblePreferredStockNetOfFinancingFeesMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughUnsecuredDebtObligationCancellationSeriesCConvertiblePreferredStockMemberus-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughUnsecuredDebtObligationCancellationSeriesCConvertiblePreferredStockMemberus-gaap:SeriesCPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughUnsecuredDebtObligationCancellationSeriesCConvertiblePreferredStockMemberus-gaap:CommonStockMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughUnsecuredDebtObligationCancellationSeriesCConvertiblePreferredStockMemberus-gaap:AdditionalPaidInCapitalMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughUnsecuredDebtObligationCancellationSeriesCConvertiblePreferredStockMemberus-gaap:RetainedEarningsMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughUnsecuredDebtObligationCancellationSeriesCConvertiblePreferredStockMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:IssuanceThroughUnsecuredDebtObligationCancellationSeriesCConvertiblePreferredStockMember2025-01-012025-12-31 0001624326pavm:ConversionsOfSeriesCConvertiblePreferredStockMemberus-gaap:SeriesCPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326pavm:ConversionsOfSeriesCConvertiblePreferredStockMemberus-gaap:CommonStockMember2025-01-012025-12-31 0001624326pavm:ConversionsOfSeriesCConvertiblePreferredStockMemberus-gaap:AdditionalPaidInCapitalMember2025-01-012025-12-31 0001624326pavm:ConversionsOfSeriesCConvertiblePreferredStockMemberus-gaap:RetainedEarningsMember2025-01-012025-12-31 0001624326pavm:ConversionsOfSeriesCConvertiblePreferredStockMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:ConversionsOfSeriesCConvertiblePreferredStockMember2025-01-012025-12-31 0001624326pavm:ExchangeSeriesCConvertiblePreferredStockToSeniorSecuredConvertibleDebtMemberus-gaap:SeriesCPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326pavm:ExchangeSeriesCConvertiblePreferredStockToSeniorSecuredConvertibleDebtMemberus-gaap:AdditionalPaidInCapitalMember2025-01-012025-12-31 0001624326pavm:ExchangeSeriesCConvertiblePreferredStockToSeniorSecuredConvertibleDebtMemberus-gaap:RetainedEarningsMember2025-01-012025-12-31 0001624326pavm:ExchangeSeriesCConvertiblePreferredStockToSeniorSecuredConvertibleDebtMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:ExchangeSeriesCConvertiblePreferredStockToSeniorSecuredConvertibleDebtMember2025-01-012025-12-31 0001624326pavm:SeriesCDividendsMemberus-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326pavm:SeriesCDividendsMemberus-gaap:SeriesCPreferredStockMemberus-gaap:PreferredStockMember2025-01-012025-12-31 0001624326pavm:SeriesCDividendsMemberus-gaap:CommonStockMember2025-01-012025-12-31 0001624326pavm:SeriesCDividendsMemberus-gaap:AdditionalPaidInCapitalMember2025-01-012025-12-31 0001624326pavm:SeriesCDividendsMemberus-gaap:RetainedEarningsMember2025-01-012025-12-31 0001624326pavm:SeriesCDividendsMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:SeriesCDividendsMember2025-01-012025-12-31 0001624326us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2025-12-31 0001624326us-gaap:SeriesCPreferredStockMemberus-gaap:PreferredStockMember2025-12-31 0001624326us-gaap:CommonStockMember2025-12-31 0001624326us-gaap:AdditionalPaidInCapitalMember2025-12-31 0001624326us-gaap:RetainedEarningsMember2025-12-31 0001624326us-gaap:NoncontrollingInterestMember2025-12-31 0001624326us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2023-12-31 0001624326us-gaap:CommonStockMember2023-12-31 0001624326us-gaap:AdditionalPaidInCapitalMember2023-12-31 0001624326us-gaap:RetainedEarningsMember2023-12-31 0001624326us-gaap:NoncontrollingInterestMember2023-12-31 00016243262023-12-31 0001624326pavm:SeriesBDividendsMemberus-gaap:PreferredStockMember2024-01-012024-12-31 0001624326pavm:SeriesBDividendsMemberus-gaap:CommonStockMember2024-01-012024-12-31 0001624326pavm:SeriesBDividendsMemberus-gaap:AdditionalPaidInCapitalMember2024-01-012024-12-31 0001624326pavm:SeriesBDividendsMemberus-gaap:RetainedEarningsMember2024-01-012024-12-31 0001624326pavm:SeriesBDividendsMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:SeriesBDividendsMember2024-01-012024-12-31 0001624326us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMemberpavm:PavmedAtmFacilityMember2024-01-012024-12-31 0001624326us-gaap:CommonStockMemberpavm:PavmedAtmFacilityMember2024-01-012024-12-31 0001624326us-gaap:AdditionalPaidInCapitalMemberpavm:PavmedAtmFacilityMember2024-01-012024-12-31 0001624326us-gaap:RetainedEarningsMemberpavm:PavmedAtmFacilityMember2024-01-012024-12-31 0001624326us-gaap:NoncontrollingInterestMemberpavm:PavmedAtmFacilityMember2024-01-012024-12-31 0001624326pavm:PavmedAtmFacilityMember2024-01-012024-12-31 0001624326us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2024-01-012024-12-31 0001624326us-gaap:CommonStockMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorConvertibleNotesIntoCommonStockMemberus-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorConvertibleNotesIntoCommonStockMemberus-gaap:CommonStockMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorConvertibleNotesIntoCommonStockMemberus-gaap:AdditionalPaidInCapitalMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorConvertibleNotesIntoCommonStockMemberus-gaap:RetainedEarningsMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorConvertibleNotesIntoCommonStockMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorConvertibleNotesIntoCommonStockMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteIntoSubsidiaryCommonStockMemberus-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteIntoSubsidiaryCommonStockMemberus-gaap:CommonStockMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteIntoSubsidiaryCommonStockMemberus-gaap:AdditionalPaidInCapitalMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteIntoSubsidiaryCommonStockMemberus-gaap:RetainedEarningsMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteIntoSubsidiaryCommonStockMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorSecuredConvertibleNoteIntoSubsidiaryCommonStockMember2024-01-012024-12-31 0001624326us-gaap:AdditionalPaidInCapitalMember2024-01-012024-12-31 0001624326us-gaap:RetainedEarningsMember2024-01-012024-12-31 0001624326us-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:SeriesA1PreferredStockMemberus-gaap:CommonStockMember2024-01-012024-12-31 0001624326pavm:SeriesA1PreferredStockMemberus-gaap:AdditionalPaidInCapitalMember2024-01-012024-12-31 0001624326pavm:SeriesA1PreferredStockMemberus-gaap:RetainedEarningsMember2024-01-012024-12-31 0001624326pavm:SeriesA1PreferredStockMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:SeriesA1PreferredStockMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeriesAAndSeriesA1PreferredStockIntoCommonStockMemberus-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeriesAAndSeriesA1PreferredStockIntoCommonStockMemberus-gaap:CommonStockMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeriesAAndSeriesA1PreferredStockIntoCommonStockMemberus-gaap:AdditionalPaidInCapitalMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeriesAAndSeriesA1PreferredStockIntoCommonStockMemberus-gaap:RetainedEarningsMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeriesAAndSeriesA1PreferredStockIntoCommonStockMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeriesAAndSeriesA1PreferredStockIntoCommonStockMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeriesBAndSeriesB1IntoCommonStockMemberus-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeriesBAndSeriesB1IntoCommonStockMemberus-gaap:CommonStockMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeriesBAndSeriesB1IntoCommonStockMemberus-gaap:AdditionalPaidInCapitalMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeriesBAndSeriesB1IntoCommonStockMemberus-gaap:RetainedEarningsMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeriesBAndSeriesB1IntoCommonStockMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeriesBAndSeriesB1IntoCommonStockMember2024-01-012024-12-31 0001624326pavm:SeriesBAndSeriesB1PreferredStockMemberus-gaap:CommonStockMember2024-01-012024-12-31 0001624326pavm:SeriesBAndSeriesB1PreferredStockMemberus-gaap:AdditionalPaidInCapitalMember2024-01-012024-12-31 0001624326pavm:SeriesBAndSeriesB1PreferredStockMemberus-gaap:RetainedEarningsMember2024-01-012024-12-31 0001624326pavm:SeriesBAndSeriesB1PreferredStockMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:SeriesBAndSeriesB1PreferredStockMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMember2025-01-012025-12-31 0001624326pavm:LucidDiagnosticsMember2024-01-012024-12-31 0001624326srt:SubsidiariesMember2025-01-012025-12-31 0001624326srt:SubsidiariesMember2024-01-012024-12-31 0001624326pavm:IssueOfCommonStockAndPrefundedWarrantsMember2025-01-012025-12-31 0001624326pavm:IssueOfCommonStockAndPrefundedWarrantsMember2024-01-012024-12-31 0001624326pavm:AtthemarketFacilityMember2025-01-012025-12-31 0001624326pavm:AtthemarketFacilityMember2024-01-012024-12-31 0001624326us-gaap:SeriesCPreferredStockMemberus-gaap:SubsequentEventMember2026-02-032026-02-03 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:SubsequentEventMember2026-02-03 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:SubsequentEventMember2026-02-032026-02-03 0001624326pavm:The2026NoteMemberus-gaap:SubsequentEventMember2026-02-03 xbrli:pure 0001624326pavm:ReverseStockSplitMembersrt:MinimumMember2025-10-012025-10-31 0001624326pavm:ReverseStockSplitMembersrt:MaximumMember2025-10-012025-10-31 00016243262023-03-30 00016243262025-10-31 0001624326pavm:ReverseStockSplitMember2025-12-012025-12-31 0001624326srt:MaximumMemberpavm:LucidDiagnosticsMember2024-09-10 0001624326pavm:LucidDiagnosticsMember2024-09-10 0001624326pavm:LucidDiagnosticsMember2024-09-10 0001624326pavm:LucidDiagnosticsMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMember2024-09-102024-09-10 0001624326pavm:LucidDiagnosticsMember2025-12-31 0001624326pavm:LucidDiagnosticsMember2024-12-31 0001624326pavm:LucidDiagnosticsMember2025-01-012025-12-31 0001624326pavm:LucidDiagnosticsMember2024-01-012024-09-10 0001624326pavm:LucidDiagnosticsMember2024-09-112024-12-31 0001624326pavm:LucidDiagnosticsMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMember2025-12-31 0001624326pavm:LucidDiagnosticsMember2024-12-31 0001624326pavm:LucidDiagnosticsMember2025-01-012025-12-31 0001624326pavm:LucidDiagnosticsMember2025-12-31 0001624326pavm:LucidDiagnosticsMember2024-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:MonthlyServicesAgreementMember2024-07-01 0001624326pavm:LucidDiagnosticsMemberpavm:MonthlyServicesAgreementMember2025-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:MonthlyServicesAgreementMember2024-09-112024-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:MonthlyServicesAgreementMember2025-01-012025-12-31 utr:Y 0001624326pavm:ComputerAndOfficeEquipmentMembersrt:MinimumMember2025-12-31 0001624326pavm:ComputerAndOfficeEquipmentMembersrt:MaximumMember2025-12-31 0001624326pavm:ComputerAndOfficeEquipmentMember2025-12-31 0001624326pavm:ComputerAndOfficeEquipmentMember2024-12-31 0001624326pavm:LaboratoryEquipmentMembersrt:MinimumMember2025-12-31 0001624326pavm:LaboratoryEquipmentMembersrt:MaximumMember2025-12-31 0001624326pavm:LaboratoryEquipmentMember2025-12-31 0001624326pavm:LaboratoryEquipmentMember2024-12-31 0001624326us-gaap:FurnitureAndFixturesMembersrt:MinimumMember2025-12-31 0001624326us-gaap:FurnitureAndFixturesMembersrt:MaximumMember2025-12-31 0001624326us-gaap:FurnitureAndFixturesMember2025-12-31 0001624326us-gaap:FurnitureAndFixturesMember2024-12-31 0001624326us-gaap:LeaseholdImprovementsMember2025-12-31 0001624326us-gaap:LeaseholdImprovementsMember2024-12-31 0001624326us-gaap:AssetUnderConstructionMember2025-12-31 0001624326us-gaap:AssetUnderConstructionMember2024-12-31 0001624326us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2025-12-31 0001624326us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2025-12-31 0001624326us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2025-12-31 0001624326us-gaap:FairValueMeasurementsRecurringMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:FairValueMeasurementsRecurringMember2025-12-31 0001624326us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-31 0001624326us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-31 0001624326us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-31 0001624326us-gaap:FairValueMeasurementsRecurringMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMemberus-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMemberus-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMemberus-gaap:FairValueMeasurementsRecurringMember2024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:FairValueMeasurementsRecurringMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMember2022-04-04 0001624326pavm:September2022SeniorConvertibleNoteMember2022-09-08 0001624326pavm:September2022SeniorConvertibleNoteMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberpavm:MeasurementInputRequiredRateOfReturnMembersrt:MinimumMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberpavm:MeasurementInputRequiredRateOfReturnMembersrt:MaximumMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputConversionPriceMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputSharePriceMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputExpectedTermMembersrt:MinimumMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputExpectedTermMembersrt:MaximumMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputPriceVolatilityMembersrt:MinimumMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputPriceVolatilityMembersrt:MaximumMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputRiskFreeInterestRateMembersrt:MinimumMember2025-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputRiskFreeInterestRateMembersrt:MaximumMember2025-12-31 0001624326pavm:April2022SeniorConvertibleNoteMember2024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMemberpavm:MeasurementInputRequiredRateOfReturnMember2024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberpavm:MeasurementInputRequiredRateOfReturnMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputConversionPriceMember2024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputConversionPriceMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputSharePriceMember2024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputSharePriceMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputExpectedTermMembersrt:MinimumMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputExpectedTermMembersrt:MaximumMember2024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputExpectedTermMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputPriceVolatilityMember2024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputPriceVolatilityMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputRiskFreeInterestRateMembersrt:MinimumMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputRiskFreeInterestRateMembersrt:MaximumMember2024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:MeasurementInputRiskFreeInterestRateMember2024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:SubsequentEventMember2026-02-012026-02-28 0001624326pavm:September2022SeniorConvertibleNoteMember2025-01-012025-12-31 0001624326pavm:April2022SeniorConvertibleNoteMember2024-01-012024-12-31 0001624326pavm:September2022SeniorConvertibleNoteMember2024-01-012024-12-31 0001624326pavm:BalanceSheetDebtComponentsMember2024-12-31 0001624326pavm:April2022SeniorConvertibleNoteMember2025-01-012025-12-31 0001624326pavm:BalanceSheetDebtComponentsMember2025-01-012025-12-31 0001624326pavm:April2022SeniorConvertibleNoteMember2025-12-31 0001624326pavm:BalanceSheetDebtComponentsMember2025-12-31 0001624326pavm:April2022SeniorConvertibleNoteMember2023-12-31 0001624326pavm:September2022SeniorConvertibleNoteMember2023-12-31 0001624326pavm:LucidMarch2023SeniorConvertibleNoteMember2023-12-31 0001624326pavm:BalanceSheetDebtComponentsMember2023-12-31 0001624326pavm:LucidMarch2023SeniorConvertibleNoteMember2024-01-012024-12-31 0001624326pavm:BalanceSheetDebtComponentsMember2024-01-012024-12-31 0001624326pavm:LucidMarch2023SeniorConvertibleNoteMember2024-12-31 0001624326pavm:SecuritiesPurchaseAgreementDebtInitialMember2022-03-31 0001624326pavm:September2022SeniorConvertibleNoteMember2025-01-17 0001624326pavm:SeniorConvertibleNotesMember2022-03-31 0001624326pavm:SeniorConvertibleNotesMember2024-01-012024-12-31 0001624326pavm:ConversionOfSeniorConvertibleNotesIntoCommonStockMember2025-01-012025-12-31 0001624326pavm:ConversionOfSeniorConvertibleNotesIntoCommonStockMember2025-12-31 0001624326pavm:ConversionOfSeniorConvertibleNotesIntoCommonStockMember2024-12-31 0001624326us-gaap:SeriesCPreferredStockMemberus-gaap:SubsequentEventMember2026-01-012026-02-03 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:SubsequentEventMember2026-01-012026-02-03 0001624326pavm:The2026NoteMembersrt:ScenarioForecastMember2026-07-01 0001624326pavm:The2026NoteMemberus-gaap:SubsequentEventMember2026-02-032026-02-03 0001624326pavm:The2026NoteMembersrt:ScenarioForecastMember2026-07-012026-07-01 0001624326pavm:The2026NoteMembersrt:MaximumMemberus-gaap:SubsequentEventMember2026-02-03 0001624326pavm:ConversionOfSeniorConvertiblesNotesIntoSeriesCPreferredStockMember2024-11-152024-11-15 0001624326us-gaap:SeriesCPreferredStockMember2024-11-15 0001624326pavm:ConversionOfSeniorConvertiblesNotesIntoSeriesCPreferredStockMember2024-11-202024-11-20 0001624326pavm:ConversionOfSeniorConvertiblesNotesIntoSeriesCPreferredStockMember2024-11-20 0001624326pavm:September2022SeniorConvertibleNoteMember2025-01-172025-01-17 0001624326pavm:LucidDiagnosticsMemberpavm:ConversionOfLucidMarch2023SeniorConvertibleNoteIntoCommonStockMember2024-01-012024-09-10 0001624326pavm:ThePavmed2014EquityPlanMember2025-12-31 0001624326pavm:StockOptionsAndRestrictedStockAwardsMemberpavm:OutsideOfThePavmed2014EquityPlanMember2025-12-31 0001624326pavm:ThePavmed2014EquityPlanMemberus-gaap:SubsequentEventMember2026-01-012026-01-31 0001624326pavm:ThePavmed2014EquityPlanMemberus-gaap:SubsequentEventMember2026-03-272026-03-27 00016243262023-01-012023-12-31 0001624326us-gaap:EmployeeStockOptionMemberpavm:ThePavmed2014EquityPlanMemberus-gaap:ShareBasedCompensationAwardTrancheOneMember2025-01-012025-12-31 0001624326us-gaap:EmployeeStockOptionMemberpavm:ThePavmed2014EquityPlanMemberus-gaap:ShareBasedCompensationAwardTrancheTwoMember2025-01-012025-12-31 0001624326us-gaap:EmployeeStockOptionMemberpavm:ThePavmed2014EquityPlanMember2025-01-012025-12-31 0001624326pavm:OutsideOfThePavmed2014EquityPlanMember2025-12-31 0001624326pavm:OutsideOfThePavmed2014EquityPlanMember2024-12-31 0001624326us-gaap:ShareBasedPaymentArrangementEmployeeMemberpavm:ThePavmed2014EquityPlanMember2025-01-012025-01-31 0001624326us-gaap:ShareBasedPaymentArrangementEmployeeMemberpavm:ThePavmed2014EquityPlanMembersrt:MinimumMember2025-01-012025-01-31 0001624326pavm:ThePavmed2014EquityPlanMemberus-gaap:SubsequentEventMember2026-02-202026-02-20 0001624326us-gaap:EmployeeStockOptionMemberpavm:ThePavmed2014EquityPlanMemberus-gaap:SubsequentEventMemberus-gaap:ShareBasedCompensationAwardTrancheOneMember2026-02-202026-02-20 0001624326us-gaap:EmployeeStockOptionMemberpavm:ThePavmed2014EquityPlanMemberus-gaap:SubsequentEventMemberus-gaap:ShareBasedCompensationAwardTrancheTwoMember2026-02-202026-02-20 0001624326us-gaap:RestrictedStockMember2023-12-31 0001624326us-gaap:RestrictedStockMember2024-01-012024-12-31 0001624326us-gaap:RestrictedStockMember2024-12-31 0001624326us-gaap:RestrictedStockMember2025-01-012025-12-31 0001624326us-gaap:RestrictedStockMember2025-12-31 0001624326us-gaap:RestrictedStockMemberpavm:ThePavmed2014EquityPlanMemberpavm:DirectorsAndCertainOfficersMember2025-09-302025-09-30 0001624326us-gaap:RestrictedStockMemberpavm:ThePavmed2014EquityPlanMemberus-gaap:SubsequentEventMember2026-02-202026-02-20 0001624326pavm:LucidDiagnosticsMember2023-12-31 0001624326pavm:LucidDiagnosticsMember2023-01-012023-12-31 0001624326us-gaap:EmployeeStockOptionMemberpavm:LucidDiagnosticsMemberpavm:LucidDiagnostics2018EquityPlanMemberus-gaap:ShareBasedCompensationAwardTrancheOneMember2025-01-012025-12-31 0001624326us-gaap:EmployeeStockOptionMemberpavm:LucidDiagnosticsMemberpavm:LucidDiagnostics2018EquityPlanMemberus-gaap:ShareBasedCompensationAwardTrancheTwoMember2025-01-012025-12-31 0001624326us-gaap:EmployeeStockOptionMemberpavm:LucidDiagnosticsMemberpavm:LucidDiagnostics2018EquityPlanMember2025-01-012025-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:OutsideOfLucidDiagnostics2018EquityPlanMember2024-09-10 0001624326pavm:LucidDiagnosticsMemberpavm:OutsideOfLucidDiagnostics2018EquityPlanMember2023-12-31 0001624326us-gaap:RestrictedStockMemberpavm:LucidDiagnosticsMember2023-12-31 0001624326us-gaap:RestrictedStockMemberpavm:LucidDiagnosticsMember2024-01-012024-09-10 0001624326us-gaap:RestrictedStockMemberpavm:LucidDiagnosticsMember2024-09-10 0001624326us-gaap:RestrictedStockMemberpavm:LucidDiagnosticsMemberpavm:LucidDiagnostics2018EquityPlanMembersrt:ManagementMember2024-05-012024-05-30 0001624326us-gaap:CostOfSalesMember2025-01-012025-12-31 0001624326us-gaap:CostOfSalesMember2024-01-012024-12-31 0001624326us-gaap:SellingAndMarketingExpenseMember2025-01-012025-12-31 0001624326us-gaap:SellingAndMarketingExpenseMember2024-01-012024-12-31 0001624326us-gaap:GeneralAndAdministrativeExpenseMember2025-01-012025-12-31 0001624326us-gaap:GeneralAndAdministrativeExpenseMember2024-01-012024-12-31 0001624326us-gaap:ResearchAndDevelopmentExpenseMember2025-01-012025-12-31 0001624326us-gaap:ResearchAndDevelopmentExpenseMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberus-gaap:CostOfSalesMemberpavm:LucidDiagnostics2018EquityPlanMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberus-gaap:SellingAndMarketingExpenseMemberpavm:LucidDiagnostics2018EquityPlanMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberus-gaap:GeneralAndAdministrativeExpenseMemberpavm:LucidDiagnostics2018EquityPlanMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberus-gaap:ResearchAndDevelopmentExpenseMemberpavm:LucidDiagnostics2018EquityPlanMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberus-gaap:CostOfSalesMemberpavm:ThePavmed2014EquityPlanMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberus-gaap:SellingAndMarketingExpenseMemberpavm:ThePavmed2014EquityPlanMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberus-gaap:GeneralAndAdministrativeExpenseMemberpavm:ThePavmed2014EquityPlanMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberus-gaap:ResearchAndDevelopmentExpenseMemberpavm:ThePavmed2014EquityPlanMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMember2024-01-012024-12-31 0001624326us-gaap:EmployeeStockOptionMemberpavm:ThePavmed2014EquityPlanMember2025-12-31 0001624326us-gaap:RestrictedStockMemberpavm:ThePavmed2014EquityPlanMember2025-12-31 0001624326us-gaap:RestrictedStockMemberpavm:ThePavmed2014EquityPlanMember2025-01-012025-12-31 0001624326pavm:ThePavmed2014EquityPlanMember2025-01-012025-12-31 0001624326pavm:ThePavmed2014EquityPlanMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:LucidDiagnostics2018EquityPlanMember2024-01-012024-12-31 0001624326pavm:PavmedEsppMember2024-04-012025-12-31 0001624326pavm:PavmedEsppMember2024-03-312024-03-31 0001624326pavm:PavmedEsppMember2025-12-31 0001624326pavm:PavmedEsppMemberus-gaap:SubsequentEventMember2026-01-012026-01-31 0001624326pavm:LucidDiagnosticsMemberpavm:LucidEsppMember2024-03-312024-03-31 0001624326us-gaap:SeriesBPreferredStockMemberus-gaap:SubsequentEventMember2026-01-012026-01-31 0001624326us-gaap:SeriesCPreferredStockMember2025-01-17 0001624326srt:MaximumMemberus-gaap:SeriesCPreferredStockMember2025-01-012025-12-31 0001624326us-gaap:SeriesCPreferredStockMember2025-11-30 0001624326us-gaap:SeriesCPreferredStockMember2025-01-31 0001624326us-gaap:SeriesCPreferredStockMember2025-06-16 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:SeriesCPreferredStockMember2025-06-162025-06-16 0001624326pavm:VerisHealthMember2025-06-232025-06-23 0001624326pavm:September2022SeniorConvertibleNoteMemberpavm:VerisHealthMemberus-gaap:SeriesCPreferredStockMember2025-06-232025-06-23 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:SeriesCPreferredStockMember2025-06-232025-06-23 0001624326us-gaap:MeasurementInputConversionPriceMemberus-gaap:SeriesCPreferredStockMember2025-01-012025-12-31 0001624326pavm:MeasurementInputRequiredRateOfReturnMemberus-gaap:SeriesCPreferredStockMember2025-01-012025-12-31 0001624326us-gaap:MeasurementInputExpectedDividendRateMemberus-gaap:SeriesCPreferredStockMember2025-01-012025-12-31 0001624326us-gaap:MeasurementInputPriceVolatilityMemberus-gaap:SeriesCPreferredStockMember2025-01-012025-12-31 0001624326us-gaap:MeasurementInputRiskFreeInterestRateMembersrt:MinimumMemberus-gaap:SeriesCPreferredStockMember2025-01-012025-12-31 0001624326us-gaap:MeasurementInputRiskFreeInterestRateMembersrt:MaximumMemberus-gaap:SeriesCPreferredStockMember2025-01-012025-12-31 0001624326pavm:ConversionOfSeriesCPreferredStockMember2025-01-012025-12-31 0001624326pavm:ConversionOfSeriesCPreferredStockMemberus-gaap:SubsequentEventMember2026-01-012026-02-28 0001624326us-gaap:SeriesCPreferredStockMemberus-gaap:SubsequentEventMember2026-01-012026-02-28 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:SubsequentEventMember2026-02-28 0001624326pavm:September2022SeniorConvertibleNoteMemberus-gaap:SubsequentEventMember2026-01-012026-02-28 0001624326pavm:The2026NoteMemberus-gaap:SubsequentEventMember2026-02-28 0001624326us-gaap:SeriesDPreferredStockMemberus-gaap:SubsequentEventMember2026-02-032026-02-03 0001624326us-gaap:SeriesDPreferredStockMemberus-gaap:SubsequentEventMember2026-02-03 0001624326pavm:SeriesDPreferredStockWarrantMemberus-gaap:SubsequentEventMember2026-02-03 0001624326us-gaap:SeriesDPreferredStockMemberus-gaap:SubsequentEventMemberpavm:EachIndividualInvestorMember2026-02-032026-02-03 0001624326us-gaap:SeriesDPreferredStockMemberus-gaap:SubsequentEventMemberpavm:EachIndividualInvestorMember2026-02-03 0001624326pavm:ConversionOfSeriesDPreferredStockIntoCommonStockMemberus-gaap:SubsequentEventMember2026-03-272026-03-27 0001624326pavm:SeriesDPreferredStockWarrantMemberus-gaap:SubsequentEventMember2026-03-27 0001624326pavm:ReverseStockSplitMembersrt:MaximumMember2023-03-312023-03-31 0001624326pavm:ConversionOfSeptember2022SeniorConvertibleNoteMember2025-01-012025-12-31 0001624326pavm:VendorsMember2025-01-012025-12-31 0001624326pavm:SubscriptionAgreementMember2025-02-212025-02-21 0001624326pavm:SubscriptionAgreementPrefundedWarrantsMember2025-02-21 0001624326pavm:SubscriptionAgreementPrefundedWarrantsMember2025-02-212025-02-21 0001624326pavm:SubscriptionAgreementPrefundedWarrantsMemberpavm:VerisHealthMember2025-02-21 0001624326pavm:SeriesZWarrantsMember2024-12-31 0001624326pavm:SeriesZWarrantsMember2025-01-012025-12-31 0001624326pavm:VerisHealthMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:VerisHealthMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:SeriesAAndSeriesA1PreferredStockMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:SeriesAAndSeriesA1PreferredStockMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:ConversionOfSeriesAAndSeriesA1PreferredStockIntoCommonStockMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:ConversionOfSeriesAAndSeriesA1PreferredStockIntoCommonStockMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:ConversionOfSeriesBAndSeriesB1IntoCommonStockMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:ConversionOfSeriesBAndSeriesB1IntoCommonStockMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:SeriesBAndSeriesB1PreferredStockMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:SeriesBAndSeriesB1PreferredStockMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:ConversionOfSeriesAAndSeriesA1IntoSeriesBPreferredStockMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:ConversionOfSeriesAAndSeriesA1IntoSeriesBPreferredStockMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:LucidDiagnosticsMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:LucidDiagnostics2018EquityPlanMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:LucidDiagnostics2018EquityPlanMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:ConversionOfSeniorSecuredConvertibleNoteMemberus-gaap:NoncontrollingInterestMember2025-01-012025-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:ConversionOfSeniorSecuredConvertibleNoteMemberus-gaap:NoncontrollingInterestMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMember2024-01-262024-01-26 0001624326pavm:LucidDiagnosticsMember2024-02-152024-02-15 0001624326pavm:LucidDiagnosticsMemberpavm:ConversionOfSeriesBAndSeriesB1IntoCommonStockMember2024-01-012024-12-31 0001624326pavm:LucidDiagnosticsMemberpavm:ConversionOfSeriesAAndSeriesA1PreferredStockIntoCommonStockMember2024-01-012024-12-31 0001624326pavm:VerisHealthMember2025-12-31 0001624326pavm:VerisHealthMember2025-12-31 0001624326pavm:OwedToPavmedMemberpavm:VerisHealthMember2025-12-31 0001624326pavm:OwedToPavmedMemberpavm:VerisHealthMember2025-01-012025-12-31 0001624326pavm:VerisHealthMembersrt:MaximumMember2025-12-31 0001624326pavm:VerisHealthMemberpavm:VerisJune2025SubscriptionAgreementMember2025-06-232025-06-23 0001624326pavm:VerisHealthMemberpavm:VerisJune2025SubscriptionAgreementMember2025-06-23 0001624326pavm:VerisWarrantsMemberpavm:VerisHealthMember2025-06-23 0001624326pavm:VerisWarrantsMemberpavm:VerisHealthMember2025-06-232025-06-23 0001624326pavm:OsucccJamesMemberpavm:VerisHealthMember2025-10-07 0001624326pavm:VerisHealthMemberus-gaap:SubsequentEventMember2026-02-012026-02-28 0001624326us-gaap:NewJerseyDivisionOfTaxationMember2025-01-012025-12-31 0001624326pavm:PennsylvaniaDepartmentOfRevenueMember2025-01-012025-12-31 0001624326pavm:OtherStatesTaxAuthoritiesMember2025-01-012025-12-31 0001624326us-gaap:InternalRevenueServiceIRSMember2025-01-012025-12-31 00016243262024-09-10 0001624326us-gaap:DomesticCountryMember2025-01-012025-12-31 00016243262024-09-112024-12-31 0001624326us-gaap:DomesticCountryMember2025-12-31 0001624326us-gaap:DomesticCountryMember2024-12-31 0001624326us-gaap:StateAndLocalJurisdictionMember2025-12-31 0001624326us-gaap:EmployeeStockOptionMember2025-01-012025-12-31 0001624326us-gaap:EmployeeStockOptionMember2024-01-012024-12-31 0001624326us-gaap:RestrictedStockMember2025-01-012025-12-31 0001624326us-gaap:RestrictedStockMember2024-01-012024-12-31 0001624326pavm:SeriesZWarrantsMember2025-01-012025-12-31 0001624326pavm:SeriesZWarrantsMember2024-01-012024-12-31 0001624326pavm:SeniorConvertibleNotesMember2025-01-012025-12-31 0001624326pavm:SeniorConvertibleNotesMember2024-01-012024-12-31 0001624326pavm:SeriesBConvertibleStockMember2025-01-012025-12-31 0001624326pavm:SeriesBConvertibleStockMember2024-01-012024-12-31 0001624326pavm:SeriesCConvertibleStockMember2025-01-012025-12-31 0001624326pavm:SeriesCConvertibleStockMember2024-01-012024-12-31 0001624326pavm:OutsideOfThePavmed2014EquityPlanMember2025-01-012025-12-31 0001624326pavm:OutsideOfThePavmed2014EquityPlanMember2024-01-012024-12-31

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-K

(Mark One)

☒	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, ~~2024~~2025

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______ to ______

Commission File Number: 001-37685

PAVMED INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware		47-1214177
(State or Other Jurisdiction of		(IRS Employer
Incorporation or Organization)		Identification No.)

360 Madison Avenue
25th Floor
New York, NY		10017
(Address of Principal Executive Offices)		(Zip Code)

(917) 813-1828

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Exchange Act:

Title of each Class	Trading Symbol(s)	Name of each Exchange on which Registered
Common Stock, $0.001 par value per share	PAVM	The NASDAQ Stock Market LLC
Series Z Warrants, each to purchase 1/15th of one share of Common Stock	PAVMZ	The NASDAQ Stock Market LLC

Securities registered under Section 12(g) of the Exchange Act:

None.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of ” “large accelerated filer”, “accelerated filer” , “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large Accelerated filer	☐	Accelerated filed	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to section 13(c) of the Exchange Act ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C.7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of June 30, ~~2024~~2025, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s voting stock held by non-affiliates was approximately $711.08 million, based on 8657,~~630,652~~665 shares of common stock held by non-affiliates and a last reported sales price per share of the registrant’s common stock of $018.~~815~~00 on such date.

As of of December 31, ~~2024~~ 2025 and March 2027, ~~2025~~2026, there were 11995,~~523,408~~673 and 166,~~787~~383,~~173~~089 shares, respectively, of the registrant’s Common Stock, par value $0.001 per share, issued and outstanding (with such number of shares inclusive of shares of common stock underlying unvested restricted stock awards granted under the PAVmed Inc. 2014 Long-Term Incentive Equity Plan as of such date).

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant’s definitive proxy statement for its ~~2025~~ 2026 annual meeting of stockholders are incorporated by reference into Part III of this Form 10-K where indicated. Such definitive proxy statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the year ended December 31, ~~2024~~2025.

TABLE OF CONTENTS

PART I	~~PART I~~
Item 1.	Business	1
Item 1A	Risk Factors	2022
Item 1B.	Unresolved Staff Comments	3948
Item 1C.	Cybersecurity	4048
Item 2.	Property	4049
Item 3.	Legal Proceedings	4049
Item 4.	Mine Safety Disclosures	4049
PART II	~~PART II~~
Item 5.	Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	4150
Item 6.	[Reserved]	4251
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	4252
Item 7A.	Quantitative and Qualitative Disclosure About Market Risk	5565
Item 8.	Financial Statements and Supplementary Data	5566
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	5566
Item 9A.	Controls and Procedures	5566
Item 9B.	Other Information	5567
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	5567
PART III	~~PART III~~
Item 10.	Directors, Executive Officers, and Corporate Governance	5668
Item 11.	Executive Compensation	5668
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	5668
Item 13.	Certain Relationships and Related Transactions and Director Independence	5668
Item 14.	Principal Accountant Fees and Services	5668
PART IV	~~PART IV~~
Item 15.	Exhibits and Financial Statement Schedules	5769
Item 16.	Form 10-K Summary	5870

FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K (this “Form 10-K”), including the discussion and analysis of our consolidated financial condition and results of operations set forth under Item 7 of this Form 10-K, contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Form 10-K, including statements regarding our future results of operations and financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ significantly from those expressed or implied in the forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”

Important factors that may affect our actual results include:

● our limited operating history; ● our financial performance, including our ability to generate revenue; ● our ability to obtain regulatory approval for the commercialization of our products; ● the risk that the FDA will cease to exercise enforcement discretion with respect to LDTs, like EsoGuard; ● the ability of our products to achieve market acceptance; ● our success in retaining or recruiting, or changes required in, our officers, key employees or directors; ● our potential ability to obtain additional financing when and if needed; ● our ability to protect our intellectual property; ● our ability to complete strategic acquisitions; ● our ability to manage growth and integrate acquired operations; ● the potential liquidity and trading of our securities; ● our regulatory and operational risks; ● cybersecurity risks; ● risks related to ~~the COVID-19 pandemic and other~~ health-related emergencies; and ● our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

In addition, our forward-looking statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions, joint ventures or investments we may make.

We may not actually achieve the results, plans, and/or objectives disclosed in our forward-looking statements, and the intended or expected developments and/or other events disclosed in our forward-looking statements may not actually occur, and accordingly you should not place undue reliance on our forward-looking statements. You should read this Annual Report on Form 10-K and the documents we have filed as exhibits to this Form 10-K completely and with the understanding our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Part I

Item 1. Business

Unless the context otherwise requires, “we”, “us”, and “our”, the “Company” and “PAVmed” refer to PAVmed Inc. and its subsidiaries, including its subsidiary Lucid Diagnostics Inc. (Nasdaq:LUCD) (“Lucid Diagnostics” or “Lucid”) and its majority-owned subsidiary Veris Health Inc. (“Veris Health” or “Veris”).

Background and Overview

PAVmed is ~~structured to be~~ a ~~multi~~diversified commercial-~~product~~stage life sciences company ~~organized~~operating toin ~~advance~~the amedical ~~pipeline~~device, ofdiagnostics, ~~innovative~~and ~~healthcare~~digital ~~technologies~~health sectors. ~~Led by~~It aoperates ~~team~~through ofmultiple ~~highly~~independently ~~skilled~~financed ~~personnel~~subsidiaries ~~with~~under a ~~track~~shared ~~record~~services ofmodel. The ~~bringing~~Company’s ~~innovative~~strategy ~~products~~is to ~~market,~~advance ~~PAVmed is focused on innovating, developing, acquiring,~~ and ~~commercializing~~commercialize ~~novel~~innovative ~~products~~healthcare ~~that~~technologies ~~target~~through ~~unmet~~its ~~medical needs with large addressable market opportunities. Leveraging our corporate structure—a parent company that will establish distinct~~ subsidiaries ~~for~~while ~~each~~maintaining ~~financed asset—we have the~~ flexibility to ~~raise~~structure ~~capital~~financing at either the PAVmed level ~~to fund product development,~~ or towithin ~~structure~~its ~~financing directly into each subsidiary in a manner tailored to the applicable product~~subsidiaries.

~~Our current~~The ~~focus~~Company’s issubsidiaries ~~multi-fold.~~include WeLucid ~~continue~~Diagnostics, toa ~~support~~commercial-stage ~~the~~cancer ~~commercial~~prevention ~~expansion~~medical ~~and~~diagnostics ~~execution~~company ofthat markets the EsoGuard,® ~~which~~Esophageal isDNA ~~the~~Test ~~flagship product~~and ofEsoCheck® ~~our~~Esophageal ~~subsidiary~~Cell ~~Lucid~~Collection ~~Diagnostics~~Device, of which ~~we remain~~ the ~~shareholder~~Company ~~with~~is the largest voting ~~interest.~~stockholder, Inand ~~addition~~Veris Health, ~~through~~ a ~~separate~~ majority-owned ~~subsidiary,~~digital ~~Veris~~health ~~Health,~~company ~~we offer the Veris Cancer Care Platform. We are~~ focused ~~in the immediate term~~ on ~~entering~~improving ~~into~~personalized ~~strategic~~cancer ~~partnership~~care ~~opportunities~~during ~~with~~treatment ~~leading~~and ~~academic~~throughout ~~oncology~~survivorship ~~systems~~through todigital ~~expand~~health ~~access~~tools toand the ~~Veris Cancer~~development ~~Care~~of ~~Platform, while concurrently developing~~ an implantable physiological monitor, designed to ~~be implanted alongside a chemotherapy port, which will~~ interface with the Veris Cancer Care Platform. In terms of other existing products and technologies, we have adopted an incubator-type platform where we are looking to obtain financing on a product-by-product basis as necessary to advance each asset to a meaningful inflection point along its path to commercialization. Finally, as resources permit, we will continue to explore external innovations that fulfill our project selection criteria without limiting ourselves to any target sector, specialty or condition.

PAVmed continues to support the commercial expansion of EsoGuard through Lucid Diagnostics and to pursue strategic partnerships to expand adoption of the Veris Cancer Care Platform. In addition, PAVmed is developing a medical device portfolio, including its PortIO implantable intraosseous vascular access device and recently licensed endoscopic imaging technology from Duke University. The Company continues to evaluate opportunities to expand its portfolio through internal development and external licensing.

~~We believe that~~ Lucid’s flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread testing tool with the goal of preventing esophageal adenocarcinoma (“EAC”) deaths, through early detection of esophageal precancer in at-risk gastroesophageal reflux disease (“GERD,” also commonly known as chronic heartburn, acid reflux or simply reflux) patients.Diagnostics

~~EsoGuard is~~Overview a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient multicenter case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and all conditions along the BE-EAC spectrum, including on samples collected with EsoCheck (Moinova, et al. Sci Transl Med. 2018 Jan 17;10(424): eaao5848). EsoGuard is commercially available in the U.S. as a Laboratory Developed Test (LDT) performed at our CLIA-certified laboratory. Cell samples, including those collected with EsoCheck, as discussed below, are sent to our laboratory for testing and analyses using our proprietary EsoGuard NGS DNA assay.

~~EsoCheck is~~Lucid anDiagnostics ~~FDA~~is ~~510(k)~~a ~~and~~commercial-stage CEcancer ~~Mark~~prevention ~~cleared~~medical ~~noninvasive~~diagnostics ~~swallowable~~technology ~~balloon~~company ~~capsule~~focused ~~catheter~~on ~~device~~patients ~~capable~~with ofgastroesophageal ~~sampling~~reflux ~~surface~~disease ~~esophageal~~(“GERD”), ~~cells in~~who aare ~~less~~at ~~than~~risk ~~five-minute office procedure. It consists~~ of adeveloping ~~vitamin~~esophageal ~~pill-sized~~precancer ~~rigid~~and ~~plastic~~cancer, ~~capsule~~including ~~tethered~~esophageal toadenocarcinoma a(“EAC”). We ~~thin~~believe ~~silicone~~that ~~catheter from~~Lucid's ~~which~~flagship aproduct, ~~soft~~the ~~silicone~~EsoGuard ~~balloon~~Esophageal ~~with~~DNA ~~textured~~Test, ~~ridges~~performed ~~emerges~~on tosamples ~~gently~~collected ~~swab~~with ~~surface~~the ~~esophageal~~EsoCheck ~~cells.~~Esophageal ~~When~~Cell ~~vacuum~~Collection ~~suction~~Device, isconstitutes ~~applied,~~ the ~~balloon~~first and ~~sampled~~only ~~cells~~commercially ~~are~~available ~~pulled~~diagnostic ~~into~~test ~~the~~capable ~~capsule,~~of ~~protecting~~serving ~~them~~as ~~from~~a ~~contamination~~widespread ~~and~~testing ~~dilution~~tool bywith ~~cells~~the ~~outside~~goal of ~~the~~preventing ~~targeted region~~EAC ~~during~~deaths, ~~device~~through ~~withdrawal.~~early Wedetection ~~believe~~of ~~this proprietary Collect+Protect™ technology makes EsoCheck the only noninvasive~~ esophageal ~~cell~~ ~~collection~~precancer ~~device~~in ~~capable~~at-risk ofGERD ~~such anatomically targeted and protected sampling~~patients.

EsoGuard ~~and~~ ~~EsoCheck~~is ~~are~~a ~~based~~bisulfite-converted targeted next-generation sequencing (NGS) DNA assay performed on ~~patented~~esophageal ~~technology~~cells ~~licensed~~collected bywith ~~Lucid~~the ~~from~~EsoCheck ~~Case~~device. ~~Western~~It ~~Reserve~~measures ~~University~~methylation ~~(“CWRU”)~~at sites on the VIM and CCNA1 genes. In clinical studies, EsoGuard demonstrated high sensitivity and ~~EsoCheck~~ ~~have~~specificity, ~~been~~with ~~developed~~a tonegative ~~provide~~predictive ~~accurate,~~value ~~non-invasive,~~of ~~patient-friendly~~approximately ~~testing~~99% for the ~~early~~ detection of ~~EAC and~~ Barrett’s ~~Esophagus~~ esophagus (“BE”), ~~including dysplastic BE~~ and ~~related pre-cursors to~~ EAC in ~~patients~~screening ~~with chronic GERD~~populations.

~~Market Opportunity~~EsoCheck is an FDA 510(k)-cleared and CE Mark certified noninvasive, swallowable balloon capsule catheter designed for in-office collection of esophageal cell samples in a brief procedure. The device enables targeted sampling of esophageal cells while minimizing contamination during retrieval.

~~In 2024,~~EsoGuard ~~approximately~~and ~~22,000~~EsoCheck ~~U.S. GERD patients~~ are ~~projected~~based toon bepatented ~~diagnosed~~technology ~~with~~licensed ~~EAC and approximately 16,000 will die~~ from ~~it.~~Case ~~Over 80%~~Western ofReserve ~~EAC~~University ~~patients~~and ~~will~~are ~~die~~intended ~~within~~to ~~five~~provide ~~years~~accurate, ~~of diagnosis~~non-invasive, ~~making~~patient-friendly ittesting ~~the~~for ~~second most lethal cancer in~~ the ~~U.S.~~early ~~The~~detection ~~U.S. incidence~~ of ~~EAC~~ ~~has~~BE ~~increased~~and ~~500% over the past four decades~~EAC, ~~while~~including ~~the~~dysplastic ~~incidences~~BE ofand ~~other~~related ~~common~~precursors ~~cancers~~to ~~have declined or remained flat. In nearly all cases,~~ EAC ~~silently~~in ~~progresses~~patients ~~until it manifests itself~~ with ~~new~~chronic ~~symptoms of advanced disease~~GERD. ~~EAC is nearly always invasive at diagnosis, and, unlike other common cancers, mortality rates are high even in its earlier stages.~~

As discussed below under the heading “Clinical Guidelines for At-Risk Population”, in July 2022, the American Gastroenterology Association (“AGA”) significantly expanded the target population for esophageal precancer screening, recommending screening in at-risk patients without symptoms of GERD. Based on this revision, we believe the cohort recommended for screening consists of an estimated 30 million U.S. individuals with at least 3 established risk factors for BE. Accordingly, we believe EsoGuard’s total addressable U.S. market opportunity approximates $60 billion based on an effective Medicare payment of $1,938 and the estimated 30 million U.S. patients recommended for screening by clinical practice guidelines. (In December 2019, Lucid secured “gapfill” determination for EsoGuard’s PLA code 0114U through the CMS CLFS process. This allowed Lucid to engage directly with Medicare contractor Palmetto GBA and its MolDx Program on CMS payment and coverage. As discussed below under the heading “Reimbursement and Market Access”, in October 2020, CMS granted EsoGuard final Medicare payment determination of $1,938.01, effective January 1, 2021.)

1Market Opportunity

~~Unfortunately~~In 2025, ~~for~~ aapproximately ~~variety of reasons~~22,000 ~~less~~U.S. ~~than~~GERD ~~10%~~patients ofwere ~~at-risk~~diagnosed ~~patients~~with ~~who~~EAC ~~are~~and ~~recommended~~approximately ~~for~~16,250 ~~screening~~died ~~undergo~~from ~~traditional~~the ~~invasive~~disease. ~~upper~~Over ~~gastrointestinal endoscopy~~80% ~~(EGD).~~of WeEAC ~~believe~~patients ~~that~~will ~~the~~die ~~profound~~within ~~tragedy~~five years of andiagnosis, ~~EAC~~making ~~diagnosis~~it isthe ~~that~~second ~~likely~~most ~~death~~lethal ~~could~~cancer ~~have~~in ~~been~~the ~~prevented~~U.S. ifThe ~~the~~U.S. ~~at-risk patient~~incidence ~~had~~of ~~been~~EAC ~~screened~~has ~~and~~increased ~~then~~500% ~~undergone~~over ~~surveillance~~the ~~and~~past ~~curative~~four ~~endoscopic~~decades, ~~esophageal~~while ~~ablation~~the incidences of ~~dysplastic~~other BEcommon cancers have declined or remained flat.

~~Since mortality~~Based ~~rates~~on ~~are~~current ~~high~~guidelines ~~even~~published inby ~~early~~the ~~stage~~American ~~EAC,~~Gastroenterology ~~preventing~~Association ~~EAC~~(“AGA”), ~~deaths~~we ~~requires~~believe ~~detection~~the ~~and~~cohort ~~intervention~~recommended atfor ~~the~~screening ~~precancer~~consists ~~stage. Most~~ of ~~the~~an ~~necessary~~estimated ~~elements~~30 ~~for~~million ~~such~~U.S. anindividuals ~~early~~with ~~detection~~at ~~program~~least ~~are~~3 ~~already well~~ established~~—an~~ ~~at-~~risk ~~population~~factors ~~(at-risk~~for ~~GERD patients)~~BE. Accordingly, awe ~~precancer~~believe ~~(BE),~~EsoGuard’s ~~and~~total anaddressable ~~intervention~~U.S. ~~which~~market ~~can~~opportunity ~~halt~~approximates ~~progression~~$60 tobillion ~~EAC~~based ~~(endoscopic~~on ~~esophageal~~an ~~ablation).~~effective ~~Until~~Medicare ~~recently, the~~payment ~~only~~of ~~missing~~$1,938 ~~element~~and ~~for~~the ~~such~~estimated an30 ~~early~~million ~~detection~~U.S. ~~program~~patients isrecommended afor ~~widespread~~ screening ~~tool~~by ~~that~~clinical ~~can~~practice ~~detect BE prior to EAC~~guidelines.

~~We believe EsoGuard~~Unfortunately, ~~used~~for ~~with~~a ~~EsoCheck~~variety of reasons, ~~constitutes~~less ~~that~~than ~~missing~~5% ~~element—the~~of ~~first~~at-risk ~~and~~patients ~~only~~who ~~commercially~~are ~~available~~recommended ~~diagnostic~~for ~~test capable~~screening ofundergo ~~serving~~traditional asinvasive aupper ~~widespread~~gastrointestinal ~~testing~~endoscopy ~~tool~~("EGD"). ~~with~~We believe that the ~~goal~~profound tragedy of ~~preventing~~an EAC ~~deaths~~diagnosis ~~through~~is ~~early~~that ~~detection~~likely ofdeath ~~esophageal~~could ~~precancer~~ have been prevented if the at-risk patient had been screened and ~~cancer~~then inundergone ~~patients~~surveillance ~~with~~and 3curative orendoscopic ~~more~~esophageal ~~risk~~ablation ~~factors~~of dysplastic BE.

~~Clinical Guidelines~~Since mortality rates are high even in early stage EAC, preventing EAC deaths requires detection and intervention at the precancer stage. Most of the necessary elements for Atsuch an early detection program are already well established—an at-~~Risk~~risk ~~Population~~population (at-risk GERD patients), a precancer (BE), and an intervention which can halt progression to EAC (endoscopic esophageal ablation). Until recently, the only missing element for such an early detection program is a widespread screening tool that can detect BE prior to EAC.

~~The subgroup~~We ofbelieve ~~long-standing~~EsoGuard, orused ~~severe~~with ~~GERD~~EsoCheck, ~~patients~~constitutes ~~at-risk~~that ~~for~~missing BEelement—the first and ~~progression~~only tocommercially ~~EAC~~available isdiagnostic ~~well~~test ~~defined~~capable inof ~~clinical~~serving ~~practice~~as ~~guidelines, including~~a ~~the~~widespread ~~American~~testing ~~College~~tool ofwith ~~Gastroenterology~~the ~~(“ACG”)~~goal BEof ~~Guidelines.~~preventing InEAC ~~its~~deaths ~~Recommendation~~through 5,early ~~the~~detection ~~ACG~~of ~~suggests~~esophageal aprecancer ~~single screening~~and ~~endoscopy~~cancer in patients with ~~chronic GERD symptoms and~~ 3 or more ~~additional~~ risk factors ~~for BE, including male sex, age greater than 50 years, White race, tobacco smoking, obesity, and family history of BE or EAC in a first-degree relative~~.

An ACG clinical guideline entitled “Diagnosis and Management of Barrett’s Esophagus: An Updated ACG Guideline,” the first such update since 2016, was published online in April 2022 in the American Journal of Gastroenterology. The clinical guideline reiterates the ACG’s long-standing recommendation for esophageal precancer screening in at-risk patients with GERD. For the first time, however, the clinical guideline also endorses non-endoscopic biomarker screening as an acceptable alternative to costly and invasive endoscopy stating that “a swallowable non-endoscopic capsule device combined with a biomarker is an acceptable alternative to endoscopy for BE.” The clinical guideline specifically mentions EsoCheck, as such swallowable, non-endoscopic esophageal cell collection devices, as well as methylated DNA biomarkers such as EsoGuard. The summary of evidence for this recommendation includes a reference to the seminal NIH-funded, multicenter, case-control study published in 2018 in Science Translational Medicine, which demonstrated that EsoGuard is highly accurate at detecting esophageal precancer and cancer, including on samples collected with EsoCheck.2

~~In July~~Commercialization 2022, the AGA published in their “Clinical Practice Update on New Technology and Innovation for Surveillance and Screening in Barrett’s Esophagus” updated clinical guidance that mirrors the same furnished by the ACG as described above, endorsing the use of non-endoscopic cell collection tools to screen for BE like our EsoCheck Cell Collection Device, which is cited in the update, as an acceptable alternative to endoscopy to directly address the need for noninvasive screening tools that are easy to administer, patient friendly, and cost-effective for the detection of BE. The clinical practice update by the AGA also significantly expands the target population for esophageal precancer screening, including for EsoGuard and EsoCheck, by recommending, for the first time, screening in at-risk patients without symptoms of GERD. The AGA does so by adding a history of chronic GERD as merely an additional, seventh risk factor to the six risk factors for BE and EAC that have traditionally identified at-risk symptomatic patients recommended for screening.

InOur ~~March~~EsoGuard ~~2025~~commercialization efforts span multiple channels including targeting primary care and GI physicians, ~~Lucid~~who ~~announced~~have generally embraced our message that aEsoGuard ~~recent~~has ~~update~~the potential to expand the ~~National~~funnel ~~Comprehensive~~of ~~Cancer~~BE-EAC ~~Network®~~patients ~~(NCCN)~~who ~~Clinical Practice~~will ~~Guidelines~~need inlong ~~Oncology~~term ~~(NCCN~~EGD ~~Guidelines®)~~surveillance ~~focused~~and, onpotentially, ~~Esophageal~~treatment with endoscopic esophageal ablation. We also provide patient access through a limited network of our own physical Lucid Test Centers in key metropolitan areas, and ~~Esophagogastric~~a ~~Junction~~satellite ~~Cancers~~test ~~(Version~~center 1program, whereby we are making our personnel available to perform cell collection services inside physician offices or in certain geographies.~~2025)~~ We ~~has added~~also aregularly ~~new~~conduct ~~section~~testing onevents, BEwhich ~~screening~~brings our precancer testing directly to patients. ~~The~~We ~~NCCN~~also ~~Guidelines®~~have ~~now~~a ~~reference~~direct ~~professional~~contracting ~~society~~strategic ~~guidelines~~initiative onto BEengage ~~screening~~directly with large Administrative Services Only (“ASO”) self-insured employers, ~~including~~ unions and other entities, seeking to replicate the ~~most~~successes ~~recent~~of ~~ACG~~other ~~clinical~~cancer ~~guideline~~screening ~~discussed~~diagnostic ~~above,~~companies ~~which~~that ~~recommends~~have ~~non~~deployed similar strategies. Other commercial channels include our cash-~~endoscopic~~pay ~~biomarker~~program targeting concierge medicine, arrangements with health systems for comprehensive, integrated esophageal precancer testing programs, ~~such~~and asan EsoGuard ~~performed on~~Telemedicine ~~samples~~Program, ~~collected~~in partnership with ~~EsoCheck~~UpScript, asLLC, an ~~acceptable~~independent ~~alternative~~third-party totelemedicine ~~invasive~~provider, ~~upper~~that ~~endoscopy~~accommodates toEsoGuard ~~detect~~self-referrals ~~esophageal~~from ~~precancer~~direct-to-consumer marketing.

~~Commercialization~~Reimbursement and Market Access

~~Lucid’s EsoGuard~~A ~~commercialization~~final ~~efforts~~Local ~~span~~Coverage ~~multiple~~Determination ~~channels~~(“LCD”) ~~including~~L39256, ~~targeting~~entitled ~~primary~~“Molecular ~~care~~Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and GINeoplasia” ~~physicians~~became effective in May 2023 on the Center for Medicare and Medicaid Services (“CMS”) website by MAC Palmetto GBA. (A substantially identical LCD was published by Noridian Healthcare Solutions, ~~who~~the ~~have~~MAC ~~generally~~whose ~~embraced~~ geographic jurisdiction covers our ~~message~~CLIA laboratory in Lake Forest, CA.) The LCD outlines criteria for future coverage that ~~EsoGuard~~MolDX ~~has~~expects ~~the~~upper ~~potential~~gastrointestinal precancer and cancer molecular diagnostic tests to ~~expand~~meet. ~~the~~These ~~funnel~~criteria include active GERD with at least three risk factors, as well as evidence of ~~BE-EAC~~analytic ~~patients~~validity, ~~who~~clinical validity, and clinical utility. Although the LCD indicated that it found that no currently existing test has fulfilled all these criteria, it indicated that it will ~~need~~“monitor ~~long~~the ~~term~~evidence ~~EGD~~and ~~surveillance~~may revise this determination based on the pertinent literature and, ~~potentially~~society recommendations.” In November 2024, ~~treatment~~ ~~with~~we ~~endoscopic~~submitted ~~esophageal~~to ~~ablation~~MolDx our complete clinical evidence package in support of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard. The package was submitted as part of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard.

~~To assure~~As ~~sufficient~~part ~~testing~~of ~~capacity~~the ~~and~~LCD ~~geographic~~reconsideration ~~coverage~~process, ~~Lucid~~MolDx-participating ~~has~~Medicare ~~undertaken~~Administrative ~~multiple~~Contractors ~~ways~~convened ~~for~~a ~~patients~~Contractor toAdvisory ~~have~~Committee ~~access~~("CAC") toMeeting ~~its~~regarding ~~test. Initially,~~the ~~Lucid~~LCD ~~built~~on aSeptember ~~limited~~4, ~~network~~2025. ofAt ~~its~~the ~~own~~meeting, ~~physical~~eleven ~~Lucid~~experts, ~~Test~~including ~~Centers,~~physicians ~~staffed~~across bymultiple ~~Lucid-employed~~specialties ~~clinical~~(GI, ~~personnel~~primary care, ~~where patients~~pathology), ~~can~~major ~~undergo~~society ~~the~~guideline ~~EsoCheck~~co-authors ~~procedure~~(ACG, AGA) and ~~have~~industry ~~the~~leaders ~~sample~~(American ~~sent~~Foregut Society, American Society for ~~EsoGuard~~Gastrointestinal ~~testing~~Endoscopy), atparticipated ~~Lucid’s~~in ~~CLIA-certified~~this ~~laboratory. Our~~extensive ~~current~~discussion ~~test~~of ~~center~~the ~~network~~unmet ~~currently~~clinical ~~includes~~need ~~locations~~with inrespect ~~metropolitan~~to ~~areas~~early indetection ~~Arizona,~~of ~~California,~~esophageal ~~Colorado,~~precancer ~~Florida,~~and ~~Georgia, Idaho,~~the ~~Michigan,~~strength ~~Nevada,~~of ~~Texas~~the EsoGuard clinical validity and ~~Utah~~clinical utility data.

In ~~addition~~ toparallel with our ~~own~~request ~~test~~for ~~center~~reconsideration ~~locations~~of the LCD, ~~Lucid~~we ~~has~~are ~~broadened~~aggressively ~~patient~~pursuing ~~access~~EsoGuard tocommercial ~~its~~insurer ~~test~~coverage byand ~~establishing~~payment. aAlthough ~~satellite~~the ~~test~~claim ~~center~~adjudication ~~program~~cycle can be prolonged during the early commercialization of a new test, ~~whereby~~ itwe ishave ~~making~~received ~~its~~and ~~personnel~~are ~~available~~continuing to ~~perform~~receive ~~cell~~out-of-network ~~collection~~commercial ~~services~~insurance ~~inside~~payments ~~physician~~for ~~offices~~the orEsoGuard intest, ~~certain~~which ~~geographies~~accounts for the vast majority of our revenue to date. Through these efforts, ~~closely~~ ~~nearby~~Highmark ~~physician~~Blue ~~offices~~Cross ~~(in~~Blue ~~Florida~~Shield, ~~for~~an independent licensee of the ~~time~~Blue ~~being)~~Cross byand ~~way~~Blue Shield Association, has issued a positive coverage policy for non-invasive screening of ~~our~~esophageal ~~Lucid~~precancer ~~Mobile~~and ~~Testing~~cancer ~~Unit~~in New York state.

~~Also~~In addition, in January ~~2023~~2026, Lucid ~~completed~~announced ~~its~~that ~~first~~it ~~#CheckYourFoodTube~~has ~~Precancer~~been ~~Testing~~awarded ~~Event,~~a ~~with~~contract ~~the San Antonio Fire Department (the “SAFD”) during Firefighter Cancer Awareness Month as designated~~ by the ~~International~~U.S. ~~Association~~Department of ~~Fire~~Veterans ~~Fighters~~Affairs ~~(IAFF).~~for AEsoGuard, ~~total~~expanding ofaccess ~~391 members who were deemed~~ to ~~be at-risk for~~ esophageal precancer, ~~underwent~~testing aacross ~~brief,~~the ~~on-site,~~nation's ~~noninvasive~~largest ~~cell~~integrated ~~collection~~healthcare ~~procedure~~system, ~~performed by~~which ~~Lucid’s~~serves ~~clinical~~more ~~personnel~~than ~~using~~nine ~~EsoCheck.~~million ~~Since~~enrolled ~~then,~~veterans ~~additional~~annually. ~~testing~~The ~~events~~contract ~~have~~is ~~been~~issued ~~hosted~~under ~~with~~ the ~~SAFD,~~VA ~~and~~Federal ~~many~~Supply ~~similar events~~Schedule ~~have~~and ~~been~~includes ~~held~~pre-negotiated ~~with~~pricing ~~fire~~for ~~departments~~EsoGuard ~~throughout~~that matches the ~~country.~~established ~~These~~Medicare ~~events~~payment ~~are~~rate ~~ongoing~~determined ~~and~~by ~~are~~the anCenters ~~extension~~for ofMedicare ~~Lucid’s~~& ~~satellite test~~Medicaid ~~center~~Services ~~program~~(CMS), ~~which~~enabling ~~brings~~VA ~~Lucid’s~~hospitals ~~precancer~~and ~~testing~~healthcare ~~directly~~facilities nationwide to ~~patients—at~~access ~~their~~EsoGuard ~~physician’s~~through ~~office~~a ~~and~~single, ~~now at~~national ~~testing~~VA ~~day~~procurement ~~events~~framework.

2Additionally, the legislatures in a number of states have passed laws mandating coverage of comprehensive biomarker testing over the past several years. We are reviewing how to leverage legislation in those states to expand access to and reimbursement of EsoGuard.

In March 2023, Lucid launched a direct contracting strategic initiative to engage directly with large Administrative Services Only (“ASO”) self-insured employers, unions and other entities, seeking to replicate the successes of other cancer screening diagnostic companies that have deployed similar strategies.3

~~In January~~Clinical ~~2025,~~Utility ~~Lucid~~and ~~expanded~~Clinical onTrials its direct contracting initiative by launching a cash-pay program targeting concierge medicine, as an important component of its strategic efforts to expand its contractually-guaranteed revenue. Lucid has already contracted with several concierge medicine practices under this initiative.

~~Lucid has~~We ~~also~~continue ~~established~~to anexpand the EsoGuard ~~Telemedicine~~and ~~Program,~~EsoCheck inevidence ~~partnership~~portfolio with ~~UpScript,~~ongoing ~~LLC~~emphasis on demonstration of clinical utility to support medical policy and payer coverage. These efforts include a large, annearly ~~independent~~12,000 ~~third~~patient real-~~party~~world ~~telemedicine~~experience ~~provider, that~~of ~~accommodates~~EsoCheck and EsoGuard ~~self-referrals~~from 18 months of commercial data that is under journal review and expected to be published within the first half of the year. Additionally, data accrual from ~~direct~~the PREVENT and PREVENT-FF registries remains ongoing and has been expanded to collect additional longitudinal follow-~~consumer~~up ~~marketing~~data. Both registries capture information on the diagnostic and/or therapeutic journey of subjects following EsoGuard testing, including provider decision impact, patient compliance, and clinical outcomes data for the Lucid evidence portfolio.

~~Reimbursement and~~Regulatory ~~Market Access~~

~~As noted~~In ~~above~~June 2019, we received FDA 510(k) clearance to market EsoCheck in ~~December~~the ~~2019,~~U.S. ~~Lucid~~as ~~secured~~a ~~“gapfill”~~device ~~determination~~indicated for ~~EsoGuard’s~~use ~~PLA~~in ~~code~~the ~~0114U~~collection ~~through~~and ~~the~~retrieval ~~CMS CLFS~~of ~~process.~~surface ~~This~~cells ~~allowed~~of ~~Lucid~~the toesophagus ~~engage~~in ~~directly~~adults ~~with~~followed ~~Medicare~~by ~~contractor~~FDA ~~Palmetto~~510(k) ~~GBA~~clearance ~~and~~in ~~its~~2022, ~~MolDx~~expanding ~~Program~~the onuse ~~CMS~~of ~~payment~~EsoCheck in adults and ~~coverage~~pediatric populations in the U. S. In ~~October~~December ~~2020~~2019, ~~CMS~~our ~~granted~~CLIA-certified then-laboratory partner, completed documentation of EsoGuard ~~final~~analytical ~~Medicare~~validity ~~payment~~allowing ~~determination~~us ofto ~~$1,938.01,~~commercialize ~~effective~~it ~~January~~as 1,a ~~2021~~LDT.

~~A final~~In ~~Local~~February ~~Coverage~~2020, ~~Determination~~we ~~(“LCD”)~~received ~~L39256,~~FDA ~~entitled~~ “~~Molecular~~Breakthrough ~~Testing~~Device ~~for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia~~Designation” ~~became effective in May 2023 on the Center~~ for ~~Medicare~~EsoGuard ~~and~~as ~~Medicaid~~an ~~Services~~in-vitro diagnostic (“~~CMS~~IVD”) ~~website~~ bymedical ~~MAC Palmetto GBA~~device. ~~(A substantially identical LCD was published by Noridian Healthcare Solutions, the MAC whose geographic jurisdiction covers our CLIA laboratory in Lake Forest, CA.)~~ The ~~LCD~~FDA ~~outlines~~Breakthrough ~~criteria~~Device ~~for~~Program ~~future~~was ~~coverage~~created ~~that~~to ~~MolDX~~offer ~~expects~~patients ~~upper~~more ~~gastrointestinal precancer~~timely ~~and~~access ~~cancer molecular diagnostic tests~~ to ~~meet.~~breakthrough ~~These~~technologies ~~criteria~~which ~~include~~provide ~~active~~for ~~GERD~~more ~~with~~effective attreatment ~~least~~or ~~two~~diagnosis ~~risk factors, as well as evidence~~ of ~~analytic~~life-threatening ~~validity,~~or ~~clinical~~irreversibly ~~validity,~~debilitating ~~and~~human ~~clinical~~disease ~~utility.~~or ~~Although~~conditions ~~the~~by ~~LCD~~expediting ~~indicated~~their ~~that it found that no currently existing test has fulfilled all these criteria~~development, itassessment ~~indicated~~and ~~that~~review itthrough ~~will~~enhanced ~~“monitor~~communications ~~the evidence~~ and ~~may~~more ~~revise~~efficient ~~this determination based on the pertinent literature~~ and ~~society~~flexible ~~recommendations.”~~clinical Instudy ~~November 2024~~design, ~~Lucid~~including ~~submitted~~more tofavorable ~~MolDx~~pre/post ~~its~~market ~~complete~~data ~~clinical~~collection ~~evidence package in support of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard~~balance.

In ~~parallel~~ ~~with~~May ~~our request for reconsideration of the LCD~~2021, ~~Lucid~~we isreceived ~~aggressively~~CE ~~pursuing~~Mark ~~EsoGuard~~certification ~~commercial~~for ~~insurer~~EsoCheck ~~coverage~~(under ~~and payment. Although~~ the ~~claim~~Medical ~~adjudication~~Devices ~~cycle~~Directive ~~can~~93/42/EEC), beand ~~prolonged~~in ~~during~~June ~~the~~2021, ~~early~~we ~~commercialization~~completed ofCE aMark ~~new~~self-certification ~~test,~~for ~~Lucid~~EsoGuard ~~has~~(under ~~received~~the ~~and~~European ~~continues to receive out~~In-~~of-network~~Vitro ~~commercial~~Diagnostic ~~insurance~~Devices ~~payments~~Directive ~~for~~(IVDD ~~the EsoGuard test~~98/79/EC)), ~~which~~indicating ~~accounts~~both ~~for~~may ~~the~~be ~~vast~~marketed ~~majority~~in ofCE ~~our~~Mark ~~revenue~~European ~~to date~~countries.

~~Additionally, the~~Our ~~legislatures~~longer-term instrategy ais ~~number~~to ofsecure ~~states~~a ~~have~~specific ~~passed~~indication, ~~laws~~based ~~mandating~~on ~~coverage~~published ofguidelines, ~~comprehensive~~for ~~biomarker~~BE testing ~~over~~in ~~the~~certain ~~past~~at-risk ~~several~~populations ~~years. Lucid~~using ~~believes that~~ EsoGuard ~~falls~~on ~~within~~samples ~~the~~collected ~~definition~~with ofEsoCheck. aThis ~~biomarker~~use ~~test~~of ~~and~~EsoGuard ~~thus~~together ~~Lucid~~with isEsoCheck ~~reviewing~~as ~~how~~a totesting ~~leverage~~system ~~legislation in~~must ~~those~~be ~~states~~cleared toor ~~expand~~approved ~~access~~by tothe ~~and~~FDA ~~reimbursement~~as ofan ~~EsoGuard~~IVD device.

~~Clinical Utility and Clinical Trials~~4

~~Demonstrating EsoGuard’s~~Competition clinical utility, which requires providing evidence that the test has a meaningful impact on clinical practice, is very important for a variety of purposes, including, importantly, for Medicare and private payor payment and coverage. It has been established that one of the most important factors to private payors in deciding whether to grant payment and coverage will be demonstration that the EsoGuard test, when ordered by physicians, provides information that can be used to identify or exclude patients who would benefit from additional management and/or treatment. Clinical utility studies are also important for general EsoGuard commercialization by facilitating physician understanding of test indications and potential benefit to the patients.

~~Lucid continues~~The toU.S. ~~expand~~market ~~the~~for ~~EsoGuard~~EAC and ~~EsoCheck~~pre-cancer ~~evidence~~(i.e., ~~portfolio~~BE, with ~~additional~~or ~~clinical~~without ~~utility~~dysplasia) ~~and~~testing ~~clinical~~is ~~validity~~large, ~~data~~consisting ~~from a range~~ of ~~ongoing~~more ~~studies~~than ~~and~~30 ~~those~~million ~~that~~at-risk ~~will~~individuals beover ~~completed in~~ the ~~upcoming~~age ~~year~~of 50. ~~These~~Given ~~efforts~~the ~~include~~large ~~completion~~market offor ~~the ESOGUARD~~pre-~~BE2~~cancer ~~study~~testing, a ~~large~~we ~~multi-center~~likely ~~case~~will ~~control~~face ~~study~~numerous ~~recruiting~~competitors, ~~patients~~some ~~from~~of ~~large~~which ~~academic~~possess ~~institutions~~significantly ingreater ~~the~~financial ~~Netherlands~~and other resources and ~~across~~development ~~the~~capabilities Uthan us.~~S., in~~ ~~the~~Our ~~first~~EsoGuard ~~half~~test offaces ~~the~~competition ~~year~~from ~~and~~procedure-based ~~submission~~detection ~~for~~technologies ~~peer~~such ~~review~~as ofupper aendoscopy, ~~publication~~and ofother ~~the~~testing ~~results~~technologies insuch ~~the~~as ~~second~~assays ~~half~~that ofincorporate ~~2025.~~biomarker ~~This~~multi-cancer ~~data~~early ~~will further~~detection ~~supplement~~products. ~~what~~Our ~~has~~EsoCheck ~~previously~~device ~~been~~faces ~~published~~competition from ~~the~~other ~~four~~manufacturers ~~earlier~~with ~~clinical~~devices ~~validation~~designed ~~studies~~to collect cell samples from ~~Moinova~~targeted ~~et.~~regions ~~al.~~of ~~(2018), Moinova~~the etesophagus. ~~al.~~For ~~(2024)~~example, ~~Greer~~EndoSign, ~~et.~~commercialized ~~al.,~~by ~~(2024)~~Cyted, and ~~Shaheen~~much ~~et.~~like ~~al.~~Cytosponge, ~~(2024).~~is Aa ~~large,~~small ~~nearly~~mesh ~~12,000~~sponge ~~patient~~within ~~real-world~~a ~~experience~~soluble ofgelatin ~~EsoCheck and~~capsule ~~EsoGuard~~that ~~from~~needs 18to ~~months~~reside ofin ~~commercial~~the ~~data~~stomach isfor ~~expected~~some totime beuntil ~~submitted~~it ~~for~~fully ~~peer~~dissolves ~~review~~and ~~publication~~then inis pulled thru the ~~first~~targeted ~~half~~region ofbrushing the ~~year. Finally,~~lining ~~data~~of ~~accrual from~~ the ~~PREVENT~~esophagus and ~~PREVENT-FF~~then ~~registries~~later ~~remains~~retrieved, ~~ongoing.~~although, ~~Both~~unlike ~~registries~~EsoCheck, ~~capture~~it ~~information~~is onunprotected from sample contamination as the ~~diagnostic and/or~~brush ~~therapeutic~~later ~~journey~~passes regions of ~~subjects~~the ~~following~~upper ~~EsoGuard~~esophagus ~~testing,~~ and inmouth. ~~addition~~Our tocompetitors ~~provider~~may ~~decision~~also ~~impact,~~be ~~will~~developing ~~contribute~~additional ~~differing levels~~methods of ~~clinical~~detecting ~~outcomes~~esophageal ~~data~~cancer toand ~~the~~pre-cancer ~~Lucid~~that ~~evidence~~have ~~portfolio~~not yet been announced.

3We will also compete in the marketplace to recruit and retain qualified scientific, management and sales personnel, as well as in acquiring technologies and licenses complementary to our products or advantageous to our business. We are aware of several companies that compete or are developing technologies in our current and future products areas. In order to compete effectively, our products will have to achieve market acceptance, receive adequate insurance coverage and reimbursement, be cost effective and be simultaneously safe and effective.

~~Manufacturing~~Veris Health

~~EsoCheck is~~Overview currently manufactured for Lucid by Coastline International (“Coastline”), a high-volume device manufacturer, and Sage Product Development. Lucid’s current line at Coastline can produce up to 25,000 units per year. With Coastline’s improvement and expansion, there is capacity to scale exponentially. Lucid’s EsoGuard specimen kits are currently manufactured by Path-Tec. Path-Tec also manages warehousing, logistics, fulfillment and customer support of Lucid’s products.

~~License Agreement~~Veris Health is a majority-owned digital health subsidiary focused on improving personalized cancer care during treatment and throughout survivorship by helping oncology teams maintain greater visibility into patient health between visits. Through integrated digital tools, Veris enables oncology teams to remain connected with patients and monitor changes in their condition between visits, supporting earlier identification of emerging issues and more informed clinical decision-making.

~~Under the~~Veris ~~terms of Lucid~~Health’s ~~license~~lead ~~agreement with CWRU (as amended to date~~product, the ~~“Amended~~Veris ~~CWRU~~Cancer ~~License~~Care ~~Agreement”)~~Platform, ~~Lucid acquired~~is ana ~~exclusive~~comprehensive ~~worldwide~~digital ~~right~~cancer tocare ~~use~~platform ~~the~~designed ~~intellectual property rights~~ to ~~the~~support ~~EsoGuard~~personalized ~~and~~cancer ~~EsoCheck~~care ~~technology~~during ~~for~~treatment ~~the detection of changes in the esophagus~~ and onthroughout ~~sample~~survivorship ~~preservation.~~by ~~Lucid~~enabling iscontinuous ~~required~~monitoring ~~to pay CWRU royalties on net sales~~ of ~~licensed~~patient ~~products~~health ~~as follows:~~between 5%visits. ofThe ~~net~~platform ~~sales~~includes ofremote ~~less~~physiological ~~than~~data ~~$100~~collection, ~~million~~symptom ~~per~~reporting, ~~year;~~telehealth capability and 8%electronic ofhealth ~~net~~record ~~sales~~(“EHR”) ~~greater than $100 million per year~~integration. ~~Lucid~~The isplatform ~~also~~offers ~~required to~~enhanced ~~pay~~personalized ~~CWRU~~cancer ~~minimum~~care ~~annual~~through ~~royalty~~the ~~payments~~early asdetection ~~follows:~~of ~~$50~~complications,~~000~~ ~~per~~reduced ~~year~~unplanned hospitalizations, ~~beginning January 1 following~~ the ~~first~~provision ~~anniversary~~ of alongitudinal ~~commercial sale~~trends of aphysiological ~~licensed~~and ~~product;~~clinical ~~$150~~data,~~000~~ ~~per~~data-driven ~~year,~~risk ifmanagement ~~net~~tools, ~~sales~~and ofincreased apatient ~~licensed~~and ~~product~~provider ~~exceed~~satisfaction. ~~$25~~Cancer ~~million~~patients inenrolled aon ~~year;~~the ~~$300,000~~platform ~~per~~receive ~~year, if net sales of~~ a ~~licensed~~VerisBox™ ~~product exceed $50 million in a year; and $600,000 per year, if net sales~~ of aVeris-branded ~~licensed~~connected ~~product~~health ~~exceed~~care ~~$100~~devices ~~million in~~which atransmit ~~year.~~physiologic ~~Minimum~~data ~~yearly royalty amounts are subject~~ to ~~increase based on~~ the ~~percentage change in the CPI~~cloud-Wbased ~~Consumer~~clinician ~~Price~~portal ~~Index~~via ~~and are~~embedded ~~credited~~cellular ~~against the royalties otherwise due~~connections. ~~The~~A ~~license~~complementary ~~agreement~~patient ~~was~~portal ~~subject~~enables patients to ~~four~~report ~~regulatory and commercialization milestones~~symptoms, of ~~which~~as ~~one~~well ~~remains~~as ~~unachieved~~general health and ~~unpaid.~~quality ~~The remaining milestone is the FDA PMA submission~~ of alife ~~licensed product~~parameters, ~~upon~~to ~~the~~their ~~achievement of~~cancer ~~which~~care weteam ~~will~~through ~~pay~~the ~~CWRU~~Veris apatient ~~milestone~~smartphone ~~payment of $200,000~~app. The ~~license~~app ~~agreement~~also ~~terminates~~allows ~~upon~~caretakers ~~the~~and ~~expiration~~family ofmembers ~~the last-~~to~~-expire licensed~~ ~~patent,~~follow oralong on ~~May~~the ~~12,~~patient’s ~~2038,~~cancer incare ~~countries where no such patents exist, or upon expiration of any exclusive marketing rights for a licensed product that have been granted by FDA or other U~~journey.~~S. government agency, whichever comes later.~~

~~Regulatory~~Veris is also developing an implantable physiological monitor, designed to be implanted alongside a vascular access port, which will interface with the Veris Cancer Care Platform. The implantable monitor is intended to further enhance the clinical and commercial value of the platform by providing remote physiologic data independent of patient compliance.

In June 2019, Lucid received FDA 510(k) clearance to market EsoCheck in the U.S. as a device indicated for use in the collection and retrieval of surface cells of the esophagus in adults followed by FDA 510(k) clearance in 2022, expanding the use of EsoCheck in adults and pediatric populations in the U.S. In December 2019, Lucid’s CLIA-certified then-laboratory partner, completed documentation of EsoGuard analytical validity allowing Lucid to commercialize it as a LDT.5

~~In February~~Market ~~2020,~~Opportunity Lucid received FDA “Breakthrough Device Designation” for EsoGuard as an in-vitro diagnostic (“IVD”) medical device. The FDA Breakthrough Device Program was created to offer patients more timely access to breakthrough technologies which provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions by expediting their development, assessment and review through enhanced communications and more efficient and flexible clinical study design, including more favorable pre/post market data collection balance.

In ~~May 2021~~ 2024, ~~Lucid~~approximately ~~received~~2 CEmillion ~~Mark~~people ~~certification~~in ~~for~~the ~~EsoCheck~~U.S. ~~(under~~were ~~the~~newly ~~Medical~~diagnosed ~~Devices~~with ~~Directive 93/42/EEC)~~cancer, and cancer incidence in ~~June~~the ~~2021,~~U.S. ~~Lucid completed~~is CEexpected ~~Mark~~to ~~self-certification~~continue ~~for~~to ~~EsoGuard~~increase. ~~(under~~Cancer patients face high rates of complications during the ~~European~~courses ~~In-Vitro~~of ~~Diagnostic~~their ~~Devices~~treatment ~~Directive~~which ~~(IVDD~~drive ~~98/79/EC)),~~poor ~~indicating both~~patient ~~may~~outcomes beand ~~marketed~~healthcare incosts. CEOne ~~Mark~~driver ~~European~~of ~~countries~~these issues is avoidable hospitalizations. We believe Veris Health’s offerings can help drive costs down and improve outcomes through providing care teams with better, more continuous data.

~~In October~~Based ~~2023,~~on ~~FDA~~the ~~proposed~~aforementioned acancer ~~policy~~prevalence ~~under~~in ~~which FDA intends to phase out its general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would generally fall under~~ the ~~same enforcement approach as other IVDs~~U.S. ~~On May 6, 2024, the FDA issued a final rule aimed at helping to ensure the safety~~ and ~~effectiveness~~our ofcurrent ~~LDTs.~~business ~~The~~model, ~~rule~~we ~~amends~~believe ~~the~~Veris ~~FDA~~Health’s ~~regulations~~total toaddressable ~~make~~U.S. ~~explicit that~~market ~~IVDs~~opportunity ~~are~~exceeds ~~devices~~$2 ~~under~~billion. In the ~~Federal Food~~future, ~~Drug,~~we ~~and~~believe ~~Cosmetic~~this ~~Act~~will ~~(“FDCA”),~~only ~~including~~expand ~~when~~through the ~~manufacturer~~implantable ofphysiological ~~the IVD is a laboratory. Along with this amendment~~monitor, ~~the~~as ~~FDA~~well isas ~~finalizing~~other aopportunities ~~policy~~or ~~under~~enhancements ~~which~~Veris ~~the~~may ~~FDA~~pursue ~~will~~as ~~provide~~resources ~~greater~~permit, ~~oversight~~such ~~of IVDs offered~~ as ~~LDTs~~data ~~through~~commercialization, aincorporating ~~phaseout~~additional ofAI-based ~~its~~features ~~general~~and ~~enforcement discretion approach for LDTs over~~ the ~~course~~expansion ofinto ~~four~~other ~~years,~~markets asaside ~~well~~from ~~as targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories~~oncology.

~~The phaseout~~ ~~policy contains the following five stages:~~Commercialization/Sales

●We ~~Stage~~are 1:currently ~~Beginning~~pursuing onstrategic ~~May~~partnerships ~~6, 2025, which is one year after the publication date of the final LDT rule, FDA will expect compliance~~ with ~~medical~~leading ~~device~~academic ~~reporting~~oncology ~~(MDR) requirements~~systems, ~~correction~~whereby ~~and~~we ~~removal~~would ~~reporting~~become ~~requirements, and quality system (QS) requirements regarding complaint files. ● Stage 2: Beginning on May 6, 2026, which is 2 years after~~ the ~~publication~~exclusive ~~date~~digital ofhealth ~~the~~solution ~~final~~for ~~LDT~~these ~~rule,~~institutions’ ~~FDA~~oncology will expect compliance with requirements not covered during other stages of the phaseout policy, including registration and listing requirements, labeling requirements, and investigational use requirementsdepartments. ●To ~~Stage~~this ~~3: Beginning on May 6~~end, ~~2027, which is 3 years after the publication date of the final LDT rule, FDA will expect compliance with QS requirements (other than requirements regarding complaint files which are already addressed~~ in ~~stage~~October ~~1). ● Stage 4: Beginning on November 6~~2025, ~~2027,~~we ~~which~~announced isthat 3½Veris ~~years~~and ~~after~~The ~~the~~Ohio ~~publication~~State ~~date~~University ofComprehensive ~~the~~Cancer ~~final~~Center ~~LDT~~- ~~rule,~~The ~~FDA~~James ~~will~~Cancer ~~expect~~Hospital ~~compliance~~and ~~with~~Solove ~~premarket~~Research ~~review~~Institute ~~requirements for high-risk IVDs offered as LDTs~~ (~~IVDs~~"OSUCCC ~~that~~– ~~may~~The ~~be classified into class III or that are subject to licensure under section 351 of the Public Health Service Act~~James"), ~~unless~~ a ~~premarket~~National ~~submission~~Cancer ~~has~~Institute-Designated ~~been~~Comprehensive ~~received~~Cancer ~~by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review. ● Stage 5: Beginning on May 6~~Center, ~~2028,~~launched ~~which is 4 years after~~ the ~~publication~~commercial ~~date~~phase of ~~the~~their ~~final LDT rule, FDA will expect compliance with premarket review requirements for moderate~~long-~~risk~~term ~~and~~strategic ~~low-risk~~partnership ~~IVDs~~agreement. This ~~offered~~transition asto ~~LDTs (that require premarket submissions), unless~~ a ~~premarket~~commercial ~~submission~~phase ~~has~~follows ~~been~~successful ~~received~~completion ~~by the beginning~~ of ~~this~~a ~~stage~~pilot inprogram ~~which~~conducted ~~case~~at ~~FDA intends to continue to exercise enforcement discretion for~~ the ~~pendency~~OSUCCC of-- ~~its~~The ~~review~~James.

4Veris is continuing to pursue similar partnerships with other leading institutions. Veris has a software-as-a-service recurring-revenue business model, where it seeks to generate recurring revenue through oncology practice and hospital-based subscriptions. These entities pay monthly fees for each patient on the platform, through which they are able to derive revenues from remote physiologic monitoring (and, in the future, device implantation) under existing CPT codes. We have identified multiple potential use cases across a number of verticals, including clinical trials, commercial use cases, and as a means to improve patient care.

~~The FDA~~Manufacturing also intends to exercise enforcement discretion and generally not enforce some or all applicable requirements for certain categories of IVDs manufactured by a laboratory. The categories of enforcement discretion that are applicable to EsoGuard are summarized in the table below.

Category of IVD	Stage 1	Stage 2	Stage 3	Stages 4 & 5 (Premarket Review)
Currently marketed IVDs offered as LDTs first marketed prior to rule publication date and not modified beyond scope described in preamble Section V.B.3 of preamble	Compliance generally expected beginning May 6, 2025	Compliance generally expected beginning May 6, 2026	Compliance with 21 CFR 820.180-820.186 generally expected beginning May 6, 2027; Compliance generally not expected with other QS requirements (except for complaint files)	Compliance generally not expected
LDTs approved by NYS CLEP Section V.B.2 of preamble	Compliance generally expected beginning May 6, 2025	Compliance generally expected beginning May 6, 2026	Compliance generally expected beginning May 6, 2027	Compliance generally not expected

The components comprising the VerisBox™ kit are currently supplied to us by a third part manufacturer. The final packaging of the overall box and order fulfillment is managed by PAVmed at its Foxborough, MA location. Customer support is currently managed internally, while partnering with Salesforce for customer service management.

~~As EsoGuard~~Regulatory was marketed prior to rule publication and is also NYS CLEP approved, hence, enforcement discretion is applicable for compliance with Stages 4 and 5. We will be implementing compliance with MDR requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files by March 31, 2025, well before the deadline of May 6, 2025. Gap analysis has been completed and we are expecting our compliance activities to be completed for Stages 2 and 3 before the FDA’s expected timeframes in 2026 and 2027, respectively. We are confident that the proposed final rule will not have a commercial impact as the Company already has a robust QS management platform for medical devices and EsoGuard will be able to easily transition to the platform to fulfill the QS requirements, as required by the FDA.

~~Our longer-term~~The ~~strategy~~Veris isCancer toCare ~~secure~~Platform qualifies as a ~~specific~~Non-Device ~~indication,~~Clinical ~~based~~Decision onSoftware ~~published~~(“CDS”) ~~guidelines,~~that ~~for~~is BEexcluded ~~testing~~from inthe ~~certain~~definition ~~at-risk~~of ~~populations using~~a ~~EsoGuard~~medical ondevice ~~samples~~under ~~collected~~the ~~with~~FDCA, ~~EsoCheck.~~as ~~This~~amended ~~use~~by ofthe ~~EsoGuard~~21st ~~together~~Century ~~with~~Cures ~~EsoCheck~~Act, asand atherefore ~~testing~~is ~~system~~not ~~must~~subject beto ~~cleared~~the ~~or approved~~FDA’s byregulatory requirements for devices, as confirmed in the FDA’s asClinical anDecision ~~IVD~~Support ~~device~~Software Guidance.

~~Laboratory Operations~~Veris Health is also developing an implantable physiological monitor and completed multiple interactions with the FDA via pre-submission process, seeking agreement on regulatory strategy and required testing to seek clearance of the monitor. We plan to make our 510(k) submission for the implantable monitor, which could happen as early as late 2026, if and to the extent resources permit us to do so.

~~On February~~Competition 25, 2022, a newly-formed wholly owned subsidiary of Lucid, LucidDx Labs Inc. (“LucidDx Labs”), acquired from ResearchDx Inc. (“RDx”), certain licenses and other related assets necessary for LucidDx Labs to operate its own new CLIA-certified, CAP-accredited clinical laboratory located in Lake Forest, CA. Since March 2022, Lucid has conducted EsoGuard testing at its own laboratory.

~~In November~~The ~~2023,~~U.S. ~~LucidDx~~market ~~Labs~~for ~~launched~~cancer ~~EsoGuard~~patient 2care is large.0 There are many existing competitors in the remote physiological monitoring space, ~~which~~some ~~uses~~of ~~multiplexing~~which ~~thereby~~possess ~~allowing~~significantly ~~both~~greater ~~genes~~financial toand beother ~~interrogated~~resources onand adevelopment ~~single DNA~~capabilities ~~sample~~than us. ~~The~~Our ~~next-generation~~Veris ~~assay~~Cancer ~~underwent~~Care ~~rigorous~~Platform ~~analytical~~faces ~~and~~competition ~~clinical~~from ~~validation~~other ~~studies,~~digital ~~including~~care ~~head-to-head~~platforms ~~comparisons~~ providing many of ~~multiplexed~~the ~~triplicate~~same ~~consensus~~features, ~~versus~~including ~~singleplex~~EHR ~~techniques,~~integration ~~consistent~~and ~~with~~remote ~~CLIA~~patient ~~standards~~monitoring capabilities. ~~Clinical~~While ~~validation~~we ~~analysis~~are ~~demonstrated improved~~not ~~sensitivity~~aware ~~and~~of ~~specificity~~other ~~for~~implantable ~~the~~physiologic ~~detection~~monitors ofcontaining ~~esophageal~~biologic ~~precancer~~sensors, ~~having~~our ~~demonstrated~~competitors ~~enhanced~~may ~~assay~~also ~~performance~~be ~~and~~developing ~~lower costs~~similar indevices ~~extensive~~that ~~validation~~have ~~studies~~not yet been announced.

~~Competition~~6

~~The U.S.~~Medical ~~market~~Device ~~for~~Pipeline esophageal cancer (i.e., EAC) and pre-cancer (i.e., BE, with or without dysplasia) testing is large, consisting of more than 30 million at-risk individuals over the age of 50. Given the large market for pre-cancer testing, Lucid likely will face numerous competitors, some of which possess significantly greater financial and other resources and development capabilities than Lucid. The EsoGuard test faces competition from procedure-based detection technologies such as upper endoscopy, and other testing technologies such as multi-cancer early detection products. The EsoCheck device faces competition from other manufacturers with devices designed to collect cell samples from targeted regions of the esophagus. For example, EndoSign, commercialized by Cyted, and much like Cytosponge, is a small mesh sponge within a soluble gelatin capsule that needs to reside in the stomach and then is pulled thru the targeted region brushing the lining of the esophagus and then later retrieved, although, unlike EsoCheck, it is unprotected from sample contamination as the brush later passes regions of the upper esophagus and mouth. Lucid’s competitors may also be developing additional methods of detecting esophageal cancer and pre-cancer that have not yet been announced.

~~Most of~~PAVmed ~~Lucid’s~~is ~~existing~~developing ~~and~~a ~~potential~~portfolio ~~competitors~~of ~~have~~medical ~~substantially~~device ~~greater financial, marketing, sales, distribution, manufacturing and technological resources~~technologies. ~~Lucid~~This ~~may~~portfolio becurrently ~~unable~~includes tothe compete effectively against our competitors either because their products and services are superior or more cost efficient, or because they have access to greater resources than Lucid. These competitors may have greater name recognition than Lucid does. Many of these competitors have obtained all desirable FDA or other regulatory approvals, and superior patent protection, for their products. Certain of LucidCompany’s ~~competitors~~PortIO ~~have~~implantable ~~already~~intraosseous ~~commercialized~~vascular ~~their~~access ~~products,~~device and ~~others~~endoscopic ~~may commercialize~~imaging ~~their~~technology ~~products~~licensed infrom ~~advance~~Duke ~~of Lucid’s products~~University. InThe ~~addition,~~Company ~~Lucid’s~~continues ~~competitors~~to ~~may~~evaluate ~~make~~opportunities ~~technical~~to ~~advances that~~expand ~~render~~its ~~Lucid’s~~medical ~~products~~device ~~obsolete.~~portfolio ~~Lucid~~through ~~may~~internal bedevelopment ~~unable~~and toexternal ~~respond to such technical advances~~licensing.

~~Veris Health~~PortIO

~~Overview~~Our PortIO implantable intraosseous vascular access device is being developed as a means for infusing fluids, medications and other substances directly into the bone marrow cavity and from there into the central venous circulation. The intraosseous route provides a means for infusing fluids, medications and other substances directly into the bone marrow cavity, which communicates with the central venous circulation via nutrient and emissary veins. This route is well established and has been used for decades in a variety of clinical settings, including trauma and pediatric emergencies, and has been shown to be bioequivalent to the intravenous route.

~~In May~~Currently ~~2021,~~available weintraosseous ~~formed~~devices ~~Veris~~pass ~~Health,~~through athe ~~majority-owned~~skin ~~subsidiary,~~into ~~focused~~the onbone ~~digital~~and ~~health~~are ~~technology.~~therefore Inlimited ~~connection~~to ~~with~~short-term ~~its~~use. ~~formation, Veris~~PortIO ~~Health~~is ~~acquired~~a ~~Oncodisc~~novel, aimplantable ~~digital~~intraosseous ~~health~~vascular ~~company~~access ~~with~~device ~~groundbreaking~~that ~~tools~~does tonot ~~improve~~require ~~personalized~~accessing ~~cancer~~the ~~care~~central ~~through~~venous ~~remote patient~~system ~~monitoring. Oncodisc’s core technologies include designs~~ and ~~patents~~does ~~that~~not ~~would~~have bean ~~the~~indwelling ~~foundation~~intravascular ~~for~~component. ~~the~~It ~~first~~is ~~intelligent implantable~~designed ~~vascular~~to ~~access~~be ~~port~~highly ~~with~~resistant ~~biologic~~to ~~sensors~~occlusion and ~~wireless~~may ~~communication,~~not ~~combined~~require ~~with~~regular anflushing. ~~oncologist-designed~~It ~~remote~~also ~~digital healthcare~~features ~~platform~~simplified, ~~that~~near-percutaneous ~~provides~~insertion ~~patients~~ and ~~physicians~~removal, ~~with~~without ~~new tools to improve outcomes and optimize~~ the ~~delivery~~need offor ~~cost-effective care~~surgical ~~through~~dissection ~~remote~~or ~~monitoring~~radiographic ~~and data analytics~~confirmation.

5 Endoscopic Imaging Technology

~~Veris Health’s~~In ~~lead~~February ~~product~~2026, ~~the~~PAVmed ~~Veris~~entered ~~Cancer~~into ~~Care Platform, is~~ a ~~comprehensive~~definitive ~~digital~~license ~~cancer~~agreement ~~care platform~~ with ~~remote~~Duke ~~physiological data collection~~University, ~~symptom reporting, telehealth capability and electronic health record (“EHR”) integration. The platform offers enhanced personalized cancer care~~ through ~~the~~a ~~early~~newly ~~detection~~formed ~~of complications~~subsidiary, ~~reduced~~for ~~unplanned hospitalizations,~~ the ~~provision~~exclusive ofworldwide ~~longitudinal trends~~rights ofto ~~physiological~~endoscopic ~~and~~imaging ~~clinical~~technology ~~data,~~involving ~~data-driven risk management tools, and increased patient and provider satisfaction. Cancer patients enrolled on the platform receive~~ a ~~VerisBox™ of Veris~~multi-~~branded~~modality ~~connected~~probe ~~health~~combining ~~care devices which transmit physiologic data to the cloud~~angle-~~based~~resolved ~~clinician~~low ~~portal~~coherence ~~via~~interferometry embedded cellular connections. A complementary patient portal enables patients to report symptoms, as well as general health and quality of life parameters, to their cancer care team through the Veris patient smartphone app. The app also allows caretakers and family members to follow along on the patient’s cancer care journey. Veris is developing an implantable physiological monitor, designed to be implanted alongside (“a/LCI”) ~~vascular access port, which will interface~~ with ~~the~~optical ~~Veris~~coherence ~~Cancer Care~~tomography ~~Platform~~(“OCT”). ~~The implantable monitor will further enhance the clinical and commercial value of the platform by providing remote physiologic data independent of patient compliance.~~

~~Market Opportunity~~This technology may be used to identify and facilitate treatment of advanced esophageal precancer (“dysplasia”) during upper endoscopy. The platform is designed to integrate with standard endoscopic procedures and may enable real-time assessment of esophageal tissue to guide clinical decision-making during the procedure.

~~In 2024~~Additionally, ~~approximately~~as ~~2.0 million people in~~ the ~~U.S.~~diagnosis ~~were newly diagnosed with cancer, and cancer incidence in the U.S. is expected to continue to increase. Cancer patients face high rates~~ of ~~complications~~dysplasia ~~during~~currently ~~the~~relies ~~courses~~on ofbiopsy-based ~~their~~approaches, ~~treatment~~ which ~~drive~~require ~~poor~~tissue ~~patient outcomes~~sampling and ~~healthcare~~subsequent ~~costs.~~pathological ~~One~~review, ~~driver~~this oftechnology ~~these~~may ~~issues~~provide isa ~~avoidable~~complementary ~~hospitalizations.~~approach Weto ~~believe~~streamline ~~Veris~~the ~~Health’s~~evaluation ~~offerings can help drive costs down~~ and ~~improve~~treatment ~~outcomes through providing care teams with better, more continuous data~~process.

Based on the aforementioned cancer prevalence in the U.S. and our current business model, we believe Veris Health’s total addressable U.S. market opportunity exceeds $2 billion. In the future, we believe this will only expand through the implantable physiologic monitor, as well as other opportunities or enhancements Veris may pursue as resources permit, such as data commercialization, incorporating additional AI-based features and the expansion into other markets aside from oncology.7

~~Commercialization/Sales~~ Recent Events

~~We are~~ currently pursuing strategic partnerships with leading academic oncology systems, whereby we would become the exclusive digital health solution for these institutions’ oncology departments. To this end, Veris and The Ohio State University Comprehensive Cancer Center - The James Cancer Hospital and Solove Research Institute (OSUCCC – The James), a National Cancer Institute-Designated Comprehensive Cancer Center, executed a memorandum of understanding to implement a pilot program where cancer patients would be enrolled on the Veris Cancer Care Platform™. The pilot program was launched in June 2024, and has been extended through the end of March 2025. This collaboration represents a significant step forward in Veris Health’s commercialization strategy, allowing the company to demonstrate the value of its platform and gather data on its effectiveness in improving personalized cancer care.Business

~~Veris is~~Medicare ~~continuing~~Coverage to pursue similar partnerships with other leading institutions. Veris has a software-as-a-service recurring-revenue business model, where it seeks to generate recurring revenue through oncology practice and hospital-based subscriptions. These entities pay monthly fees for each patient on the platform, through which they are able to derive revenues from remote physiologic monitoring (~~and, in the future, device implantation~~Lucid) under existing CPT codes. Veris also plans to build a commercialization model around the oncology data it is collecting, as resources permit. We have identified multiple potential use cases across a number of verticals, including clinical trials, commercial use cases, and as a means to improve patient care.

~~Manufacturing~~In November 2024, Lucid submitted to MolDx its complete clinical evidence package in support of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard. The EsoGuard clinical evidence package included six new peer-reviewed publications: three clinical validation studies (two in the intended use population, one case control), two clinical utility studies, and one analytical validation study. The current LCD provides clear coverage criteria consistent with the ACG guidelines for esophageal precancer testing. The package was submitted as part of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard.

~~The components~~As ~~comprising~~part of the ~~Veris~~LCD ~~Cancer~~reconsideration ~~Care~~process, ~~Platform~~MolDx-participating ~~are~~Medicare ~~currently~~Administrative ~~supplied~~Contractors toconvened usa byCAC ~~our~~Meeting ~~partners~~regarding ~~TransTek~~the ~~and~~LCD ~~their~~on ~~U.S.-based subsidiary~~September 4, ~~Mio Labs~~2025. ~~Each~~At ~~has~~the ~~passed~~meeting, aeleven ~~SOC-2~~experts, ~~audit~~including byphysicians anacross ~~outside~~multiple ~~auditor.~~specialties ~~The~~(GI, ~~final~~primary ~~packaging~~care, ofpathology), ~~the~~major ~~overall~~society ~~box~~guideline co-authors (ACG, AGA) and ~~order fulfillment~~industry isleaders ~~managed~~(American byForegut ~~PAVmed~~Society, atAmerican ~~its~~Society ~~Foxborough~~for Gastrointestinal Endoscopy), MAparticipated ~~location.~~in ~~Customer~~this ~~support~~extensive isdiscussion ~~currently~~of ~~managed~~the ~~internally,~~unmet ~~while~~clinical ~~partnering~~ need with ~~Zendesk~~respect ~~for~~to ~~customer~~early ~~service~~detection ~~management~~of esophageal precancer and the strength of the EsoGuard clinical validity and clinical utility data.

~~Regulatory~~Medical Device Developments

~~The Veris~~In ~~Cancer~~March ~~Care~~2026, ~~Platform~~PAVmed ~~qualifies~~hired ~~as a Non~~industry-~~Device~~veteran ~~Clinical~~Joseph ~~Decision~~Virgilio ~~Software~~to ~~(“CDS”)~~serve ~~that~~as isPAVmed's ~~excluded~~Chief ~~from~~Business ~~the definition~~Officer offor aMedical ~~medical~~Devices. ~~device~~Prior ~~under~~to ~~the~~joining ~~FDCA~~PAVmed, asMr. ~~amended~~Virgilio byheld ~~the~~leadership ~~21st~~roles ~~Century~~at ~~Cures~~a ~~Act,~~diverse ~~and~~group ~~therefore~~of ismedical ~~not~~device ~~subject~~companies toover the ~~FDA’s~~ ~~regulatory~~course ~~requirements~~of ~~for~~his ~~devices,~~25-year ~~as confirmed in the FDA’s Clinical Decision Support Software Guidance~~career.

~~Veris Health~~In isthis ~~also~~capacity, ~~developing~~Mr. anVirgilio ~~implantable~~will ~~cardiac~~oversee ~~monitor~~the development and iscommercialization ~~currently~~of ~~interacting~~PAVmed's ~~with~~current ~~the~~and ~~FDA~~future ~~via~~medical ~~pre-submission~~device ~~process,~~portfolio. ~~seeking agreement~~Such onportfolio ~~regulatory~~includes ~~strategy~~at ~~and~~this ~~required~~time ~~testing~~the toCompany's ~~seek~~PortIO ~~clearance~~implantable ofintraosseous ~~the~~vascular ~~monitor.~~access Wedevice, ~~plan~~which tois ~~make~~being ~~our~~developed ~~510(k)~~as ~~submission~~a means for ~~the implantable~~infusing ~~monitor~~fluids, ~~which~~medications ~~could~~and ~~happen~~other assubstances ~~early~~directly asinto ~~late~~the ~~2025,~~bone ifmarrow cavity and tofrom there into the ~~extent~~central ~~resources~~venous ~~permit~~circulation. The usportfolio toalso doincludes sotechnology licensed by PAVmed from Duke University that involves a multi-modality probe combining ("a/LCI") with optical coherence tomography ("OCT"), as more fully described below.

~~Competition~~Endoscopic Imaging Technology

~~The U.S.~~In ~~market~~February ~~for~~2026, ~~cancer~~PAVmed ~~patient~~entered ~~care~~into isa ~~large.~~definitive ~~There~~license ~~are~~agreement ~~many~~with ~~existing~~Duke ~~competitors~~University, inthrough a newly formed subsidiary, for the ~~remote~~exclusive ~~physiological~~worldwide ~~monitoring~~rights ~~space,~~to ~~some of~~technology ~~which~~involving ~~possess~~a ~~significantly~~multi-modality ~~greater~~probe ~~financial~~combining ~~and~~angle-resolved ~~other~~low ~~resources~~coherence ~~and~~interferometry ~~development~~(“a/LCI”) ~~capabilities~~with ~~than~~endoscopic usimaging. This ~~Our~~technology ~~Veris~~may ~~Cancer~~be ~~Care Platform~~used ~~faces~~to ~~competition~~identify ~~from~~and ~~other~~facilitate ~~digital~~treatment ~~care~~of ~~platforms~~advanced ~~providing~~esophageal ~~many~~precancer of(“dysplasia”) ~~the~~during ~~same~~upper ~~features,~~endoscopy. ~~including~~The ~~EHR~~platform ~~integration~~is designed to integrate with standard endoscopic procedures and ~~remote~~ ~~patient~~may ~~monitoring~~enable ~~capabilities.~~real-time ~~While~~assessment weof ~~are~~esophageal ~~not~~tissue ~~aware~~to guide clinical decision-making during the procedure. Additionally, as the diagnosis of ~~other~~dysplasia ~~implantable~~currently ~~physiologic~~relies ~~monitors~~on ~~containing~~biopsy-based ~~biologic sensors~~approaches, ~~our~~which ~~competitors~~require tissue sampling and subsequent pathological review, this technology may ~~also~~provide bea ~~developing~~complementary ~~similar~~approach ~~devices~~to ~~that~~streamline ~~have~~the ~~not~~evaluation ~~yet~~and ~~been~~treatment ~~announced~~process.

6Department of Veteran Affairs (Lucid)

~~Incubator Program~~In January 2026, Lucid announced that it has been awarded a contract by the U.S. Department of Veterans Affairs for EsoGuard expanding access to esophageal precancer testing across the nation's largest integrated healthcare system, which serves more than nine million enrolled veterans annually. The contract is issued under the VA Federal Supply Schedule and includes pre-negotiated pricing for EsoGuard that matches the established Medicare payment rate determined by the Centers for Medicare & Medicaid Services (CMS), enabling VA hospitals and healthcare facilities nationwide to access EsoGuard through a single, national VA procurement framework.

~~On March~~Real-World ~~21,~~Experience ~~2024,~~Data ~~PAVmed~~(Lucid) announced that it had launched a wholly owned incubator, PMX, to complete development and commercialization of existing portfolio technologies, including PortIO, EsoCure and CarpX. Although PMX may seek to expand its portfolio with internal or externally sourced technologies in the future, its initial assets will include the following products:

~~PortIO~~In December 2025, Lucid announced results from an 18-month real-world experience evaluating EsoGuard and EsoCheck in approximately 12,000 patients. The analysis demonstrated high technical success rates, rapid procedure times, and appropriate physician utilization in routine clinical practice, consistent with previously reported clinical studies. The data are currently under peer review for publication.

~~Our PortIO~~Strategic ~~implantable~~Commercial ~~intraosseous~~Partnership ~~vascular~~(Veris) access device is being developed as a means for infusing fluids, medications and other substances directly into the bone marrow cavity and from there into the central venous circulation. The intraosseous route provides a means for infusing fluids, medications and other substances directly into the bone marrow cavity which communicates with the central venous circulation via nutrient and emissary veins. This route is well established, having been used for decades in a variety of settings including trauma, especially military trauma, and pediatric emergencies. It has been shown to be bioequivalent to the intravenous route. Complication rates are low and there are few contraindications. Currently available intraosseous devices pass through the skin into the bone and are therefore limited to short term use. PortIO is a novel, implantable intraosseous vascular access device which does not require accessing the central venous system and does not have an indwelling intravascular component. It is designed to be highly resistant to occlusion and, we believe, may not require regular flushing. It features simplified, near-percutaneous insertion and removal, without the need for surgical dissection or radiographic confirmation.

~~Esocure~~ In October 2025, we announced that Veris and The Ohio State University Comprehensive Cancer Center - The James Cancer Hospital and Solove Research Institute ("OSUCCC – The James"), a National Cancer Institute-Designated Comprehensive Cancer Center, launched the commercial phase of their long-term strategic partnership agreement. This transition to a commercial phase follows successful completion of a pilot program conducted at the OSUCCC -- The James.

~~In connection~~Clinical ~~with~~Study ~~our~~Publications efforts to expand our presence in the EAC diagnostic market, we were developing the EsoCure Esophageal Ablation Device, with the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer, and to do so without the need for complex and expensive capital equipment. We have successfully completed a pre-clinical feasibility animal study of EsoCure demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining. An acute and survival animal study of EsoCure Esophageal Ablation Device has also been completed, demonstrating successful direct thermal balloon catheter ablation of esophageal lining through the working channel of a standard endoscope. When resources permit, we plan to conduct additional development work and animal testing of EsoCure to support a future FDA 510(kLucid) ~~submission.~~

~~CarpX~~In September 2025, a case series published in Gastroenterology & Hepatology highlighted four real-world cases in which EsoGuard facilitated the timely detection of either high-grade dysplasia ("HGD") or intramucosal carcinoma ("IMC"; T1a esophageal adenocarcinoma). In all four cases, the patients had no prior history of EGD, including one individual who had previously declined multiple EGD referrals. Following positive in-office EsoGuard results, each patient proceeded with endoscopic evaluation, which led to successful identification and eradication of disease in all cases. This case series underscores both the clinical utility of EsoGuard in detecting early-stage neoplasia and the ease with which the test can be integrated into standard office workflows to enhance screening uptake and early disease detection.

~~CarpX is~~Russell a2000® patented, single-use, disposable, minimally invasive surgical device for use in the treatment of carpal tunnel syndrome. CarpX is designed to allow the physician to relieve the compression on the median nerve without an open incision or the need for endoscopic or other imaging equipment, and ~~therefore~~3000® weIndexes ~~believe~~(Lucid) it will be significantly less invasive than existing treatments. To use CarpX, the operator first advances a guidewire through the carpal tunnel under the ligament, and then advanced over the wire and positioned in the carpal tunnel under ultrasonic and/or fluoroscopic guidance. When the CarpX balloon is inflated it creates tension in the ligament positioning the cutting electrodes underneath it and creates space within the tunnel, providing anatomic separation between the target ligament and critical structures such as the median nerve. Radiofrequency energy is briefly delivered to the electrodes, rapidly cutting the ligament, and relieving the pressure on the nerve. We believe CarpX will be significantly less invasive than existing treatments.

~~CarpX received~~On ~~FDA~~June ~~510(k)~~27, ~~marketing clearance in April 2020~~2025, ~~with~~Lucid ~~the first commercial procedure successfully performed in December 2020. In May 2021 European CE Mark Certification~~ was ~~received~~added ~~for CarpX. Our limited-release commercialization efforts through 2022 were focused on engaging key opinion hand surgeons designed~~ to ~~solicit input for ergonomic improvements to~~ the ~~device,~~Russell ~~procedure~~2000® ~~development~~Index and ~~surgical-time optimization,~~the ~~and~~Russell ~~ease~~3000® ~~of use. As a result of this clinical input~~Index, wefollowing ~~have initiated a product development project to incorporate intraluminal ultrasound into~~ the ~~device~~2025 toannual ~~include~~reconstitution ~~real~~by ~~time~~FTSE ~~imaging of the ligament to be cut together with critical anatomic structures, and will continue to pursue that project, as resources permit~~Russell.

7NCCN Clinical Practice Guidelines Update (Lucid)

~~Recent Developments~~In March 2025, Lucid announced that a recent update to the NCCN Guidelines® focused on Esophageal and Esophagogastric Junction Cancers (Version 1.2025) has added a new section on BE screening. The NCCN Guidelines® now reference professional society guidelines on BE screening, including the most recent ACG clinical guideline discussed above, which recommends non-endoscopic biomarker testing, such as EsoGuard performed on samples collected with EsoCheck, as an acceptable alternative to invasive upper endoscopy to detect esophageal precancer.

~~Business~~8

~~EsoGuard Medicare~~Highmark ~~Coverage~~Reimbursement Approval (Lucid)

~~In November~~On ~~2024~~March 13, 2025, Lucid ~~submitted~~announced tothat ~~MolDx~~Highmark ~~its~~Blue ~~complete~~Cross ~~clinical~~Blue ~~evidence~~Shield, ~~package~~an inindependent ~~support~~licensee of ~~a request for reconsideration of~~ the ~~non-coverage language~~Blue inCross ~~the~~and ~~LCD~~Blue toShield ~~secure Medicare coverage for EsoGuard. The EsoGuard clinical evidence package included six new peer-reviewed publications: three clinical validation studies (two in the intended use population~~Association, ~~one~~has ~~case~~issued ~~control),~~a ~~two~~positive ~~clinical utility studies, and one analytical validation study. The current LCD provides clear~~ coverage ~~criteria~~policy ~~consistent~~for ~~with~~non-invasive ~~the~~screening ~~ACG~~of ~~guidelines for~~ esophageal precancer ~~testing.~~and ~~The~~cancer ~~package was submitted as part of a request for reconsideration of the non-coverage language~~ in ~~the~~ ~~LCD~~New toYork ~~secure Medicare coverage for EsoGuard~~state.

~~NCCN~~Financing ~~Clinical Practice Guidelines Update~~

InSeries ~~March~~D ~~2025,~~Offering ~~Lucid announced that a recent update to the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) focused on Esophageal~~ and ~~Esophagogastric~~Recapitalization; ~~Junction~~Series ~~Cancers~~D ~~(Version~~Conversion 1.2025) has added a new section on BE screening. The NCCN Guidelines® now reference professional society guidelines on BE screening, including the most recent ACG clinical guideline discussed above, which recommends non-endoscopic biomarker testing, such as EsoGuard performed on samples collected with EsoCheck, as an acceptable alternative to invasive upper endoscopy to detect esophageal precancer.

~~Clinical~~On ~~Study~~February ~~Publications~~3, 2026, PAVmed entered into subscription agreements (the “Subscription Agreements”) with certain accredited investors (the “Investors”) and, pursuant to and concurrently with the execution of the Subscription Agreements, sold to the Investors, for an aggregate purchase price of $30 million, (i) 30,000 shares of the Company’s newly designated Series D Convertible Preferred Stock, par value $0.001 per share (the “Series D Preferred Stock”), and (ii) warrants (the “Warrant”) to purchase an additional 30,000 shares of Series D Preferred Stock, with each investor receiving 100 shares of Series D Preferred Stock and a warrant to purchase 100 shares of Series D Preferred Stock for each $100,000 of its investment (the “Offering”). The initial conversion price of the Series D Preferred Stock is $6.50 per share, subject to adjustment in the event of stock splits, stock dividends, and similar transactions.

OnConcurrently ~~March~~with ~~18,~~the ~~2025~~Offering, ~~Lucid~~the ~~announced that~~Company ~~its~~redeemed ~~ENVET-BE~~all ~~clinical~~16,962 ~~utility~~shares ~~study has been accepted for publication in Gastroenterology & Hepatology—the fifth peer-reviewed publication~~ of ~~clinical~~Series ~~utility~~C ~~data~~Preferred ~~for~~Stock ~~Lucid’s~~outstanding ~~EsoGuard® Esophageal DNA Test,~~ and ~~the~~refinanced ~~second~~all ~~to present findings from a real-world screening population~~$8.4 ~~The~~million ~~manuscript,~~in ~~entitled~~principal ~~“Enhancing~~and ~~the~~interest ~~Diagnostic Yield~~ of ~~EGD~~its ~~for~~Senior ~~Diagnosis~~Secured ofConvertible ~~Barrett’s~~Note ~~Esophagus~~issued ~~Through Methylated~~in ~~DNA~~September ~~Biomarker~~(the ~~Triage,”~~“2022 ~~demonstrates that confirmatory upper endoscopy (EGD~~Note”), ~~performed~~ in ~~EsoGuard-positive~~consideration ~~patients~~of ~~had~~ a ~~substantially~~cash ~~higher~~payment ~~diagnostic~~to ~~yield~~the ~~for~~holder ~~detecting~~thereof ~~esophageal precancer~~ (~~Barrett’s~~the ~~Esophagus or BE~~“Holder”) ~~than the expected yield~~ of ~~screening EGD~~approximately ~~alone in at-risk patients~~$22.3 ~~The~~million ~~ENVET-BE~~(which ~~study~~was ~~reviewed~~made ~~real-world~~using ~~data~~proceeds from athe ~~cohort~~sale of ~~199~~the ~~EsoGuard-positive~~Series ~~patients~~D ~~who~~Preferred ~~completed confirmatory~~Stock), ~~EGD.~~and ~~The~~the ~~overall~~issuance ~~positive~~to ~~diagnostic yield for BE was 2.4-fold higher than~~ the ~~expected~~Holder ~~yield~~ of ~~screening EGD alone, based on disease prevalence within~~ an ~~at-risk~~amended ~~population.~~and ~~The~~restated ~~yield~~2022 ~~was~~Note ~~nearly~~(the ~~three-fold~~“2026 ~~higher~~Note”) inwith ~~patients~~a ~~meeting~~principal ~~American~~amount ~~College~~ of ~~Gastroenterology (ACG)~~$15.0 ~~screening criteria~~million.

OnThe ~~November~~net 7,proceeds ~~2024,~~of ~~Lucid~~the ~~announced~~Offering, ~~that~~taking ~~its manuscript~~into ~~for~~account ~~its~~the ~~multi-center~~cash ~~ESOGUARD~~payments ~~BE-1~~made ~~study has been accepted for publication~~ in ~~The~~respect ~~American Journal~~ of ~~Gastroenterology,~~ the ~~official~~redemption ~~journal~~ of the ~~American~~Series ~~College~~C ofPreferred ~~Gastroenterology~~Stock ~~(ACG). This is the fourth publication presenting clinical validation data for Lucid’s EsoGuard® Esophageal DNA Test,~~ and the ~~second~~2022 ~~to demonstrate its performance in an intended-use screening population. Consistent with previous studies~~Note, EsoGuard showed high sensitivity and negative predictive value in detecting esophageal precancer (Barrett’s Esophagus or BE). The prospective, multi-center study presented data from a cohort of patients who met ACG guideline criteria for esophageal precancer screening and underwent non-endoscopic EsoGuard testing followed by traditional upper endoscopy. EsoGuard sensitivity and negative predictive value for detecting BE were approximately ~~88% and 99%, respectively~~$7.6 ~~Specificity and positive predictive value were approximately 81% and 30%, respectively~~million. ~~No serious adverse events were reported.~~

~~Highmark Reimbursement~~On ~~Approval~~March 27, 2026, PAVmed's shareholders approved the conversion of the Series D Preferred Stock into shares of our common stock. Promptly following such approval, 100% of the Series D Preferred Stock was converted in full into 4,615,393 shares of our common stock.

~~On March~~Reverse ~~13,~~Stock ~~2025,~~Split; ~~Lucid~~Reduction announced that Highmark Blue Cross Blue Shield, an independent licensee of the Blue Cross and Blue Shield Association, has issued a positive coverage policy for non-invasive screening of esophageal precancer and cancer in ~~New~~Authorized ~~York~~Shares ~~state. The new policy will cover EsoGuard in patients who meet established criteria for esophageal precancer testing consistent with professional society guidelines.~~

~~CWRU NIH~~At ~~Grant~~a ~~Related~~special meeting of the Company’s stockholders held on December 5, 2025, the Company’s stockholders approved a reverse stock split of the Company’s outstanding shares of common stock (the “Reverse Split”) at a specific ratio, ranging from 1-for-10 to ~~EsoGuard~~1-for-30, ~~and~~to ~~EsoCheck~~be determined by the Company’s board of directors (the “Board”) in its sole discretion, as well as an associated reduction in the number of shares of common stock the Company is authorized to issue (the “Reduction in Authorized Common Stock”) from 250,000,000 shares to 25,000,000 shares.

OnFollowing ~~February~~the ~~27,~~special ~~2025~~meeting, ~~Lucid~~the ~~announced~~Board ~~that~~approved ~~principal~~a ~~investigators~~ratio ~~from CWRU and University Hospitals (“UH”), were awarded an $8 million National Institutes~~ of ~~Health (“NIH”) R01 grant to conduct a five~~1-~~year clinical study designed to evaluate esophageal precancer detection using EsoCheck and EsoGuard among at~~for-~~risk~~30 ~~individuals~~for ~~without~~the ~~symptoms~~Reverse ofSplit. ~~chronic~~On ~~GERD.~~December ~~The study~~30, “A2025, ~~Clinical~~in ~~Trial~~order ofto ~~Cancer~~effect ~~Prevention~~the byReverse ~~Biomarker~~Split ~~Based~~and ~~Detections~~the ofReduction ~~Barrett’s~~in ~~Esophagus~~Authorized ~~and~~Common ~~Its Progression~~Stock,~~” aims~~ ~~to evaluate~~ the ~~effectiveness~~Company offiled ~~EsoCheck~~a ~~and~~certificate ~~EsoGuard~~of inamendment ~~detecting esophageal precancer (Barrett’s Esophagus or BE)~~ to ~~prevent esophageal~~its ~~cancer~~certificate ~~(EAC)~~of ~~within~~incorporation, aas ~~non-GERD at-risk population. To accomplish this aim~~amended, ~~800~~pursuant ~~patients~~to ~~without~~which ~~GERD~~the ~~symptoms~~Reverse ~~who~~Split ~~meet~~and the ~~AGA~~ ~~risk~~Reduction ~~criteria~~in ~~for~~Authorized ~~screening~~Common ~~will~~Stock bebecame ~~recruited~~effective ~~across~~on ~~five participating research centers: University Hospitals~~Friday, ~~University~~January ~~of Colorado~~2, ~~Johns~~ ~~Hopkins University, University of North Carolina, and Cleveland Clinic~~2026.

~~Veris NIH~~The ~~Grant~~purpose of the Reverse Split was to help the Company regain compliance with the $1 minimum bid requirement for continued listing on the Capital Market of the Nasdaq Stock Market LLC ("Nasdaq"), which it did, as discussed below. All shares and per share amounts set forth herein give effect to the reverse stock split.

On October 10, 2024, PAVmed announced that Veris has been awarded a $1.8 million grant from the National Institute on Minority Health and Health Disparities (NIMHD), an institute of NIH. The two-year grant will fund research to optimize and validate the Veris Cancer Care Platform for the needs of medically underserved cancer patients, in partnership with an academic cancer center. The research project, “Bridging the Gap: Enhancing Cancer Care for Underserved Populations with the Veris Health Cancer Care Platform,” will focus on patients facing language barriers, limited access to technology, and socioeconomic disparities.9

~~Changes to~~NASDAQ ~~Board~~Compliance ~~Composition~~

~~Effective as~~On ofJanuary ~~September 10~~21, ~~2024~~2026, ~~James~~the L.Company ~~Cox,~~received ~~M.D.,~~a ~~and~~notification ~~Joan~~letter ~~B. Harvey resigned~~ from the ~~Company’s~~Nasdaq ~~board~~Listing ofQualifications ~~directors.~~department ~~Neither~~stating ~~Dr.~~that ~~Cox’s nor~~the ~~Ms.~~Company ~~Harvey’s~~had ~~resignation~~regained ~~was~~compliance ~~due~~with tothe ~~any~~$1 ~~disagreement~~minimum ~~with~~bid ~~the~~price ~~Company~~requirement onfor ~~any~~continued ~~matter~~listing ~~relating~~on tothe ~~its~~Nasdaq ~~operations,~~Capital ~~policies or practices~~Market.

~~Also effective~~As aspreviously ofreported, ~~September~~on 10January 23, ~~2024~~2025, the Company’s ~~board~~had ofreceived ~~directors~~a ~~appointed~~notification ~~Sundeep~~letter ~~Agrawal,~~from ~~M.D.~~the asListing aQualifications ~~Class~~department Bstating ~~director.~~that, ~~Prior to~~for ~~being~~the ~~appointed~~prior to30 ~~the~~consecutive ~~Company’s~~business ~~board~~days of(through ~~directors~~January 22, ~~Dr.~~2025), ~~Agrawal~~the ~~had~~closing ~~entered~~bid ~~into~~price aof ~~strategic~~the ~~advisory~~Company’s ~~agreement~~common ~~with~~stock ~~the~~had ~~Company to~~been ~~provide~~below ~~certain~~the ~~M&A~~minimum ~~advisory~~of ~~services.~~$1 ~~Such~~per ~~agreement~~share ~~remains~~required infor ~~effect.~~continued ~~Pursuant~~listing toon the ~~agreement,~~ ~~Dr.~~Nasdaq ~~Agrawal~~Capital ~~will~~Market ~~receive~~under aNasdaq ~~monthly~~Listing ~~consulting~~Rule ~~fee~~5550(a)(2). ofSubsequently, $3Nasdaq determined that,~~333.~~ ~~The~~from ~~agreement~~January is2, ~~terminable~~2026 byto ~~the~~January ~~Company~~19, on2026, 10the ~~days’ written~~closing ~~notice.~~bid ~~Except~~price ~~for~~of the ~~foregoing,~~Company’s ~~Dr.~~common ~~Agrawal~~stock ~~has~~had ~~not~~been ~~engaged~~at in$1 ~~any~~per ~~transactions~~share ~~with~~or greater. Accordingly, the Company ~~that~~had ~~are~~regained ~~required~~compliance towith beNasdaq ~~reported pursuant~~Listing toRule ~~Item 404~~5550(a) ~~of Regulation S-K~~(2).

~~Intercompany Agreements~~Veris ~~with~~Financing ~~Lucid~~(June 2025)

On ~~August~~ 6June 23, ~~2024~~2025, ~~the~~Veris ~~Company~~entered ~~and~~into ~~Lucid~~subscription ~~entered~~agreements ~~into~~(each, a ~~ninth~~“Veris ~~amendment~~June to2025 ~~the~~Subscription ~~management~~Agreement”) ~~services~~with ~~agreement~~certain ~~between~~accredited ~~them~~investors (collectively, the “~~MSA~~June 2025 Investors”) , pursuant to ~~increase~~which ~~the~~Veris ~~monthly~~agreed ~~fee~~to ~~thereunder~~sell ~~from~~and ~~$0.83~~the ~~million~~June ~~per~~2025 ~~month~~Investors agreed to ~~$1.05~~purchase ~~million~~(the ~~per~~“June ~~month,~~2025 ~~effective~~Offering”) as1,800,000 shares of ~~July~~common 1stock, ~~2024~~par value $0.001 Inper ~~addition~~share, ~~under~~ ~~the~~of ~~terms~~Veris (“Veris Common Stock”) and warrants to purchase 1,800,000 shares of ~~our~~Veris ~~convertible~~Common ~~debt~~Stock (as“Veris ~~amended~~Warrants”), asat a purchase price of ~~January~~$1.40 17per share of Veris Common Stock. On the same day, Veris consummated the June 2025) Offering, wegenerating ~~are~~gross ~~required~~proceeds to ~~elect~~Veris ~~that~~of ~~these~~approximately ~~payments~~$2.5 million. The proceeds of the offering will be ~~made~~used into ~~cash~~continue development activities related to Veris’ implantable physiological monitor and for general working capital purposes.

The Veris ~~Cancer~~ ~~Care~~Warrants ~~Platform~~become exercisable six months after issuance and expire on the earlier of (i) the five-year anniversary of the initial exercise date and (ii) the 60th day following receipt by Veris of FDA approval of its implantable physiological monitor. The Veris Warrants have an exercise price of $1.40 per share, subject to adjustment under certain circumstances.

~~On June 13, 2024, we announced that~~ PAVmed/Veris ~~and~~Financing a(February ~~National~~2025) ~~Cancer Institute-Designated Comprehensive Cancer Center launched a pilot program and has enrolled the first patients from such center in such program on the Veris Cancer Care Platform.~~

8On February 18, 2025, the Company and Veris, entered into subscription agreements (each, a “Subscription Agreement”) with certain accredited investors (collectively, the “Investors”), pursuant to which the Company agreed to sell and the Investors agreed to purchase (the “Offering”) 85,812 shares of the Company’s common stock and pre-funded warrants to purchase 25,225 shares of the Company’s common stock (the “Pre-Funded Warrants”), at a purchase price of $21.345 per share or warrant share (as applicable). In addition, Veris agreed to issue to each Investor approximately 6.098 shares of Veris Common Stock for each share or warrant share (as applicable) purchased by such Investor, for an aggregate of 677,143 shares of Veris Common Stock. On February 21, 2025, the Company consummated the Offering, generating gross proceeds to the Company of $2.37 million. The proceeds of the offering will be used to resume development activities related to Veris’ implantable physiological monitor and for general working capital purposes.

~~Financing~~The Pre-Funded Warrants were exercised as of June 19, 2025.

~~PAVmed/Veris Common Stock Offering~~10

~~On February~~PAVmed ~~18,~~ATM 2025, the Company and Veris entered into subscription agreements (each, a “Subscription Agreement”) with certain accredited investors (collectively, the “Investors”), pursuant to which the Company agreed to sell and the Investors agreed to purchase (the “Offering”) 2,574,350 shares of the Company’s common stock and pre-funded warrants to purchase 756,734 shares of the Company’s common stock (the “Pre-Funded Warrants”), at a purchase price of $0.7115 per share or warrant share (as applicable). In addition, Veris agreed to issue to each Investor approximately 0.2033 shares of Veris’ common stock for each share or warrant share (as applicable) purchased by such Investor, for an aggregate of 677,143 shares of Veris’ common stock. On February 21, 2025, the Company consummated the Offering, generating gross proceeds to the Company of $2.37 million. The proceeds of the offering will be used to resume development activities related to Veris’ implantable physiological monitor and for general working capital purposes.

~~The Subscription~~On ~~Agreement~~April ~~contains customary representations~~17, ~~warranties~~2025, ~~covenants and indemnities of~~ the Company ~~and~~entered ~~the~~into ~~Investors, as well as~~ a ~~covenant~~Sales byAgreement (the ~~Company~~“Sales toAgreement”) ~~provide the Investors~~ with ~~protection~~Maxim ~~against~~Group ~~subsequent~~LLC, ~~equity~~as ~~raises~~sales byagent ~~the Company or Veris at a lower purchase price~~ (~~solely~~“Maxim”), topursuant ~~the extent the Investors continue~~ to ~~hold~~which the ~~shares~~Company ~~issued~~may inoffer ~~the~~and ~~Offering)~~sell, ~~with~~from ~~such protection~~time to betime ~~effected~~ through ~~the~~or ~~issuance~~to ofMaxim, ~~additional~~ shares of ~~Veris’~~its common stock. InUnder ~~addition,~~ the ~~Company~~Sales ~~(i) agreed~~Agreement, ~~to solicit~~ the ~~affirmative~~Company ~~vote~~may ofnot ~~its~~issue ~~stockholders~~or bysell nothrough ~~later~~Maxim ~~than~~a ~~its~~dollar ~~next~~amount ~~meeting~~ of ~~stockholders,~~shares ~~which~~that ~~will~~would beexceed ~~held~~$2.88 ~~no later~~million ~~than June 30, 2025, for approval, for the purposes~~ of ~~the~~shares. ~~rules of~~ The ~~Nasdaq~~Company ~~Stock~~will ~~Market~~pay ~~LLC~~Maxim ~~(“Nasdaq”),~~a ofcommission ~~the issuance~~ of ~~all of the shares underlying the Pre-Funded Warrants, and to hold additional meetings quarterly thereafter to the extent such approval is not obtained, (ii) granted the Investors a 100~~3.0% ~~participation right in future offerings~~ of ~~equity securities of~~ the ~~Company~~aggregate orgross ~~its majority-owned~~sales ~~subsidiaries,~~prices ~~subject to existing participation rights~~ of the ~~Company’s debt holder, and (iii) agreed not to incur, and not to permit its majority-owned subsidiaries to incur, any indebtedness until August 18, 2026, subject to certain exceptions~~shares. InThe ~~accordance with the Subscription Agreement, the~~ Company ~~also~~intends ~~entered into a registration rights agreement (the “Registration Rights Agreement”) with the Investors, pursuant~~ to ~~which~~use the ~~Company~~net ~~agreed~~proceeds tofrom ~~file~~any asuch ~~registration statement~~sales ~~covering~~for ~~the~~working ~~resale~~capital ofand ~~the~~general ~~shares~~corporate ~~of the Company’s common stock issued in the Offering, including the shares underlying the Pre-Funded Warrants~~purposes.

~~The Pre-Funded~~This ~~Warrants~~facility ~~become~~replaced ~~exercisable upon~~ the ~~receipt~~“at of the stockholder approval described above, expire on February 18, 2030, and have an exercise price of $0.001 per share, subject to adjustment as described below. The Pre-Funded Warrants may be exercised for cash, or on a cashless basis. In the event the Pre-Funded Warrants are exercised on a cashless basis, the holder will be entitled to receive a number of shares of the Company’s common stock equal to (x) the excess of the market” ~~value~~facility ofPAVmed ~~the~~previously ~~Company’s~~maintained ~~common~~with ~~stock over~~Cantor ~~the exercise price, multiplied by~~ (~~y) the number of shares as to~~ which ~~the~~facility ~~Pre-Funded~~was ~~Warrant is being exercised, divided by (z) the market value of the Company’s common stock. The exercise price and number and type of securities or other property issuable~~ on ~~exercise~~substantially ~~of the Pre-Funded Warrants may be adjusted in certain circumstances, including in the event of a stock split or combination, stock dividend, or a recapitalization, reorganization, merger or~~ similar ~~transaction~~terms). In addition, a holder of the Pre-Funded Warrants will be entitled to participate in rights offerings or pro rata distributions by the Company. However, there will be no adjustment for issuances of shares of common stock at a price below the exercise price.

~~The lead~~Lucid ~~investor~~Diagnostics in— ~~the~~Confidentially ~~Offering~~Marketed ~~also~~Public ~~agreed~~Offering ~~with the Company that it would, with respect to the election of the Company’s directors, vote its shares of the Company’s common stock~~ (~~including~~September ~~those exercisable in respect of their Pre-Funded Warrants~~2025) ~~in accordance with the Company’s board’s recommendations.~~

~~Nasdaq~~On ~~Compliance~~September ~~with~~11, ~~Stockholders’~~2025, ~~Equity Continued~~Lucid ~~Listing~~closed ~~Standard~~on the sale of 28,750,000 shares of its common stock, pursuant to its previously announced offering of shares of common stock at a price of $1.00 per share (the “Lucid September CMPO”). The net proceeds from the Lucid September CMPO, after deducting the underwriting discount and other expenses of the Lucid September CMPO, were approximately $27.0 million. Lucid is using the net proceeds from the Lucid September CMPO for working capital and general corporate purposes.

OnLucid ~~February~~ATM ~~14,~~Facility 2025, the Company received a notification letter from the Nasdaq Listing Qualifications Department, stating that the Company had regained compliance with the Nasdaq continued listing standard under Nasdaq Listing Rule 5550(b)(1), which requires, among other things, that the Company maintain at least $2.5 million in stockholders’ equity.

AsOn ~~previously~~May ~~disclosed~~30, ~~on March 7~~2025, ~~2024,~~Lucid ~~the~~entered ~~Company~~into ~~received~~ a ~~notice~~Controlled ~~from~~Equity ~~the~~Offering ~~Nasdaq~~Agreement ~~Listing Qualifications Department stating that, for the prior 30 consecutive business days~~ (~~through~~also ~~March~~“ATM” 6,or ~~2024),~~ “at-the -market” ~~value~~offering) ofbetween ~~the~~Lucid ~~Company’s~~and ~~listed~~Maxim ~~securities~~Group ~~had~~LLC ~~been~~for ~~below~~up ~~the~~to ~~minimum of~~ $3525 million ~~required for~~of ~~continued~~its ~~inclusion~~common onstock ~~the~~that ~~Nasdaq~~may ~~Capital~~be ~~Market~~offered ~~under~~and ~~Nasdaq~~sold ~~Listing~~from ~~Rule 5550(b)(2). The Company did not regain compliance with the rule during the~~ time ~~period~~to ~~originally allotted under Nasdaq rules~~time. ~~Accordingly,~~Subsequent ~~the~~to December ~~Company timely requested a hearing before a Nasdaq Hearings Panel (the “Panel”)~~31, ~~which~~2025 as ~~took~~of ~~place~~March ~~on October 29~~27, ~~2024. On November 8~~2026, ~~2024,~~Lucid ~~the~~sold ~~Panel granted the Company an extension~~4, ~~until January 31~~161,747 ~~2025,~~shares tothrough ~~regain~~its ~~compliance with~~ at-the-market ~~Nasdaq~~equity ~~continued~~facility ~~listing~~for ~~standards~~net ~~under~~proceeds ~~Nasdaq~~of ~~Listing~~approximately ~~Rule~~$5.3 ~~5550(b)(1)~~million, in ~~lieu~~after payment of ~~Nasdaq~~3% ~~Listing Rule 5550(b)(2)~~commissions.

The Company achieved compliance through (1) the exchange of secured convertible notes with a principal amount outstanding of $22.3 million for shares of Series C convertible preferred stock, par value $0.001 (the “Series C Preferred Stock”), which was consummated on January 17, 2025, (2) the issuance of additional shares of Series C Preferred Stock for an aggregate purchase price of $2.653 million, which was consummated on January 24, 2025, and (3) a reduction in operating expenses as a result of the Company’s completed deconsolidation of Lucid from its balance sheet, each of which transactions was previously disclosed and is outlined in more detail below. As a result, the Company met the terms of the Panel’s decision.11

~~Series C~~Intellectual ~~Preferred~~Property Stock Debt Exchange; Amendments to September 2022 Convertible Note. Under a Securities Purchase Agreement dated March 31, 2022, the Company issued a Senior Secured Convertible Note dated April 4, 2022, referred to herein as the “April 2022 Senior Convertible Note”, and a Senior Secured Convertible Note dated September 8, 2022, referred to herein as the “September 2022 Senior Convertible Note”.

~~On November~~Our ~~15,~~business ~~2024,~~will ~~the~~depend ~~Company~~on ~~entered~~proprietary ~~into~~medical andevice ~~Exchange~~and ~~Agreement~~diagnostic ~~(the~~technologies ~~“Debt~~to ~~Exchange~~commercialize. ~~Agreement”)~~We ~~with~~own ~~the~~or ~~holder~~have (the ~~“Holder”) of~~right ~~the~~to ~~April~~use ~~2022~~intellectual ~~Senior~~property ~~Convertible~~rights, ~~Note~~such ~~and~~as ~~the~~patents, ~~September~~trademarks, ~~2022~~copyrights, ~~Senior~~trade ~~Convertible~~secrets ~~Note.~~and ~~The~~know-how, ~~Debt~~pertaining ~~Exchange~~to ~~Agreement~~our ~~provided~~EsoCheck ~~for the exchange of $22.3 million in principal amount of the April 2022 Senior Convertible Note~~ and ~~the~~EsoGuard ~~September~~technology, ~~2022~~our ~~Senior~~Veris ~~Convertible~~technology ~~Note~~ and ~~interest thereon for 22~~PortIO,~~347~~ ~~shares~~among ofother ~~Series~~technologies Cand ~~Preferred Stock~~products.

~~On January~~We ~~17,~~intend ~~2025,~~to ~~after~~vigorously ~~satisfaction~~protect ofour ~~all~~proprietary ~~conditions~~technologies’ tointellectual ~~closing~~property ~~the~~rights ~~Exchange~~in patents, ~~the~~trademarks ~~parties~~and ~~consummated~~copyrights, as available through registration in the ~~Exchange~~United States and internationally. ~~Following consummation~~Patent protection and other proprietary rights are thus essential to our business. Each of ~~the~~our ~~Exchange,~~technologies ~~the~~is ~~April~~protected ~~2022~~by ~~Senior~~multiple ~~Convertible~~patent ~~Note~~families. ~~was~~For ~~satisfied~~select intechnologies ~~full~~shown below, ~~and~~patents ~~the~~have ~~outstanding~~been ~~principal~~granted ~~balance~~with of protection extending to at least the ~~remaining~~date ~~September~~shown ~~2022~~below ~~Senior~~(although ~~Convertible~~currently ~~Note~~pending ~~was~~patent ~~approximately~~applications, ~~$6.6~~both ~~million~~foreign and domestic, provide protection beyond such date in each instance).

Technology		Year
EsoCheck		May 2034
EsoGuard		August 2024
Veris Health		November 2038
EsoCure		March 2036
CarpX		November 2037
PortIO		November 2035

~~Under the~~Our ~~Debt~~policy ~~Exchange~~is ~~Agreement discussed above, effective as of consummation on the Exchange as of January 17, 2025, the Company also agreed~~ to ~~certain~~aggressively ~~amendments~~file ~~and~~patent ~~modifications~~applications to ~~the~~protect ~~September~~our ~~2022~~proprietary ~~Convertible~~technologies ~~Note,~~ including, ~~without~~inventions limitation, that the conversion price thereunder was reset to $1.068; that the maturity date was extended to December 31, 2025; that any change of control or disposition by the Company of its shares of Lucid common stock would require the prior written consent of the Required Holders (as defined in the September 2022 Convertible Note); certain other terms and ~~conditions~~improvements ~~regarding payments under the MSA and the application of the same (including that all MSA payments from Lucid must be made in cash); that the Company waives its right~~ to redeem the September 2022 Convertible Note so long as any shares of Series C Preferred Stock are outstanding; that the Holder waives, until December 31, 2025, the financial covenants under the September 2022 Convertible Note requiring that (i) the amount of the Company’s available cash equal or exceed $8inventions.0 ~~million~~We ~~at all~~seek ~~times,~~patent ~~(ii) the ratio of (a) the outstanding principal amount of the September 2022 Convertible Note~~protection, accrued and unpaid interest thereon and accrued and unpaid late charges to (b) the Company’s average market capitalization over the prior ten trading days, not exceed 30%, and (iii) that the Company’s market capitalization shall at no time be less than $75 million; and that so long as ~~any shares of Series C Preferred Stock remain outstanding~~appropriate, the Holder will be entitled to exchange all, or any portion, of the September 2022 Convertible Note (including any interest that would accrue thereon through the maturity date thereof) into shares of Lucid common stock held by the Company, at an exchange price per share of Lucid common stock equal to $0.85 per share (as adjusted for stock splits, stock dividends, stock combinations, recapitalizations and similar events), subject to certain beneficial ownership limitations.on:

~~The~~● ~~key~~the ~~terms~~product ofitself ~~the~~including ~~Series~~all Cembodiments ~~Preferred~~with ~~Stock~~future ~~can~~commercial bepotential; ~~found~~● onthe ~~Exhibit~~methods ~~4.1~~of tousing ~~this~~the ~~Form~~product; ~~10-K~~and ● the methods of manufacturing the product.

~~Series C~~In ~~Preferred~~addition ~~Stock~~to ~~Security~~filing ~~Purchase~~and ~~Agreement.~~prosecuting Onpatent ~~November~~applications ~~20,~~in ~~2024,~~ the ~~Company~~United ~~entered~~States, ~~into~~we aintend ~~Securities~~to ~~Purchase Agreement~~file ~~(the~~counterpart ~~“Series~~patent Capplications ~~Securities~~in ~~Purchase~~other ~~Agreement”)~~countries ~~with~~worldwide ~~the~~where ~~Holder.~~there ~~The~~is ~~Series~~a Cvalue ~~Securities~~in ~~Purchase~~doing ~~Agreement provides~~so. ~~for~~Foreign ~~the~~filings ~~purchase~~can ofbe ~~2,653~~cumbersome ~~shares~~and ofexpensive, ~~Series~~and Cwe ~~Preferred~~will ~~Stock~~pursue atsuch afilings ~~price~~when ofwe ~~$1,000~~believe ~~per~~they ~~share,~~are ~~with~~warranted ~~the~~as ~~purchase~~we ~~price~~try to ~~be satisfied~~balance ~~through~~our ~~the~~international ~~cancellation~~commercialization ofplans ~~$2.6~~with ~~million~~our ofdesire ~~certain~~to ~~unsecured~~protect ~~debt obligations owed by~~ the ~~Company~~global tovalue ~~the~~of ~~Holder (~~the ~~“Purchase”)~~ technology.

~~On January~~The ~~24,~~term ~~2025~~of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we file, ~~after~~the ~~satisfaction~~patent term is 20 years from the earliest date of ~~all~~filing ~~conditions~~a tonon-provisional ~~closing~~patent application. In the ~~Purchase~~United States, a patent’s term may be shortened if a patent is terminally disclaimed over another patent or as a result of delays in patent prosecution by the ~~parties~~patentee, ~~consummated~~and a patent’s term may be lengthened by patent term adjustment (PTA), which compensates a patentee for administrative delays by the ~~Purchase~~U.S. Patent and Trademark Office (“USPTO”) in granting a patent, or patent term extension, which restores time lost due to regulatory delays.

~~Lucid~~We ~~Deconsolidation.~~intend Onto ~~September~~continuously ~~10, 2024,~~reassess ~~the Company determined that Lucid~~ and ~~its~~fine-tune ~~subsidiaries~~our ~~will~~intellectual beproperty ~~deconsolidated~~strategy ~~from~~in ~~the~~order ~~Company’s~~to ~~financial~~fortify ~~statements~~our asposition ~~of September 10, 2024, as a result of the changes~~ in the ~~composition~~United ofStates ~~the~~and ~~Company’s~~internationally. ~~board~~Prior ~~of directors discussed above, in combination with the Company ceasing~~ to ~~have~~acquiring ~~control~~or ~~over~~licensing a ~~majority~~technology offrom ~~the voting power of Lucid. As~~ a ~~result~~third ~~of these events~~party, ~~the~~we ~~Company~~will isevaluate ~~considered to cease to have control over Lucid for~~ the ~~purposes~~existing ofproprietary ~~U.S.~~rights, ~~generally~~our ~~accepted~~ability ~~accounting~~to ~~principles,~~adequately ~~even~~obtain ~~though~~and itprotect ~~continues~~these torights ~~own,~~ and ~~has~~the ~~not~~likelihood ~~disposed~~or ~~any~~possibility of ~~its,~~infringement ~~31,302,444~~upon ~~shares~~competing ofrights ~~common stock~~ of ~~Lucid~~others.

~~Nasdaq Notice of Noncompliance with the Minimum Bid Price Requirement~~12

~~On January~~We ~~23,~~also ~~2025,~~rely ~~the~~upon ~~Company~~trade ~~received~~secrets, aknow-how, ~~notice~~continuing ~~from~~technological ~~the Listing Qualifications Department of Nasdaq stating that~~innovation, ~~for~~and ~~the~~upon ~~prior~~licensing ~~30 consecutive business days (through January 22~~opportunities, ~~2025),~~to ~~the~~develop ~~closing~~and ~~bid~~maintain ~~price~~our ofcompetitive ~~the Company’s common stock had been below the minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2)~~position. ~~The notification~~We ~~letter~~intend ~~stated that the Company would be afforded 180 calendar days (until July 22, 2025)~~ to ~~regain~~protect ~~compliance.~~our Inproprietary ~~order to~~rights ~~regain~~through ~~compliance, the closing bid price of the Company’s common stock must be at least $1 for~~ a ~~minimum~~variety of ~~ten consecutive business days. The notification letter also stated that~~methods, inincluding ~~the~~confidentiality ~~event~~agreements ~~the~~and/or ~~Company~~proprietary ~~does~~information ~~not~~agreements ~~regain~~with ~~compliance~~suppliers, ~~within~~employees, ~~the initial 180-day period~~consultants, ~~the~~independent ~~Company~~contractors ~~may~~and beother ~~eligible~~entities ~~for~~who anmay ~~additional~~have ~~180-day~~access ~~period. If the Company is not eligible for the additional 180-day period, or if it appears~~ to ~~the~~proprietary ~~Nasdaq~~information. ~~staff~~We ~~that the Company~~ will ~~not~~generally berequire ~~able~~employees to ~~cure~~assign ~~the~~patents ~~deficiency,~~and ~~the~~other ~~Nasdaq~~intellectual ~~Listing Qualifications~~property ~~Department~~to ~~will~~us ~~provide~~as ~~notice~~a ~~after~~condition ~~the end~~ of ~~the~~employment ~~initial~~with ~~180-day~~us. ~~period~~All ~~that~~of ~~the~~our ~~Company’s~~consulting ~~securities~~agreements will be ~~subject~~pre-emptively assign to ~~delisting.~~us ~~The~~all ~~Nasdaq~~new ~~notification~~and ~~has~~improved nointellectual ~~effect~~property atthat ~~this~~arise ~~time~~during on the ~~listing~~term of the ~~Company’s common stock or Series Z warrants, and the common stock and Series Z warrants will continue to trade uninterrupted under the symbol “PAVM” and “PAVMZ,” respectively~~agreement.

~~2014 Long-Term~~PAVmed ~~Incentive~~also ~~Plan~~has (directly or through its subsidiaries) proprietary rights to a range of trademarks, including, among others, PAVmed™, Lucid Diagnostics™, LUCID™, VERIS™, EsoCheck®, EsoGuard®, EsoCheck Cell Collection Device®, Collect + Protect®, and PortIO™. (Solely as a matter of convenience, trademarks and trade names referred to herein may or may not be accompanied with the requisite marks of “™” or “®”. However, the absence of such marks is not intended to indicate, in any way, PAVmed Inc. or its subsidiaries will not assert, to the fullest extent possible under applicable law, their respective rights to such trademarks and trade names.)

~~In January~~Health ~~2025,~~Insurance ~~the~~Coverage ~~Company accepted from employees the voluntary forfeiture of approximately 494,202 of previously granted Company stock options, each with an exercise price greater than $4.00 per share~~ and ~~collectively~~Reimbursement ~~with a weighted average exercise price of $23.38 per share. None of the forfeitures were from Section 16 officers or board members.~~

~~Authorized Share~~Our ~~Increase~~ability to successfully commercialize our products will depend in part on the extent to which governmental authorities, private health insurers and other third-party payors provide coverage for and establish adequate reimbursement levels for the procedures during which our products are used.

~~On January~~In ~~15,~~the ~~2025~~United States, third-party payors continue to implement initiatives that restrict the ~~Company~~use ~~received~~of ~~shareholder~~certain ~~approval~~technologies to ~~amend~~those ~~its~~that ~~certificate~~meet ofcertain ~~incorporation,~~clinical asevidentiary ~~amended~~requirements. In addition to uncertainties surrounding coverage policies, there are periodic changes to ~~increase~~reimbursement. ~~the~~Third-party ~~total number~~payors ofregularly ~~shares~~update ofreimbursement ~~common~~amounts ~~stock~~and ~~the~~also ~~Company~~from istime ~~authorized~~to time revise the methodologies used to ~~issue~~determine byreimbursement ~~200~~amounts. ~~million~~This ~~shares~~includes ~~from~~annual 50updates ~~million~~to ~~shares~~payments to ~~250~~physicians, ~~million~~hospitals ~~shares~~and ambulatory surgery centers for procedures during which our products are used. An ~~amendment~~example ~~effecting~~of ~~such~~payment ~~change~~updates ~~was~~is ~~filed~~the ~~with~~Medicare program’s updates to hospital and physician payments, which are done on an annual basis using a prescribed statutory formula. In the ~~Secretary~~past, ofwhen ~~State~~the application of ~~Delaware~~the onformula ~~January~~resulted 15in lower payment, ~~2025~~Congress has passed interim legislation to prevent the reductions.

10A product’s reimbursement profile, both in the U.S. and internationally, is an important component of the product’s commercial opportunity. We prefer projects with existing reimbursement codes, the opportunity to seek reimbursement under higher-value surgical procedure codes or the potential to seek reimbursement under narrow, product-specific codes as opposed to bundled procedure codes. For those products that have high strategic value, but with less defined reimbursement, we have engaged reimbursement experts and support from industry associations to accelerate the acquisition of satisfactory reimbursement levels.

~~Lucid Diagnostics — Registered Direct Offering~~13

~~On March~~Competition 5,for ~~2025,~~New ~~Lucid~~Medical ~~closed~~Device onInnovation ~~the sale of 13,939,331 shares of its common stock, pursuant to its previously announced offering of shares of common stock at a price of $1.10 per share (the “Lucid Offering”).~~

Developing and commercializing new products is highly competitive. The ~~net~~ ~~proceeds~~market ofis ~~the~~characterized ~~Lucid~~by ~~Offering,~~extensive ~~after~~research ~~deducting~~and ~~the~~clinical ~~estimated~~efforts ~~placement~~and ~~agent’s~~rapid ~~fees~~technological change. We face intense competition worldwide from medical device, biomedical technology and ~~other~~medical ~~expenses~~products ofand ~~the~~combination ~~Lucid~~products ~~Offering~~companies, ~~was~~ ~~approximately~~including ~~$14.5~~major ~~million~~medical products companies. ~~Lucid~~We ~~intends~~may be unable to ~~use~~respond to technological advances through the ~~net~~development ~~proceeds~~and ~~from~~introduction of new products. Most of our existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing and technological resources. These competitors may also be in the ~~Lucid~~process ~~Offering~~of seeking FDA or other regulatory approvals, or patent protection, for ~~working~~new ~~capital~~products. Our competitors may commercialize new products in advance of our products. Our products also face competition from numerous existing products and ~~other~~procedures, ~~general corporate~~some ~~purposes~~of which currently are considered part of the standard of care. We believe the principal competitive factors in our markets are:

~~In connection~~● ~~with~~ the ~~Lucid~~quality ~~Offering,~~of ~~Lucid~~outcomes ~~suspended~~for ~~its~~medical ~~“at~~conditions; ~~the~~● ~~market~~acceptance ~~offering”~~by ~~program.~~surgeons Inand ~~November 2022, Lucid entered into a Controlled Equity Offering℠ Sales Agreement (~~the ~~“Lucid~~medical ~~Sales~~device ~~Agreement”)~~market ~~with~~generally; ~~Cantor~~● ~~Fitzgerald &~~ease ~~Co.~~of ~~(“Cantor”).~~use ~~Pursuant~~and toreliability; ~~the~~● ~~Sales~~technical ~~Agreement,~~leadership ~~from~~and ~~time~~superiority; to● ~~time,~~effective ~~Lucid~~marketing ~~may offer~~ and ~~sell~~distribution; ~~shares~~● ofspeed ~~its common stock~~ to or through Cantor, acting as sales agent or principal. Sales of Lucid’s common stock by Cantor, if any, under the Sales Agreement may be made by any method permitted by law and deemed to be an “at the market; offering” as defined in Rule 415(a)(4) promulgated under the Securities Act (the “Lucid ATM Offering”). Lucid filed a prospectus supplement dated December 6, 2022 (the “Lucid ATM Prospectus Supplement”), for the offer and ~~sale~~● ofproduct ~~shares of its common stock having an aggregate offering~~ price of up to $6,500,000 in the Lucid ATM Offering. Effective as of March 4, 2025, Lucid terminated the Lucid ATM Prospectus Supplement. Lucid will not make any sales of common stock in the Lucid ATM Offering unless and ~~until~~qualification afor ~~new prospectus~~coverage ~~or prospectus supplement is filed. Other than the termination of the Lucid ATM Prospectus Supplement, the Lucid Sales Agreement remains in full force~~ and ~~effect~~reimbursement.

~~Lucid Diagnostics~~We —will ~~Debt~~also ~~Refinancing~~compete in the marketplace to recruit and retain qualified scientific, management and sales personnel, as well as in acquiring technologies and licenses complementary to our products or advantageous to our business. We are aware of several companies that compete or are developing technologies in our current and future products areas. In order to compete effectively, our products will have to achieve market acceptance, receive adequate insurance coverage and reimbursement, be cost effective and be simultaneously safe and effective.

On November 22, 2024, Lucid closed on the sale of $21.975 million in principal amount of 12.0% Senior Secured Convertible Notes due 2029 (collectively, the “Lucid 2024 Convertible Notes”), in a private placement, to certain accredited investors (the “Lucid 2024 Note Investors”). The sale of the Lucid 2024 Convertible Notes was completed pursuant to the terms of the previously disclosed Securities Purchase Agreement, dated as of November 12, 2024 (the “Lucid 2024 SPA”), between Lucid and the Lucid 2024 Note Investors. Lucid realized gross proceeds of $21.95 million and, after giving effect to the repayment in full of the Lucid 2023 Convertible Note (as defined below), net proceeds of $18.3 million from the sale of the Lucid 2024 Convertible Notes.14

~~Lucid used~~Government aRegulation portion of the proceeds from the sale of the Lucid 2024 Convertible Notes to repay the Senior Convertible Note (the “Lucid 2023 Convertible Note”) issued pursuant to that certain Securities Purchase Agreement, dated as of March 13, 2023. Pursuant to the terms of the Lucid 2023 Convertible Note, on November 22, 2024, Lucid redeemed the Lucid 2023 Convertible Note by paying the contractual redemption price of approximately $3.7 million.

11Key U.S. Regulation

~~PAVmed Inc.~~FDA ~~ATM~~Regulation ~~Facility~~

~~In December~~Before ~~2021, we entered into an “at-the-market offering” for up to $50 million of our common stock that may be offered~~ and ~~sold~~after ~~under~~approval aor ~~Controlled~~clearance ~~Equity~~in ~~Offering~~the ~~Agreement~~United ~~between us and Cantor. In March 2023~~States, ~~the~~our ~~“at-the-market~~products ~~offering” became~~are subject to ~~General~~extensive ~~Instruction~~regulation ~~I.B.6~~by ofthe ~~Form~~FDA ~~S-3, which limits sales of our securities~~ under ~~this~~the ~~instruction~~FDCA inand/or ~~any 12-month period to one-third of~~ the ~~aggregate~~Public ~~market~~Health ~~value~~Service ~~of our public float (unless our public float rises to $75 million or more~~Act, inas ~~which case~~well ~~the~~as ~~instruction~~by ~~will~~other ~~cease~~regulatory ~~to apply)~~bodies. AsFDA aregulations ~~result of this limitation and our then-current public float~~govern, inamong ~~May~~other ~~2023~~things, ~~we amended our “at-~~the~~-market~~ ~~offering” to cover up to an additional $18 million of our common stock. In the year ended December 31~~development, ~~2024,~~ ~~the Company sold 1~~testing,~~032,298~~ ~~shares through its at-the-market equity facility for net proceeds of approximately $1.3 million~~manufacturing, ~~after payment of 3% commissions. Subsequent to December 31~~labeling, ~~2024~~safety, ~~as of March 20~~storage, ~~2025~~recordkeeping, ~~the~~market ~~Company~~clearance ~~sold~~or 1approval,~~210,704~~ ~~shares~~advertising ~~through their~~and ~~at-market~~promotion, ~~equity~~import ~~facility~~and ~~for~~export, ~~net~~marketing ~~proceeds~~and ~~of approximately $0.8 million~~sales, ~~after~~and ~~payment~~distribution of 3%medical ~~commissions~~devices and products.

~~Intellectual Property~~In the United States, medical devices are subject to varying degrees of regulatory control and are classified in one of three classes depending on the extent of controls the FDA determines are necessary to reasonably ensure their safety and efficacy:

~~Our business~~● ~~will~~Class ~~depend~~I: ongeneral ~~proprietary~~controls, ~~medical~~such ~~device~~as labeling and ~~diagnostic~~adherence ~~technologies~~ to ~~commercialize.~~quality Wesystem ~~own~~regulations; or● ~~have~~Class ~~the~~II: ~~right~~special controls, pre-market notification (often referred to ~~use intellectual~~as ~~property~~a ~~rights~~510(k) application), specific controls such as ~~patents~~performance standards, ~~trademarks~~patient registries, ~~copyrights~~post-market surveillance, ~~trade~~additional ~~secrets~~controls ~~and~~such ~~know-how,~~as ~~pertaining~~labeling and adherence to ~~our~~quality ~~EsoCheck~~system regulations; and ~~EsoGuard~~ ~~technology,~~● ~~our~~Class ~~Veris~~III: ~~technology~~special controls and ~~our~~approval ~~EsoCure,~~of ~~CarpX~~a ~~and~~de ~~PortIO~~novo ~~products~~request or PMA application, ~~among~~likely ~~other~~with ~~technologies~~clinical ~~and products~~data requirements.

~~We intend~~In general, the higher the classification, the greater the time and cost to ~~vigorously~~obtain ~~protect~~approval ~~our~~to ~~proprietary~~market. ~~technologies’~~There ~~intellectual~~are ~~property~~no ~~rights~~“standardized” inrequirements ~~patents~~for approval, ~~trademarks~~even ~~and~~within ~~copyrights, as~~each ~~available~~class. ~~through~~For ~~registration~~example, inFDA ~~the~~could ~~United~~grant ~~States~~510(k) ~~and~~status, ~~internationally.~~but ~~Patent~~require ~~protection~~a ~~and~~human ~~other~~clinical ~~proprietary~~trial, ~~rights~~a ~~are~~typical ~~thus~~requirement ~~essential to~~of ~~our~~a ~~business~~PMA. WeThey ~~currently~~could ~~have~~also ~~applied~~initially ~~for,~~assign ~~license~~a ordevice ~~own~~Class 55III ~~domestic~~status ~~and~~but ~~foreign~~end ~~patents~~up ~~across~~clearing 11a ~~families~~device ofas ~~products,~~a ~~including patents~~510(k) ~~protecting~~device ~~our~~or ~~EsoCheck,~~under ~~EsoGuard~~a ~~and~~de ~~Veris~~novo ~~technology~~classification pathway if certain requirements are met. ~~Each~~The range of the ~~technologies~~number ~~noted~~and ~~below~~expense isof ~~protected~~the byvarious ~~multiple~~requirements ~~families~~is significant. The ~~date~~quickest ~~the~~and ~~patents~~least ~~protecting~~expensive ~~certain~~pathway would be 510(k) clearance with a review of ~~our~~existing ~~owned~~bench and ~~licensed~~animal ~~technology~~data. ~~will~~A ~~first~~de ~~begin~~novo toclassification ~~expire~~pathway iswould ashave ~~set~~a ~~forth~~similar incost ~~the~~to ~~table below~~seeking 510(~~although~~k) ~~currently~~clearance, ~~pending~~but ~~patent~~with ~~applications,~~a ~~both~~slightly ~~foreign~~longer review timeline. The longest and ~~domestic,~~most ~~provide~~expensive ~~protection~~path ~~beyond~~would ~~such~~be ~~date~~a inPMA ~~each~~with ~~instance)~~extensive randomized human clinical trials. ~~For~~ ~~EsoGuard~~We cannot predict fully how FDA will classify our products, ~~additional~~nor ~~patents~~predict ~~have~~what ~~been~~requirements ~~issued~~will ~~that~~be ~~offer~~placed ~~protection~~upon ~~until~~us atto ~~least~~obtain ~~2037~~market clearance or approve our products at all.

Technology	Year
EsoCheck	May 2034
EsoGuard	August 2024
Veris Health	November 2038
EsoCure	March 2036
CarpX	November 2037
PortIO	November 2035

To request marketing authorization by means of a 510(k) clearance, we must submit a pre-market notification demonstrating the proposed device is substantially equivalent to another currently legally marketed medical device, has the same intended use, and is as safe and effective as a currently legally marketed device and does not raise different questions of safety and effectiveness than does a currently legally marketed device. 510(k) submissions generally include, among other things, a description of the device and its manufacturing, device labeling, medical devices to which the device is substantially equivalent, safety and biocompatibility information, and the results of performance testing. In some cases, a 510(k) submission must include data from human clinical studies. Marketing may commence only when the FDA issues a clearance letter finding substantial equivalence. After a device receives 510(k) clearance, any product modification that could significantly affect the safety or effectiveness of the product, or would constitute a significant change in intended use, requires a new 510(k) clearance or, if the device would no longer be substantially equivalent, would require PMA, or possibly, a de novo pathway under section 513(f)(2) of the FDCA. In addition, any additional claims the Company wished to make at a later date may require a PMA. If the FDA determines the product does not qualify for 510(k) clearance, they will issue a Not Substantially Equivalent (“NSE”) letter, at which point the Company must submit and the FDA must approve a PMA or issue premarket clearance using the de novo before marketing can begin.

~~Our policy~~In is1997, tothe ~~aggressively~~Food ~~file~~and ~~patent~~Drug ~~applications~~Administration Modernization Act (“FDAMA”) added the de novo classification pathway under section 513(f)(2) of the FDCA, establishing an alternate pathway to ~~protect~~classify ~~our~~new ~~proprietary~~devices ~~technologies~~into ~~including~~Class ~~inventions~~I ~~and~~or ~~improvements~~II that had automatically been placed in Class III after receiving an NSE determination in response to ~~inventions~~a 510(k) submission. We ~~seek~~In ~~patent~~this ~~protection~~process, asa ~~appropriate~~sponsor who receives an NSE determination may, ~~on:~~within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act.

~~● the product itself including all embodiments with future commercial potential; ● the methods of using the product; and ● the methods of manufacturing the product.~~15

In ~~addition~~ to2012, ~~filing~~section ~~and~~513(f)(2) ~~prosecuting~~of ~~patent~~the ~~applications~~FDCA inwas ~~the~~amended ~~United~~by ~~States,~~section we607 ~~intend~~of tothe ~~file~~Food ~~counterpart~~and ~~patent~~Drug ~~applications~~Administration inSafety ~~other countries~~and ~~worldwide~~Innovation ~~where~~Act ~~there~~(“FDASIA”), isto provide a ~~value~~second inoption ~~doing~~for sode novo classification. ~~Foreign~~In ~~filings~~this ~~can~~second bepathway, ~~cumbersome~~a ~~and~~sponsor ~~expensive,~~who ~~and~~determines wethere ~~will~~is ~~pursue~~no ~~such~~legally ~~filings when~~marketed wedevice ~~believe~~upon ~~they~~which ~~are~~to ~~warranted~~base asa wedetermination ~~try~~of tosubstantial ~~balance~~equivalence ~~our~~may ~~international~~request ~~commercialization~~FDA ~~plans~~to ~~with~~make ~~our~~a ~~desire~~risk-based toclassification ~~protect~~of the ~~global value~~device under section 513(a)(1) of the ~~technology~~Act without first submitting a 510(k).

~~The term~~During ~~of individual patents depends upon~~ the ~~legal~~review ~~term~~ of ~~the~~a ~~patents~~510(k) insubmission, the ~~countries~~FDA inmay ~~which~~request ~~they~~more ~~are~~information ~~obtained.~~or Inadditional ~~most~~studies ~~countries in~~and ~~which~~may wedecide ~~file,~~ the ~~patent~~indications ~~term~~for iswhich 20we ~~years~~seek ~~from~~approval ~~the~~or ~~earliest~~clearance ~~date~~should ofbe ~~filing a non-provisional patent application~~limited. In ~~the United States~~addition, a ~~patent’s~~laws ~~term~~and ~~may~~regulations beand ~~shortened~~the ifinterpretation ~~a patent is terminally disclaimed over another patent or as a result~~ of ~~delays~~those inlaws ~~patent~~and ~~prosecution~~ regulations by the ~~patentee,~~FDA ~~and a patent’s term~~ may bechange ~~lengthened~~in ~~by patent term adjustment (PTA), which compensates a patentee for administrative delays by~~ the Ufuture.S. ~~Patent~~We ~~and~~cannot ~~Trademark~~foresee ~~Office~~what ~~(“USPTO”) in granting a patent~~effect, orif ~~patent term extension~~any, ~~which~~such ~~restores~~changes ~~time lost~~may ~~due~~have toon ~~regulatory delays~~us.

~~We intend~~Clinical toTrials continuously reassess and fine-tune our intellectual property strategy in order to fortify our position in the United States and internationally. Prior to acquiring or licensing a technology from a third party, we will evaluate the existing proprietary rights, our ability to adequately obtain and protect these rights and the likelihood or possibility of ~~infringement~~Medical ~~upon~~Technology ~~competing rights of others.~~

12One or more clinical trials may be necessary to support an FDA submission. Clinical studies of unapproved or uncleared medical devices or devices being studied for uses for which they are not approved or cleared (investigational devices) must be conducted in compliance with FDA requirements. If an investigational device could pose a significant risk to patients, the sponsor company must submit an Investigational Device Exemption (“IDE”) application to the FDA prior to initiation of the clinical study. An IDE application must be supported by appropriate data, such as animal and laboratory test results, showing it is safe to test the device on humans and the testing protocol is scientifically sound. The IDE will automatically become effective 30 days after receipt by the FDA unless the FDA notifies the company the investigation may not begin. Clinical studies of investigational devices may not begin until an institutional review board (“IRB”) has approved the study.

~~We also~~During ~~rely~~any ~~upon~~study, ~~trade~~the ~~secrets~~sponsor must comply with the FDA’s IDE requirements. These requirements include investigator selection, ~~know-how~~trial monitoring, ~~continuing~~adverse ~~technological~~event ~~innovation~~reporting, and ~~upon~~record ~~licensing~~keeping. ~~opportunities,~~The toinvestigators ~~develop~~must ~~and~~obtain ~~maintain our~~patient ~~competitive~~informed ~~position.~~consent, Werigorously ~~intend~~follow tothe ~~protect~~investigational ~~our~~plan ~~proprietary~~and ~~rights~~study ~~through~~protocol, acontrol ~~variety~~the disposition of ~~methods~~investigational devices, ~~including~~and ~~confidentiality~~comply ~~agreements and/or~~with ~~proprietary~~reporting ~~information~~and ~~agreements~~record ~~with~~keeping ~~suppliers,~~requirements. ~~employees~~We, ~~consultants~~the FDA, ~~independent~~or ~~contractors~~the ~~and~~IRB ~~other~~at ~~entities~~each ~~who~~institution ~~may have~~at ~~access~~which toa ~~proprietary~~clinical ~~information.~~trial Weis ~~will~~being ~~generally~~conducted ~~require~~may ~~employees~~suspend toa ~~assign~~clinical ~~patents~~trial ~~and~~at ~~other~~any ~~intellectual~~time ~~property~~for tovarious usreasons, as including a ~~condition~~belief ofthe ~~employment~~subjects ~~with~~are usbeing exposed to an unacceptable risk. ~~All~~During ofthe ~~our~~approval ~~consulting~~or ~~agreements~~clearance ~~will~~process, ~~pre-emptively~~the ~~assign~~FDA typically inspects the records relating to usthe ~~all~~conduct ~~new~~of ~~and~~one ~~improved~~or ~~intellectual property~~more ~~that~~investigational ~~arise~~sites ~~during~~participating in the ~~term~~study ofsupporting the ~~agreement~~application.

~~PAVmed also~~Post-Approval ~~has~~Regulation ~~(directly or through its subsidiaries) proprietary rights to a range~~ of ~~trademarks,~~Medical ~~including,~~Devices among others, PAVmed™, Lucid Diagnostics™, LUCID™, VERIS™, Oncodisc™, CarpX®, EsoCheck®, EsoGuard®, EsoCheck Cell Collection Device®, Collect + Protect®, EsoCure Esophageal Ablation Device™, and ~~PortIO™.~~Diagnostic ~~(Solely~~Tests as a matter of convenience, trademarks and trade names referred to herein may or may not be accompanied with the requisite marks of “™” or “®”. However, the absence of such marks is not intended to indicate, in any way, PAVmed Inc. or its subsidiaries will not assert, to the fullest extent possible under applicable law, their respective rights to such trademarks and trade names.)

~~Health Insurance~~After ~~Coverage~~a ~~and~~device ~~Reimbursement~~is cleared or approved for marketing, numerous regulatory requirements continue to apply. These include:

~~Our ability~~● tothe ~~successfully~~FDA ~~commercialize~~Quality ~~our~~Systems ~~products~~Regulation ~~will~~(QSR), ~~depend~~which ingoverns, ~~part~~among onother ~~the~~things, ~~extent~~how tomanufacturers ~~which~~design, ~~governmental~~test ~~authorities~~manufacture, ~~private~~exercise ~~health insurers~~quality control over, and ~~other~~document ~~third-party~~manufacturing ~~payors~~of ~~provide~~their ~~coverage~~products; ~~for~~● labeling and ~~establish~~claims ~~adequate~~regulations, ~~reimbursement~~which ~~levels~~prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling; and, ● the ~~procedures~~Medical ~~during~~Device Reporting regulation, which ~~our~~ ~~products~~requires ~~are~~reporting ~~used~~to FDA of certain adverse experience associated with use of the product.

~~In the~~We ~~United~~will ~~States, third-party payors~~ continue to ~~implement~~be ~~initiatives~~subject ~~that restrict the use of certain technologies~~ to ~~those~~inspection ~~that~~by ~~meet certain~~FDA ~~clinical evidentiary requirements. In addition~~ to uncertainties surrounding coverage policies, there are periodic changes to reimbursement. Third-party payors regularly update reimbursement amounts and also from time to time revise the methodologies used to determine ~~reimbursement amounts. This includes annual updates to payments to physicians, hospitals and ambulatory surgery centers for procedures during which~~ our ~~products~~compliance ~~are~~with ~~used.~~regulatory ~~An example of payment updates is the Medicare program’s updates to hospital and physician payments, which are done on an annual basis using a prescribed statutory formula~~requirements. ~~In the past, when the application of the formula resulted in lower payment, Congress has passed interim legislation to prevent the reductions.~~

~~A product’s~~Manufacturing ~~reimbursement~~cGMP ~~profile,~~Requirements both in the U.S. and internationally, is an important component of the product’s commercial opportunity. We prefer projects with existing reimbursement codes, the opportunity to seek reimbursement under higher-value surgical procedure codes or the potential to seek reimbursement under narrow, product-specific codes as opposed to bundled procedure codes. For those products that have high strategic value, but with less defined reimbursement, we have engaged reimbursement experts and support from industry associations to accelerate the acquisition of satisfactory reimbursement levels.

~~See~~ Manufacturers of medical devices are required to comply with FDA manufacturing requirements contained in the FDA’s current Good Manufacturing Practices (“~~EsoGuard~~cGMP”) set forth in the quality system regulations promulgated under section 520 of the FDCA. cGMP regulations require, among other things, quality control and ~~EsoCheck—Reimbursement~~quality assurance as well as the corresponding maintenance of records and ~~Market~~documentation. ~~Access”~~Failure ~~above~~to ~~for~~comply with statutory and regulatory requirements subjects a ~~fuller~~manufacturer ~~discussion~~to possible legal or regulatory action, including the seizure or recall of products, injunctions, consent decrees placing significant restrictions on or suspending manufacturing operations, and civil and criminal penalties. Adverse experiences with the ~~reimbursement~~product ~~status for~~must ~~EsoCheck~~be reported to the FDA and ~~EsoGuard~~could result in the imposition of marketing restrictions through labeling changes or in product withdrawal. Product approvals may be withdrawn if compliance with regulatory requirements is not maintained or if problems concerning safety or efficacy of the product occur following the approval. We expect to use contract manufacturers to manufacture our products for the foreseeable future we will therefore be dependent on their compliance with these requirements to market our products. We work closely with our contract manufacturers to assure our products are in strict compliance with these regulations.

~~Competition for New Medical Device Innovation~~16

~~Developing and~~Laboratory commercializing new products is highly competitive. The market is characterized by extensive research and clinical efforts and rapid technological change. We face intense competition worldwide from medical deviceCertification, ~~biomedical~~Accreditation ~~technology~~ and ~~medical~~Licensing products and combination products companies, including major medical products companies. We may be unable to respond to technological advances through the development and introduction of new products. Most of our existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing and technological resources. These competitors may also be in the process of seeking FDA or other regulatory approvals, or patent protection, for new products. Our competitors may commercialize new products in advance of our products. Our products also face competition from numerous existing products and procedures, some of which currently are considered part of the standard of care. We believe the principal competitive factors in our markets are:

●Lucid's CLIA-certified laboratory is subject to U.S. federal and state laws and regulations governing the ~~quality~~operation of ~~outcomes~~clinical ~~for~~laboratories. ~~medical~~CLIA ~~conditions;~~requirements ●establish ~~acceptance~~certification byrequirements ~~surgeons~~and standards relating to quality systems, quality control, personnel qualifications, and ~~the~~operational ~~medical~~requirements. ~~device~~We ~~market~~are ~~generally;~~accredited ●by ~~ease~~the College of ~~use~~American ~~and~~Pathologists ~~reliability;~~("CAP"), ●a ~~technical~~CMS ~~leadership~~approved ~~and~~accrediting ~~superiority;~~organization ●under ~~effective~~CLIA’s ~~marketing~~authority. As a CAP accredited laboratory, Lucid is subject to periodic inspections conducted by CAP and, ~~distribution;~~in ●certain ~~speed~~circumstances, by CMS. CAP accreditation is designed to ~~market~~meet or exceed CLIA requirements; ~~and~~however, ●failure ~~product~~to ~~price~~maintain ~~and~~CAP ~~qualification~~accreditation ~~for~~could ~~coverage~~result ~~and~~in ~~reimbursement~~loss of our ability to operate under CLIA.

~~We will~~In ~~also~~addition ~~compete~~to inCLIA, ~~the~~certain ~~marketplace~~states, toincluding ~~recruit~~California, ~~and~~New ~~retain~~York, ~~qualified~~Maryland, ~~scientific~~Pennsylvania, ~~management~~New ~~and~~Jersey, ~~sales~~Rhode ~~personnel,~~Island asand ~~well~~Florida, asimpose inseparate ~~acquiring technologies~~certification and/or ~~licenses~~licensure ~~complementary~~requirements tofor ~~our~~clinical ~~products~~laboratories operating within or ~~advantageous~~offering testing services to ~~our~~patients ~~business~~in those states. WeCLIA ~~are~~allows ~~aware~~states ofto ~~several~~adopt ~~companies~~laboratory regulations that ~~compete~~ are equal to or more stringent than federal requirements, and allows states to apply for exemption from CLIA oversight if CMS determines that the state’s requirements are ~~developing~~at ~~technologies~~least inas ~~our~~stringent ~~current~~as ~~and~~or ~~future~~more ~~products~~stringent ~~areas~~than, CLIA. InFor ~~order~~example, tothe ~~compete~~State ~~effectively~~of New York’s clinical laboratory regulations received such an exemption, ~~our~~and ~~products~~in ~~will~~certain ~~have~~respects, toimposes ~~achieve market~~requirements ~~acceptance~~more stringent than those under federal CLIA standards. Accordingly, ~~receive~~to ~~adequate~~the ~~insurance~~extent ~~coverage~~Lucid ~~and~~offers ~~reimbursement~~testing services in New York or for New York patients, beit ~~cost~~must ~~effective~~comply ~~and~~with bethese ~~simultaneously~~applicable ~~safe~~New ~~and~~York ~~effective~~State Department of Health requirements.

~~See “EsoGuard~~Lucid currently holds the certificates, licenses, and ~~EsoCheck—Competition”~~accreditations required to perform its clinical laboratory testing. Clinical laboratories are subject to periodic inspection by federal and ~~“Veris~~state ~~Cancer~~regulators ~~Care~~and ~~Platform—Competition”~~accrediting ~~above~~ bodies, and may be subject to sanctions for noncompliance. Sanctions available under CLIA and applicable state laws include suspending, limiting, or revoking certificates or licenses; prohibiting a ~~fuller~~laboratory ~~discussion~~from ofrunning ~~the~~tests; ~~competitive~~requiring ~~environment~~a ~~for~~laboratory ~~our~~to ~~key~~implement ~~products~~a corrective action plan; imposing civil monetary penalties; and, ~~EsoCheck~~in certain cases, ~~EsoGuard~~exclusion from participation in federal healthcare programs. Failure to comply with applicable CLIA or state laboratory requirements could result in enforcement action, interruption of our laboratory operations, and increased cost. It could also adversely affect the ~~Veris~~commercialization ~~Cancer~~of ~~Care~~Lucid's ~~Platform~~products and services or future regulatory determinations by CMS or other governmental authorities.

13Other U.S. Healthcare Regulation

~~Government Regulation~~In addition to FDA restrictions on marketing and promotion of drugs and devices, other federal and state laws restrict our business practices. These laws include, without limitation, anti-kickback and false claims laws, data privacy and security laws, as well as transparency laws regarding payments or other items of value provided to healthcare providers.

~~Key U~~Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available under such laws, it is possible that some of our business activities, including certain sales and marketing practices and the provision of certain items and services to our customers, could be subject to challenge under one or more of such laws.S If our operations are found to be in violation of any of the health regulatory laws described above or any other laws that apply to us, we may be subject to penalties, including potentially significant criminal and civil and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government healthcare programs, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. ~~Regulation~~To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.

~~FDA Regulation~~In any event, we have established a substantial regulatory and compliance infrastructure that is designed to ensure compliance with these regulations.

Before and after approval or clearance in the United States, our products are subject to extensive regulation by the FDA under the FDCA and/or the Public Health Service Act, as well as by other regulatory bodies. FDA regulations govern, among other things, the development, testing, manufacturing, labeling, safety, storage, recordkeeping, market clearance or approval, advertising and promotion, import and export, marketing and sales, and distribution of medical devices and products.17

~~In the~~Physician ~~United~~Payment ~~States,~~Sunshine ~~medical~~Act devices are subject to varying degrees of regulatory control and are classified in one of three classes depending on the extent of controls the FDA determines are necessary to reasonably ensure their safety and efficacy:

●On ~~Class~~February I:8, ~~general~~2013, ~~controls~~the Centers for Medicare & Medicaid Services, ~~such~~or CMS, released its final rule implementing section 6002 of the Affordable Care Act known as ~~labeling~~the Physician Payment Sunshine Act that imposes annual reporting requirements on device manufacturers for payments and ~~adherence~~other totransfers ~~quality~~of ~~system~~value ~~regulations;~~provided ●by ~~Class~~them, ~~II:~~directly ~~special~~or ~~controls~~indirectly, ~~pre-market~~to ~~notification~~physicians ~~(often~~and ~~referred~~teaching tohospitals, as awell ~~510(k)~~as ~~application),~~ownership ~~specific~~and ~~controls~~investment ~~such~~interests asheld ~~performance~~by ~~standards,~~physicians ~~patient~~and ~~registries~~their family members. A manufacturer’s failure to submit timely, ~~post-market~~accurately ~~surveillance~~and completely the required information for all payments, ~~additional~~transfers ~~controls~~of ~~such~~value asor ~~labeling~~ownership or investment interests may result in civil monetary penalties of up to an aggregate of $150,000 per year, and ~~adherence~~up to ~~quality~~an ~~system~~aggregate ~~regulations;~~of $1 million per year for “knowing failures.” Manufacturers that produce at least one product reimbursed by Medicare, Medicaid, or Children’s Health Insurance Program and ●(i) ~~Class~~if ~~III:~~the ~~special~~product ~~controls~~is a drug or biological, and ~~approval~~it ofrequires a deprescription ~~novo~~(or ~~request~~physician’s authorization) to administer; or ~~PMA~~(ii) ~~application~~if the product is a device or medical supply, ~~likely~~and it requires premarket approval or premarket notification by the FDA are required to comply with ~~clinical~~the ~~data~~Open Payments (commonly referred to as the Sunshine Act) filing requirements under CMS.

~~In general,~~Certain ~~the higher the classification~~states, ~~the~~also ~~greater~~mandate ~~the~~implementation ~~time~~of ~~and~~commercial ~~cost~~compliance ~~to obtain approval to market. There are no “standardized” requirements for approval~~programs, ~~even~~and ~~within~~other ~~each~~states ~~class.~~impose ~~For~~restrictions ~~example,~~on ~~FDA~~device ~~could~~manufacturer ~~grant~~marketing ~~510(k)~~practices ~~status,~~and ~~but~~ require atracking ~~human~~and ~~clinical~~reporting ~~trial, a typical requirement~~ of agifts, ~~PMA.~~compensation ~~They~~and ~~could~~other ~~also~~remuneration ~~initially~~to ~~assign~~healthcare aprofessionals ~~device~~and ~~Class III status but end up clearing a device as a 510(k) device or under a de novo classification pathway if certain requirements are met~~entities. The ~~range~~shifting ofcommercial ~~the~~compliance ~~number~~environment and ~~expense of~~ the ~~various~~need ~~requirements is~~to ~~significant.~~build ~~The quickest~~ and ~~least~~maintain ~~expensive~~robust ~~pathway would be 510(k) clearance with a review of existing bench~~ and ~~animal~~expandable ~~data.~~systems ~~A de novo classification pathway would have a similar cost~~ to ~~seeking~~comply ~~510(k) clearance, but~~ with adifferent ~~slightly~~compliance ~~longer~~or ~~review~~reporting ~~timeline.~~requirements ~~The longest~~in ~~and~~multiple ~~most~~jurisdictions ~~expensive~~increase ~~path~~the ~~would~~possibility be a ~~PMA~~healthcare ~~with~~company ~~extensive~~may ~~randomized~~fail ~~human~~to ~~clinical~~comply ~~trials. We cannot predict~~ fully ~~how~~with ~~FDA~~one ~~will classify our products, nor predict what requirements will be placed upon us to obtain market clearance~~ or ~~approve~~more ~~our~~of ~~products~~these ~~at all~~requirements.

~~To request~~Federal ~~marketing authorization by means of a 510(k) clearance, we must submit a pre~~Anti-~~market~~Kickback ~~notification~~Statute demonstrating the proposed device is substantially equivalent to another currently legally marketed medical device, has the same intended use, and is as safe and effective as a currently legally marketed device and does not raise different questions of safety and effectiveness than does a currently legally marketed device. 510(k) submissions generally include, among other things, a description of the device and its manufacturing, device labeling, medical devices to which the device is substantially equivalent, safety and biocompatibility information, and the results of performance testing. In some cases, a 510(k) submission must include data from human clinical studies. Marketing may commence only when the FDA issues a clearance letter finding substantial equivalence. After a device receives 510(k) clearance, any product modification that could significantly affect the safety or effectiveness of the product, or would constitute a significant change in intended use, requires a new 510(k) clearance or, if the device would no longer be substantially equivalent, would require PMA, or possibly, a de novo pathway under section 513(f)(2) of the FDCA. In addition, any additional claims the Company wished to make at a later date may require a PMA. If the FDA determines the product does not qualify for 510(k) clearance, they will issue a Not Substantially Equivalent (“NSE”) letter, at which point the Company must submit and the FDA must approve a PMA or issue premarket clearance using the de novo before marketing can begin.

~~In 1997~~The Federal Anti-Kickback Statute prohibits, ~~the~~among ~~Food~~other things, knowingly and ~~Drug~~willfully ~~Administration~~offering, ~~Modernization~~paying, ~~Act~~soliciting or receiving any remuneration (~~“FDAMA”~~including any kickback, bribe or rebate), ~~added~~directly ~~the~~or deindirectly, ~~novo~~overtly ~~classification~~or ~~pathway~~covertly, ~~under~~to ~~section~~induce ~~513(f)(2)~~or of in return for purchasing, leasing, ordering or arranging for or recommending the ~~FDCA~~purchase, ~~establishing~~lease anor ~~alternate~~order ~~pathway~~of toany ~~classify~~good, ~~new~~facility, ~~devices~~item ~~into~~or ~~Class~~service Ireimbursable, in whole or IIin ~~that~~part, ~~had~~under ~~automatically~~Medicare, ~~been~~Medicaid ~~placed~~or inother ~~Class~~federal ~~III after~~healthcare ~~receiving~~programs. anThe ~~NSE~~term ~~determination~~“remuneration” inhas ~~response~~been broadly interpreted to ainclude ~~510(k)~~anything ~~submission~~of value. InAlthough ~~this~~there ~~process,~~are a ~~sponsor~~number ~~who receives~~of anstatutory ~~NSE~~exceptions ~~determination~~and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, ~~within~~purchases 30or ~~days~~recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of ~~receiving~~the ~~notice~~requirements of a particular applicable statutory exception or regulatory safe harbor does not make the ~~NSE~~conduct ~~determination~~per se illegal under the Anti-Kickback Statute. Instead, ~~request~~the ~~FDA~~legality toof ~~make~~the arrangement will be evaluated on a ~~risk~~case-by-case basis based ~~classification~~ on a cumulative review of all its facts and circumstances. Several courts have interpreted the ~~device~~statute’s ~~under~~intent ~~section~~requirement ~~513(a)(1)~~to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the ~~Act~~Anti-Kickback Statute has been violated.

~~In 2012~~Additionally, ~~section~~the ~~513(f)(2)~~intent ofstandard under the ~~FDCA~~Anti-Kickback Statute was amended by ~~section~~the ~~607~~Patient Protection and Affordable Care Act of ~~the~~2010, ~~Food~~as ~~and~~amended ~~Drug~~by ~~Administration~~the ~~Safety~~Health Care and ~~Innovation~~Education Reconciliation Act ~~(“FDASIA”)~~of 2010, collectively the Affordable Care Act, to ~~provide~~a stricter standard such that a ~~second~~person ~~option~~or ~~for~~entity deno ~~novo~~longer ~~classification.~~needs Into ~~this~~have ~~second~~actual ~~pathway,~~knowledge aof ~~sponsor~~the ~~who~~statute ~~determines~~or ~~there~~specific isintent noto ~~legally~~violate ~~marketed device~~it ~~upon~~in ~~which~~order to ~~base~~have committed a ~~determination~~violation. ofIn ~~substantial~~addition, ~~equivalence~~the ~~may~~Affordable ~~request~~Care ~~FDA~~Act tocodified ~~make~~case law that a ~~risk-based~~claim ~~classification~~including items or services resulting from a violation of the ~~device under~~federal ~~section~~Anti-Kickback ~~513(~~Statute constitutes a~~)(1)~~ false or fraudulent claim for purposes of the federal civil False Claims Act. ~~without~~We ~~first~~are ~~submitting~~subject ato ~~510(k)~~comparable state laws, including those pertaining to fee splitting, some of which apply to all payors regardless of source of payment, and do not contain identical safe harbors.

During the review of a 510(k) submission, the FDA may request more information or additional studies and may decide the indications for which we seek approval or clearance should be limited. In addition, laws and regulations and the interpretation of those laws and regulations by the FDA may change in the future. We cannot foresee what effect, if any, such changes may have on us.18

~~Clinical Trials~~Federal ofFalse ~~Medical~~Claims ~~Technology~~Act

~~One or~~The ~~more~~False ~~clinical~~Claims ~~trials~~Act ~~may~~prohibits, beamong ~~necessary~~other tothings, ~~support~~any anperson ~~FDA~~or ~~submission.~~entity ~~Clinical~~from ~~studies~~knowingly ofpresenting, ~~unapproved~~ or ~~uncleared~~causing ~~medical~~to ~~devices or~~be ~~devices~~presented, ~~being~~a ~~studied~~false ~~for~~or ~~uses~~fraudulent claim for ~~which~~payment ~~they~~or ~~are~~approval ~~not~~to ~~approved~~the federal government or ~~cleared~~knowingly ~~(investigational~~making, ~~devices)~~using ~~must~~or becausing ~~conducted~~to ~~in compliance~~be ~~with~~made ~~FDA~~or ~~requirements.~~used Ifa anfalse ~~investigational~~record ~~device~~or ~~could~~statement ~~pose~~material to a ~~significant~~false ~~risk~~or tofraudulent ~~patients,~~claim to the ~~sponsor~~federal ~~company~~government. ~~must submit~~A anclaim ~~Investigational~~includes ~~Device~~“any ~~Exemption~~request ~~(“IDE~~or demand”) ~~application~~for money or property presented to the ~~FDA~~U.S. ~~prior~~government. The False Claims Act also applies to ~~initiation~~false ofsubmissions that cause the ~~clinical~~government ~~study.~~to Anbe ~~IDE~~paid ~~application must~~less bethan ~~supported~~the byamount ~~appropriate~~to ~~data~~which it is entitled, such as ~~animal~~a ~~and~~rebate. ~~laboratory~~Intent ~~test~~to ~~results,~~deceive ~~showing it~~ is ~~safe~~not required to ~~test~~establish liability under the ~~device~~False onClaims ~~humans~~ Act. Several pharmaceutical, device and ~~the~~other ~~testing~~healthcare ~~protocol~~companies ishave ~~scientifically~~been ~~sound.~~prosecuted ~~The~~under ~~IDE~~these ~~will~~laws ~~automatically~~for, ~~become~~among ~~effective~~other 30things, ~~days~~allegedly ~~after~~providing ~~receipt~~free byproduct ~~the~~to ~~FDA unless~~customers with the ~~FDA~~expectation ~~notifies~~that the ~~company~~customers ~~the~~would ~~investigation~~bill ~~may~~federal ~~not~~programs ~~begin.~~for ~~Clinical~~the ~~studies~~product. ofOther ~~investigational~~companies ~~devices~~have ~~may~~been ~~not~~prosecuted ~~begin~~for ~~until an~~causing ~~institutional~~false ~~review~~claims ~~board~~to ~~(“IRB”)~~be ~~has~~submitted ~~approved~~because of the ~~study~~companies’ marketing of products for unapproved, and thus noncovered uses.

14The government may further prosecute, as a crime, conduct constituting a false claim under the False Claims Act. The False Claims Act prohibits the making or presenting of a claim to the government knowing such claim to be false, fictitious, or fraudulent and, unlike civil claims under the False Claims Act, requires proof of intent to submit a false claim.

~~During any study, the sponsor must comply with the FDA’s IDE requirements. These requirements include investigator selection, trial monitoring, adverse event reporting, and record keeping.~~ The ~~investigators~~Foreign ~~must~~Corrupt ~~obtain~~Practices ~~patient~~Act informed consent, rigorously follow the investigational plan and study protocol, control the disposition of investigational devices, and comply with reporting and record keeping requirements. We, the FDA, or the IRB at each institution at which a clinical trial is being conducted may suspend a clinical trial at any time for various reasons, including a belief the subjects are being exposed to an unacceptable risk. During the approval or clearance process, the FDA typically inspects the records relating to the conduct of one or more investigational sites participating in the study supporting the application.

~~Post-Approval Regulation~~The Foreign Corrupt Practices Act, or the FCPA, prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of ~~Medical~~anything ~~Devices~~of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the company to maintain books and ~~Diagnostic~~records ~~Tests~~that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. Activities that violate the FCPA, even if they occur wholly outside the United States, can result in criminal and civil fines, imprisonment, disgorgement, oversight, and debarment from government contracts.

~~After a~~Healthcare ~~device~~Reform ~~is cleared or approved for marketing, numerous regulatory requirements continue to apply. These include:~~

●Current ~~the~~and ~~FDA~~future ~~Quality~~legislative ~~Systems~~proposals ~~Regulation~~to ~~(QSR),~~further ~~which~~reform ~~governs,~~healthcare ~~among~~or ~~other~~reduce ~~things,~~healthcare ~~how~~costs ~~manufacturers~~may ~~design,~~result ~~test~~in ~~manufacture~~lower reimbursement for our products, ~~exercise~~or ~~quality~~for ~~control~~the ~~over~~procedures associated with the use of our products, ~~and~~or ~~document~~limit ~~manufacturing~~coverage of ~~their~~our products;. ●The ~~labeling~~cost containment measures that payors and ~~claims~~providers ~~regulations,~~are ~~which~~instituting ~~prohibit~~and the ~~promotion~~effect of ~~products~~any ~~for~~healthcare ~~unapproved~~reform orinitiative ~~“off-label”~~implemented ~~uses~~in ~~and~~the ~~impose~~future ~~other~~could ~~restrictions~~significantly onreduce ~~labeling;~~our ~~and,~~revenues ●from the ~~Medical~~sale ~~Device~~of ~~Reporting~~our ~~regulation~~products. Alternatively, ~~which~~the ~~requires~~shift ~~reporting~~away from fee-for-service agreements to ~~FDA~~capitated payment models may support the value of ~~certain~~our ~~adverse~~products ~~experience~~which ~~associated~~can ~~with~~be ~~use~~shown ofto ~~the~~decrease ~~product~~resource utilization and lead to cost savings for both payors and providers.

~~We will~~HIPAA ~~continue~~and toOther bePrivacy ~~subject~~Laws ~~to inspection by FDA to determine our compliance with regulatory requirements.~~

~~Manufacturing cGMP~~The ~~Requirements~~Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”) established comprehensive protection for the privacy and security of health information. The HIPAA standards apply to three types of organizations, or “Covered Entities”: health plans, healthcare clearinghouses, and healthcare providers that conduct certain healthcare transactions electronically. Covered Entities and their business associates must have in place administrative, physical, and technical standards to guard against the misuse of individually identifiable health information. Some of our activities involve interactions with patients and their health information which implicate HIPAA. Our activities also involve us entering into specific kinds of relationships with Covered Entities and business associates of Covered Entities, which also implicate HIPAA. Penalties for violations of HIPAA include civil money and criminal penalties.

~~Manufacturers of~~Our ~~medical~~activities ~~devices~~must ~~are~~also ~~required to~~ comply with ~~FDA~~other ~~manufacturing~~applicable ~~requirements~~privacy ~~contained~~laws, inwhich ~~the~~impose ~~FDA’s~~restrictions ~~current~~on ~~Good~~the ~~Manufacturing Practices~~access, ~~(“cGMP”)~~use ~~set~~and ~~forth~~disclosure inof ~~the~~personal ~~quality~~information. ~~system~~More ~~regulations~~state ~~promulgated~~and ~~under~~international ~~section~~privacy ~~520~~laws ofare ~~the~~being ~~FDCA~~adopted. ~~cGMP~~Many ~~regulations~~state ~~require,~~laws ~~among other~~are ~~things,~~not ~~quality~~preempted ~~control~~by ~~and~~HIPAA ~~quality~~because ~~assurance~~they asare ~~well~~more asstringent ~~the~~or ~~corresponding~~are ~~maintenance~~broader ofin ~~records~~scope ~~and~~than ~~documentation~~HIPAA. ~~Failure~~Since ~~to comply~~2020 ~~with~~we ~~statutory~~have ~~and~~also ~~regulatory~~had ~~requirements subjects a manufacturer~~ to ~~possible~~comply ~~legal~~with orthe ~~regulatory~~California ~~action,~~Consumer ~~including~~Privacy ~~the~~Act ~~seizure or recall~~ of ~~products~~2018, ~~injunctions,~~which ~~consent~~protects ~~decrees~~personal ~~placing~~information ~~significant~~other ~~restrictions~~than onhealth orinformation ~~suspending~~covered ~~manufacturing~~by ~~operations,~~HIPAA. ~~and~~In ~~civil and~~the ~~criminal penalties~~E.U., ~~Adverse~~the ~~experiences~~General ~~with~~Data ~~the~~Protection ~~product~~Regulation ~~must~~(“GDPR”) betook ~~reported~~effect toin ~~the~~May ~~FDA~~2018 and ~~could~~imposes ~~result~~increasingly instringent ~~the~~data ~~imposition~~protection ofand ~~marketing restrictions~~privacy ~~through~~rules. ~~labeling~~All ~~changes~~of orthese inlaws ~~product~~may ~~withdrawal.~~impact ~~Product~~our ~~approvals~~business and may bechange ~~withdrawn~~periodically, ifwhich ~~compliance~~could ~~with~~have ~~regulatory~~an ~~requirements is~~effect ~~not~~on ~~maintained~~our orbusiness operations if ~~problems~~compliance ~~concerning~~becomes ~~safety~~substantially orcostlier ~~efficacy~~than ofunder ~~the~~current ~~product occur following the approval~~requirements. WeOur ~~expect~~failure to ~~use~~comply ~~contract manufacturers~~with tothese ~~manufacture~~privacy ~~our~~laws ~~products~~or ~~for~~significant ~~the~~changes ~~foreseeable~~in ~~future~~the welaws ~~will~~restricting ~~therefore~~our beability ~~dependent~~to onobtain ~~their~~patient ~~compliance~~samples ~~with~~and ~~these~~associated ~~requirements to~~patient ~~market~~information ~~our~~could ~~products.~~significantly Weimpact ~~work closely with~~ our ~~contract~~business ~~manufacturers~~and ~~to assure~~ our ~~products~~future ~~are~~business ~~in strict compliance with these regulations~~plans.

~~Laboratory Certification, Accreditation and Licensing~~19

~~Lucid’s CLIA~~Self-~~certified~~Referral ~~laboratory~~Law is subject to U.S. and state laws and regulations regarding the operation of clinical laboratories. CLIA requirements and laws of certain states, including those of California, New York, Maryland, Pennsylvania, Rhode Island and Florida, impose certification requirements for clinical laboratories, and establish standards for quality assurance and quality control, among other things. CLIA provides that a state may adopt different or more stringent regulations than federal law and permits states to apply for exemption from CLIA if the state’s laboratory laws are equivalent to, or more stringent than, CLIA. For example, the State of New York’s clinical laboratory regulations, which have received an exemption from CLIA, contain provisions that are in certain respects more stringent than federal law. Therefore, as long as New York maintains a licensure program that is CLIA-exempt, Lucid will need to comply with New York’s clinical laboratory regulations in order to offer Lucid clinical laboratory products and services in New York.

~~Lucid has~~The ~~current~~federal ~~certificates~~“self-referral” tolaw, ~~perform~~commonly ~~clinical~~referred ~~laboratory~~to ~~testing.~~as ~~Clinical~~the ~~laboratories~~“Stark” ~~are~~law, ~~subject~~provides tothat ~~inspection~~physicians bywho, ~~regulators~~personally ~~and~~or ~~to sanctions~~through ~~for~~a ~~failing~~family tomember, ~~comply~~have ~~with~~ownership ~~applicable~~interests ~~requirements.~~in ~~Sanctions~~or ~~available~~compensation ~~under~~arrangements ~~CLIA~~with ~~and~~a ~~certain~~laboratory ~~state~~are ~~laws~~prohibited ~~include~~from ~~prohibiting~~ making a referral to that laboratory ~~from~~for ~~running~~laboratory tests reimbursable by Medicare, ~~requiring~~and also prohibits laboratories from submitting a claim for Medicare payments for laboratory totests ~~implement~~referred by physicians who, personally or through a ~~corrective~~family ~~plan~~member, ~~and~~have ~~imposing~~ownership ~~civil~~interests ~~monetary~~in ~~penalties.~~or Ifcompensation ~~Lucid’s CLIA-certified~~arrangements with the testing laboratory. ~~fails~~The toStark ~~meet~~law ~~any~~contains ~~applicable~~a ~~requirements~~number of ~~CLIA~~specific orexceptions ~~state~~which, ~~law~~if met, ~~that~~permit ~~failure~~physicians ~~could~~who ~~adversely~~have ~~affect~~ownership ~~any~~or ~~future CMS~~compensation ~~consideration~~arrangements ofwith ~~its~~a ~~technologies,~~testing ~~prevent~~laboratory ~~their~~to ~~approval~~make ~~entirely,~~referrals to that laboratory and~~/or~~ ~~interrupt~~permit the ~~commercial~~laboratory ~~sale~~to submit claims for Medicare payments for laboratory tests performed pursuant to such referrals. We are subject to comparable state laws, some of ~~any~~which ~~products~~apply ~~and~~to ~~services~~ all payors regardless of source of payment, and ~~otherwise~~do ~~cause~~not ~~Lucid~~contain identical exceptions to ~~incur~~the ~~significant~~Stark ~~expense~~law.

15International Regulation

~~Other U~~In order to market any of our products outside of the United States, we would need to comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of our products.S We may be subject to regulations and product registration requirements in the areas of product standards, packaging requirements, labeling requirements, import and export restrictions and tariff regulations, duties and tax requirements. ~~Healthcare~~Whether ~~Regulation~~or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable foreign regulatory authorities before we can commence clinical trials or marketing of the product in foreign countries and jurisdictions. The time required to obtain clearance required by foreign countries may be longer or shorter than that required for FDA clearance, and requirements for licensing a product in a foreign country may differ significantly from FDA requirements.

~~In addition~~European toUnion FDA restrictions on marketing and promotion of drugs and devices, other federal and state laws restrict our business practices. These laws include, without limitation, anti-kickback and false claims laws, data privacy and security laws, as well as transparency laws regarding payments or other items of value provided to healthcare providers.

~~Because of~~The ~~the~~European ~~breadth~~Union of(“EU”) ~~these~~will ~~laws~~require ~~and~~a ~~the~~CE ~~narrowness~~mark ofcertification ~~the~~or ~~statutory~~approval ~~exceptions~~in ~~and~~order ~~safe~~to ~~harbors~~market ~~available~~our ~~under~~products ~~such~~in ~~laws,~~the itvarious iscountries ~~possible that some~~ of ~~our~~the ~~business~~European ~~activities,~~Union ~~including~~or ~~certain~~other ~~sales~~countries ~~and~~outside ~~marketing~~the ~~practices~~United ~~and~~States. ~~the~~To ~~provision~~obtain ofCE ~~certain~~mark ~~items~~certification ~~and~~of ~~services to~~ our ~~customers~~products, ~~could~~we will be ~~subject~~required to ~~challenge~~work ~~under~~with ~~one~~an oraccredited ~~more~~European ofnotified ~~such~~body ~~laws.~~organization ~~If our operations are found~~ to bedetermine ~~in violation of any of~~ the ~~health~~appropriate ~~regulatory~~documents ~~laws~~required ~~described above or any other laws that apply~~ to ~~us,~~support wecertification ~~may be subject to penalties, including potentially significant criminal and civil and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation~~ in ~~government~~accordance ~~healthcare~~with ~~programs,~~existing ~~contractual~~medical ~~damages,~~device ~~reputational~~directive. ~~harm,~~The ~~administrative~~predictability ~~burdens,~~of ~~diminished~~the ~~profits~~length ~~and~~of ~~future~~time ~~earnings,~~ and ~~the~~cost ~~curtailment~~associated orwith ~~restructuring~~such ofa ~~our~~CE ~~operations,~~mark ~~any~~may ofvary ~~which~~or ~~could~~may ~~adversely~~include ~~affect~~lengthy ~~our~~clinical ~~ability~~trials to ~~operate~~support ~~our~~such ~~business~~a ~~and our results of operations~~marking. ToOnce the ~~extent~~CE ~~that~~mark ~~any~~is ~~of our products are sold in a foreign country~~obtained, we may bemarket ~~subject~~our toproduct ~~similar~~in ~~foreign~~the ~~laws, which~~countries ~~may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws and implementation~~ of ~~corporate~~the ~~compliance programs and reporting of payments or transfers of value to healthcare professionals~~EU.

~~In any~~European ~~event,~~Good weManufacturing ~~have~~Practices ~~established a substantial regulatory and compliance infrastructure that is designed to ensure compliance with these regulations.~~

~~Physician Payment~~In ~~Sunshine~~the ~~Act~~European Union, the manufacture of medical devices is subject to good manufacturing practice (“GMP”), as set forth in the relevant laws and guidelines of the European Union and its member states. Compliance with GMP is generally assessed by the competent regulatory authorities. Typically, quality system evaluation is performed by a Notified Body, which also recommends to the relevant competent authority for the European Community CE Marking of a device. The Competent Authority may conduct inspections of relevant facilities, and review manufacturing procedures, operating systems and personnel qualifications. In addition to obtaining approval for each product, in many cases each device manufacturing facility must be audited on a periodic basis by the Notified Body. Further inspections may occur over the life of the product.

On February 8, 2013, the Centers for Medicare & Medicaid Services, or CMS, released its final rule implementing section 6002 of the Affordable Care Act known as the Physician Payment Sunshine Act that imposes annual reporting requirements on device manufacturers for payments and other transfers of value provided by them, directly or indirectly, to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their family members. A manufacturer’s failure to submit timely, accurately and completely the required information for all payments, transfers of value or ownership or investment interests may result in civil monetary penalties of up to an aggregate of $150,000 per year, and up to an aggregate of $1 million per year for “knowing failures.” Manufacturers that produce at least one product reimbursed by Medicare, Medicaid, or Children’s Health Insurance Program and (i) if the product is a drug or biological, and it requires a prescription (or physician’s authorization) to administer; or (ii) if the product is a device or medical supply, and it requires premarket approval or premarket notification by the FDA are required to comply with the Open Payments (commonly referred to as the Sunshine Act) filing requirements under CMS. We currently do not have any products covered by Medicare, Medicaid, or Children’s Health Insurance Program as none of our products have premarket approval or clearance notification. We expect once our products receive regulatory clearance, we will be required to comply with the Sunshine Act provisions.20

~~Certain states,~~Other ~~also~~Laws mandate implementation of commercial compliance programs, and other states impose restrictions on device manufacturer marketing practices and require tracking and reporting of gifts, compensation and other remuneration to healthcare professionals and entities. The shifting commercial compliance environment and the need to build and maintain robust and expandable systems to comply with different compliance or reporting requirements in multiple jurisdictions increase the possibility a healthcare company may fail to comply fully with one or more of these requirements.

~~Federal Anti-Kickback~~Occupational ~~Statute~~Safety and Health

~~The Federal~~In ~~Anti-Kickback~~addition ~~Statute~~to ~~prohibits,~~its ~~among~~comprehensive ~~other~~regulation ~~things,~~of ~~knowingly~~health and ~~willfully~~safety ~~offering,~~in ~~paying,~~the ~~soliciting~~workplace ~~or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, to induce or~~ in ~~return for purchasing~~general, ~~leasing, ordering or arranging for or recommending~~ the ~~purchase,~~Occupational ~~lease~~Safety orand ~~order~~Health ofAdministration ~~any~~has ~~good,~~established ~~facility,~~extensive ~~item~~requirements oraimed ~~service~~specifically ~~reimbursable,~~at inlaboratories ~~whole or~~and ~~in part, under Medicare, Medicaid or~~ other ~~federal~~ healthcare-related ~~programs~~facilities. ~~The~~In ~~term~~addition, ~~“remuneration”~~because ~~has~~Lucid’s ~~been~~operations ~~broadly~~may ~~interpreted to~~require ~~include~~employees ~~anything~~to ofuse ~~value.~~certain ~~Although~~hazardous ~~there~~chemicals, ~~are~~Lucid aalso ~~number~~must ofcomply ~~statutory~~with ~~exceptions~~regulations ~~and~~on ~~regulatory~~hazard ~~safe~~communication ~~harbors protecting some common activities from prosecution, the exceptions~~ and ~~safe~~hazardous ~~harbors~~chemicals ~~are~~in ~~drawn narrowly~~laboratories. ~~Practices~~These ~~that~~regulations ~~involve~~require ~~remuneration~~Lucid, ~~that~~among ~~may~~other bethings, ~~alleged~~ to bedevelop ~~intended~~written toprograms ~~induce~~and ~~prescribing~~plans, ~~purchases~~which ormust ~~recommendations~~address ~~may~~methods ~~be subject to scrutiny if they do not qualify~~ for anpreventing ~~exception or~~and ~~safe~~mitigating ~~harbor.~~employee ~~Failure~~exposure, ~~to meet all of~~ the ~~requirements~~use of apersonal ~~particular~~protective ~~applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute. Instead~~equipment, ~~the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all its facts~~ and ~~circumstances~~training. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the Anti-Kickback Statute has been violated.

~~Additionally, the~~Specimen ~~intent~~Transportation standard under the Anti-Kickback Statute was amended by the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, collectively the Affordable Care Act, to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. In addition, the Affordable Care Act codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

16Our commercialization activities for EsoGuard subject Lucid to regulations of the Department of Transportation, the United States Postal Service, and the Centers for Disease Control and Prevention that apply to the surface and air transportation of clinical laboratory specimens.

~~Federal False~~Environmental ~~Claims Act~~

The ~~False~~ ~~Claims~~cost ~~Act~~of ~~prohibits,~~compliance ~~among~~with ~~other things~~federal, ~~any~~state ~~person~~and orlocal ~~entity~~provisions ~~from~~related ~~knowingly presenting, or causing~~ to bethe ~~presented,~~protection aof ~~false or fraudulent claim for payment or approval to~~ the ~~federal~~environment ~~government~~has orhad ~~knowingly~~no ~~making, using or causing to be made or used a false record or statement~~ material toeffect aon ~~false~~our ~~or fraudulent claim to the federal government~~business. AThere ~~claim~~were ~~includes~~no ~~“any~~material ~~request~~capital orexpenditures ~~demand”~~ for ~~money~~environmental orcontrol ~~property~~facilities ~~presented~~in to the ~~U.S.~~years ~~government.~~ended ~~The~~December ~~False Claims Act also applies to false submissions that cause the government to be paid less than the amount to which it is entitled~~31, ~~such~~2025 ~~as a rebate. Intent to deceive is not required to establish liability under the False Claims Act. Several pharmaceutical, device~~ and other healthcare companies have been prosecuted under these laws for, among other things, allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product2024. ~~Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of products for unapproved, and thus noncovered uses.~~

The government may further prosecute, as a crime, conduct constituting a false claim under the False Claims Act. The False Claims Act prohibits the making or presenting of a claim to the government knowing such claim to be false, fictitious, or fraudulent and, unlike civil claims under the False Claims Act, requires proof of intent to submit a false claim.Employees

~~The Foreign~~As ~~Corrupt~~of ~~Practices~~March ~~Act~~27, 2026 we had 41 employees (all of whom were full-time employees), inclusive of our executive officers — our Chairman of the Board of Directors and Chief Executive Officer (“CEO”), our President and Chief Financial Officer (“CFO”), our Chief Operating Officer (“COO”), our General Counsel and Secretary (“General Counsel”) and our Chief Medical Officer ("CMO"). No employees are covered by a collective bargaining agreement. We consider our relationship with our employees to be good.

~~The Foreign~~Corporate ~~Corrupt~~Information Practices Act, or the FCPA, prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. Activities that violate the FCPA, even if they occur wholly outside the United States, can result in criminal and civil fines, imprisonment, disgorgement, oversight, and debarment from government contracts.

~~Healthcare Reform~~We were incorporated in Delaware on June 26, 2014. Our corporate headquarters address is 360 Madison Avenue, 25th Floor, New York, NY 10017, and our main telephone number is (917) 813-1828.

~~Current and~~Available ~~future~~Information legislative proposals to further reform healthcare or reduce healthcare costs may result in lower reimbursement for our products, or for the procedures associated with the use of our products, or limit coverage of our products. The cost containment measures that payors and providers are instituting and the effect of any healthcare reform initiative implemented in the future could significantly reduce our revenues from the sale of our products. Alternatively, the shift away from fee-for-service agreements to capitated payment models may support the value of our products which can be shown to decrease resource utilization and lead to cost savings for both payors and providers.

~~HIPAA~~ We file or furnish our current and ~~Other~~periodic ~~Privacy~~reports, ~~Laws~~proxy statements, registration statements and other information filed with the United States Securities and Exchange Commission (“SEC”) pursuant to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports. We make these reports available through our website (www.pavmed.com) as soon as reasonably practicable after we electronically file such reports with, or furnish such reports to, the SEC. We also make available, free of charge on our website, the reports filed with the SEC by our named executive officers, directors, and 10% stockholders pursuant to Section 16 under the Exchange Act as soon as reasonably practicable after those filings are provided to us by those persons.

The ~~Health~~ ~~Insurance~~public ~~Portability~~also ~~and~~may ~~Accountability~~read ~~Act of 1996, as amended by the Health Information Technology for Economic~~ and ~~Clinical Health~~copy ~~Act~~any ~~(“HIPAA”)~~materials ~~established~~we ~~comprehensive~~file ~~protection~~with ~~for~~ the ~~privacy~~SEC ~~and~~at ~~security~~the ofSEC’s ~~health~~Public ~~information.~~Reference ~~The~~Room ~~HIPAA~~at ~~standards apply~~100 toF ~~three~~Street, ~~types of organizations~~NE., ~~or “Covered Entities”: health plans~~Washington, ~~healthcare~~DC ~~clearinghouses~~20549, ~~and~~on ~~healthcare~~official ~~providers that conduct certain healthcare transactions electronically. Covered Entities and their~~ business ~~associates~~days ~~must~~during ~~have in place administrative, physical, and technical standards to guard against~~ the ~~misuse~~hours of ~~individually~~10 ~~identifiable health information~~a.m. ~~Some~~to of3 ~~our~~p.m. ~~activities, including~~The atpublic ~~our~~may ~~Lucid~~obtain ~~Test~~information ~~Centers~~on ~~and~~the ~~within~~operation ~~our~~of ~~clinical~~the ~~trials,~~Public ~~involve~~Reference ~~interactions~~Room ~~with~~by ~~patients~~calling ~~and~~the ~~their~~Commission ~~health~~at ~~information which implicate HIPAA~~1-800-SEC-0330. ~~Our~~The ~~activities~~SEC also ~~involve~~maintains usan ~~entering~~Internet ~~into~~site ~~specific~~(http://www.sec.gov) ~~kinds~~that ofcontains ~~relationships~~reports, ~~with~~proxy ~~Covered Entities~~ and ~~business~~information ~~associates of Covered Entities~~statements, ~~which~~and ~~also~~other ~~implicate~~information ~~HIPAA.~~regarding ~~Penalties~~us ~~for~~that ~~violations~~we offile ~~HIPAA~~electronically ~~include~~with ~~civil~~the ~~money and criminal penalties~~SEC.

Our ~~activities~~ ~~must~~website ~~also~~address ~~comply~~is ~~with~~www.pavmed.com. ~~other~~The ~~applicable~~content ~~privacy laws, which impose restrictions on the access, use and disclosure~~ of ~~personal information.~~our ~~More~~website ~~state~~is ~~and international privacy laws are being adopted. Many state laws are~~ not ~~preempted~~incorporated by ~~HIPAA~~reference ~~because~~into ~~they~~this ~~are more~~Annual ~~stringent~~Report oron ~~are~~Form ~~broader~~10-K, nor in ~~scope~~any ~~than~~other ~~HIPAA.~~report ~~Since~~or ~~2020~~document we ~~have~~file ~~also~~or ~~had~~furnish ~~to comply~~ with ~~the~~and ~~California~~/or ~~Consumer~~submit ~~Privacy~~to ~~Act of 2018, which protects personal information other than health information covered by HIPAA. In~~ the ~~E.U.~~SEC, ~~the General Data Protection Regulation (“GDPR”) took effect in May 2018~~ and ~~imposes~~any ~~increasingly~~reference ~~stringent~~to ~~data protection and privacy rules. All of these laws may impact~~ our ~~business~~website ~~and~~are ~~may~~intended ~~change periodically, which could have an effect on our business operations if compliance becomes substantially costlier than under current requirements. Our failure~~ to ~~comply~~be ~~with~~inactive ~~these~~textual ~~privacy~~references ~~laws or significant changes in the laws restricting our ability to obtain patient samples and associated patient information could significantly impact our business and our future business plans~~only.

~~Self-Referral Law~~21

~~The federal~~Item “self-referral” law, commonly referred to as the “Stark” law, provides that physicians who, personally or through a family member, have ownership interests in or compensation arrangements with a laboratory are prohibited from making a referral to that laboratory for laboratory tests reimbursable by Medicare, and also prohibits laboratories from submitting a claim for Medicare payments for laboratory tests referred by physicians who, personally or through a family member, have ownership interests in or compensation arrangements with the testing laboratory1A. ~~The~~Risk Stark law contains a number of specific exceptions which, if met, permit physicians who have ownership or compensation arrangements with a testing laboratory to make referrals to that laboratory and permit the laboratory to submit claims for Medicare payments for laboratory tests performed pursuant to such referrals. We are subject to comparable state laws, some of which apply to all payors regardless of source of payment, and do not contain identical exceptions to the Stark law.Factors

17The following risk factors and other information included in this Annual Report on Form 10-K should be carefully considered. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or we presently deem less significant may also impair our business operations. If any of the following risks occur, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected.

~~International Regulation~~Risk Factor Summary

~~In order~~Our tobusiness ~~market~~is ~~any~~subject ~~of our products outside of the United States, we would need~~ to ~~comply with~~ numerous ~~and~~risks ~~varying regulatory requirements of other countries~~ and ~~jurisdictions~~uncertainties ~~regarding~~that ~~quality,~~you ~~safety~~should ~~and~~consider ~~efficacy~~before ~~and~~investing ~~governing,~~in ~~among other things, clinical trials, marketing authorization, commercial sales and distribution of~~ our ~~products~~common stock. WeThese ~~may~~risks beare ~~subject~~described tomore ~~regulations~~fully ~~and~~below ~~product registration requirements in the areas of product standards, packaging requirements, labeling requirements, import~~ and ~~export restrictions and tariff regulations~~include, ~~duties~~ ~~and~~but ~~tax~~are ~~requirements. Whether or~~ not welimited ~~obtain FDA approval for a product~~to, werisks ~~would~~relating ~~need~~ to ~~obtain~~ the necessary approvals by the comparable foreign regulatory authorities before we can commence clinical trials or marketing of the product in foreign countries and jurisdictions. The time required to obtain clearance required by foreign countries may be longer or shorter than that required for FDA clearance, and requirements for licensing a product in a foreign country may differ significantly from FDA requirements.following:

~~European Union~~Risks Related to Financial Position and Capital Resources

~~The European~~● ~~Union~~We ~~(“EU”)~~have ~~will~~incurred ~~require~~operating alosses CEsince ~~mark~~our ~~certification~~inception orand ~~approval~~may innot ~~order~~be able to ~~market~~achieve ~~our~~profitability. ~~products~~● inWe ~~the~~have ~~various~~concluded ~~countries~~ there is substantial doubt of ~~the~~our ~~European~~ability ~~Union~~to orcontinue ~~other~~as ~~countries~~a ~~outside~~going ~~the~~concern ~~United~~and ~~States.~~our Toindependent ~~obtain~~registered CEpublic ~~mark~~accounting ~~certification~~firm’s ofreport on our ~~products,~~financial westatements ~~will~~contains bean ~~required~~ explanatory paragraph describing our ability to ~~work~~continue ~~with~~as ana ~~accredited~~going ~~European~~concern. ~~notified~~● ~~body~~We ~~organization~~and toour ~~determine~~subsidiaries have faced significant challenges raising capital under the ~~appropriate~~current ~~documents~~market ~~required~~conditions. ● There can be no assurance that our common stock will continue to ~~support~~trade ~~certification in~~on ~~accordance~~the ~~with~~Nasdaq ~~existing~~Capital ~~medical~~Market ~~device~~or ~~directive~~another national securities exchange. ~~The~~● ~~predictability~~Our subsidiary Lucid may issue shares of its common and/or preferred stock in the ~~length~~future. These events could reduce the percentage equity interest of ~~time~~PAVmed in Lucid, and ~~cost~~thereby ~~associated~~reduce ~~with~~its ~~such~~influence aover CEmatters ~~mark may~~subject ~~vary~~to ora ~~may~~shareholder ~~include~~vote ~~lengthy~~and ~~clinical~~otherwise ~~trials~~adversely toaffect ~~support~~your ~~such~~investment ain ~~marking~~PAVmed. ~~Once~~● ~~the~~Servicing CEour ~~mark~~indebtedness ismay ~~obtained~~require a significant amount of cash, weand ~~may~~the ~~market~~restrictive ~~our~~covenants ~~product~~contained in the ~~countries~~documents ofthat ~~the~~govern EUour indebtedness and preferred stock could adversely affect our business plan, liquidity, financial condition, and results of operations.

~~European Good Manufacturing Practices~~22

~~In the~~Risks ~~European~~Associated Union, the manufacture of medical devices is subject to good manufacturing practice (“GMP”), as set forth in the relevant laws and guidelines of the European Union and its member states. Compliance with ~~GMP~~Our isBusiness generally assessed by the competent regulatory authorities. Typically, quality system evaluation is performed by a Notified Body, which also recommends to the relevant competent authority for the European Community CE Marking of a device. The Competent Authority may conduct inspections of relevant facilities, and review manufacturing procedures, operating systems and personnel qualifications. In addition to obtaining approval for each product, in many cases each device manufacturing facility must be audited on a periodic basis by the Notified Body. Further inspections may occur over the life of the product.

~~Other Laws~~● We will need substantial additional funding and may be unable to raise capital when needed, which could force us to delay, reduce, eliminate or abandon growth initiatives or product development programs. ● The markets in which we operate are highly competitive, and we may not be able to effectively compete against other providers of medical devices, particularly those with greater resources. ● We have finite resources, which may restrict our success in commercializing our current products and other products we may develop, and we may be unsuccessful in entering into or maintaining third-party arrangements to support our internal efforts. ● If we are unable to deploy and maintain effective sales, marketing and medical affairs capabilities, we will have difficulty achieving market awareness and selling our tests and other products. ● Our products may never achieve market acceptance. ● Recommendations, guidelines and quality metrics issued by various organizations may significantly affect payors’ willingness to cover, and healthcare providers’ willingness to prescribe, our products. ● We or our third-party manufacturers may not have the manufacturing and processing capacity to meet the production requirements of clinical testing or consumer demand in a timely manner. ● If demand for our EsoGuard test grows, we may lack adequate facility space and capabilities to meet increased processing requirements. Moreover, if these or any future facilities or our equipment were damaged or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operate our business could be materially harmed. ● We may make investments in products we have not yet developed, and those investments may not be realized. ● Our products and services may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, thereby harming our business. ● Our products and services may cause serious adverse side effects or even death or have other properties that could delay or prevent their regulatory approval, limit the commercial desirability of an approved label or result in significant negative consequences following any marketing approval. ● Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop. ● We may not be able to protect or enforce our intellectual property rights, which could impair our competitive position. ● We may be subject to intellectual property infringement claims by third parties which could be costly to defend, divert management’s attention and resources, and may result in liability. ● Competitors may violate our intellectual property rights, and we may bring litigation to protect and enforce our intellectual property rights, which may result in substantial expense and may divert our attention from implementing our business strategy. ● Our business may suffer if we are unable to manage our growth. ● Our ability to be successful will be totally dependent upon the efforts of our key personnel. ● Our officers and directors have fiduciary obligations to other companies and, accordingly, may have conflicts of interest in determining to which entity a particular business opportunity should be presented. ● Our business, financial condition and results of operations could be adversely affected by the political and economic conditions of the countries in which we conduct business. ● Failure in our information technology or storage systems could significantly disrupt our operations and our research and development efforts, which could adversely impact our revenues, as well as our research, development and commercialization efforts. ● We may become the subject of various claims, threats of litigation, litigation or investigations which could have a material adverse effect on our business, financial condition, results of operations or price of our common stock.

~~Occupational Safety and Health~~23

~~In addition~~Risks toAssociated ~~its~~with ~~comprehensive~~Healthcare ~~regulation of health and safety in the workplace in general~~Regulation, ~~the~~Billing ~~Occupational Safety~~ and ~~Health Administration has established extensive requirements aimed specifically at laboratories and other healthcare-related facilities. In addition~~Reimbursement, ~~because Lucid’s operations may require employees to use certain hazardous chemicals, Lucid also must comply with regulations on hazard communication~~ and ~~hazardous~~Product ~~chemicals~~Safety ~~in laboratories. These regulations require Lucid, among other things, to develop written programs~~ and ~~plans,~~Effectiveness ~~which must address methods for preventing and mitigating employee exposure, the use of personal protective equipment, and training.~~

~~Specimen Transportation~~● If private or governmental third-party payors do not maintain reimbursement for our products at adequate reimbursement rates, we may be unable to successfully commercialize our products which would limit or slow our revenue generation and likely have a material adverse effect on our business. ● Any future products or services we may develop may not be approved for sale in the U.S. or in any other country. In order to obtain approval, we may need to conduct clinical trials necessary to support a FDA 510(k) notice or PMA application will be expensive and will require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. ● The results of the Company’s clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects. ● Even if we receive regulatory approval for any product we may develop, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements. ● Healthcare reform measures, including those targeting Medicare or Medicaid, could hinder or prevent our products’ commercial success. ● If we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected. ● The Company’s medical products may in the future be subject to product recalls that could harm its reputation, business and financial results. ● If the Company’s medical products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions. ● If the Company is found to be promoting the use of its devices for unapproved or “off-label” uses or engaging in other noncompliant activities, the Company may be subject to recalls, seizures, fines, penalties, injunctions, adverse publicity, prosecution, or other adverse actions, resulting in damage to its reputation and business.

~~Our commercialization~~Risks ~~activities~~Associated ~~for~~with ~~EsoGuard~~Ownership ~~subject Lucid to regulations~~ of ~~the~~Our ~~Department~~Common ofStock ~~Transportation, the United States Postal Service, and the Centers for Disease Control and Prevention that apply to the surface and air transportation of clinical laboratory specimens.~~

~~Environmental~~● We may issue shares of our common and/or preferred stock in the future (including shares of our common stock upon exercise of the outstanding Series D warrants) which could reduce the equity interest of our stockholders and might cause a change in control of our ownership. ● The holder of our debt has certain rights with respect to the shares in Lucid Diagnostics that we own, which may have a material impact on the return on any investment in shares of our common stock. ● Our management and their affiliates control a substantial interest in us and thus may influence certain actions requiring a stockholder vote. ● A robust public market for our common stock may not be sustained, which could affect your ability to sell our common stock or depress the market price of our common stock. ● Our stock price may be volatile, and purchasers of our securities could incur substantial losses. ● Our outstanding warrants and other convertible securities may have an adverse effect on the market price of our common stock and the value of your investment in us. ● We do not intend to pay any cash dividends on our common stock at this time. ● We have made distributions of shares of Lucid common stock to our shareholders in the past, but there is no assurance we will do so in the future. ● We are subject to evolving corporate governance and public disclosure expectations and regulations that impact compliance costs and risks of noncompliance. ● We incur significant costs as a result of our and Lucid Diagnostics operating as a public company, and our management will be required to devote substantial time to compliance initiatives. ● If we experience material weaknesses in our internal control over financial reporting in the future, our business may be harmed. ● If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock price and trading volume could decline. ● Provisions in our corporate charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our current management.

The cost of compliance with federal, state and local provisions related to the protection of the environment has had no material effect on our business. There were no material capital expenditures for environmental control facilities in the years ended December 31, 2024 and 2023.24

~~Employees~~Risks Related to Financial Position and Capital Resources

~~As of~~We ~~March~~have ~~20,~~incurred ~~2025~~operating welosses ~~had~~since ~~39 employees (all of whom were full-time employees), inclusive of~~ our ~~executive~~inception ~~officers — our Chairman of the Board of Directors~~ and ~~Chief~~may ~~Executive~~not ~~Officer~~be ~~(“CEO”),~~able our President and Chief Financial Officer (“CFO”), our Chief Operating Officer (“COO”), and our General Counsel and Secretary (“General Counsel”). No employees are covered by a collective bargaining agreement. We consider our relationship with our employees to beachieve ~~good~~profitability.

18We have incurred net losses since our inception.

~~Corporate Information~~To date, since our inception in June 2014, we have financed our operations principally through issuances (by us or by our subsidiaries) of common stock, preferred stock, warrants, and debt, in both private placements and public offerings of our securities. Our ability to generate sufficient revenue from any of our products in development, and to transition to profitability and generate consistent positive cash flows is dependent upon factors that may be outside of our control. While we have taken steps to reduce operating expenses, we expect to continue to incur operating expenses in excess of our revenues as we continue to maintain our commercial infrastructure, develop, enhance and commercialize products and incur additional operational and reporting costs associated with being a public company. As a result, we expect to continue to incur operating losses for the foreseeable future.

We ~~were~~ ~~incorporated~~have inconcluded ~~Delaware~~there onis ~~June~~substantial ~~26,~~doubt ~~2014.~~of ~~Our~~our ~~corporate~~ability ~~headquarters~~to ~~address~~continue isas ~~360~~a ~~Madison~~going ~~Avenue,~~concern ~~25th~~and ~~Floor,~~our ~~New~~independent ~~York,~~registered NYpublic ~~10017, and~~accounting firm’s report on our ~~main~~financial ~~telephone~~statements ~~number~~contains isan ~~(917)~~explanatory ~~813-1828~~paragraph describing our ability to continue as a going concern.

~~Available Information~~In our December 31, 2025 consolidated financial statements, we have concluded and stated that our recurring losses from operations, recurring cash flows used in operations and the requirement that we will need to raise additional capital in order to fund our ongoing operations beyond March 2026 raise substantial doubt regarding our ability to continue as a going concern. Additionally, our independent registered public accounting firm’s report on our consolidated financial statements includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. Our plans to address this going concern risk include pursuing further financings at PAVmed or our subsidiaries, and pursuing additional offerings of debt and/or equity securities. The consolidated financial statements do not include any adjustments that might result from our inability to consummate such offerings or our ability to continue as a going concern. Moreover, there is no assurance if we consummate additional offerings, we will raise sufficient proceeds in such offerings to pay our financial obligations as they become due. These factors raise substantial doubt about our ability to continue as a going concern.

We ~~make~~ ~~available free of charge through our website (www.pavmed.com) our periodic reports~~ and ~~registration statements filed with the United States Securities and Exchange Commission (“SEC”), including~~ our ~~Annual~~subsidiaries ~~Report~~have onfaced ~~Form~~significant ~~10-K,~~challenges ~~Quarterly~~raising ~~Reports~~capital onunder ~~Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Sections 13(a) and 15(d) of~~ the ~~Securities Exchange~~current ~~Act~~market ~~of 1934, as amended, or the “Exchange Act~~conditions.” ~~We make these reports available through our website as soon as reasonably practicable after we electronically file such reports with, or furnish such reports to the SEC.~~

~~We also~~Due ~~make~~to ~~available,~~challenging ~~free~~market ~~of charge on our website~~conditions, ~~the~~we ~~reports~~have ~~filed~~found ~~with~~it ~~the~~difficult ~~SEC~~to byraise ~~our~~capital ~~named~~directly ~~executive~~into ~~officers,~~PAVmed ~~directors,~~or ~~and~~any ~~10% stockholders~~of ~~pursuant~~our tosubsidiaries. ~~Section~~There 16is ~~under~~no ~~the~~assurance ~~Exchange~~that ~~Act~~we asor ~~soon~~our assubsidiaries ~~reasonably~~will ~~practicable~~be ~~after~~able ~~those~~to ~~filings~~raise ~~are~~capital ~~provided~~as needed to usfund ~~by those~~our ~~persons.~~or ~~The~~their ~~public~~future ~~also~~operations, ~~may~~or ~~read~~that ~~and copy~~ any ~~materials~~of weus ~~file~~or ~~with~~them ~~the~~will ~~SEC~~be atable ~~the~~to ~~SEC’s~~do ~~Public~~so ~~Reference~~on ~~Room~~commercially atreasonable ~~100 F Street, NE~~terms., ~~Washington~~Accordingly, ~~DC 20549, on official business days during~~ the ~~hours~~failure of 10us ~~a.m.~~or toany ~~3 p.m. The public may obtain information on the operation~~ of ~~the~~our ~~Public~~subsidiaries ~~Reference~~to ~~Room~~raise ~~by calling~~ the ~~Commission~~capital atwe ~~1-800-SEC-0330.~~or ~~The~~it ~~SEC~~needs ~~also~~to ~~maintains~~fund anoperations, ~~Internet~~could ~~site~~have ~~(http://www.sec.gov) that~~a ~~contains~~material ~~reports,~~adverse ~~proxy~~effect ~~and~~on ~~information~~us ~~statements,~~ and/or ~~other~~the ~~information~~portion ~~regarding~~of usour ~~that~~business werelated ~~file~~to ~~electronically~~such ~~with the SEC~~subsidiary.

~~Our website~~In ~~address~~our isrecent ~~www.pavmed.com.~~offering ~~The~~of ~~content~~Series ofD ~~our~~Preferred ~~website~~Stock, iswe ~~not~~issued ~~incorporated~~warrants byexercisable ~~reference~~for ~~into~~an ~~this~~aggregate ~~Annual~~purchase ~~Report~~price onof ~~Form~~$30 ~~10-K, nor~~million. inThere ~~any~~can ~~other~~be ~~report~~no assurance that all or ~~document~~any weof ~~file~~such orwarrants ~~furnish~~will ~~with~~be ~~and~~exercised. ~~/or~~To ~~submit~~the toextent the ~~SEC~~warrants are not exercised, ~~and~~we ~~any~~will ~~reference~~need to ~~our~~find ~~website~~alternate ~~are~~sources ~~intended to~~of capital, which may not be ~~inactive~~available ~~textual~~on ~~references~~commercially ~~only~~reasonable terms.

19In addition, because of the challenges PAVmed has faced in terms of raising capital, we are highly dependent on our subsidiaries, including Lucid Diagnostics, as resources for funding our operations (notably, PAVmed has recently elected that Lucid Diagnostics satisfy its obligations under our management services agreement through cash payment). If Lucid Diagnostics is unable to continue to make any such cash payments we elect to receive, or if Lucid Diagnostics determines to terminate the management services agreement (i.e., because it retains its own management team to oversee its operations), and PAVmed is unable to raise sufficient capital itself, it may not have sufficient capital to fund its operations, which in turn could have a material adverse effect on our business.

~~Item 1A~~If we are successful in raising capital directly or through our subsidiaries, such transaction would dilute our shareholders' interests in PAVmed, and/or PAVmed’s (and accordingly, our shareholders’) interest in such subsidiaries, which in turn could reduce the proceeds available to PAVmed and its shareholders upon any disposition or liquidation of PAVmed or any such subsidiaries. ~~Risk~~In ~~Factors~~addition, the terms of any such investment into our subsidiaries could contain covenants and other restrictions that impair PAVmed’s control over such subsidiaries or the manner in which such subsidiaries operate.

The following risk factors and other information included in this Annual Report on Form 10-K should be carefully considered. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or we presently deem less significant may also impair our business operations. If any of the following risks occur, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected.25

~~Risk Factor~~There ~~Summary~~can be no assurance that our common stock will continue to trade on the Nasdaq Capital Market or another national securities exchange.

~~Our business~~There iscan ~~subject~~be no assurance that we will be able to ~~numerous~~continue ~~risks~~to ~~and~~meet ~~uncertainties~~Nasdaq ~~that~~Capital ~~you~~Market ~~should~~listing ~~consider~~standards. ~~before~~If ~~investing~~we inare unable to maintain compliance with all applicable listing standards, our common stock. ~~These~~may ~~risks~~no ~~are described~~longer ~~more~~be ~~fully~~listed ~~below~~on ~~and~~the ~~include,~~Nasdaq ~~but~~Capital ~~are~~Market ~~not~~or ~~limited~~another ~~to,~~national ~~risks~~securities ~~relating~~exchange toand the ~~following:~~liquidity and market price of our common stock may be adversely affected.

~~Risks Related~~On toJanuary ~~Financial~~21, ~~Position~~2026, ~~and~~the Company received a notification letter from the Listing Qualifications department of Nasdaq stating that the Company had regained compliance with the $1 minimum bid price requirement for continued listing on the Nasdaq Capital ~~Resources~~Market. As previously reported, on January 23, 2025, the Company had received a notification letter from the Listing Qualifications department stating that, for the prior 30 consecutive business days (through January 22, 2025), the closing bid price of the Company’s common stock had been below the minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). Subsequently, Nasdaq determined that, from January 2, 2026 to January 19, 2026, the closing bid price of the Company’s common stock had been at $1 per share or greater. Accordingly, the Company had regained compliance with Nasdaq Listing Rule 5550(a)(2).

●In Weany ~~have~~event, ~~incurred~~if ~~operating~~we ~~losses~~fail ~~since our inception and may not be able~~ to ~~achieve~~remain ~~profitability.~~in ●compliance Wewith ~~have~~the ~~concluded~~minimum ~~there~~bid isprice ~~substantial~~or ~~doubt~~any ofother ~~our~~Nasdaq ~~ability~~listing torequirement ~~continue~~in as a going concern and our independent registered public accounting firm’s report on our financial statements contains an explanatory paragraph describing our ability to continue as a going concern. ● We have faced significant challenges raising capital under the ~~current market conditions~~future, ~~and~~there ~~therefore are highly dependent on the ability of each of our subsidiaries to raise capital to fund its own and our operations. ● There~~ can be no assurance that ~~our~~we ~~common stock~~ will ~~continue~~be able to ~~trade~~regain oncompliance within the ~~Nasdaq~~applicable ~~Capital~~grace ~~Market~~period, orin ~~another~~which ~~national~~case ~~securities~~we ~~exchange.~~could ●be ~~Our~~delisted. ~~subsidiary~~Moreover, ~~Lucid~~Nasdaq, ~~may issue shares of its common and/or preferred stock~~ in ~~the~~light ~~future, and the holder~~ of our ~~convertible~~history ~~debt may exchange such debt for our shares~~ of ~~Lucid~~noncompliance, ~~common~~may ~~stock.~~not ~~These~~allow ~~events~~us ~~could reduce the percentage equity interest of PAVmed in Lucid. and thereby reduce its influence over matters subject~~ to aleverage ~~shareholder~~tools ~~vote~~we ~~and~~have ~~otherwise~~used ~~adversely affect your investment~~ in ~~PAVmed. ● Servicing our indebtedness may require a significant amount of cash, and~~ the ~~restrictive covenants contained in the documents that govern our indebtedness and preferred stock could adversely affect our business plan~~past, ~~liquidity, financial condition, and results of operations. ● The accounting method for convertible debt securities that may be settled in cash,~~ such as ~~the~~a ~~September~~reverse ~~2022~~stock ~~Senior Convertible Note~~split, ~~could~~to ~~have~~regain ~~a material effect on our reported financial results~~compliance.

~~Risks Associated~~If ~~with~~we ~~Our~~were ~~Business~~delisted, that could have a material adverse effect on your investment in the Company, including without limitation by substantially reducing the liquidity of our common stock, and by further limiting our access to capital markets for fundraising.

● We will need substantial additional funding and may be unable to raise capital when needed, which could force us to delay, reduce, eliminate or abandon growth initiatives or product development programs. ● The markets in which we operate are highly competitive, and we may not be able to effectively compete against other providers of medical devices, particularly those with greater resources. ● We have finite resources, which may restrict our success in commercializing our current products and other products we may develop, and we may be unsuccessful in entering into or maintaining third-party arrangements to support our internal efforts. ● If we are unable to deploy and maintain effective sales, marketing and medical affairs capabilities, we will have difficulty achieving market awareness and selling our tests and other products. ● Our ~~products~~subsidiary ~~may~~Lucid ~~never achieve market acceptance. ● Recommendations, guidelines and quality metrics issued by various organizations~~ may ~~significantly~~issue ~~affect~~shares payors’ willingness to cover, and healthcare providers’ willingness to prescribe, our products. ● We or our third-party manufacturers may not have the manufacturing and processing capacity to meet the production requirements of ~~clinical~~its ~~testing~~common ~~or consumer demand in a timely manner. ● If demand for our EsoGuard test grows, we may lack adequate facility space~~ and ~~capabilities to meet increased processing requirements. Moreover, if these~~ /or ~~any~~preferred ~~future~~stock ~~facilities or our equipment were damaged or destroyed, or if we experience a significant disruption~~ in our operations for any reason, our ability to continue to operate our business could be materially harmed. ● We may make investments in products we have not yet developed, and those investments may not be realized. ● We may not obtain the ~~expected benefits of the incubator financing structure and may incur additional costs~~future. ●These ~~Our~~events products and services may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, thereby harming our business. ● Our products and services may cause serious adverse side effects or even death or have other properties that could ~~delay~~reduce ~~or prevent their regulatory approval, limit~~ the ~~commercial~~percentage ~~desirability~~equity ofinterest an approved label or result in significant negative consequences following any marketing approval. ● Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of ~~any~~PAVmed products that we may develop. ● We may not be able to protect or enforce our intellectual property rights, which could impair our competitive position. ● We may be subject to intellectual property infringement claims by third parties which could be costly to defend, divert management’s attention and resources, and may result in ~~liability. ● Competitors may violate our intellectual property rights~~Lucid, and wethereby ~~may~~reduce ~~bring~~its ~~litigation~~influence toover ~~protect~~matters ~~and~~subject ~~enforce our intellectual property rights, which may result in substantial expense and may divert our attention from implementing our business strategy. ● Our business may suffer if we are unable~~ to manage our growth. ● Our ability to be successful will be totally dependent upon the efforts of our key personnel. ● Our officers and directors have fiduciary obligations to other companies and, accordingly, may have conflicts of interest in determining to which entity a ~~particular~~shareholder ~~business~~vote ~~opportunity should be presented. ● Our business, financial condition~~ and ~~results~~otherwise ~~of operations could be~~ adversely ~~affected~~affect byyour ~~the~~investment ~~political and economic conditions of the countries~~ in ~~which we conduct business~~PAVmed. ● Failure in our information technology or storage systems could significantly disrupt our operations and our research and development efforts, which could adversely impact our revenues, as well as our research, development and commercialization efforts. ● We may become the subject of various claims, threats of litigation, litigation or investigations which could have a material adverse effect on our business, financial condition, results of operations or price of our common stock.

20PAVmed beneficially owned approximately 27.5% as of December 31, 2025 and 27.1% as of March 23, 2026 of our outstanding common stock (with such percentage inclusive of shares of our common stock underlying granted but unvested restricted stock awards and shares over which PAVmed otherwise has been granted voting control by the holder thereof). This percentage would be diluted in the event of future convertible debt or stock issuances by Lucid or by issuances under Lucid’s long-term incentive plan and employee stock purchase plan. While PAVmed may still have a significant ownership interest in Lucid in such event, the more its interest in Lucid is diluted, the less influence it will have on matters requiring shareholder approval, including the election of Lucid’s board of directors.

~~Risks Associated~~If ~~with~~PAVmed’s ~~Healthcare~~ownership ~~Regulation~~interest (in terms of voting power) in Lucid declines, ~~Billing~~depending ~~and~~on ~~Reimbursement~~the extent of such decline, ~~and~~PAVmed ~~Product~~may ~~Safety~~no ~~and~~longer ~~Effectiveness~~be deemed to primarily control Lucid for the purposes of the Investment Company Act of 1940, as amended (the “Investment Company Act”). In such event, the securities of Lucid held by PAVmed would no longer be excluded under certain tests used to determine whether PAVmed is deemed to be an investment company under the Investment Company Act. PAVmed still could claim that it otherwise does not meet the definition of an investment company, or that it qualifies for an exemption therefrom, but there can be no assurance that any such claim would be tenable or any such exemption would be available.

● If ~~private~~PAVmed orwas ~~governmental~~deemed ~~third-party~~to ~~payors~~be doan ~~not~~investment ~~maintain reimbursement for our products at adequate reimbursement rates~~company, weit ~~may~~could beseek ~~unable~~ to ~~successfully~~rely ~~commercialize our products which would limit or slow our revenue generation and likely have a material adverse effect~~ on ~~our~~the ~~business.~~temporary ●exemption ~~FDA has proposed a policy under which it would phase out its general enforcement discretion approach~~ for ~~LDTs~~transient soinvestment ~~that IVDs manufactured at a laboratory would generally fall under the same enforcement approach as other IVDs~~companies. ~~While~~If weit ~~are~~was ~~confident that the proposed policy will~~ not ~~have~~able ato ~~material~~rely ~~impact~~ on ~~our~~such ~~business~~exemption, ~~there~~or ~~can be no assurance that will be~~ the ~~case.~~period ~~● Any future products or services we may develop may not be approved~~ for ~~sale~~relief inunder ~~the~~such ~~U.S.~~exemption orexpired inand ~~any~~PAVmed ~~other~~was ~~country.~~still Indeemed ~~order~~ to ~~obtain~~be ~~approval,~~an weinvestment ~~may~~company, ~~need~~PAVmed tocould ~~conduct~~be ~~clinical~~forced ~~trials necessary~~ to ~~support~~register aas ~~FDA~~an ~~510(k)~~investment ~~notice~~company orand ~~PMA~~comply ~~application~~with ~~will~~substantive berequirements ~~expensive~~under ~~and will require~~ the ~~enrollment~~Investment ofCompany ~~large numbers of patients~~Act, ~~and~~including ~~suitable~~limitations ~~patients~~on ~~may~~its beability ~~difficult~~ to ~~identify~~borrow, ~~and~~limitations ~~recruit.~~on ●its ~~The~~capital ~~results~~structure, ofrestrictions ~~the~~on ~~Company’s~~acquisitions ~~clinical~~of ~~trials~~interests ~~may not support our product candidate claims or may result~~ in ~~the~~associated ~~discovery~~companies, ofprohibitions ~~adverse~~on ~~side~~transactions ~~effects.~~with ~~● Even if we receive regulatory approval for any product we may develop~~affiliates, werestrictions ~~will~~on bespecific ~~subject to ongoing regulatory obligations and continued regulatory review~~investments, ~~which may result in significant additional expense~~ and ~~subject~~compliance ~~us to penalties if we fail to comply~~ with ~~applicable~~reporting, ~~regulatory~~record ~~requirements. ● Healthcare reform measures~~keeping, ~~including those targeting Medicare or Medicaid~~voting, ~~could~~proxy ~~hinder~~disclosure orand ~~prevent~~other ~~our~~rules ~~products’~~and ~~commercial success~~regulations. ● If wePAVmed ~~fail~~were forced to comply with ~~healthcare~~the ~~regulations,~~Investment weCompany ~~could~~Act, ~~face~~its ~~substantial~~operations ~~penalties~~would ~~and~~significantly ~~our business~~change, ~~operations~~ and ~~financial~~it ~~condition~~would ~~could~~ be ~~adversely~~prevented ~~affected.~~from ●successfully ~~The~~executing ~~Company’s medical products may in the future be subject to product recalls that could harm~~ its ~~reputation,~~ business ~~and financial results~~strategy. ● If ~~the~~PAVmed ~~Company’s~~was ~~medical~~forced ~~products~~to ~~cause~~sell or ~~contribute~~distribute to aits ~~death~~shareholders orits ainterest ~~serious injury, or malfunction~~ in ~~certain~~Lucid ~~ways, we will be subject~~ to ~~medical~~avoid ~~device~~regulation ~~reporting~~under ~~regulations, which can result in voluntary corrective actions or agency enforcement actions. ● If~~ the Investment Company ~~is found to be promoting the use of its devices for unapproved or “off-label” uses or engaging in other noncompliant activities~~Act, ~~the~~it ~~Company~~also ~~may~~could be ~~subject~~prevented tofrom ~~recalls,~~successfully ~~seizures,~~executing ~~fines, penalties, injunctions, adverse publicity, prosecution, or other adverse actions, resulting in damage to~~ its ~~reputation and~~ business strategy.

~~Risks Associated with Ownership of Our Common Stock~~26

●Servicing ~~We may issue shares of~~ our ~~common~~indebtedness and /or preferred stock in the future which could reduce the equity interest of our stockholders and might cause a change in control of our ownership. ● The holder of our convertible debt and the holder of our Series C Preferred Stock have certain rights with respect to the shares in Lucid Diagnostics that we own, which may ~~have~~require a ~~material~~significant ~~impact~~amount ~~on the return on any investment in shares~~ of our common stock. ● Our management and their affiliates control a substantial interest in us and thus may influence certain actions requiring a stockholder vote. ● A robust public market for our common stock may not be sustainedcash, ~~which could affect your ability to sell our common stock or depress the market price of our common stock. ● Our stock price may be volatile,~~ and ~~purchasers of our securities could incur substantial losses. ● Our outstanding warrants and other convertible securities may have an adverse effect on~~ the ~~market~~restrictive ~~price~~covenants ofcontained ~~our common stock and the value of your investment~~ in ~~us. ● We do not intend to pay any cash dividends on our common stock at this time. ● We have made distributions of shares of Lucid common stock to our shareholders in~~ the ~~past,~~documents ~~but there is no assurance we will do so in the future. ● We are subject to evolving corporate governance and public disclosure expectations and regulations~~ that ~~impact~~govern ~~compliance costs and risks of noncompliance. ● We incur significant costs as a result of~~ our ~~and~~indebtedness ~~Lucid Diagnostics operating as a public company,~~ and ~~our~~preferred ~~management~~stock ~~will~~could beadversely ~~required~~affect ~~to devote substantial time to compliance initiatives. ● If we experience material weaknesses in~~ our ~~internal control over financial reporting in the future, our~~ business ~~may be harmed. ● If securities or industry analysts do not publish research~~plan, ~~or publish inaccurate or unfavorable research~~liquidity, ~~about~~financial ~~our business~~condition, ~~our stock price~~ and ~~trading~~results ~~volume could decline. ● Provisions in our corporate charter documents and under Delaware law could make an acquisition~~ of ~~us more difficult and may prevent attempts by our stockholders to replace or remove our current management~~operations.

21We and our subsidiaries may be required to repay or redeem, or to pay interest on, the 2026 Note or any future permitted indebtedness incurred by us or our subsidiaries, in cash. For example, while we do not have to make any principal installment payments on under the 2026 Note prior to maturity in 2029, under the terms of such debt, we will owe annual cash interest payments of approximately $2.25 million, and are required to maintain a minimum cash balance of $5 million, which minimum balance increases to $8 million as of July 1, 2026. Moreover, we may be required to repay the outstanding principal balance and accrued but unpaid interest, along with a premium, upon the occurrence of certain changes of control or an event of default.

~~Risks Related~~Our ability to ~~Financial~~make ~~Position~~payments of the principal of, to pay interest on, or to redeem our indebtedness in cash, and ~~Capital~~to ~~Resources~~meet our minimum cash balance obligations, depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. We have not generated material revenue from operations to date, and our business may not generate cash flow from operations in the future sufficient to service our indebtedness and make necessary capital expenditures. In addition, the 2026 Note contains, and any future indebtedness may contain, restrictive covenants, including financial covenants. These payment obligations and covenants could have important consequences on our business. In particular, they could:

~~We have~~● ~~incurred~~require ~~operating~~us ~~losses~~to ~~since~~dedicate a substantial portion of our ~~inception~~cash flow from operations to payments on our indebtedness; ● limit, among other things, our ability to borrow additional funds and ~~may~~otherwise ~~not~~raise beadditional ~~able~~capital, and our ability to ~~achieve~~conduct ~~profitability~~acquisitions, joint ventures or similar arrangements, as a result of our obligations to make such payments and comply with the restrictive covenants in the indebtedness; ● limit our flexibility in planning for, or reacting to, changes in our businesses and the industries in which we operate; ● increase our vulnerability to general adverse economic and industry conditions; and ● place us at a competitive disadvantage compared to our competitors that have lower fixed costs.

~~We have~~The ~~incurred~~debt ~~net~~service ~~losses~~requirements ~~since~~of ~~our~~any ~~inception~~other permitted indebtedness we incur or issue in the future, as well as the restrictive covenants contained in the governing documents for any such indebtedness, could intensify these risks. For example, we may fall out of compliance such restrictive covenants. There is no assurance that the holder of the 2026 Note will be willing to waive any future non-compliance, or if they are willing to do so, if the terms on which they are so willing will be acceptable to us.

~~To date,~~If ~~since~~we ~~our~~are ~~inception~~unable into ~~June~~make ~~2014,~~the werequired ~~have~~cash ~~financed~~payments, ~~our~~there ~~operations~~could ~~principally~~be ~~through~~a ~~issuances~~default ~~(by~~under usone or bymore ~~our subsidiaries)~~ of ~~common~~the ~~stock,~~instruments ~~preferred~~governing ~~stock,~~our ~~warrants,~~indebtedness. ~~and~~Any ~~debt,~~such indefault ~~both~~or ~~private~~acceleration ~~placements~~may ~~and~~further ~~public~~result ~~offerings~~in ofan ~~our~~event ~~securities.~~of ~~Our~~default ~~ability to~~and ~~generate~~acceleration ~~sufficient revenue from any~~ of our ~~products~~other inindebtedness. ~~development,~~In ~~and~~such toevent, ~~transition~~or toif ~~profitability~~a ~~and~~default ~~generate~~otherwise ~~consistent~~occurs ~~positive cash~~under ~~flows~~our isindebtedness, ~~dependent~~including ~~upon~~as ~~factors~~a ~~that~~result ~~may be outside~~ of our ~~control.~~failure ~~While we have taken steps~~ to ~~reduce~~comply ~~operating~~with ~~expenses,~~the wefinancial ~~expect to~~or ~~continue~~other tocovenants ~~incur~~contained ~~operating~~therein, ~~expenses~~the inholders ~~excess~~ of our ~~revenues~~indebtedness ascould werequire ~~continue~~us to ~~maintain~~immediately ~~our~~repay ~~commercial~~the ~~infrastructure,~~outstanding ~~develop, enhance~~principal and ~~commercialize~~interest ~~products~~on ~~and~~such ~~incur~~indebtedness ~~additional~~in ~~operational~~cash, ~~and~~in ~~reporting~~some ~~costs~~cases ~~associated~~subject ~~with~~to ~~being~~ a ~~public company~~premium. ~~As a result~~Furthermore, wethe ~~expect~~holder toof ~~continue~~our tosecured ~~incur~~indebtedness ~~operating~~could ~~losses~~foreclose ~~for~~on ~~the~~its ~~foreseeable~~security ~~future~~interest in our assets.

WeIf ~~have~~we ~~concluded~~are ~~there~~required isto ~~substantial~~make ~~doubt~~ payments under our indebtedness in cash and are unable to generate sufficient cash flow from operations, we may be required to sell assets, or we may seek to refinance the remaining balance, by either refinancing with the holder of the indebtedness, by raising sufficient funds through a sale of equity or debt securities or by obtaining a credit facility. No assurances can be given that we will be successful in making the required payments under our indebtedness, or in refinancing our obligations on favorable terms, or at all. Our ability to ~~continue~~refinance asour aindebtedness ~~going~~will ~~concern~~depend on the capital markets and our ~~independent~~financial ~~registered~~condition ~~public~~at ~~accounting~~such ~~firm’s~~time. ~~report~~A failure to refinance could have a material adverse effect on our liquidity, financial ~~statements contains~~position, anand ~~explanatory~~results ~~paragraph~~of ~~describing~~operations. ~~our~~Should ~~ability~~we refinance, it could be dilutive to ~~continue~~shareholders asor aimpose ~~going~~onerous ~~concern~~terms on us.

In ~~our December 31~~addition, ~~2024~~Lucid ~~consolidated~~may ~~financial~~be ~~statements,~~required weto ~~have~~repay ~~concluded~~or ~~and~~redeem ~~stated~~at ~~that~~maturity ~~our~~in ~~recurring~~2029 ~~losses from~~(or ~~operations~~sooner, ~~recurring~~upon ~~cash flows used in operations and~~ the ~~requirement~~occurrence ~~that~~of wecertain ~~will~~changes ~~need~~of tocontrol ~~raise~~or ~~additional~~an ~~capital~~event inof ~~order~~default), ~~to fund~~or ~~our ongoing operations beyond March 2026 raise substantial doubt regarding our ability~~ to ~~continue~~pay asinterest ~~a going concern. Additionally~~on, ~~our~~ ~~independent~~the ~~registered~~November ~~public~~2024 ~~accounting~~Senior ~~firm’s~~Convertible ~~report~~Notes onor ~~our~~any ~~consolidated~~future ~~financial~~permitted ~~statements~~indebtedness ~~includes~~incurred anby ~~explanatory~~it ~~paragraph expressing~~or ~~substantial~~its ~~doubt~~subsidiaries, ~~about~~in ~~our ability to continue as a going concern~~cash. ~~Our~~Such ~~plans~~payment toobligations ~~address~~could ~~this~~have ~~going concern risk include pursuing further financings at PAVmed in addition to~~ the ~~recently~~same ~~completed~~important ~~Series~~consequences Con ~~Preferred~~its ~~Stock~~business, ~~Debt Exchange~~ and ~~the~~these ~~PAVmed~~debt ~~and~~service ~~Veris~~requirements ~~Common Stock~~or ~~Offering~~any ~~(we~~debt ~~recently~~service ~~raised~~requirements ~~over $2.4 million~~ in ~~such~~respect ~~offering) and pursuing additional offerings~~ of ~~debt and/or equity securities. The consolidated financial statements do not include~~ any ~~adjustments~~other ~~that~~permitted ~~might~~indebtedness ~~result~~Lucid ~~from~~may ~~our~~incur ~~inability to consummate such offerings~~ or ~~our~~issue ~~ability~~in tothe ~~continue~~future, as awell ~~going~~as ~~concern.~~the ~~Moreover,~~restrictive ~~there~~covenants iscontained noin ~~assurance~~the ifgoverning wedocuments ~~consummate~~for ~~additional~~any ~~offerings, we will raise sufficient proceeds in~~ such ~~offerings~~indebtedness, tocould ~~pay~~intensify ~~our~~these ~~financial obligations as they become due~~risks. ~~These factors raise substantial doubt about our ability to continue as a going concern.~~

We have faced significant challenges raising capital under the current market conditions, and therefore are highly dependent on the ability of each of our subsidiaries to raise capital to fund its own and our operations.27

~~Due to~~Risks ~~challenging~~Associated ~~market~~with ~~conditions,~~Our weBusiness have found it difficult to raise capital directly into PAVmed (notwithstanding our recent $2.37 million capital raise at PAVmed). As a result, we have become highly dependent on the ability of each of our subsidiaries to raise capital to fund their own operations. There is no assurance that our subsidiaries will be able to raise capital as needed to fund its operations, or that any of them will be able to do so on commercially reasonable terms. Accordingly, the failure of any of our subsidiaries to raise the capital it needs to fund its operations, could have a material adverse effect on the portion of our business related to such subsidiary.

~~In addition,~~We ~~because~~will ofneed ~~the~~substantial ~~challenges~~additional ~~PAVmed has faced in terms of raising capital, we are highly dependent on our subsidiaries, including Lucid Diagnostics, as resources for~~ funding ~~our~~and ~~operations (notably, PAVmed~~ may ~~elect~~be ~~that~~unable ~~Lucid Diagnostics satisfy its obligations under our management services agreement through cash payment and, under the terms of our outstanding convertible debt, we are required~~ to ~~elect~~raise tocapital ~~receive~~when ~~such payments in cash). In addition~~needed, ~~under~~which ~~the~~could ~~terms~~force ofus ~~our outstanding convertible debt, if the price per share of our common stock is less than the $1.068 conversion price of our Series C Preferred Stock, we are required~~ to ~~reserve 50% of all management services agreement fees we receive~~delay, ~~unless the holder of our debt waives such requirement (which it has through March 31~~reduce, ~~2025).~~eliminate ~~If Lucid Diagnostics is unable to continue to make any such cash payments we elect to receive,~~ or ifabandon wegrowth ~~are~~initiatives ~~so required to reserve 50% of the management services agreement fees we receive,~~ or ifproduct ~~Lucid~~development ~~Diagnostics determines to terminate the management services agreement (i~~programs.~~e., because~~ it retains its own management team to oversee its operations), and PAVmed is unable to raise sufficient capital itself, it may not have sufficient capital to fund its operations, which in turn could have a material adverse effect on our business.

If Notwithstanding that we ~~are~~were ~~successful~~recently inable ~~raising~~to raise capital ~~through~~directly ~~our~~into ~~subsidiaries,~~PAVmed ~~such~~and ~~transaction~~that ~~would~~we ~~dilute~~believe ~~PAVmed’s~~we have sufficient access to capital (~~and~~including ~~accordingly,~~under our ~~shareholders’) interest~~management inservices ~~such~~agreement ~~subsidiaries,~~with ~~which~~Lucid inDiagnostics) ~~turn~~to ~~could~~maintain ~~reduce~~our ~~the~~current ~~proceeds~~level ~~available~~of tobusiness ~~PAVmed~~activity, ~~(and~~we ~~its~~intend ~~shareholders)~~to ~~upon~~raise ~~any~~additional ~~disposition~~ capital, directly or ~~liquidation~~through each of ~~such~~our subsidiaries~~. In addition~~, ~~the~~to ~~terms~~support of any ~~such~~business ~~investment~~growth ~~into~~and our ~~subsidiaries~~long ~~could~~term ~~contain~~business ~~covenants~~operations. ~~and other~~Because ~~restrictions~~we ~~that~~have ~~impair~~not ~~PAVmed’s~~in ~~control~~the ~~over~~near ~~such~~term ~~subsidiaries~~generated substantial revenue or ~~the~~cash ~~manner~~flow to date, unless we are able to generate substantial revenue in the near-term (which ~~such~~we ~~subsidiaries~~do ~~operate.~~not anticipate being able to do), we will require additional funds to:

~~There can~~● beContinue noour ~~assurance~~research ~~that~~and development; ● Pursue clinical trials; ● Commercialize our ~~common~~new ~~stock~~products ~~will~~and ~~continue~~services; to● ~~trade~~Achieve onmarket ~~the~~acceptance ~~Nasdaq~~of ~~Capital~~our ~~Market~~products and services; ● Establish and expand our sales, marketing, and distribution capabilities for our products and services; ● Protect our intellectual property rights or ~~another~~defend, ~~national~~in ~~securities~~litigation ~~exchange~~or otherwise, any claims we infringe third-party patents or other intellectual property rights; and ● Acquire or otherwise invest in businesses, products and technologies, although we currently have no commitments or agreements relating to do so.

~~There can~~If bewe nodo ~~assurance~~not ~~that~~have, weor ~~will~~are benot able to ~~continue~~obtain, tosufficient ~~meet~~funds, ~~Nasdaq~~we ~~Capital~~may ~~Market~~have ~~listing~~to ~~standards.~~delay Ifproduct weacquisition ~~are~~or ~~unable~~development toinitiatives ~~maintain~~or ~~compliance with~~license ~~all~~to ~~applicable~~third ~~listing~~parties ~~standards,~~the ~~our~~rights ~~common~~to ~~stock~~commercialize ~~may~~products noor ~~longer~~technologies bewe ~~listed~~would onotherwise ~~the~~seek ~~Nasdaq~~to ~~Capital~~market. ~~Market~~We oralso ~~another~~may ~~national~~have ~~securities exchange~~to ~~and~~reduce ~~the~~marketing, ~~liquidity~~customer ~~and~~support ~~market~~or ~~price~~other ofresources ~~our~~devoted ~~common~~to ~~stock~~our ~~may be adversely affected~~products.

The ~~Company~~ ~~currently~~markets isin ~~(and~~which ~~from~~we ~~time~~operate toare ~~time~~highly incompetitive, ~~the~~and ~~recent~~we ~~past,~~may ~~the~~not ~~Company~~be ~~has~~able ~~been)~~to ~~out~~effectively ofcompete ~~compliance~~against ~~with~~other ~~the~~providers ~~standards~~of ~~and~~medical ~~requirements for~~devices, ~~continued~~particularly ~~listing~~those onwith ~~Nasdaq~~greater resources.

~~Most~~We ~~recently, on~~face ~~January~~intense ~~23,~~competition ~~2025, the Company received a notice~~ from ~~the~~companies ~~Listing~~with ~~Qualifications~~dominant ~~Department~~market ofpositions ~~Nasdaq~~in ~~stating that, for~~ the ~~prior~~medical ~~30 consecutive~~device business days (through January 22, 2025), the closing bid price of the Company’s common stock had been below the minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2)industry. ~~The~~These ~~notification~~competitors ~~letter stated~~have ~~that~~significantly ~~the~~greater ~~Company would be afforded 180 calendar days (until July 22~~financial, ~~2025) to regain compliance. In order to regain compliance~~technical, ~~the~~ ~~closing~~marketing ~~bid~~and ~~price~~other ofresources ~~the~~than ~~Company’s~~we ~~common~~have ~~stock~~and must be at least $1 for a minimum of ten consecutive business days. The notification letter also stated that, in the event the Company does not regain compliance within the initial 180-day period, the Company may be ~~eligible for~~better ~~an additional 180-day period. If the Company is not eligible for the additional 180-day period, or if it appears to the Nasdaq staff that the Company will not be~~ able to cure the deficiency, the Nasdaq Listing Qualifications Department will provide notice after the end of the initial 180-day period that the Company’s securities will be subject to delisting. In any event, there can be no assurance that the Company will be able to regain compliance by the current or any extended deadline, in which case, the Company’s stock would be delisted.:

22● respond to new technologies or technical standards; ● react to changing customer requirements and expectations; ● acquire other companies to gain new technologies or products may displace our products; ● manufacture, market and sell products; ● acquire, prosecute, enforce and defend patents and other intellectual property; ● devote resources to the development, production, promotion, support and sale of products; and ● deliver a broad range of competitive products at lower prices.

~~If we~~We ~~were~~expect ~~delisted,~~competition ~~that could have a material adverse effect on your investment~~ in the ~~Company,~~markets ~~including~~in ~~without~~which ~~limitation~~we byparticipate ~~substantially reducing~~to ~~the~~continue ~~liquidity~~to ofincrease ~~our~~as ~~common~~existing ~~stock,~~competitors ~~and~~improve byor ~~further~~expand ~~limiting~~their ~~our~~product ~~access to capital markets for fundraising~~offerings.

Our subsidiary Lucid may issue shares of its common and/or preferred stock in the future, and the holder of our convertible debt may exchange such debt for our shares of Lucid common stock. These events could reduce the percentage equity interest of PAVmed in Lucid. and thereby reduce its influence over matters subject to a shareholder vote and otherwise adversely affect your investment in PAVmed.28

~~As of~~We ~~the~~have ~~date~~finite ~~hereof~~resources, ifwhich ~~the~~may ~~maximum~~restrict ~~amount~~our ofsuccess ~~common~~in ~~stock~~commercializing ~~underlying~~our ~~Lucid’s~~current ~~outstanding~~products ~~convertible~~and ~~securities~~other ~~were~~products ~~issued (including~~we ~~shares~~may ~~of Lucid common stock issued as a dividend thereon)~~develop, ~~the~~and ~~percentage~~we ofmay ~~shares of Lucid common stock held by PAVmed would~~ be ~~reduced~~unsuccessful ~~from approximately 34% to approximately 18%. This reduced percentage would be further diluted~~ in ~~the event~~entering ofinto ~~future convertible debt~~ or ~~stock~~maintaining ~~issuances by Lucid or by issuances under Lucid’s long~~third-~~term~~party ~~incentive~~arrangements ~~plan~~to ~~and employee~~support ~~stock~~our ~~purchase~~internal ~~plan~~efforts. While PAVmed still has a significant ownership interest in Lucid in such event, the more its interest in Lucid is diluted, the less influence it will have on matters requiring shareholder approval, including the election of Lucid’s board of directors.

InTo ~~addition,~~grow soour ~~long~~business as ~~any~~planned, ~~shares of~~we ~~our~~must ~~Series~~expand Cour ~~Preferred Stock remain outstanding~~acquisition, ~~the~~research ~~holder~~and ofdevelopment ~~the~~sales, ~~September~~marketing ~~2022~~and ~~Senior~~customer ~~Convertible~~support ~~Note~~capabilities, ~~may~~which ~~elect~~will toinvolve ~~exchange~~developing ~~any or~~and ~~all~~administering ofour ~~such~~commercial ~~debt~~infrastructure ~~for~~and/or ~~the~~collaborative ~~shares~~commercial ofarrangements ~~Lucid~~and ~~Diagnostics we own at an exchange price of $0~~partnerships.85 ~~per~~We ~~share,~~must asalso ofmaintain ~~the~~satisfactory ~~date~~arrangements ~~hereof,~~for ~~which would further reduce our ownership from~~ the ~~18%~~manufacture ~~to 13% (~~and asdistribution of ~~March~~our ~~20,~~tests ~~2025,~~and ~~the closing~~other ~~bid price of a share of Lucid Diagnostics’ common stock was $1~~products.~~57).~~

IfThe ~~PAVmed’s~~only ~~ownership~~two ~~interest in Lucid declines~~products, ~~PAVmed~~EsoGuard ~~may~~and nothe ~~longer~~Veris beCancer ~~deemed~~Care toPlatform, ~~primarily~~that ~~control~~we ~~Lucid~~are ~~for~~actively ~~the~~seeking ~~purposes~~to ofcommercialize ~~the~~have ~~Investment~~not ~~Company~~generated ~~Act~~substantial ofrevenue ~~1940,~~from ~~as amended~~product ~~(the~~sales ~~“Investment~~to ~~Company Act”)~~date. ~~In such event~~Accordingly, ~~the~~we ~~securities~~will ofneed ~~Lucid~~to ~~held~~find byother ~~PAVmed~~sources ~~would~~of nocapital ~~longer~~to befund ~~excluded under~~their ~~certain~~activities, ~~tests~~and ~~used~~there tocan ~~determine~~be ~~whether~~no ~~PAVmed~~assurance isthat ~~deemed~~we towill be anable ~~investment~~to ~~company~~do ~~under~~so. ~~the~~We ~~Investment~~may ~~Company~~also ~~Act.~~encounter ~~PAVmed~~difficulties ~~still could~~retaining ~~claim~~and ~~that~~managing itthe ~~otherwise~~specialized ~~does~~workforce ~~not~~our ~~meet~~activities ~~the~~require. ~~definition~~We ofmay anseek ~~investment~~to ~~company,~~partner orwith ~~that~~others itto ~~qualifies~~assist ~~for~~us anwith ~~exemption~~any ~~therefrom, but~~or ~~there~~all ~~can~~of bethese nofunctions, ~~assurance~~although ~~that~~we ~~any~~may ~~such~~be ~~claim~~unable ~~would~~to befind ~~tenable~~appropriate orthird ~~any~~parties ~~such~~with ~~exemption~~whom ~~would~~to beenter ~~available~~into these arrangements.

If ~~PAVmed~~we ~~was~~are ~~deemed~~unable to bedeploy an investment company, it could seek to rely on the temporary exemption for transient investment companies. If it was not able to rely on such exemption, or the period for relief under such exemption expired and ~~PAVmed~~maintain ~~was still~~effective ~~deemed to be an investment company~~sales, ~~PAVmed~~marketing ~~could be forced to register as an investment company~~ and ~~comply~~medical ~~with~~affairs ~~substantive requirements under the Investment Company Act~~capabilities, ~~including~~we ~~limitations~~will onhave ~~its~~difficulty ~~ability~~achieving tomarket ~~borrow,~~awareness ~~limitations on its capital structure, restrictions on acquisitions of interests in associated companies, prohibitions on transactions with affiliates, restrictions on specific investments,~~ and ~~compliance~~selling ~~with~~our ~~reporting,~~tests ~~record keeping, voting, proxy disclosure~~ and other ~~rules and regulations~~products. If PAVmed were forced to comply with the Investment Company Act, its operations would significantly change, and it would be prevented from successfully executing its business strategy. If PAVmed was forced to sell assets to avoid regulation under the Investment Company Act, it also could be prevented from successfully executing its business strategy.

~~Servicing~~ To achieve commercial success for our ~~indebtedness~~EsoGuard ~~may~~test ~~require~~and athe ~~significant~~Veris ~~amount~~Cancer ofCare ~~cash~~Platform, ~~and~~as ~~the~~well ~~restrictive~~as ~~covenants~~any ~~contained~~products we commercialize in the ~~documents~~future, ~~that~~we ~~govern~~must continue to develop and grow our ~~indebtedness~~ sales, marketing and ~~preferred~~medical ~~stock~~affairs ~~could~~organizations ~~adversely~~to ~~affect~~effectively explain to healthcare providers the reliability, effectiveness and benefits of our ~~business~~current ~~plan~~and future tests and other products as compared to alternatives. We may not be able to successfully manage our dispersed or inside sales forces or our sales force may not be effective. Because of the competition for their services, ~~liquidity~~we may be unable to hire, ~~financial~~partner ~~condition~~with or retain additional qualified sales representatives or marketing or medical affairs personnel, either as our employees or independent contractors or through independent sales or other third-party organizations. Market competition for commercial, marketing and ~~results~~medical ofaffairs ~~operations~~talent is significant, and we may not be able to hire or retain such talent on commercially reasonable terms, if at all.

We Establishing and ~~our~~maintaining ~~subsidiaries may be required to repay or redeem~~sales, ormarketing toand ~~pay~~medical ~~interest~~affairs ~~on,~~capabilities ~~the~~will ~~September~~be ~~2022~~expensive ~~Senior~~and ~~Convertible~~time-consuming. ~~Note~~Our orexpenses ~~any~~associated ~~future permitted~~with ~~indebtedness~~maintaining ~~incurred by us or~~ our ~~subsidiaries,~~sales inforce ~~cash.~~may ~~Despite~~be ~~our~~disproportional ~~right~~compared to ~~pay~~ the ~~interest~~revenues ~~and principal balance of the September 2022 Senior Convertible Note by issuing shares of our common stock,~~ we may be ~~required~~able to ~~repay~~generate ~~such~~on ~~indebtedness~~sales inof ~~cash, if~~our weEsoGuard dotest ~~not~~and ~~meet~~the ~~certain~~Veris ~~customary~~Cancer ~~equity~~Care ~~conditions~~Platform ~~(including~~or ~~minimum~~any ~~price~~future ~~and~~tests ~~volume thresholds)~~ or ~~in certain~~ other ~~circumstances~~products. ~~For~~ ~~example,~~Establishing weand ~~may~~maintaining bethese ~~required~~capabilities tomay ~~repay~~require ~~the~~our ~~outstanding~~raising ~~principal~~additional ~~balance and accrued but unpaid interest~~capital, ~~along~~which ~~with~~we amay ~~premium,~~be ~~upon the~~unable ~~occurrence~~to ~~of certain changes of control or an event of default~~do.

Our ~~ability~~ toproducts make payments of the principal of, to pay interest on, or to redeem our indebtedness in cash, depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. We have not generated material revenue from operations to date, and our business may ~~not~~never ~~generate~~achieve ~~cash~~market ~~flow from operations in the future sufficient to service our indebtedness and make necessary capital expenditures~~acceptance. In addition, the September 2022 Senior Convertible Note contains, and any future indebtedness may contain, restrictive covenants, including financial covenants. These payment obligations and covenants could have important consequences on our business. In particular, they could:

●To ~~require~~date, uswe tohave ~~dedicate~~not agenerated ~~substantial~~significant ~~portion~~sales ofrevenues ~~our cash flow~~ from ~~operations to payments on~~ our ~~indebtedness;~~products ●and ~~limit,~~services. ~~among~~Our ~~other things, our~~ ability to ~~borrow~~generate ~~additional~~sales ~~funds~~revenues ~~and~~from ~~otherwise~~product ~~raise~~and ~~additional capital~~services, and ~~our ability~~ to ~~conduct~~achieve ~~acquisitions,~~profitability ~~joint~~will ~~ventures~~depend orupon ~~similar arrangements, as a result of~~ our ~~obligations~~ability to ~~make~~successfully ~~such~~commercialize ~~payments~~our products and ~~comply~~services. ~~with~~As ~~the~~we ~~restrictive~~only ~~covenants~~relatively inrecently ~~the~~began ~~indebtedness;~~to ●market ~~limit~~ our ~~flexibility~~two inproducts ~~planning~~and services for, ~~or reacting to~~sale, ~~changes~~we inhave ~~our~~no ~~businesses~~basis ~~and~~to ~~the~~predict ~~industries~~whether inour ~~which~~current weproducts ~~operate;~~and ●services ~~increase~~(or ~~our~~potential ~~vulnerability~~future toproducts ~~general adverse economic~~ and ~~industry~~services) ~~conditions;~~will ~~and~~achieve ●market ~~place~~acceptance. usA atnumber aof ~~competitive~~factors ~~disadvantage~~may ~~compared~~limit tothe ~~our~~market ~~competitors~~acceptance ~~that~~of ~~have~~any ~~lower~~of ~~fixed~~our ~~costs.~~products, including:

~~The debt~~● ~~service~~the ~~requirements~~timing of ~~any~~regulatory ~~other~~approvals ~~permitted~~of ~~indebtedness~~our weproducts ~~incur~~and orservices ~~issue~~and inmarket ~~the~~entry ~~future,~~compared asto ~~well~~competitive asproducts; ~~the~~● ~~restrictive covenants contained in~~ the ~~governing~~effectiveness ~~documents~~of ~~for~~our ~~any~~products ~~such~~and ~~indebtedness~~services, ~~could~~including ~~intensify~~any ~~these~~potential ~~risks.~~side ~~For example~~effects, ~~from~~as ~~time~~compared to ~~time~~alternative ~~since~~ treatments; ● the ~~date~~rate of ~~issuance~~adoption of ~~the~~our ~~September~~products ~~2022~~and ~~Convertible~~services ~~Note~~by hospitals, doctors and nurses and acceptance by the ~~Company~~health ~~was~~care ~~not~~community; in● ~~compliance~~the ~~with~~labeling ~~certain~~and ~~financial~~/or ~~covenants thereunder.~~inserts ~~The~~required ~~holders~~by regulatory authorities for each of ~~such~~our ~~notes~~products ~~agreed~~and toservices; ~~waive~~● ~~any~~the ~~such~~competitive ~~non-compliance~~features ~~through~~of ~~December~~our 31products and services, ~~2025.~~including ~~There~~price, isas ~~also~~compared noto ~~assurance that~~other ~~the~~similar ~~holders~~products ~~will~~and beservices; ~~willing~~● tothe ~~waive~~availability ~~any~~of ~~future~~insurance ~~non~~or other third-~~compliance~~party ~~with~~reimbursement, ~~this~~such oras ~~any~~Medicare, ~~other~~for ~~provision~~patients ~~under~~using our products and services; ● the ~~September~~extent ~~2022~~and ~~Senior Convertible~~success ~~Note,~~of orour ifmarketing ~~they~~efforts ~~are~~and ~~willing~~those toof doour ~~so,~~collaborators; ifand ~~the~~● ~~terms~~unfavorable onpublicity ~~which~~concerning ~~they~~our ~~are~~products soand ~~willing~~services ~~will~~or besimilar ~~acceptable~~products toand usservices.

If we are unable to make the required cash payments, there could be a default under one or more of the instruments governing our indebtedness. Any such default or acceleration may further result in an event of default and acceleration of our other indebtedness. In such event, or if a default otherwise occurs under our indebtedness, including as a result of our failure to comply with the financial or other covenants contained therein, the holders of our indebtedness could require us to immediately repay the outstanding principal and interest on such indebtedness in cash, in some cases subject to a premium. Furthermore, the holders of our secured indebtedness could foreclose on their security interests in our assets.29

~~If we~~Recommendations, ~~are~~guidelines ~~required to make payments under our indebtedness in cash~~ and ~~are~~quality ~~unable~~metrics toissued ~~generate~~by ~~sufficient~~various ~~cash~~organizations ~~flow from operations, we~~ may be ~~required~~significantly toaffect ~~sell~~payors’ ~~assets,~~willingness ~~or we may seek~~ to ~~refinance the remaining balance~~cover, by either refinancing with the holder of the indebtedness, by raising sufficient funds through a sale of equity or debt securities or by obtaining a credit facility. No assurances can be given that we will be successful in making the required payments under our indebtedness, or in refinancing our obligations on favorable terms, or at all. Our ability to refinance our indebtedness will depend on the capital markets and ~~our~~healthcare ~~financial~~providers’ ~~condition~~willingness ~~at such time. A failure~~ to ~~refinance~~prescribe, ~~could have a material adverse effect on~~ our ~~liquidity, financial position, and results of operations~~products. ~~Should we refinance, it could be dilutive to shareholders or impose onerous terms on us.~~

~~The terms~~Securing ofinfluential ~~our~~recommendations, ~~Series~~inclusion Cin ~~Preferred~~healthcare ~~Stock~~guidelines ~~also~~and ~~include~~inclusion ~~covenants~~in ~~substantially~~quality ~~similar~~measures are keys to ~~those~~our inhealthcare ~~the~~provider ~~documentation~~and ~~that~~payor ~~governs~~engagement ~~our outstanding~~strategies. ~~indebtedness~~These guidelines, recommendations and ~~accordingly,~~quality ~~those~~metrics ~~covenants~~may (shape payors’ coverage decisions and ~~our~~healthcare ~~failure~~providers’ tocancer screening procedures. There can be no assurance that we will be able to secure such recommendations or inclusion in ~~compliance~~healthcare ~~with~~guidelines ~~the~~and ~~same)~~inclusion in quality measures. Any such failures could have ~~the~~a ~~same important~~material ~~consequences~~impact on our ~~business~~ability to commercialize our products.

~~In addition,~~We ~~Lucid may be required to repay~~ or ~~redeem~~our atthird-party ~~maturity~~manufacturers inmay ~~2029~~not ~~(or~~have ~~sooner, upon~~ the ~~occurrence~~manufacturing ofand ~~certain~~processing ~~changes of~~capacity ~~control or an event of default), or~~ to ~~pay~~meet ~~interest on,~~ the ~~November~~production 2024 Senior Convertible Notes or any future permitted indebtedness incurred by it or its subsidiaries, in cash. Such payment obligations could have the same important consequences on its business, and these debt service requirements ~~or any debt service requirements in respect~~ of ~~any~~clinical ~~other~~testing ~~permitted indebtedness Lucid may incur~~ or ~~issue~~consumer indemand ~~the future, as well as the restrictive covenants contained~~ in ~~the~~a ~~governing~~timely ~~documents for any such indebtedness, could intensify these risks~~manner.

23Our capacity to conduct clinical trials and commercialize our products will depend in part on our ability to manufacture or provide our products on a large scale, at a competitive cost and in accordance with regulatory requirements. We must establish and maintain a commercial scale manufacturing process for all of our products to complete clinical trials. We or our third-party manufacturers may encounter difficulties with these processes at any time that could result in delays in clinical trials, regulatory submissions or the commercialization of products.

~~The accounting~~Currently, ~~method~~we do not directly manufacture our products and rely on third parties to do so for ~~convertible~~us. ~~debt~~If ~~securities~~our manufacturing and distribution agreements are not satisfactory, we may not be able to develop or commercialize products as planned. In addition, we may not be able to contract with third parties to manufacture our products in an economical manner. Furthermore, third-party manufacturers may not adequately perform their obligations, may delay clinical development or submission of products for regulatory approval or otherwise may impair our competitive position. We may not be able to enter into or maintain relationships with manufacturers that comply with good manufacturing practices. If a product manufacturer fails to comply with good manufacturing practices, we could experience significant time delays or we may be ~~settled~~unable to commercialize or continue to market the products. Changes in ~~cash~~our manufacturers could require costly new product testing and facility compliance inspections. In the United States, ~~such~~failure asto comply with good manufacturing practices or other applicable legal requirements can lead to federal seizure of violative products, injunctive actions brought by the ~~September~~federal ~~2022~~government, ~~Senior~~and ~~Convertible~~potential ~~Note~~criminal and civil liability on the part of a company and its officers and employees. Because of these and other factors, ~~could have~~we may not be able to replace our manufacturing capacity quickly or efficiently in the event that our manufacturers are unable to manufacture our products at one or more of their facilities. As a ~~material~~result, ~~effect~~the onsales and marketing of our ~~reported~~products ~~financial~~could ~~results~~be delayed or we could be forced to develop our own manufacturing capacity, which could require substantial additional funds and personnel and compliance with extensive regulations.

~~In May~~The ~~2008,~~manufacturing ~~the~~processes ~~Financial Accounting Standards Board (“FASB”) issued FASB Staff Position No. APB 14-1, Accounting~~ for ~~Convertible Debt~~our ~~Instruments~~products ~~That~~have ~~May~~not Beyet ~~Settled in Cash Upon Conversion (Including Partial Cash Settlement), which has subsequently~~ been ~~codified as~~tested ~~Accounting~~at ~~Standards~~commercial ~~Codification 470-20~~levels, ~~Debt with Conversion~~ and ~~Other~~it Options, or “ASC 470-20.” Under ASC 470-20, an entity must separately account for the liability and equity components of the convertible debt instruments (such as the September 2022 Senior Convertible Note) that may benot settled entirely or partially in cash in a manner that reflects the issuer’s economic interest cost. The effect of ASC 470-20 on the accounting for the September 2022 Senior Convertible Note is that the equity component is required to be ~~included~~possible in the additional paid-in capital section of stockholders’ equity on our consolidated balance sheet and the value of the equity component would be treated as original issue discount for purposes of accounting for the debt component of the September 2022 Senior Convertible Note. As a result, we will be required to ~~record~~manufacture aor ~~greater~~process ~~amount~~these ofmaterials ~~non-cash interest expense~~ in ~~current periods presented as~~ a result of the amortization of the discounted carrying value of the September 2022 Senior Convertible Note to their face amount over the term of the September 2022 Senior Convertible Note. We will report lower net income in our financial results because ASC 470cost-20effective will require interest to include both the current period’s amortization of the debt discount and the instrument’s coupon interest, which could adversely affect our reported or future financial results, and the market price of our common stockmanner.

~~In addition,~~If ~~under~~demand ~~certain circumstances, convertible debt instruments (such as the September 2022 Senior Convertible Note) that may be settled entirely or partially in cash are currently accounted~~ for ~~utilizing~~our ~~the~~EsoGuard ~~treasury~~test ~~stock method~~grows, ~~the~~we ~~effect~~may oflack ~~which~~adequate isfacility ~~that~~space ~~the shares~~and ~~issuable~~capabilities ~~upon conversion of the September 2022 Senior Convertible Note are not included in the calculation of diluted earnings per share except~~ to ~~the~~meet ~~extent~~increased ~~that~~processing ~~the conversion value of the September 2022 Senior Convertible Note exceeds their principal amount~~requirements. ~~Under~~ ~~the treasury stock method~~Moreover, ~~for~~if ~~diluted~~these ~~earnings~~or ~~per~~any ~~share~~future ~~purposes,~~facilities ~~the~~or ~~transaction is accounted for as if the number of shares of~~ our ~~common~~equipment ~~stock~~were ~~that~~damaged ~~would~~or ~~be necessary to settle such excess~~destroyed, or if we ~~elected~~experience toa ~~settle~~significant ~~such~~disruption ~~excess~~ in ~~shares,~~our ~~are~~operations ~~issued.~~for Weany ~~cannot be~~reason, ~~sure~~our ~~that~~ability ~~the~~to ~~accounting standards in the future will~~ continue to ~~permit~~operate ~~the use of the treasury stock method. If we are unable to use the treasury stock method in accounting for the shares issuable upon conversion of the September 2022 Senior Convertible Note, then~~ our ~~diluted~~business ~~earnings~~could ~~per share would~~ be ~~adversely~~materially ~~affected~~harmed.

~~Risks Associated~~Lucid currently has adequate capacity to process EsoGuard tests, based on current test volumes. If demand for the EsoGuard test outstrips this capacity, and we fail to add additional equipment and staff, or complete, or timely complete, an expansion of Lucid’s available laboratory facilities, it may significantly delay EsoGuard processing times and limit the volume of EsoGuard tests Lucid can process, which may adversely affect our business, financial condition and results of operation. In addition, our financial condition may be adversely affected if they are unable to complete these expansion projects on budget and otherwise on terms and conditions acceptable to us. Finally, our financial condition will be adversely affected if demand for our products and services does not materialize in line with ~~Our~~our ~~Business~~current expectations and if, as a result, we end up building excess capacity that does not yield a reasonable return on our investment.

~~We will~~If ~~need~~our ~~substantial~~present, ~~additional~~or ~~funding~~any ~~and~~future, ~~may~~laboratory facilities were to be damaged, destroyed or otherwise unable to ~~raise~~operate, ~~capital~~whether ~~when~~due ~~needed~~to fire, ~~which~~floods, storms, tornadoes, other inclement weather events or natural disasters, employee malfeasance, terrorist acts, power outages, or otherwise, our business could ~~force~~be usseverely disrupted. We may not be able to ~~delay,~~perform ~~reduce~~our EsoGuard test or generate test reports as promptly as patients and healthcare providers require or expect, ~~eliminate~~ or ~~abandon~~possibly ~~growth~~not ~~initiatives~~at all. If we are unable to perform our EsoGuard test or ~~product~~generate ~~development~~test ~~programs~~reports within a timeframe that meets patient and healthcare provider expectations, our business, financial results and reputation could be materially harmed.

~~Notwithstanding that~~We wecurrently ~~were~~maintain ~~recently~~insurance ~~able~~against todamage ~~raise capital directly into PAVmed and that we believe we have sufficient access~~ to ~~capital (including under~~ our ~~management~~property ~~services~~and ~~agreement~~equipment ~~with~~and ~~Lucid~~against ~~Diagnostics) to maintain our current level of~~ business ~~activity~~interruption, wesubject ~~intend~~ to ~~raise additional~~deductibles ~~capital,~~and ~~likely~~other ~~through each of our subsidiaries, to support any business growth~~limitations. ~~Because~~If we have ~~not~~underestimated ~~generated~~our ~~substantial revenue~~insurance orneeds ~~cash~~with ~~flow~~respect to ~~date~~an interruption, ~~unless~~or weif ~~are~~an ~~able~~interruption tois ~~generate~~not ~~substantial~~subject ~~revenue~~to incoverage ~~the~~under ~~near-term~~our ~~(which~~insurance policies, we domay not ~~anticipate~~be ~~being~~ able to ~~do),~~cover weour ~~will require additional funds to:~~losses.

● Continue our research and development; ● Pursue clinical trials; ● Commercialize our new products and services; ● Achieve market acceptance of our products and services; ● Establish and expand our sales, marketing, and distribution capabilities for our products and services; ● Protect our intellectual property rights or defend, in litigation or otherwise, any claims we infringe third-party patents or other intellectual property rights; and ● Invest in businesses, products and technologies, although we currently have no commitments or agreements relating to do so.30

~~If we~~We ~~do not have, or are not able to obtain, sufficient funds, we~~ may ~~have~~make toinvestments ~~delay~~in ~~product development initiatives or license to third parties the rights to commercialize~~ products ~~or technologies~~ we ~~would otherwise seek to market. We also may~~ have tonot ~~reduce~~yet ~~marketing~~developed, ~~customer~~ ~~support~~and orthose ~~other~~investments ~~resources~~may ~~devoted~~not tobe ~~our products~~realized.

~~The markets~~We inmay ~~which~~expend considerable funds and other resources on the development of new and existing products without any guarantee these products will be successful. For example, we ~~operate~~recently ~~are~~hired ~~highly~~a ~~competitive~~Chief Business Officer of Medical Devices and we expect to make meaningful investments in the technologies that comprise the business segment he will oversee (e.g., PortIO, and the technology we ~~may~~license from Duke University that is comprised of a multi-modality probe combining a/LCI with OCT). If we are not besuccessful ~~able~~in tobringing ~~effectively~~one ~~compete~~or ~~against~~more of these or any other ~~providers~~products ofto ~~medical devices~~market, ~~particularly~~whether ~~those~~because ~~with~~we ~~greater~~fail ~~resources~~to address marketplace demand, fail to develop viable technologies or otherwise, we may not generate any revenues and our results of operations could be seriously harmed.

~~We face~~Our ~~intense~~products ~~competition~~and ~~from~~services ~~companies~~may ~~with~~become ~~dominant~~subject ~~market~~to ~~positions~~unfavorable inpricing ~~the~~regulations, ~~medical~~third-party ~~device~~reimbursement ~~industry.~~practices ~~These~~or ~~competitors~~healthcare ~~have~~reform ~~significantly greater financial~~initiatives, ~~technical,~~thereby ~~marketing~~harming ~~and~~our ~~other~~business. ~~resources than we have and may be better able to:~~

●The ~~respond~~regulations tothat ~~new~~govern ~~technologies~~marketing orapprovals, ~~technical~~pricing ~~standards;~~and ●reimbursement ~~react~~for tonew ~~changing~~products ~~customer~~vary ~~requirements~~widely ~~and~~from ~~expectations;~~country ●to ~~acquire~~country. ~~other~~Some ~~companies~~countries torequire ~~gain~~approval ~~new~~of ~~technologies~~the orsale ~~products~~price ~~may~~of ~~displace~~a ~~our~~product ~~products;~~before ●it ~~manufacture~~can be marketed. In many countries, ~~market~~the ~~and~~pricing ~~sell~~review ~~products;~~period ●begins ~~acquire,~~after ~~prosecute~~marketing approval is granted. In some foreign markets, ~~enforce~~pricing ~~and~~remains ~~defend~~subject ~~patents~~to ~~and~~continuing ~~other~~governmental ~~intellectual~~control ~~property;~~even ●after ~~devote~~initial ~~resources~~approval tois ~~the~~granted. ~~development,~~As ~~production~~a result, ~~promotion~~we might obtain regulatory approval for a product in a particular country, ~~support~~but ~~and~~then ~~sale~~be subject to price regulations that delay our commercial launch of ~~products;~~the product and ●negatively ~~deliver~~impact athe ~~broad~~revenue ~~range~~we are able to generate from the sale of ~~competitive~~the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more other products atwe ~~lower~~may ~~prices~~develop, even if our other products we may develop obtain regulatory approval.

24Our ability to commercialize any products we may develop successfully also will depend in part on the extent to which reimbursement for these products and related treatments becomes available from government health administration authorities, private health insurers and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which treatments they will pay for and establish reimbursement levels. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and these third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular treatments. We cannot be sure reimbursement will be available for any product we commercialize and, if reimbursement is available, what the level of reimbursement will be. Reimbursement may impact the demand for, or the price of, any product for which we obtain marketing approval. If reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize any product we successfully develop.

~~We expect~~Moreover, ~~competition~~eligibility for reimbursement does not imply any product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Payment rates may vary according to the ~~markets~~use of the product and the clinical setting in which weit ~~participate~~is toused, ~~continue~~may tobe ~~increase~~based ason payments allowed for lower cost products that are already reimbursed and may be incorporated into existing ~~competitors~~payments ~~improve~~for other services. Net prices for products may be reduced by mandatory discounts or ~~expand~~rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of products from countries where they may be sold at lower prices than in the U.S. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. Our inability to promptly obtain coverage and profitable payment rates from both government funded and private payors could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product ~~offerings~~ to other available therapies. Our business could be materially harmed if reimbursement of any products we may develop, if any, is unavailable or limited in scope or amount or if pricing is set at unsatisfactory levels.

We have finite resources, which may restrict our success in commercializing our current products and other products we may develop, and we may be unsuccessful in entering into or maintaining third-party arrangements to support our internal efforts.31

~~To grow~~Our ~~our~~products ~~business~~and asservices ~~planned,~~may wecause ~~must~~serious ~~expand~~adverse ~~our~~side ~~sales,~~effects ~~marketing~~or ~~and~~even ~~customer~~death ~~support~~or ~~capabilities,~~have ~~which~~other ~~will~~properties ~~involve~~that ~~developing~~could ~~and administering~~delay ~~our commercial infrastructure and/~~or ~~collaborative~~prevent ~~commercial~~their ~~arrangements~~regulatory ~~and~~approval, ~~partnerships.~~limit Wethe ~~must~~commercial ~~also~~desirability ~~maintain~~of ~~satisfactory arrangements~~an ~~for~~approved ~~the~~label ~~manufacture~~or ~~and~~result ~~distribution~~in ofsignificant ~~our~~negative ~~tests~~consequences ~~and~~following ~~other~~any ~~products~~marketing approval.

The ~~only~~ ~~two~~risk ~~products,~~of ~~EsoGuard~~failure ~~and~~of ~~the~~clinical ~~Veris~~development ~~Cancer~~is ~~Care~~high. ~~Platform,~~It ~~that~~is weimpossible ~~are actively seeking~~ to ~~commercialize~~predict ~~have~~when ~~not~~or ~~generated~~if ~~substantial revenue~~our ~~from~~current ~~product~~products ~~sales~~and toservices ~~date.~~or ~~Accordingly,~~any we ~~will~~may ~~need~~develop towill ~~find~~prove ~~other~~safe ~~sources~~enough ~~of capital~~ to ~~fund~~receive ~~their~~regulatory ~~activities,~~approval. ~~and~~Undesirable ~~there~~side ~~can be~~effects nocaused ~~assurance~~by ~~that~~our weproducts ~~will~~and beservices ~~able~~or towe domay ~~so.~~develop Wecould ~~may~~cause ~~also~~us ~~encounter~~or ~~difficulties~~regulatory ~~retaining~~authorities ~~and~~to ~~managing~~interrupt, ~~the~~delay ~~specialized~~or ~~workforce~~halt ~~our activities~~clinical ~~require~~trials. WeThey ~~may~~could ~~seek~~also toresult ~~partner~~in ~~with~~a ~~others~~more torestrictive ~~assist~~label usor ~~with~~the ~~any~~delay or ~~all~~denial of ~~these~~regulatory ~~functions,~~approval ~~although~~by wethe ~~may~~FDA beor ~~unable~~other ~~to find~~comparable ~~appropriate~~foreign ~~third~~regulatory ~~parties with whom to enter into these arrangements~~authority.

~~If we~~Additionally, ~~are~~even ~~unable~~after toreceipt ~~deploy~~of ~~and~~marketing ~~maintain~~approval ~~effective~~of ~~sales,~~our ~~marketing~~products and ~~medical affairs capabilities~~services, if we ~~will~~or ~~have~~others ~~difficulty~~later ~~achieving~~identify ~~market awareness~~undesirable ~~and~~side ~~selling~~effects ~~our~~or ~~tests~~even ~~and~~deaths ~~other~~caused ~~products.~~by such product, a number of potentially significant negative consequences could result, including:

~~To achieve~~● ~~commercial~~we ~~success~~may ~~for~~be ~~our~~forced ~~EsoGuard~~to ~~test~~recall such product and suspend the ~~Veris~~marketing ~~Cancer~~of ~~Care~~such ~~Platform,~~product; as● ~~well~~regulatory asauthorities ~~any~~may ~~products~~withdraw wetheir ~~commercialize~~approvals inof ~~the future,~~such weproduct; ~~must~~● ~~continue~~regulatory toauthorities ~~develop~~may ~~and~~require ~~grow~~additional ~~our~~warnings ~~sales,~~on ~~marketing~~the ~~and~~label ~~medical~~that ~~affairs~~could ~~organizations~~diminish tothe ~~effectively~~usage ~~explain~~or tootherwise ~~healthcare providers~~limit the ~~reliability,~~commercial ~~effectiveness~~success ~~and benefits~~ of ~~our~~such ~~current~~products; ~~and~~● ~~future~~the ~~tests~~FDA ~~and~~or other ~~products~~regulatory asbodies ~~compared~~may toissue ~~alternatives. We~~safety ~~may~~alerts, ~~not~~Dear beHealthcare ~~able~~Provider toletters, ~~successfully~~press ~~manage~~releases ~~our~~or ~~dispersed~~other orcommunications ~~inside~~containing ~~sales~~warnings ~~forces~~about orsuch ~~our~~product; ~~sales~~● ~~force~~the FDA may ~~not~~require bethe ~~effective.~~establishment ~~Because~~or modification of ~~the competition~~Risk ~~for~~Evaluation ~~their~~Mitigation ~~services,~~Strategies weor ~~may~~a becomparable ~~unable~~foreign toregulatory ~~hire,~~authority ~~partner~~may ~~with~~require orthe ~~retain~~establishment ~~additional~~or ~~qualified~~modification ~~sales~~of ~~representatives~~a orsimilar ~~marketing or~~strategy ~~medical~~that ~~affairs~~may, ~~personnel~~for instance, ~~either~~restrict asdistribution of our ~~employees~~products orand ~~independent~~impose ~~contractors~~burdensome orimplementation ~~through~~requirements ~~independent~~on ~~sales~~us; ● we may be required to change the way the product is administered or ~~other~~conduct ~~third-party~~additional ~~organizations. Market~~clinical ~~competition~~trials; ~~for~~● ~~commercial,~~we ~~marketing~~could be sued and ~~medical~~held ~~affairs~~liable ~~talent~~for isharm ~~significant,~~caused ~~and~~to subjects or patients; ● we may ~~not~~ be ~~able~~subject to ~~hire~~litigation or ~~retain~~product ~~such talent~~liability onclaims; ~~commercially~~and ~~reasonable~~● ~~terms,~~our ifreputation atmay ~~all~~suffer.

~~Establishing and~~Any ~~maintaining~~of ~~sales,~~these ~~marketing~~events ~~and~~could ~~medical~~prevent ~~affairs~~us ~~capabilities~~from ~~will~~achieving beor ~~expensive and time-consuming. Our expenses associated with~~ maintaining ~~our~~market ~~sales~~acceptance ~~force may be disproportional compared to the revenues we may be able to generate on sales~~ of ~~our EsoGuard test and~~ the ~~Veris~~particular ~~Cancer Care Platform or any future tests or other products~~product. ~~Establishing and maintaining these capabilities may require our raising additional capital, which we may be unable to do.~~

~~Our products~~Product ~~may~~liability ~~never~~lawsuits ~~achieve~~against ~~market~~us ~~acceptance~~could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.

~~To date,~~We weface ~~have~~an ~~not~~inherent ~~generated~~risk ~~significant~~of ~~sales~~product ~~revenues~~liability ~~from~~exposure ~~our~~related to the sale of any products ~~and~~we ~~services~~may develop. ~~Our~~The ~~ability~~marketing, tosale ~~generate~~and ~~sales~~use ~~revenues~~of ~~from~~our ~~product~~ current products and services, and any we may additionally develop could lead to ~~achieve~~the ~~profitability~~filing ~~will~~of ~~depend~~product ~~upon~~liability ~~our~~claims ~~ability~~against tous ~~successfully~~if ~~commercialize~~someone ~~our~~alleges ~~products~~product ~~and~~failures, ~~services.~~product Asmalfunctions, ~~we only~~manufacturing ~~relatively~~flaws, ~~recently~~or ~~began~~design defects, resulted in injury to ~~market~~patients. ~~our~~We ~~two~~may ~~products~~also ~~and~~be ~~services~~subject to liability for ~~sale~~a misunderstanding of, weor ~~have~~inappropriate noreliance ~~basis~~upon, tothe ~~predict~~information ~~whether~~we ~~our~~provide. ~~current~~If ~~products and~~we ~~services~~cannot ~~(or~~successfully ~~potential~~defend ~~future~~ourselves ~~products~~against ~~and~~claims ~~services)~~that ~~will~~any ~~achieve~~product, ~~market~~we ~~acceptance.~~may Adevelop ~~number~~caused ofinjuries, ~~factors~~we may ~~limit~~incur ~~the~~substantial ~~market~~liabilities. ~~acceptance~~ Regardless of ~~any~~merit ofor ~~our~~eventual ~~products~~outcome, ~~including~~liability claims may result in:

● ~~the~~decreased ~~timing~~demand offor ~~regulatory approvals of~~ our products ~~and services and market entry compared to competitive products~~; ● ~~the~~injury ~~effectiveness~~to of our ~~products~~reputation and ~~services,~~significant ~~including~~negative ~~any~~media ~~potential side effects, as compared to alternative treatments~~attention; ● ~~the~~withdrawal ~~rate~~ of ~~adoption~~patients offrom ~~our~~clinical ~~products~~studies ~~and services by hospitals, doctors and nurses and acceptance by the health care community; ● the labeling and /~~or ~~inserts~~cancellation ~~required by regulatory authorities for each~~ of ~~our products and services~~studies; ● ~~the~~significant ~~competitive~~costs ~~features~~to ofdefend ~~our~~the ~~products~~related litigation and ~~services,~~distraction ~~including price, as compared~~ to ~~other~~our ~~similar~~management ~~products and services~~team; ● ~~the~~substantial ~~availability~~monetary ofawards ~~insurance~~to ~~or other third-party reimbursement, such as Medicare, for~~ patients ~~using our products and services~~; ● ~~the~~loss ~~extent and success~~ of ~~our marketing efforts and those of our collaborators~~revenue; and ● ~~unfavorable~~the ~~publicity~~inability ~~concerning~~to ~~our~~commercialize any products ~~and~~that ~~services~~we ormay ~~similar products and services~~develop.

~~Recommendations~~In addition, ~~guidelines~~ ~~and~~insurance ~~quality~~coverage ~~metrics~~is ~~issued~~increasingly byexpensive. ~~various~~We ~~organizations~~ may ~~significantly~~not ~~affect~~be ~~payors’~~able ~~willingness~~ to ~~cover,~~maintain ~~and~~insurance ~~healthcare providers’~~coverage ~~willingness~~at a reasonable cost or in an amount adequate to ~~prescribe,~~satisfy ~~our~~any ~~products~~liability that may arise.

Securing influential recommendations, inclusion in healthcare guidelines and inclusion in quality measures are keys to our healthcare provider and payor engagement strategies. These guidelines, recommendations and quality metrics may shape payors’ coverage decisions and healthcare providers’ cancer screening procedures. There can be no assurance that we will be able to secure such recommendations or inclusion in healthcare guidelines and inclusion in quality measures. Any such failures could have a material impact on our ability to commercialize our products.32

25We may not be able to protect or enforce our intellectual property rights, which could impair our competitive position.

~~We or~~Our success depends significantly on our ~~third-party~~ability ~~manufacturers~~to ~~may~~protect ~~not~~our ~~have~~rights to the ~~manufacturing~~patents, trademarks, trade secrets, copyrights and ~~processing~~all ~~capacity~~the other intellectual property rights used, or expected to ~~meet~~be ~~the~~used, ~~production~~in ~~requirements~~our products. Protecting intellectual property rights is costly and time consuming. We rely primarily on patent protection and trade secrets, as well as a combination of ~~clinical testing~~copyright and trademark laws and nondisclosure and confidentiality agreements to protect our technology and intellectual property rights. However, these legal means afford only limited protection and may not adequately protect our rights or ~~consumer~~permit ~~demand~~us into gain or maintain any competitive advantage. Despite our intellectual property rights practices, it may be possible for a ~~timely~~third ~~manner~~party to copy or otherwise obtain and use our technology without authorization, develop similar technology independently or design around our patents.

~~Our capacity~~We tocannot ~~conduct~~be ~~clinical~~assured ~~trials~~that ~~and~~any ~~commercialize~~of our ~~products~~pending patent applications will ~~depend~~result in ~~part~~the onissuance ~~our~~of ~~ability~~a patent to ~~manufacture~~us. orThe ~~provide~~U.S. ~~our~~Patent ~~products on~~and aTrademark ~~large~~Office ~~scale~~(the “PTO”), ator athe ~~competitive~~applicable ~~cost~~authorized ~~and~~in other countries in ~~accordance~~which ~~with~~we ~~regulatory~~may ~~requirements.~~seek Weto ~~must~~protect ~~establish~~our ~~and~~intellectual ~~maintain~~property arights, ~~commercial~~may ~~scale manufacturing~~deny ~~process~~or ~~for~~require ~~all~~significant narrowing of claims in our ~~products~~pending topatent ~~complete~~applications, ~~clinical~~and ~~trials.~~patents Weissued oras ~~our~~a ~~third-party~~result ~~manufacturers~~of the pending patent applications, if any, may ~~encounter~~not ~~difficulties~~ provide us with ~~these~~significant ~~processes~~commercial atprotection ~~any~~or ~~time~~be issued in a form that is advantageous to us. We could ~~result~~also inincur ~~delays~~substantial costs in ~~clinical~~proceedings ~~trials~~before the PTO, ~~regulatory~~or ~~submissions~~foreign patent offices. Patents that may be issued to or licensed by us in the ~~commercialization~~future may expire or may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related technologies. Upon expiration of our issued or licensed patents, we may lose some of our rights to exclude others from making, using, selling or importing products using the technology based on the expired patents. There is no assurance that competitors will not be able to design around our patents.

~~Initially, we~~We ~~will~~also ~~not directly manufacture our products and will~~ rely on ~~third~~unpatented ~~parties~~proprietary ~~to do so for us~~technology. IfWe ~~our~~cannot ~~manufacturing~~assure ~~and~~you ~~distribution~~that ~~agreements are not satisfactory,~~ we ~~may~~can ~~not~~meaningfully beprotect ~~able~~all toour ~~develop~~rights orin ~~commercialize~~our ~~products~~unpatented asproprietary ~~planned.~~technology Inor ~~addition,~~that weothers ~~may~~will not beindependently ~~able~~develop tosubstantially ~~contract with~~equivalent ~~third~~proprietary ~~parties to manufacture our~~ products ~~in an economical manner. Furthermore, third-party manufacturers may not adequately perform their obligations, may delay clinical development~~ or ~~submission~~processes ~~of products for regulatory approval~~ or otherwise ~~may~~gain ~~impair~~access ~~our competitive position. We may not be able~~ to ~~enter~~our ~~into~~unpatented orproprietary ~~maintain relationships with manufacturers that comply with good manufacturing practices~~technology. If aWe ~~product~~seek ~~manufacturer fails~~ to ~~comply~~protect ~~with~~our ~~good~~know-how ~~manufacturing~~and ~~practices,~~other weunpatented ~~could~~proprietary ~~experience~~technology, ~~significant~~as ~~time~~trade ~~delays~~secrets or weotherwise, ~~may~~with ~~be unable~~confidentiality toagreements ~~commercialize~~ and/or ~~continue~~intellectual toproperty ~~market~~assignment ~~the~~agreements ~~products.~~with ~~Changes in~~ our ~~manufacturers~~team ~~could~~members, ~~require~~independent ~~costly~~distributors ~~new product testing~~ and ~~facility~~ ~~compliance inspections~~consultants. ~~In the United States~~However, ~~failure~~such toagreements ~~comply~~may ~~with~~not ~~good~~be ~~manufacturing~~enforceable ~~practices~~ or ~~other~~may ~~applicable~~not ~~legal requirements~~provide ~~can~~meaningful ~~lead~~protection tofor ~~federal~~our ~~seizure~~proprietary ofinformation ~~violative~~in ~~products, injunctive actions brought by~~ the ~~federal~~event ~~government, and potential criminal and civil liability on the part~~ of aunauthorized ~~company~~use ~~and~~or ~~its~~disclosure ~~officers~~or ~~and~~other ~~employees.~~breaches ~~Because~~ of ~~these~~the ~~and~~agreements ~~other factors, we may not be able to replace our manufacturing capacity quickly~~ or ~~efficiently~~ in the event that our ~~manufacturers~~competitors ~~are~~discover ~~unable~~or toindependently ~~manufacture~~develop ~~our~~similar ~~products at~~or ~~one~~identical designs or ~~more~~other ofproprietary ~~their facilities~~information. AsOur atrade ~~result,~~secrets ~~the~~may ~~sales and marketing of our products could~~ be ~~delayed~~vulnerable ~~or we could be forced~~ to ~~develop our~~disclosure ~~own~~or ~~manufacturing~~misappropriation ~~capacity~~by employees, ~~which~~contractors ~~could require substantial additional funds~~ and ~~personnel~~other ~~and compliance with extensive regulations~~persons.

~~The manufacturing processes for our products have not yet been tested at commercial levels, and it may not be possible to manufacture or process these materials in a cost-effective manner.~~33

~~If demand~~We ~~for our EsoGuard test grows, we~~ may ~~lack~~be ~~adequate~~subject ~~facility space and capabilities~~ to ~~meet~~intellectual ~~increased~~property ~~processing~~infringement ~~requirements.~~claims ~~Moreover, if~~by ~~these~~third orparties ~~any~~which ~~future~~could ~~facilities~~be orcostly ~~our~~to ~~equipment were damaged or destroyed~~defend, ordivert ifmanagement’s weattention ~~experience~~and ~~a significant disruption in our operations for any reason~~resources, ~~our~~and ~~ability~~may toresult ~~continue~~in ~~to operate our business could be materially harmed~~liability.

~~Lucid currently~~The ~~has~~medical ~~adequate~~device ~~capacity~~industry tois ~~process~~characterized ~~EsoGuard~~by ~~tests,~~vigorous ~~based~~protection onand ~~current~~pursuit ~~test~~of ~~volumes.~~intellectual Ifproperty ~~demand~~rights. ~~for~~Companies in the ~~EsoGuard~~medical ~~test~~device ~~outstrips this~~industry ~~capacity,~~have ~~and~~used weintellectual ~~fail~~property litigation to ~~add~~gain ~~additional~~a ~~equipment~~competitive ~~and~~advantage ~~staff,~~in orthe ~~complete,~~marketplace. orFrom ~~timely~~time ~~complete~~to time, anthird ~~expansion~~parties ofmay ~~Lucid’s available~~assert ~~laboratory~~against ~~facilities~~us their patent, itcopyright, trademark and other intellectual property rights relating to technologies that are important to our business. Searching for existing intellectual property rights may ~~significantly~~not ~~delay~~reveal ~~EsoGuard~~important ~~processing~~intellectual ~~times~~property and ~~limit~~our ~~the~~competitors ~~volume~~may ofalso ~~EsoGuard~~have ~~tests~~filed ~~Lucid~~for ~~can~~patent ~~process~~protection, which ~~may~~is ~~adversely~~not ~~affect~~publicly-available ~~our business~~information, ~~financial~~or ~~condition~~claimed ~~and~~trademark ~~results~~rights ofthat ~~operation.~~have Innot ~~addition,~~been revealed through our ~~financial~~ ~~condition~~availability searches. We may be ~~adversely~~subject ~~affected~~to ifclaims ~~they~~that ~~are~~our ~~unable~~team tomembers ~~complete~~have ~~these~~disclosed, ~~expansion~~or ~~projects~~that onwe ~~budget~~have used, trade secrets or other proprietary information of our team members’ former employers. Our efforts to identify and ~~otherwise~~avoid infringing on ~~terms~~ ~~and~~third ~~conditions~~parties’ ~~acceptable~~intellectual toproperty usrights may not always be successful. ~~Finally,~~Any claims that our ~~financial~~products ~~condition~~or ~~will~~processes beinfringe ~~adversely~~these ~~affected~~rights, ifregardless ~~demand~~of ~~for~~their ~~our~~merit ~~products~~or resolution, could be costly, time consuming and ~~services~~ ~~does~~may ~~not~~divert ~~materialize~~the inefforts ~~line~~and ~~with~~attention of our ~~current~~management ~~expectations~~ and ~~if,~~technical aspersonnel. aIn ~~result~~addition, we ~~end~~may upnot ~~building~~prevail ~~excess~~in ~~capacity~~such ~~that does~~proceedings ~~not~~given ~~yield~~the acomplex ~~reasonable~~technical ~~return~~issues onand ~~our~~inherent ~~investment~~uncertainties in intellectual property litigation.

~~If our~~Any ~~present,~~claims orof ~~any~~patent ~~future, laboratory facilities were to be damaged, destroyed~~ or ~~otherwise unable to operate, whether due to fire, floods, storms, tornadoes,~~ other ~~inclement~~intellectual ~~weather~~property ~~events~~infringement oragainst ~~natural disasters~~us, ~~employee~~even ~~malfeasance,~~those ~~terrorist~~without ~~acts~~merit, ~~power outages, or otherwise, our business~~ could be severely disrupted. We may not be able to perform our EsoGuard test or generate test reports as promptly as patients and healthcare providers require or expect, or possibly not at all. If we are unable to perform our EsoGuard test or generate test reports within a timeframe that meets patient and healthcare provider expectations, our business, financial results and reputation could be materially harmed.:

~~We currently~~● ~~maintain~~increase ~~insurance~~the ~~against~~cost ~~damage~~of our products; ● be expensive and/or time consuming to defend; ● result in our ~~property~~being ~~and~~required ~~equipment~~to ~~and~~pay ~~against~~significant ~~business~~damages ~~interruption,~~to ~~subject~~third parties; ● force us to ~~deductibles~~cease ~~and other~~making ~~limitations.~~or Ifselling weproducts ~~have~~that ~~underestimated~~incorporate the challenged intellectual property; ● require us to redesign, reengineer or rebrand our ~~insurance~~products ~~needs~~and ~~with~~technologies; ~~respect~~● require us to anenter ~~interruption,~~into royalty or iflicensing anagreements ~~interruption~~in isorder ~~not~~to ~~subject~~ obtain the right to ~~coverage~~use ~~under~~a ~~our~~third ~~insurance~~party’s ~~policies,~~intellectual weproperty on terms that may not be ~~able~~favorable or acceptable to ~~cover~~us; ● require us to develop alternative non-infringing technology, which could require significant effort and expense; ● require us to indemnify third parties pursuant to contracts in which we have agreed to provide indemnification for intellectual property infringement claims; and, ● result in our ~~losses~~customers or potential customers deferring or limiting their purchase or use of the affected products impacted by the claims until the claims are resolved.

~~We may~~Any ~~make~~of ~~investments~~the inforegoing ~~products~~could weaffect our ability to compete or have ~~not~~a ~~yet~~material ~~developed,~~adverse ~~and~~effect ~~those~~on ~~investments~~our ~~may~~business, ~~not~~financial becondition ~~realized~~and results of operations.

We Competitors may ~~expend~~violate ~~considerable~~our ~~funds~~intellectual ~~and~~property ~~other~~rights, ~~resources on the development of new~~ and ~~existing products without any guarantee these products will be successful. If~~ we ~~are~~may ~~not~~bring ~~successful~~litigation ~~in bringing one or more products~~ to ~~market,~~protect ~~whether~~and ~~because~~enforce weour ~~fail~~intellectual toproperty ~~address marketplace demand~~rights, ~~fail~~which tomay ~~develop~~result ~~viable~~in ~~technologies~~substantial orexpense ~~otherwise,~~and we may ~~not~~divert ~~generate~~our ~~any~~attention ~~revenues~~from ~~and~~implementing our ~~results~~business ~~of operations could be seriously harmed~~strategy.

26We believe that the success of our business depends, in significant part, on obtaining patent protection for our products and technologies, defending our patents and preserving our trade secrets. Our failure to pursue any potential claim could result in the loss of our proprietary rights and harm our position in the marketplace. Therefore, we may be forced to pursue litigation to enforce our rights. Future litigation could result in significant costs and divert the attention of our management and key personnel from our business operations and the implementation of our business strategy.

~~We may~~Our ~~not~~business ~~obtain~~may ~~the~~suffer ~~expected~~if ~~benefits~~we ofare ~~the~~unable ~~incubator~~to ~~financing~~manage ~~structure~~our ~~and may incur additional costs~~growth.

~~We believe~~If that the incubator financing structure will provide us with future benefits. These expected benefits are not guaranteed and may not be obtained if market conditions or other circumstances prevent us from taking advantage of the investment, financing and structuring flexibility we ~~expect~~fail to ~~gain~~effectively asmanage aour ~~result~~growth, ofour ~~the~~ability ~~incubator financing structure (~~to ~~date,~~execute ~~we have been unsuccessful in~~ our ~~efforts~~business ~~to raise~~strategy ~~capital~~could ~~through~~be ~~this structure)~~impaired. IfAny weunanticipated ~~fail~~rapid togrowth ~~achieve some or all~~ of ~~the expected benefits of~~ our ~~incubator~~business ~~financing~~may ~~structure, it~~place ~~could have~~ a ~~material~~strain ~~adverse effect~~ on our ~~competitive position~~management, ~~business, financial condition, results of~~ operations and ~~cash~~financial ~~flows~~systems. ~~The~~ ~~implementation~~We ofneed ~~our~~to ~~incubator~~ensure ~~financing~~our ~~structure~~existing ~~also~~systems ~~may~~and ~~result~~controls ~~in substantial direct costs, which~~ are ~~expected~~adequate to ~~consist~~support ~~primarily of~~our ~~attorneys’~~business ~~fees~~ and ~~accountants’~~its ~~fees,~~anticipated ~~as well as loss of certain efficiencies~~growth. Moreover, the incubator financing structure may not fully insulate the liabilities of our subsidiaries from each other or from PAVmed, especially if we do not observe the requisite corporate formalities or adequately capitalize PAVmed or its subsidiaries.

~~Our products and services may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, thereby harming our business.~~34

~~The regulations~~Our ~~that~~ability ~~govern marketing approvals, pricing and reimbursement for new products vary widely from country~~ to ~~country. Some countries require approval of the sale price of a product before it can~~ be ~~marketed.~~successful Inwill many countries, the pricing review period begins after marketing approval is granted. In some foreign markets, pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain regulatory approval for a product in a particular country, but then be ~~subject~~totally todependent ~~price regulations~~upon ~~that delay our commercial launch of~~ the ~~product~~efforts ~~and negatively impact the revenue we are able to generate from the sale~~ of ~~the~~ ~~product in that country. Adverse pricing limitations may hinder~~ our ~~ability~~key ~~to recoup our investment in one or more other products we may develop, even if our other products we may develop obtain regulatory approval~~personnel.

Our ability to ~~commercialize~~successfully ~~any~~carry ~~products~~out weour ~~may~~business ~~develop~~plan ~~successfully~~is ~~also~~dependent ~~will~~upon ~~depend in part on~~ the ~~extent~~efforts toof ~~which~~our ~~reimbursement~~key ~~for these products and related treatments becomes available from government health administration authorities, private health insurers and other organizations~~personnel. ~~Government~~We ~~authorities~~cannot ~~and~~assure ~~third-party~~you ~~payors,~~that ~~such~~any asof ~~private~~our ~~health~~key ~~insurers~~personnel ~~and~~will ~~health~~remain ~~maintenance~~with ~~organizations,~~us ~~decide which treatments they will pay~~ for ~~and~~the ~~establish~~immediate ~~reimbursement~~or ~~levels~~foreseeable future. AThe ~~primary~~unexpected ~~trend~~loss inof the ~~U.S.~~services ~~healthcare~~of ~~industry~~our ~~and~~key ~~elsewhere is~~personnel ~~cost~~could ~~containment.~~have ~~Government~~a ~~authorities~~detrimental ~~and~~effect ~~these~~on ~~third-party~~us. ~~payors~~We ~~have~~may ~~attempted~~also tobe ~~control~~unable ~~costs~~to byattract ~~limiting coverage~~ and ~~the amount~~retain ofadditional ~~reimbursement~~key ~~for~~personnel ~~particular~~in ~~treatments~~the future. We ~~cannot~~are belimited ~~sure~~in ~~reimbursement~~shares ~~will be~~ available for ~~any~~issuance ~~product~~under weour ~~commercialize and,~~long-term ifincentive ~~reimbursement is available~~plan, ~~what~~which ~~the~~could ~~level~~limit ofour ~~reimbursement~~ability ~~will~~to ~~be.~~attract ~~Reimbursement~~and ~~may~~retain ~~impact~~key ~~the demand for~~personnel, oruntil ~~the~~such ~~price~~amount ~~of, any~~is ~~product for which we obtain marketing approval~~increased. IfAn ~~reimbursement~~inability isto ~~not~~attract ~~available~~and orretain iskey ~~available~~personnel ~~only to limited levels, we~~ may ~~not~~ beimpact ~~able~~our ability to ~~successfully~~continue ~~commercialize~~and ~~any~~grow ~~product~~our ~~we successfully develop~~operations.

~~Moreover, eligibility~~Our ~~for~~officers ~~reimbursement does not imply any product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale~~ and ~~distribution.~~directors ~~Payment~~have ~~rates~~fiduciary ~~may~~obligations ~~vary according~~ to ~~the~~other ~~use~~companies ~~of the product~~ and, ~~the clinical setting in which it is used~~accordingly, may behave ~~based~~conflicts on payments allowed for lower cost products that are already reimbursed and may be incorporated into existing payments for other services. Net prices for products may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of ~~laws~~interest ~~that presently restrict imports of products from countries where they may be sold at lower prices than~~ in ~~the~~determining ~~U.S. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. Our inability~~ to ~~promptly~~which ~~obtain~~entity ~~coverage and profitable payment rates from both government funded and private payors could have~~ a ~~material~~particular ~~adverse~~business ~~effect~~opportunity onshould ~~our operating results, our ability to raise capital needed to commercialize products and our overall financial condition. To obtain reimbursement or pricing approval in some countries, we may~~ be ~~required to conduct a clinical trial that compares the cost-effectiveness of our product to other available therapies~~presented. ~~Our business could be materially harmed if reimbursement of any products we may develop, if any, is unavailable or limited in scope or amount or if pricing is set at unsatisfactory levels.~~

~~Our products~~Certain of our officers and ~~services~~directors ~~may~~have ~~cause~~fiduciary ~~serious~~obligations ~~adverse~~to ~~side~~other ~~effects~~companies orengaged ~~even~~in ~~death~~medical ordevice ~~have~~business ~~other~~activities. ~~properties~~Accordingly, they may participate in transactions and have obligations that ~~could~~may ~~delay~~be in conflict or ~~prevent~~competition ~~their regulatory~~with ~~approval~~our business. As a result, ~~limit~~a ~~the~~potential ~~commercial~~business ~~desirability~~opportunity ofmay anbe ~~approved~~presented ~~label~~by certain members of our board or ~~result~~management inteam ~~significant~~to ~~negative~~another ~~consequences~~entity ~~following any~~prior ~~marketing~~to ~~approval~~its presentation to us and we may not be afforded the opportunity to engage in such a transaction.

~~The risk~~Our ofbusiness, ~~failure~~financial ofcondition ~~clinical development is high. It is impossible to predict when or if our current products~~ and ~~services~~results orof ~~any~~operations wecould ~~may develop~~be ~~will~~adversely ~~prove~~affected ~~safe enough to receive regulatory approval. Undesirable side effects caused~~ by ~~our~~the ~~products~~political and ~~services~~economic orconditions ~~we may develop could cause us or regulatory authorities to interrupt, delay or halt clinical trials. They could also result in a more restrictive label or the delay or denial~~ of ~~regulatory approval by~~ the ~~FDA~~countries orin ~~other~~which ~~comparable~~we ~~foreign~~conduct ~~regulatory authority~~business.

27Our business, financial condition and results of operations could be adversely affected by the political and economic conditions of the countries in which we conduct business. These factors include:

~~Additionally, even~~● ~~after~~varying ~~receipt~~practices of ~~marketing~~the ~~approval~~regulatory, tax, judicial and administrative bodies in the U.S. and other jurisdictions where we operate; ● potentially burdensome taxation and changes in domestic and foreign tariffs; ● challenges associated with cultural differences, languages and distance; ● differences in clinical practices, needs, products, modalities and preferences; ● longer payment cycles in some countries; ● credit risks of many kinds; ● legal and regulatory differences and restrictions; ● currency exchange fluctuations; ● foreign exchange controls that might prevent us from repatriating cash earned in certain countries; ● political and economic instability and export restrictions; ● variability in sterilization requirements for multi-usage surgical devices; ● potential adverse tax consequences; ● higher cost associated with doing business internationally; ● challenges in implementing educational programs required by our ~~products~~approach to doing business; ● negative economic developments in economies around the world and ~~services~~the instability of governments, ifincluding wethe threat of war, terrorist attacks, epidemic or ~~others~~civil ~~later~~unrest; ~~identify~~● ~~undesirable~~adverse ~~side~~changes ~~effects~~in orlaws ~~even deaths~~and ~~caused~~governmental bypolicies, especially those affecting trade and investment; ● health epidemics and /or pandemics, such ~~product~~as the COVID-19 pandemic, epidemics resulting from the Ebola virus, or the enterovirus, or the avian influenza virus, or the pandemic resulting from a ~~number~~novel strain of ~~potentially~~a ~~significant~~coronavirus ~~negative~~designated ~~consequences~~“Severe ~~could~~Acute ~~result~~Respiratory Syndrome Coronavirus 2” - or “SARS-CoV-2”, ~~including:~~which may adversely affect our workforce as well as our local suppliers and customers; ● import or export licensing requirements imposed by governments; ● differing labor standards; ● differing levels of protection of intellectual property; and ● the threat that our operations or property could be subject to nationalization and expropriation.

● we may be forced to recall such product and suspend the marketing of such product; ● regulatory authorities may withdraw their approvals of such product; ● regulatory authorities may require additional warnings on the label that could diminish the usage or otherwise limit the commercial success of such products; ● the FDA or other regulatory bodies may issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings about such product; ● the FDA may require the establishment or modification of Risk Evaluation Mitigation Strategies or a comparable foreign regulatory authority may require the establishment or modification of a similar strategy that may, for instance, restrict distribution of our products and impose burdensome implementation requirements on us; ● we may be required to change the way the product is administered or conduct additional clinical trials; ● we could be sued and held liable for harm caused to subjects or patients; ● we may be subject to litigation or product liability claims; and ● our reputation may suffer.35

~~Any of~~Failure ~~these~~in ~~events~~our information technology or storage systems could ~~prevent~~significantly usdisrupt ~~from~~our ~~achieving~~operations orand ~~maintaining~~our ~~market~~research ~~acceptance~~and ofdevelopment ~~the~~efforts, ~~particular~~which ~~product~~could adversely impact our revenues, as well as our research, development and commercialization efforts.

~~Product liability~~Our ~~lawsuits~~ability ~~against~~to usexecute ~~could~~our ~~cause~~business usstrategy depends, in part, on the continued and uninterrupted performance of our information technology (“IT”) systems that support our operations and our research and development efforts, and those IT systems within the control of our contract manufacturers and contract laboratories. The integrity and protection of our own data, and that of our customers and employees, is critical to ~~incur~~our ~~substantial~~business. ~~liabilities~~The regulatory environment governing information, security and privacy laws is increasingly demanding and continues to ~~limit~~evolve. ~~commercialization~~IT systems are vulnerable to damage from a variety of sources, including telecommunications or network failures, malicious human acts and natural disasters. Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptive problems. Despite the precautionary measures we have taken to prevent unanticipated problems that could affect our IT systems, and the precautionary measures taken by our contract parties, sustained or repeated system failures that interrupt our ability to generate and maintain data, could adversely affect our ability to operate our business. Furthermore, any ~~products~~breach in our IT systems could lead to the unauthorized access, disclosure and use of non-public information, including protected health information, which is protected by HIPAA and other laws. Any such access, disclosure, or other loss of information could result in legal claims or proceedings, liability under laws that ~~we may~~protect ~~develop~~the privacy of personal information, and damage to our reputation.

~~We face~~System anupgrades, ~~inherent~~enhancements ~~risk~~and ofreplacements, ~~product~~as ~~liability~~well ~~exposure~~as ~~related~~new systems, are required from time to ~~the~~time, ~~sale~~and ofrequire ~~any~~significant ~~products~~expenditures weand ~~may~~allocation ~~develop~~of valuable employee resources. ~~The~~Delays ~~marketing,~~in ~~sale~~integration ~~and~~or ~~use~~disruptions of to our ~~current~~business ~~products~~from ~~and~~implementation ~~services~~of ~~and~~these ~~any~~new weor ~~may~~upgraded ~~additionally~~systems ~~develop~~ could ~~lead~~have toa ~~the~~material ~~filing~~adverse ofimpact ~~product~~on ~~liability~~our ~~claims~~financial ~~against~~condition ~~us if~~and ~~someone~~operating ~~alleges~~results. ~~product~~There ~~failures,~~can ~~product~~be ~~malfunctions,~~no ~~manufacturing~~assurance ~~flaws,~~that orour ~~design~~process ~~defects~~of improving existing systems, ~~resulted~~developing innew ~~injury~~systems to ~~patients.~~support ~~We may~~our ~~also~~expanding beoperations, ~~subject~~integrating tonew ~~liability~~systems, ~~for~~protecting aconfidential ~~misunderstanding~~patient ofinformation, orand ~~inappropriate~~improving ~~reliance~~service ~~upon,~~levels ~~the~~will ~~information~~not webe ~~provide.~~delayed Ifor wethat ~~cannot successfully~~additional ~~defend~~systems ~~ourselves~~issues ~~against~~will ~~claims~~not ~~that~~arise ~~any~~in ~~product,~~the wefuture. ~~may~~Failure ~~develop~~to ~~caused~~adequately ~~injuries,~~protect weand ~~may~~maintain ~~incur~~the ~~substantial~~integrity ~~liabilities. Regardless~~ of ~~merit~~our orinformation ~~eventual~~systems ~~outcome,~~issues ~~liability~~and ~~claims~~data may result in: a material adverse effect on our financial position, results of operations and cash flows.

●We ~~decreased~~may ~~demand~~become ~~for~~the ~~our~~subject ~~products;~~of ●various ~~injury~~claims, tothreats ~~our reputation and significant negative media attention; ● withdrawal~~ of ~~patients~~litigation, ~~from~~litigation ~~clinical studies~~ or ~~cancellation~~investigations ofwhich ~~studies;~~could ●have ~~significant~~a ~~costs~~material toadverse ~~defend~~effect ~~the~~on ~~related litigation and distraction to~~ our ~~management~~business, ~~team;~~financial ●condition, ~~substantial~~results ~~monetary~~of ~~awards~~operations toor ~~patients;~~price ~~● loss~~ of ~~revenue;~~our ~~and~~common ~~● the inability to commercialize any products that we may develop~~stock.

~~In addition~~We may become subject to various claims, ~~insurance~~threats ~~coverage~~of islitigation, ~~increasingly~~litigation ~~expensive.~~or Weinvestigations, ~~may~~including ~~not~~commercial bedisputes ~~able~~and employee claims, and from time to ~~maintain~~time ~~insurance~~may ~~coverage~~be atinvolved ain ~~reasonable~~governmental ~~cost~~or regulatory investigations or in similar matters. Any claims asserted against us or our management, regardless of merit or eventual outcome, could harm our reputation and have an ~~amount~~adverse ~~adequate~~impact on our relationship with our clients, distribution partners and other third parties and could lead to ~~satisfy~~additional ~~any~~related ~~liability~~claims. Furthermore, there is no guarantee that ~~may~~we ~~arise~~will be successful in defending ourselves in pending or future litigation or similar matters under various laws. Any judgments or settlements in any pending litigation or future claims, litigation or investigation could have a material adverse effect on our business, financial condition, results of operations and price of our common stock.

~~We may not be able to protect or enforce our intellectual property rights, which could impair our competitive position.~~36

~~Our success~~Risks ~~depends~~Associated ~~significantly~~with onHealthcare ~~our ability to protect our rights to the patents~~Regulation, ~~trademarks,~~Billing ~~trade secrets, copyrights~~ and ~~all the other intellectual property rights used~~Reimbursement, ~~or expected to be used, in our products. Protecting intellectual property rights is costly~~ and ~~time~~ ~~consuming.~~Product WeSafety ~~rely primarily on patent protection~~ and ~~trade~~Effectiveness secrets, as well as a combination of copyright and trademark laws and nondisclosure and confidentiality agreements to protect our technology and intellectual property rights. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or maintain any competitive advantage. Despite our intellectual property rights practices, it may be possible for a third party to copy or otherwise obtain and use our technology without authorization, develop similar technology independently or design around our patents.

~~We cannot~~If beprivate ~~assured that any of our pending patent applications will result in the issuance of a patent to us. The U.S. Patent and Trademark Office (the “PTO”),~~ or ~~the~~governmental ~~applicable~~third-party ~~authorized~~payors indo ~~other~~not ~~countries~~maintain inreimbursement ~~which~~for ~~we may seek to protect~~ our ~~intellectual~~products ~~property rights,~~at ~~may~~adequate ~~deny~~reimbursement ~~or require significant narrowing of claims in our pending patent applications~~rates, ~~and~~we ~~patents issued as a result of the pending patent applications, if any,~~ may ~~not provide us with significant commercial protection or~~ be ~~issued~~unable ~~in a form that is advantageous~~ to ~~us.~~successfully Wecommercialize ~~could~~our ~~also~~products incur substantial costs in proceedings before the PTO, or foreign patent offices. Patents that may be issued to or licensed by us in the future may expire or may be challenged, invalidated or circumvented, which ~~could~~would limit ~~our ability to stop competitors from marketing related technologies. Upon expiration of our issued~~ or ~~licensed~~slow ~~patents, we may lose some of~~ our ~~rights~~revenue togeneration ~~exclude~~and ~~others from~~likely ~~making,~~have ~~using,~~a ~~selling~~material oradverse ~~importing~~effect ~~products using the technology based~~ on ~~the expired patents. There is no assurance that competitors will not be able to design around~~ our ~~patents~~business.

~~We also~~Despite ~~rely on unpatented proprietary technology. We cannot assure you that we can meaningfully protect all~~ our ~~rights~~initiative ~~in our unpatented proprietary technology or that others will not independently develop substantially equivalent proprietary products or processes or otherwise gain access~~ to ~~our~~establish ~~unpatented~~a ~~proprietary~~robust ~~technology.~~cash Wepay ~~seek to protect our know-how and other unpatented proprietary technology~~program, ~~as trade~~successful ~~secrets~~commercialization orof ~~otherwise,~~Lucid’s ~~with~~EsoGuard ~~confidentiality~~test ~~agreements~~ and~~/or~~ ~~intellectual~~EsoCheck ~~property assignment agreements with our team members~~device, ~~independent~~ ~~distributors~~ and ~~consultants. However, such agreements may not be enforceable or may not provide meaningful protection for our proprietary information in the event~~ of ~~unauthorized~~any ~~use or disclosure or~~ other ~~breaches~~product ~~of the agreements~~ or inservice ~~the~~we ~~event that our competitors discover or independently~~ develop, ~~similar~~license or ~~identical~~acquire ~~designs~~depends, orin ~~other~~large ~~proprietary~~part, ~~information.~~on ~~Our~~the ~~trade~~availability ~~secrets~~of ~~may~~adequate ~~be vulnerable~~reimbursement tofrom ~~disclosure~~private or ~~misappropriation~~governmental bythird-party ~~employees, contractors and other persons~~payors.

28EsoGuard’s PLA code 0114U has been granted “gapfill” determination through the CMS CLFS process, allowing us to engage directly with Medicare Administrative Contractor (“MAC”) Palmetto GBA, whose Molecular Diagnostics Program (“MolDx”) performs technical assessment of molecular diagnostic tests on behalf of itself and other MACs. Although CMS granted EsoGuard final Medicare payment determination of $1,938.01, effective January 1, 2021, we have not received a final Medicare local coverage determination from MolDx. Most recently, in May 2023, a LCD L39256, entitled “Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia” became effective on the CMS website by MAC Palmetto GBA. (A substantially identical LCD was published by Noridian Healthcare Solutions, the MAC whose geographic jurisdiction covers our CLIA laboratory in Lake Forest, CA). The LCD outlines criteria for future coverage that MolDX expects upper gastrointestinal precancer and cancer molecular diagnostic tests to meet. These criteria include active GERD with at least two risk factors, as well as evidence of analytic validity, clinical validity, and clinical utility. Although the LCD indicated that it found that no currently existing test has fulfilled all these criteria, it indicated that it will “monitor the evidence and may revise this determination based on the pertinent literature and society recommendations.”

~~We may~~In beNovember ~~subject~~2024, we announced that we submitted to ~~intellectual~~MolDx ~~property~~our ~~infringement~~complete ~~claims~~clinical byevidence ~~third~~package ~~parties~~in ~~which~~support ~~could~~of bea ~~costly~~request for reconsideration of the non-coverage language in the LCD to ~~defend~~secure Medicare coverage for EsoGuard. As part of the LCD reconsideration process, ~~divert~~MolDx-participating ~~management’s attention~~Medicare Administrative Contractors convened a CAC Meeting regarding the LCD on September 4, 2025. At the meeting, eleven experts, including physicians across multiple specialties (GI, primary care, pathology), major society guideline co-authors (ACG, AGA) and ~~resources~~industry leaders (American Foregut Society, American Society for Gastrointestinal Endoscopy), participated in this extensive discussion of the unmet clinical need with respect to early detection of esophageal precancer and ~~may~~the ~~result~~strength of the EsoGuard clinical validity and clinical utility data. However, there can be no assurance that MolDx will determine that we meet the criteria for coverage as specified in ~~liability~~the LCD. If we are not granted coverage, or if a determination is substantially delayed, that could have a material adverse effect on our ability to commercialize EsoGuard.

~~The medical~~Commercial ~~device~~third-party ~~industry~~payors isoften ~~characterized~~rely byupon ~~vigorous~~Medicare ~~protection~~coverage policy and ~~pursuit~~payment oflimitations ~~intellectual property rights. Companies~~ in ~~the~~setting ~~medical device~~their ~~industry~~own ~~have~~reimbursement ~~used~~policies. ~~intellectual~~Third-party ~~property~~payors ~~litigation~~are toincreasingly ~~gain~~attempting ~~a competitive advantage in the marketplace. From time~~ to ~~time,~~contain ~~third parties~~healthcare ~~may~~costs ~~assert~~by ~~against~~limiting usboth ~~their~~coverage ~~patent, copyright, trademark~~ and ~~other~~the ~~intellectual~~level ~~property~~of ~~rights~~reimbursement ~~relating~~for tonew ~~technologies~~healthcare ~~that are~~products. ~~important~~As toa ~~our~~result, ~~business.~~there ~~Searching~~is ~~for~~uncertainty ~~existing~~surrounding ~~intellectual~~whether ~~property~~EsoGuard ~~rights~~or ~~may~~EsoCheck, ~~not~~or ~~reveal~~any ~~important~~other ~~intellectual~~product ~~property~~or ~~and our~~service ~~competitors~~we ~~may~~develop, ~~also~~will ~~have~~be ~~filed~~eligible for ~~patent~~coverage ~~protection,~~by ~~which is not publicly~~third-~~available~~party ~~information,~~payors or, ~~claimed~~if ~~trademark~~eligible ~~rights~~for ~~that have~~coverage, ~~not~~what ~~been~~the ~~revealed~~reimbursement ~~through~~rates ~~our~~will ~~availability searches~~be. WeFor ~~may~~example, bewith ~~subject~~respect to ~~claims~~EsoGuard ~~that~~and ~~our team members have disclosed~~EsoCheck, orreimbursement ~~that we have used, trade secrets or other proprietary information~~ of ~~our~~esophageal ~~team~~precancer ~~members’~~and ~~former~~cancer ~~employers.~~screening ~~Our~~by ~~efforts~~a tothird-party ~~identify~~payor ~~and~~may ~~avoid infringing~~depend on ~~third~~a ~~parties’~~number ~~intellectual~~of ~~property~~factors, ~~rights~~including ~~may~~a ~~not~~payor’s ~~always~~determination ~~be successful. Any claims~~ that ~~our~~tests ~~products~~using ~~or processes infringe~~ these ~~rights,~~technologies ~~regardless~~are ofsufficiently ~~their~~sensitive ~~merit~~and orspecific ~~resolution,~~for ~~could~~esophageal becancer ~~costly, time consuming~~ and ~~may~~precancer; ~~divert~~not ~~the~~experimental ~~efforts~~or ~~and~~investigational; ~~attention of~~approved ~~our~~or ~~management~~recommended ~~and~~by ~~technical~~the ~~personnel.~~major Inguidelines ~~addition~~organizations; reliable, wesafe ~~may~~and ~~not~~effective; ~~prevail~~medically innecessary; ~~such~~appropriate ~~proceedings~~for ~~given~~ the ~~complex~~specific ~~technical~~patient; ~~issues~~ and ~~inherent~~ ~~uncertainties in intellectual property litigation~~cost-effective.

~~Any claims~~Coverage determinations and reimbursement rates are also subject to the effects of ~~patent~~federal and state coverage mandates and other healthcare regulations and reform initiatives as described below. As noted below, federal and state coverage mandates may be deemed not to apply to EsoGuard and EsoCheck (or any other ~~intellectual~~product ~~property~~or ~~infringement~~service ~~against~~we usdevelop), ~~even~~may ~~those~~be ~~without~~interpreted ~~merit~~in a manner unfavorable to us, ~~could:~~may be difficult to enforce and are subject to repeal or modification.

● increase the cost of our products; ● be expensive and/or time consuming to defend; ● result in our being required to pay significant damages to third parties; ● force us to cease making or selling products that incorporate the challenged intellectual property; ● require us to redesign, reengineer or rebrand our products and technologies; ● require us to enter into royalty or licensing agreements in order to obtain the right to use a third party’s intellectual property on terms that may not be favorable or acceptable to us; ● require us to develop alternative non-infringing technology, which could require significant effort and expense; ● require us to indemnify third parties pursuant to contracts in which we have agreed to provide indemnification for intellectual property infringement claims; and, ● result in our customers or potential customers deferring or limiting their purchase or use of the affected products impacted by the claims until the claims are resolved.37

~~Any of~~In addition to the ~~foregoing~~risk ~~could~~of ~~affect~~adverse reimbursement decisions, we also may experience material delays in obtaining such reimbursement decisions and payment that are beyond our ~~ability~~control. Further, there can be no assurance that CMS and other third-party payors who initially decide to ~~compete~~cover orour ~~have~~products will continue to do so. Coverage determinations and reimbursement rates are subject to change, including as a ~~material~~result ~~adverse~~of ~~effect~~reimbursement onrate ~~our~~adjustments ~~business~~under the Protecting Access to Medicare Act of 2014, ~~financial~~(“PAMA”) ~~condition~~as described below, and ~~results of~~we ~~operations~~cannot guarantee that even if we initially achieve coverage and adequate reimbursement rates, they will continue to be applicable to our products in the future. Furthermore, it is possible that Medicare or other federal payors that provide reimbursement for our tests may suspend, revoke or discontinue coverage at any time, may require co-payments from patients, or may reduce the reimbursement rates payable to us.

~~Competitors may~~If ~~violate~~we ~~our~~are ~~intellectual~~unable ~~property~~to ~~rights~~obtain favorable decisions from third-party payors, including CMS and wemanaged ~~may~~care ~~bring~~organizations, ~~litigation~~approving toreimbursement ~~protect~~at ~~and~~adequate ~~enforce~~levels for our ~~intellectual~~EsoGuard ~~property~~test ~~rights~~and EsoCheck device, ~~which may~~and ~~result~~any inother ~~substantial~~product ~~expense~~or ~~and~~service we may ~~divert~~develop, or if coverage is later revoked or reimbursement levels are reduced, our ~~attention~~commercial ~~from~~success ~~implementing~~will be compromised, our ~~business~~ability ~~strategy~~to raise capital may be restricted and our revenues would be significantly limited.

~~We believe~~Even ~~that~~where ~~the~~a ~~success~~third-party ofpayor ~~our~~agrees ~~business~~to ~~depends~~cover EsoGuard and EsoCheck or any other product or service we develop at an adequate reimbursement rate, inother factors may have a significant ~~part,~~impact on ~~obtaining~~the ~~patent~~actual ~~protection~~reimbursement ~~for~~we ~~our~~receive ~~products~~from ~~and~~that ~~technologies~~payor. For example, ~~defending~~ ~~our~~if ~~patents~~we ~~and~~do ~~preserving~~not ~~our~~have ~~trade~~a ~~secrets.~~contract ~~Our~~with ~~failure~~a togiven ~~pursue~~payor, ~~any~~we ~~potential~~may ~~claim~~be deemed an “out-of-network” provider by that payor, which could result in the ~~loss~~payor allocating a portion of the cost of the product or service to the patient, notwithstanding any applicable coverage mandate. We may be unsuccessful in our ~~proprietary rights~~efforts to enter into, or maintain, a network contract with a given payor, and ~~harm~~we expect that our ~~position~~network instatus ~~the~~with ~~marketplace~~a given payor may change from time to time for a variety of reasons, many of which may be outside our control. ~~Therefore~~To the extent a product or service is out of network for a given payor, wephysicians may be ~~forced~~less likely to ~~pursue~~prescribe ~~litigation~~such product or service for their patients and their patients may be less likely to ~~enforce~~comply ~~our~~with ~~rights~~those prescriptions that are written. ~~Future~~Also, ~~litigation could~~some ~~result~~payors inmay ~~significant~~require ~~costs~~that ~~and~~they ~~divert~~give prior authorization for a product or service before they are willing to pay for it or review claims post-service to ensure the ~~attention~~service ofwas ~~our~~medically appropriate for specific patients. Prior authorization and other medical management practices may require that we, patients or physicians provide the payor with extensive medical records and ~~key~~other ~~personnel~~information. ~~from~~Prior authorization and other medical management practices impose a significant additional cost on us, may be difficult to comply with given our ~~business~~position ~~operations~~as a laboratory that generally does not have direct access to patient medical records, may make physicians less likely to prescribe our product or service for their patients, and may make patients less likely to comply with physician orders for the ~~implementation~~ same, all or any of which may have an adverse effect on our ~~business~~revenues. ~~strategy~~Payment rates also may vary according to the use of the product and the clinical setting in which it is used, may be based on payments allowed for lower cost products that are already reimbursed and may be incorporated into existing payments for other services.

~~Our business~~Any future products or services we may ~~suffer~~develop ifmay not be approved for sale in the U.S. or in any other country. In order to obtain approval, we ~~are~~may ~~unable~~need to ~~manage~~conduct ~~our~~clinical ~~growth~~trials necessary to support a FDA 510(k) notice or PMA application will be expensive and will require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.

If Our only products for which we ~~fail~~have toobtained ~~effectively~~approval ~~manage~~or clearance from the FDA or a comparable foreign regulatory authority is our ~~growth~~EsoCheck cell sample collection device and our CarpX minimally invasive surgical device. In certain limited circumstances, we also may market our ~~ability~~products without such approval or clearance, as is the case for the EsoGuard LDT. Generally, however, neither we nor any future collaboration partner can commercialize any products we may develop in the U.S. or in any foreign country without first obtaining regulatory approval for the product, where applicable, from the FDA or comparable foreign regulatory authorities. The approval route in the U.S. for any products we may develop may be either via the PMA process, a de novo 510(k) pathway, or traditional 510(k). The PMA approval process is more complex, costly and time consuming than the 510(k) process. Additional randomized, controlled clinical trials may be necessary to ~~execute~~obtain ~~our~~approval. ~~business~~The ~~strategy~~approval ~~could~~process may take several years to complete and may never be ~~impaired~~obtained. ~~Any~~Before ~~unanticipated~~obtaining ~~rapid~~regulatory ~~growth~~ approvals for the commercial sale of ~~our~~any ~~business~~product we may ~~place~~develop ain ~~strain~~the onU.S., ~~our~~we ~~management~~must demonstrate with substantial evidence, ~~operations~~gathered in preclinical and ~~financial~~well-controlled ~~systems~~clinical studies, that the planned products are safe and effective for use for that target indication. We ~~need~~may tonot ~~ensure~~conduct ~~our~~such ~~existing~~a ~~systems~~trial or may not successfully enroll or complete any such trial. Any products we may develop may not achieve the required primary endpoint in the clinical trial and may not receive regulatory approval. We must also demonstrate that the manufacturing facilities, processes and controls for any products we may develop are adequate. Moreover, obtaining regulatory approval in one country for marketing of any products we may develop does not ensure we will be able to ~~support~~obtain ~~our~~regulatory ~~business~~approval ~~and~~in ~~its~~other ~~anticipated~~countries, ~~growth~~while a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in other countries. Failure to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our products internationally.

~~Our ability to be successful will be totally dependent upon the efforts of our key personnel.~~38

~~Our ability~~Even toif ~~successfully~~we ~~carry~~or ~~out~~any ~~our~~future ~~business~~collaboration ~~plan~~partner iswere ~~dependent~~to ~~upon~~successfully ~~the~~obtain ~~efforts~~a ofregulatory ~~our~~approval ~~key~~for ~~personnel.~~any Weproduct ~~cannot~~we ~~assure~~may ~~you~~develop, ~~that~~ any of ~~our~~approval ~~key~~might ~~personnel~~contain ~~will~~significant ~~remain~~limitations ~~with~~related usto ~~for~~use ~~the~~restrictions ~~immediate~~for orspecified ~~foreseeable~~age ~~future.~~groups, ~~The~~warnings, ~~unexpected~~precautions ~~loss~~or ofcontraindications, ~~the~~or ~~services~~may ofbe ~~our~~subject ~~key~~to ~~personnel could~~burdensome ~~have~~post-approval astudy ~~detrimental~~or ~~effect~~risk onmanagement usrequirements. WeIf ~~may~~we ~~also~~are be unable to ~~attract~~obtain ~~and~~regulatory ~~retain~~approval ~~additional~~for ~~key~~any ~~personnel~~products, we may develop in ~~the~~one ~~future.~~or Wemore ~~are~~jurisdictions, ~~limited in~~or ~~shares~~any ~~available~~approval ~~for~~contains ~~issuance~~significant ~~under~~limitations, ~~our~~we ~~long-term~~may ~~incentive~~not ~~plan,~~be ~~which~~able ~~could~~to ~~limit~~obtain ~~our~~sufficient ~~ability~~revenue to ~~attract~~justify ~~and~~commercial ~~retain~~launch. ~~key~~Also, ~~personnel~~any regulatory approval of a product, ~~until~~ ~~such~~once ~~amount~~obtained, ismay ~~increased~~be withdrawn. AnIf ~~inability~~we are unable to ~~attract~~successfully ~~and~~obtain ~~retain~~regulatory ~~key~~approval ~~personnel~~to sell any products we may ~~impact~~develop ~~our~~in ~~ability~~the toU.S. ~~continue~~or ~~and~~other ~~grow~~countries, our business, financial condition, results of operations and growth prospects could be adversely affected.

29Initiating and completing clinical trials necessary to support a FDA 510(k) notice or a PMA application will be time-consuming and expensive and the outcome uncertain. Moreover, the results of early clinical trials are not necessarily predictive of future results, and any product the Company advances into clinical trials may not have favorable results in early or later clinical trials. Conducting successful clinical studies will require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Patient enrollment in clinical trials and completion of patient participation and follow-up depend on many factors, including the size of the patient population, the nature of the trial protocol, the attractiveness of, or the discomforts and risks associated with, the treatments received by patients enrolled as subjects, the availability of appropriate clinical trial investigators, support staff, and proximity of patients to clinical sites and ability to comply with the eligibility and exclusion criteria for participation in the clinical trial and patient compliance. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness of our products or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts. Patients may also not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive products. In addition, patients participating in clinical trials may die before completion of the trial or suffer adverse medical events unrelated to investigational products. Further, the FDA may require the Company to submit data on a greater number of patients than it originally anticipated and/or for a longer follow-up period or change the data collection requirements or data analysis for any clinical trials. Delays in patient enrollment or failure of patients to continue to participate in a clinical trial may cause an increase in costs and delays in the approval and attempted commercialization of our products or result in the failure of the clinical trial. Such increased costs and delays or failures could adversely affect our business, operating results and prospects.

~~Our officers~~The ~~and~~results ~~directors~~of ~~have~~the ~~fiduciary~~Company’s ~~obligations~~clinical totrials ~~other companies and, accordingly,~~ may ~~have~~not ~~conflicts~~support ofour ~~interest~~product incandidate ~~determining to~~claims ~~which~~or ~~entity~~may aresult ~~particular~~in ~~business~~the ~~opportunity~~discovery ~~should~~of beadverse ~~presented~~side effects.

~~Certain of~~As the Company’s clinical trials are completed as planned, it cannot be certain that study results will support product candidate claims or that the FDA or foreign regulatory authorities will agree with our ~~officers~~conclusions regarding them. Success in pre-clinical evaluation and ~~directors~~early ~~have~~clinical ~~fiduciary~~trials ~~obligations~~does tonot ~~other~~ensure ~~companies~~that ~~engaged~~later inclinical ~~medical~~trials ~~device~~will ~~business~~be ~~activities~~successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies. ~~Accordingly, they~~The clinical trial process may ~~participate~~fail into ~~transactions~~demonstrate that our product candidates are safe and ~~have~~effective ~~obligations~~for ~~that~~the ~~may~~proposed beindicated uses or otherwise influence medical decisions in ~~conflict~~the ormanner ~~competition~~we ~~with~~need ~~our~~to ~~business.~~show Asto aevidence ~~result~~the clinical utility of our product candidates, which could cause us to abandon a ~~potential business~~product ~~opportunity~~candidate and may bedelay ~~presented~~development byof ~~certain~~others. ~~members~~In ofaddition, if clinical data does not support our ~~board~~product candidate claims, the FDA could then bring legal or ~~management~~regulatory ~~team~~enforcement toactions ~~another~~against ~~entity~~the ~~prior~~Company toand/or its ~~presentation~~ products including, but not limited to, usrecalls ~~and~~or werequirements ~~may~~for ~~not~~pre-market 510(k) authorizations. The Company can give no assurance that its data will be ~~afforded~~substantiated in studies involving more patients. In such a case, the ~~opportunity~~Company may never achieve significant revenues or profitability. Any delay or termination of our clinical trials will delay the filing of any related product submissions and, ultimately, our ability to ~~engage~~commercialize our product candidates and generate revenues (in ~~such~~particular where evidence of clinical utility is a ~~transaction~~critical factor to payor’s decisions around reimbursement). It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.

~~Our business,~~Even ~~financial~~if ~~condition~~we ~~and~~receive ~~results~~regulatory ofapproval ~~operations~~for ~~could~~any product we may develop, we will be ~~adversely~~subject ~~affected~~to byongoing ~~the~~regulatory ~~political~~obligations and ~~economic~~continued ~~conditions~~regulatory ofreview, ~~the~~which ~~countries~~ may result in ~~which~~significant additional expense and subject us to penalties if we ~~conduct~~fail ~~business~~to comply with applicable regulatory requirements.

~~Our business~~Once regulatory approval has been obtained, ~~financial~~the ~~condition~~approved product and ~~results~~its ofmanufacturer ~~operations~~are ~~could~~subject beto ~~adversely~~continual ~~affected~~review by the ~~political~~FDA ~~and~~or ~~economic~~non-U.S. ~~conditions~~regulatory ofauthorities. Our regulatory approval for any products we may develop may be subject to limitations on the ~~countries in~~indicated uses for which the product may be marketed. Future approvals may contain requirements for potentially costly post-marketing follow-up studies to monitor the safety and efficacy of the approved product. In addition, we ~~conduct~~are ~~business~~subject to extensive and ongoing regulatory requirements by the FDA and other regulatory authorities with regard to the labeling, packaging, adverse event reporting, storage, advertising, promotion and recordkeeping for our products. ~~These~~In ~~factors~~addition, we are required to comply with cGMP regulations regarding the manufacture of any products we may develop, which include: requirements related to quality control and quality assurance as well as the corresponding maintenance of records and documentation. Further, these manufacturing facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP regulations. If we or a third party discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory authority may impose restrictions on that product, the manufacturer or us, including requiring withdrawal of the product from the market or suspension of manufacturing.

● varying practices of the regulatory, tax, judicial and administrative bodies in the U.S. and other jurisdictions where we operate; ● potentially burdensome taxation and changes in domestic and foreign tariffs; ● challenges associated with cultural differences, languages and distance; ● differences in clinical practices, needs, products, modalities and preferences; ● longer payment cycles in some countries; ● credit risks of many kinds; ● legal and regulatory differences and restrictions; ● currency exchange fluctuations; ● foreign exchange controls that might prevent us from repatriating cash earned in certain countries; ● political and economic instability and export restrictions; ● variability in sterilization requirements for multi-usage surgical devices; ● potential adverse tax consequences; ● higher cost associated with doing business internationally; ● challenges in implementing educational programs required by our approach to doing business; ● negative economic developments in economies around the world and the instability of governments, including the threat of war, terrorist attacks, epidemic or civil unrest; ● adverse changes in laws and governmental policies, especially those affecting trade and investment; ● health epidemics and /or pandemics, such as the COVID-19 pandemic, epidemics resulting from the Ebola virus, or the enterovirus, or the avian influenza virus, or the pandemic resulting from a novel strain of a coronavirus designated “Severe Acute Respiratory Syndrome Coronavirus 2” - or “SARS-CoV-2”, which may adversely affect our workforce as well as our local suppliers and customers; ● import or export licensing requirements imposed by governments; ● differing labor standards; ● differing levels of protection of intellectual property; and ● the threat that our operations or property could be subject to nationalization and expropriation.39

~~Failure in~~Healthcare ~~our~~reform ~~information~~measures, ~~technology~~including orthose ~~storage~~targeting ~~systems~~Medicare ~~could~~or ~~significantly disrupt our operations and our research and development efforts~~Medicaid, ~~which~~ could ~~adversely~~hinder ~~impact~~or ~~our~~prevent ~~revenues, as well as~~ our ~~research,~~products’ ~~development~~commercial ~~and commercialization efforts~~success.

~~Our ability~~There tolikely ~~execute~~will ~~our~~be ~~business~~legislative ~~strategy~~and ~~depends,~~regulatory inproposals ~~part,~~at on the ~~continued~~federal and ~~uninterrupted~~state ~~performance~~levels ofdirected ~~our~~at ~~information~~containing ~~technology (“IT”)~~or ~~systems~~lowering ~~that support our operations and our research and development efforts, and those IT systems within~~ the ~~control of~~cost ~~our contract manufacturers and contract laboratories. The integrity and protection~~ of ~~our~~health ~~own data~~care, ~~and~~including ~~that~~those oftargeting ~~our~~Medicare customers and employees, is critical to our business. The regulatory environment governing information, security and privacy laws is increasingly demanding and continues to evolve. IT systems are vulnerable to damage from a variety of sources, including telecommunications or ~~network failures, malicious human acts and natural disasters~~Medicaid. ~~Moreover,~~We ~~despite~~cannot ~~network~~predict ~~security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptive problems. Despite~~ the ~~precautionary~~initiatives ~~measures we have taken to prevent unanticipated problems~~ that ~~could~~may ~~affect~~be ~~our~~adopted ITin ~~systems, and~~ the ~~precautionary~~future ~~measures taken by our contract parties, sustained~~ or ~~repeated~~their ~~system~~full ~~failures that interrupt our ability to generate and maintain data, could adversely affect our ability to operate our business~~impact. ~~Furthermore,~~The ~~any~~continuing ~~breach~~efforts inof ~~our IT systems could lead to~~ the ~~unauthorized access~~government, ~~disclosure~~insurance ~~and use of non-public information~~companies, ~~including~~managed ~~protected~~care ~~health~~organizations ~~information, which is protected by HIPAA~~ and other ~~laws.~~payors ~~Any such access, disclosure, or other loss~~ of ~~information~~healthcare ~~could~~services ~~result~~to incontain ~~legal claims~~ or ~~proceedings,~~reduce ~~liability~~costs ~~under laws that protect the privacy~~ of ~~personal~~health ~~information, and~~care ~~damage~~may toadversely ~~our reputation.~~affect:

~~System upgrades,~~● ~~enhancements~~our ~~and~~ability ~~replacements, as well as new systems, are required from time~~ to ~~time,~~set ~~and~~a ~~require~~price ~~significant~~that ~~expenditures and~~we ~~allocation~~believe ofis ~~valuable~~fair ~~employee~~for ~~resources. Delays in integration or disruptions to~~ our ~~business~~products; ~~from~~● ~~implementation of these new or upgraded systems could have a material adverse impact on~~ our ~~financial~~ability ~~condition and operating results. There can be no assurance that our process of improving existing systems, developing new systems~~ to ~~support~~generate ~~our~~revenue ~~expanding operations, integrating new systems, protecting confidential patient information,~~ and ~~improving~~achieve ~~service levels will not be delayed~~ or ~~that~~maintain ~~additional~~profitability; ~~systems issues will not arise in the future. Failure to adequately protect~~ and ~~maintain~~● the ~~integrity~~availability of ~~our information systems issues and data may result in a material adverse effect on our financial position, results of operations and cash flows~~capital.

30Further, changes in regulatory requirements and guidance may occur, both in the United States and in foreign countries, and we may need to amend clinical study protocols to reflect these changes. Amendments may require us to resubmit our clinical study protocols to IRB’s for reexamination, which may impact the costs, timing or successful completion of a clinical study. In light of widely publicized events concerning the safety risk of certain drug and medical device products, regulatory authorities, members of Congress, the Governmental Accounting Office, medical professionals and the general public have raised concerns about potential safety issues. These events have resulted in the recall and withdrawal of medical device products, revisions to product labeling that further limit use of products and establishment of risk management programs that may, for instance, restrict distribution of certain products or require safety surveillance or patient education. The increased attention to safety issues may result in a more cautious approach by the FDA or other regulatory authorities to clinical studies and the drug approval process. Data from clinical studies may receive greater scrutiny with respect to safety, which may make the FDA or other regulatory authorities more likely to terminate or suspend clinical studies before completion or require longer or additional clinical studies that may result in substantial additional expense and a delay or failure in obtaining approval or approval for a more limited indication than originally sought.

~~We may~~Given ~~become~~ the ~~subject~~serious public health risks of ~~various~~high ~~claims~~profile adverse safety events with certain products, ~~threats~~the FDA or other regulatory authorities may require, as a condition of ~~litigation~~approval, ~~litigation~~costly orrisk ~~investigations~~evaluation and mitigation strategies, which ~~could~~may ~~have~~include asafety ~~material~~surveillance, ~~adverse~~restricted ~~effect on~~distribution ~~our~~and ~~business~~use, ~~financial~~patient ~~condition~~education, ~~results~~enhanced oflabeling, ~~operations~~special packaging or ~~price~~labeling, expedited reporting of ~~our~~certain ~~common~~adverse ~~stock~~events, preapproval of promotional materials and restrictions on direct-to-consumer advertising.

We may become subject to various claims, threats of litigation, litigation or investigations, including commercial disputes and employee claims, and from time to time may be involved in governmental or regulatory investigations or similar matters. Any claims asserted against us or our management, regardless of merit or eventual outcome, could harm our reputation and have an adverse impact on our relationship with our clients, distribution partners and other third parties and could lead to additional related claims. Furthermore, there is no guarantee that we will be successful in defending ourselves in pending or future litigation or similar matters under various laws. Any judgments or settlements in any pending litigation or future claims, litigation or investigation could have a material adverse effect on our business, financial condition, results of operations and price of our common stock.40

~~Risks Associated~~If we fail to comply with ~~Healthcare~~healthcare ~~Regulation~~regulations, ~~Billing~~we could face substantial penalties and ~~Reimbursement~~our business, operations and ~~Product~~financial ~~Safety~~condition ~~and~~could ~~Effectiveness~~be adversely affected.

~~If private~~Even though we do not and will not control referrals of healthcare services or ~~governmental~~bill directly to Medicare, Medicaid or other third-party payors, docertain ~~not~~federal ~~maintain~~and ~~reimbursement~~state ~~for~~healthcare ~~our~~laws ~~products~~and atregulations ~~adequate~~pertaining ~~reimbursement~~to ~~rates,~~fraud weand ~~may~~abuse and patients’ rights are and will be ~~unable~~ applicable to ~~successfully~~our ~~commercialize~~business. ~~our~~We ~~products~~could ~~which~~be ~~would~~subject ~~limit~~to orhealthcare ~~slow~~fraud ~~our~~and ~~revenue~~abuse ~~generation~~and patient privacy regulation by both the federal government and ~~likely~~the ~~have~~states ain ~~material~~which ~~adverse effect~~we onconduct our business. The regulations that may affect our ability to operate include, without limitation:

~~Despite our~~● ~~initiative~~the federal healthcare program Anti-Kickback Statute, which prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing remuneration, directly or indirectly, in exchange for or to ~~establish~~induce aeither ~~robust~~the ~~cash~~referral ~~pay~~of ~~program~~an individual for, ~~successful~~or ~~commercialization~~the purchase, order or recommendation of, ~~Lucid’s~~any ~~EsoGuard~~good ~~test~~or ~~and~~service ~~EsoCheck~~for ~~device~~which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs; ● the U.S. Foreign Corrupt Practices Act, or FCPA, which prohibits payments or the provision of ~~any~~anything of value to foreign officials for the purpose of obtaining or keeping business; ● the federal False Claims Act, or FCA, which prohibits, among other ~~product~~things, individuals or ~~service~~entities wefrom ~~develop~~knowingly presenting, ~~license~~or causing to be presented, false claims, or ~~acquire~~knowingly ~~depends~~using false statements, into ~~large~~obtain ~~part~~payment from the federal government, onand which may apply to entities like us which provide coding and billing advice to customers; ● federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● the ~~availability~~federal transparency requirements under the Health Care Reform Law requires manufacturers of ~~adequate~~drugs, ~~reimbursement from~~devices, ~~private~~biologics and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests; ● the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or ~~governmental~~services reimbursed by any third-party ~~payors~~payor, including commercial insurers.

~~EsoGuard’s PLA~~If ~~code~~our ~~0114U~~operations ~~has~~are ~~been~~found ~~granted “gapfill” determination through the CMS CLFS process, allowing us~~ to ~~engage~~be ~~directly~~in ~~with Medicare~~violation ~~Administrative~~of ~~Contractor~~any ~~(“MAC”) Palmetto GBA, whose Molecular Diagnostics Program (“MolDx”) performs technical assessment~~ of ~~molecular~~the ~~diagnostic~~laws ~~tests~~described onabove ~~behalf~~or ofany ~~itself and~~ other ~~MACs.~~governmental ~~Although~~regulations ~~CMS~~that ~~granted~~apply ~~EsoGuard~~to ~~final Medicare payment determination of $1~~us,~~938.01,~~ ~~effective January 1, 2021,~~ we ~~have~~may ~~not~~be ~~received~~subject ato ~~final Medicare local coverage determination from MolDx. Most recently~~penalties, inincluding ~~May~~civil ~~2023,~~and acriminal ~~final Local Coverage Determination (“LCD”) L39256~~penalties, ~~entitled “Molecular Testing for Detection of Upper Gastrointestinal Metaplasia~~damages, ~~Dysplasia,~~fines and ~~Neoplasia” became effective on~~ the ~~CMS~~curtailment ~~website~~or byrestructuring ~~MAC~~of ~~Palmetto GBA~~our operations. (AAny ~~substantially~~penalties, ~~identical~~damages, ~~LCD was published by Noridian Healthcare Solutions~~fines, ~~the~~curtailment ~~MAC~~or ~~whose~~restructuring ~~geographic~~of ~~jurisdiction covers~~ our ~~CLIA~~ ~~laboratory~~operations incould ~~Lake~~adversely ~~Forest,~~affect ~~CA.)~~our ~~The~~ability ~~LCD~~to ~~outlines~~operate ~~criteria~~our ~~for~~business ~~future coverage that MolDX expects upper gastrointestinal precancer~~ and ~~cancer~~our ~~molecular~~financial ~~diagnostic tests to meet~~results. ~~These~~Any ~~criteria~~action ~~include~~against ~~active~~us ~~GERD~~for ~~with~~violation ~~at least two risk factors, as well as evidence~~ of ~~analytic~~these ~~validity~~laws, ~~clinical~~even ~~validity,~~if ~~and~~we ~~clinical~~successfully ~~utility.~~defend ~~Although~~against ~~the LCD indicated that~~ it ~~found that no currently existing test has fulfilled all these criteria~~, itcould ~~indicated~~cause ~~that~~us itto ~~will~~incur ~~“monitor~~significant ~~the~~legal ~~evidence~~expenses and ~~may~~divert ~~revise~~our ~~this~~management’s ~~determination~~attention ~~based~~from on the ~~pertinent~~ ~~literature~~operation ~~and~~of ~~society recommendations.” In November 2024, we announced that we submitted to MolDx~~ our ~~complete clinical evidence package in support of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard~~business. ~~However~~Moreover, ~~there~~achieving ~~can~~and besustaining nocompliance ~~assurance~~with ~~that~~applicable ~~MolDx~~federal ~~will~~and ~~determine~~state ~~that EsoGuard meets the criteria for coverage as specified in the LCD. If Lucid is not granted coverage~~privacy, orsecurity ifand afraud ~~determination~~laws ismay ~~substantially~~prove ~~delayed, that could have a material adverse effect on Lucid’s ability to commercialize EsoGuard~~costly.

Commercial third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. Third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement for new healthcare products. As a result, there is uncertainty surrounding whether EsoGuard or EsoCheck, or any other product or service we develop, will be eligible for coverage by third-party payors or, if eligible for coverage, what the reimbursement rates will be. For example, with respect to EsoGuard and EsoCheck, reimbursement of esophageal precancer and cancer screening by a third-party payor may depend on a number of factors, including a payor’s determination that tests using these technologies are sufficiently sensitive and specific for esophageal cancer and precancer; not experimental or investigational; approved or recommended by the major guidelines organizations; reliable, safe and effective; medically necessary; appropriate for the specific patient; and cost-effective.41

~~Coverage determinations~~The ~~and~~Company’s ~~reimbursement~~medical ~~rates~~products ~~are~~may ~~also~~in ~~subject to~~ the ~~effects~~future ~~of federal and state coverage mandates and other healthcare regulations and reform initiatives as described below. As noted below, federal and state coverage mandates may~~ be ~~deemed~~subject ~~not~~ to ~~apply to EsoGuard and EsoCheck (or any other~~ product orrecalls ~~service~~that wecould ~~develop),~~harm ~~may~~its ~~be interpreted in a manner unfavorable to us~~reputation, ~~may~~business ~~be difficult to enforce~~ and ~~are~~financial ~~subject to repeal or modification~~results.

~~In addition~~The FDA has the authority to require the ~~risk~~recall of ~~adverse~~commercialized ~~reimbursement~~medical ~~decisions,~~device weproducts ~~also~~in ~~may~~the ~~experience~~event of material ~~delays~~deficiencies inor ~~obtaining~~defects ~~such~~in ~~reimbursement~~design ~~decisions and~~or ~~payment~~manufacture. ~~that~~In ~~are~~the ~~beyond~~case ~~our~~of ~~control.~~the ~~Further~~FDA, ~~there~~the ~~can~~authority to require a recall must be nobased ~~assurance~~on an FDA finding that ~~CMS~~there ~~and~~is ~~other~~a ~~third-party~~reasonable ~~payors~~probability ~~who~~that ~~initially~~the ~~decide to~~device ~~cover~~would ~~our~~cause ~~products~~serious ~~will~~injury ~~continue~~or todeath. doManufacturers somay, under their own initiative, recall a product if any material deficiency in a device is found. ~~Coverage~~A ~~determinations~~government-mandated ~~and~~or ~~reimbursement~~voluntary ~~rates~~recall ~~are~~by ~~subject~~the toCompany ~~change,~~or ~~including~~one of its distributors could occur as a result of ~~reimbursement~~component ~~rate~~failures, ~~adjustments~~manufacturing ~~under~~errors, ~~the~~design ~~Protecting~~or ~~Access~~labeling todefects ~~Medicare~~or ~~Act~~other deficiencies and issues. Recalls of ~~2014,~~any ~~(“PAMA”)~~of asthe ~~described~~Company’s ~~below,~~products would divert managerial and ~~we cannot~~financial ~~guarantee~~resources ~~that~~and ~~even~~have ifan weadverse ~~initially~~effect ~~achieve~~on ~~coverage~~its financial condition and ~~adequate~~results ~~reimbursement~~of ~~rates~~operations. The FDA requires that certain classifications of recalls be reported to the FDA within ten (10) working days after the recall is initiated. Companies are required to maintain certain records of recalls, even if they ~~will~~are ~~continue~~not reportable to bethe ~~applicable~~FDA. ~~to our~~The Company may initiate voluntary recalls involving its products in the future that the Company determines do not require notification of the FDA. ~~Furthermore~~If the FDA disagrees with the Company’s determinations, itthey iscould ~~possible~~require ~~that~~the ~~Medicare~~Company orto ~~other~~report ~~federal~~those ~~payors~~actions ~~that~~as ~~provide~~recalls. ~~reimbursement~~A ~~for~~future ~~our~~recall ~~tests may~~announcement ~~suspend,~~could ~~revoke~~harm orthe ~~discontinue~~Company’s ~~coverage~~reputation atwith ~~any~~customers ~~time,~~and ~~may~~negatively ~~require~~affect ~~co-payments~~its ~~from~~sales. ~~patients~~In addition, orthe ~~may~~FDA ~~reduce~~could take enforcement action for failing to report the ~~reimbursement~~recalls ~~rates payable~~when they were conducted. No recalls of the Company’s medical products that we are seeking to uscommercialize have been reported to the FDA.

If we ~~are~~the ~~unable~~Company’s tomedical ~~obtain~~products ~~favorable~~cause ~~decisions~~or ~~from~~contribute ~~third-party~~to ~~payors,~~a ~~including~~death ~~CMS and managed care organizations, approving reimbursement at adequate levels for our EsoGuard test and EsoCheck device, and any other product~~ or ~~service~~a weserious ~~may develop~~injury, or ifmalfunction ~~coverage~~in iscertain ~~later revoked or reimbursement levels are reduced~~ways, ~~our~~we ~~commercial success~~ will be ~~compromised,~~subject ~~our ability~~ to ~~raise~~medical ~~capital~~device ~~may~~reporting beregulations, ~~restricted and~~which ~~our~~can ~~revenues~~result ~~would~~in bevoluntary ~~significantly~~corrective ~~limited.~~actions ~~Healthcare~~or ~~providers~~agency ~~may~~enforcement ~~be reluctant to prescribe our products if they believe that reimbursement for the test will not be available for a significant number of their patients~~actions.

31Under the FDA medical device reporting regulations, medical device manufacturers are required to report to the FDA information that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury if the malfunction of the device or one of our similar devices were to recur. If the Company fails to report these events to the FDA within the required timeframes, or at all, the FDA could take enforcement action against the Company. Any such adverse event involving its products also could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of the Company’s time and capital, distract management from operating our business, and may harm its reputation and financial results.

~~Even where~~If athe ~~third-party~~Company ~~payor~~is ~~agrees~~found to ~~cover~~be ~~EsoGuard~~promoting ~~and EsoCheck or any other product or service we develop at an adequate reimbursement rate, other factors may have a significant impact on~~ the ~~actual~~use ~~reimbursement~~of weits ~~receive~~devices ~~from~~for ~~that~~unapproved ~~payor.~~or ~~For example, if we do not have a contract with a given payor, we may be deemed an~~ “~~out~~off-~~of-network~~label” ~~provider~~uses byor ~~that~~engaging ~~payor, which could result~~ in ~~the~~other ~~payor allocating~~noncompliant aactivities, ~~portion of~~ the ~~cost~~Company ~~of the product or service to the patient, notwithstanding any applicable coverage mandate. We~~ may be ~~unsuccessful~~ insubject ~~our efforts~~ to ~~enter into~~recalls, ~~or maintain~~seizures, ~~a network contract with a given payor~~fines, ~~and we expect that our network status with a given payor may change from time to time for a variety of reasons~~penalties, ~~many of which may be outside our control. To the extent a product or service is out of network for a given payor~~injunctions, ~~physicians~~adverse ~~may be less likely to prescribe such product or service for their patients and their patients may be less likely to comply with those prescriptions that are written. Also~~publicity, some payors may require that they give prior authorization for a product or service before they are willing to pay for it or review claims post-service to ensure the service was medically appropriate for specific patients. Prior authorization and other medical management practices may require that weprosecution, ~~patients~~ or ~~physicians provide the payor with extensive medical records and~~ other ~~information.~~adverse ~~Prior authorization and other medical management practices impose a significant additional cost on us~~actions, ~~may~~resulting bein ~~difficult~~damage to ~~comply~~its ~~with~~reputation ~~given our position as a laboratory that generally does not have direct access to patient medical records, may make physicians less likely to prescribe our product or service for their patients,~~ and ~~may make patients less likely to comply with physician orders for the same, all or any of which may have an adverse effect on our revenues~~business. Payment rates also may vary according to the use of the product and the clinical setting in which it is used, may be based on payments allowed for lower cost products that are already reimbursed and may be incorporated into existing payments for other services.

The Company’s labeling, advertising, promotional materials and user training materials must comply with the FDA ~~has~~ ~~proposed~~and aother ~~policy~~applicable ~~under~~laws ~~which~~and itregulations, ~~would~~including ~~phase~~the ~~out~~prohibition ~~its~~of ~~general~~the ~~enforcement~~promotion ~~discretion~~of ~~approach~~a medical device for ~~LDTs~~a souse that ~~IVDs~~has ~~manufactured~~not ~~at a~~been ~~laboratory~~cleared ~~would~~or ~~generally~~approved ~~fall~~by ~~under~~the FDA. Obtaining 510(k) clearance or PMA approval only permits the ~~same~~Company ~~enforcement~~to ~~approach~~promote its products for the uses specifically cleared by the FDA. Use of a device outside its cleared or approved indications is known as ~~other~~“off-label” ~~IVDs~~use. ~~While~~Physicians weand ~~are~~consumers ~~confident~~may ~~that~~use the ~~proposed~~Company’s ~~policy will~~products off-label because the FDA does not ~~have~~restrict or regulate a ~~material~~physician’s ~~impact~~choice of treatment within the practice of medicine nor is there oversight on patient use of over-the-counter devices. Although the Company may request additional cleared indications for our ~~business~~current products, ~~there~~the ~~can~~FDA may deny those requests, require additional expensive clinical data to support any additional indications or impose limitations on the intended use of any cleared product as a condition of clearance. Even if regulatory clearance or approval of a product is granted, such clearance or approval may be nosubject ~~assurance~~to ~~that~~limitations ~~will~~on the intended uses for which the product may be marketed and reduce our potential to successfully commercialize the ~~case~~product and generate revenue from the product.

~~On May~~If 6the FDA determines that the Company’s labeling, ~~2024~~advertising, promotional materials, or user training materials, or representations made by Company personnel, include the ~~FDA~~promotion ~~issued~~of aan ~~final~~off-label ~~rule~~use ~~aimed~~for atthe ~~helping~~device, toor ~~ensure~~that the ~~safety~~Company has made false or misleading or inadequately substantiated promotional claims, or claims that could potentially change the regulatory status of the product, the agency could take the position that these materials have misbranded the Company’s devices and ~~effectiveness~~request that the Company modifies its labeling, advertising, or user training or promotional materials and/or subject the Company to regulatory or legal enforcement actions, including the issuance of ~~LDTs~~an Untitled Letter or a Warning Letter, injunction, seizure, recall, adverse publicity, civil penalties, criminal penalties, or other adverse actions. ~~The~~It ~~rule~~is ~~amends~~also possible that other federal, state, or foreign enforcement authorities might take action if they consider the ~~FDA~~Company’s ~~regulations~~ labeling, advertising, promotional, or user training materials to ~~make~~constitute ~~explicit~~promotion ~~that~~of ~~IVDs~~an ~~are~~unapproved ~~devices~~use, which could result in significant fines, penalties, or other adverse actions under ~~the~~other ~~Federal~~statutory ~~Food~~authorities, ~~Drug~~such as laws prohibiting false claims for reimbursement. In that event, ~~and~~we ~~Cosmetic~~would ~~Act~~be ~~(FD&C~~subject ~~Act)~~to ~~including~~extensive ~~when~~fines and penalties and the ~~manufacturer~~ Company’s reputation could be damaged and adoption of the ~~IVD~~products iswould abe ~~laboratory~~impaired. ~~Along~~Although ~~with~~the ~~this~~Company ~~amendment~~intends to refrain from statements that could be considered off-label promotion of its products, the FDA isor ~~finalizing~~another aregulatory ~~policy~~agency ~~under~~could ~~which~~disagree and conclude that the ~~FDA~~Company ~~will~~has ~~provide~~engaged ~~greater~~in ~~oversight~~ off-label promotion. For example, the Company has made statements regarding some of ~~IVDs~~its ~~offered~~devices that the FDA may view as ~~LDTs~~off-label ~~through~~promotion. aIn ~~phaseout~~addition, any such off-label use of ~~its~~the ~~general~~Company’s ~~enforcement~~products ~~discretion~~may ~~approach~~increase ~~for~~the ~~LDTs~~risk ~~over~~of injury to patients, and, in turn, the ~~course~~risk of ~~four~~product ~~years~~liability claims, ~~as well~~and assuch ~~targeted~~claims ~~enforcement~~are ~~discretion~~expensive ~~policies~~to ~~for~~defend ~~certain~~and ~~categories~~could ofdivert ~~IVDs~~the ~~manufactured~~Company’s bymanagement’s ~~laboratories~~attention and result in substantial damage awards against the Company.

~~The phaseout policy contains the following five stages:~~42

●Risks ~~Stage~~Associated ~~1: Beginning on May 6, 2025, which is one year after the publication date of the final LDT rule, FDA will expect compliance~~ with ~~medical~~Ownership device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files. ● Stage 2: Beginning on May 6, 2026, which is 2 years after the publication date of ~~the~~Our ~~final~~Common ~~LDT~~Stock rule, FDA will expect compliance with requirements not covered during other stages of the phaseout policy, including registration and listing requirements, labeling requirements, and investigational use requirements. ● Stage 3: Beginning on May 6, 2027, which is 3 years after the publication date of the final LDT rule, FDA will expect compliance with QS requirements (other than requirements regarding complaint files which are already addressed in stage 1). ● Stage 4: Beginning on November 6, 2027, which is 3½ years after the publication date of the final LDT rule, FDA will expect compliance with premarket review requirements for high-risk IVDs offered as LDTs (IVDs that may be classified into class III or that are subject to licensure under section 351 of the Public Health Service Act), unless a premarket submission has been received by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review. ● Stage 5: Beginning on May 6, 2028, which is 4 years after the publication date of the final LDT rule, FDA will expect compliance with premarket review requirements for moderate-risk and low-risk IVDs offered as LDTs (that require premarket submissions), unless a premarket submission has been received by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review.

~~The FDA~~We ~~also~~may ~~intends~~issue toshares ~~exercise~~of ~~enforcement~~our ~~discretion~~common and/or ~~generally~~preferred ~~not~~stock ~~enforce~~in ~~some~~the orfuture ~~all~~(including ~~applicable~~shares ~~requirements~~of ~~for~~our ~~certain~~common ~~categories~~ stock upon exercise of ~~IVDs~~the ~~manufactured~~outstanding bySeries aD ~~laboratory.~~warrants) ~~The~~which ~~categories~~could ofreduce ~~enforcement~~the ~~discretion~~equity ~~that~~interest ~~are~~of ~~applicable~~our tostockholders ~~EsoGuard~~and ~~are~~might ~~summarized~~cause a change in ~~the table~~control ~~below~~of our ownership.

Category of IVD	Stage 1	Stage 2	Stage 3	Stages 4 & 5 (Premarket Review)
Currently marketed IVDs offered as LDTs first marketed prior to rule publication date and not modified beyond scope described in preamble Section V.B.3 of preamble	Compliance generally expected beginning May 6, 2025	Compliance generally expected beginning May 6, 2026	Compliance with 21 CFR 820.180-820.186 generally expected beginning May 6, 2027; Compliance generally not expected with other QS requirements (except for complaint files)	Compliance generally not expected
LDTs approved by NYS CLEP Section V.B.2 of preamble	Compliance generally expected beginning May 6, 2025	Compliance generally expected beginning May 6, 2026	Compliance generally expected beginning May 6, 2027	Compliance generally not expected

Our certificate of incorporation authorizes the issuance of up to 25,000,000 shares of common stock, par value $.001 per share, and 20,000,000 shares of preferred stock, par value $.001 per share. We may issue a substantial number of additional shares of our common stock or preferred stock, or a combination of common and preferred stock, to raise additional funds or in connection with any strategic acquisition. The issuance of additional shares of our common stock or any number of shares of our preferred stock:

32● may significantly reduce the equity interest of investors; ● may subordinate the rights of holders of common stock if preferred stock is issued with rights senior to those afforded to our common stockholders; ● may cause a change in control if a substantial number of our shares of common stock are issued, which may affect, among other things, our ability to use our net operating loss carryforwards, if any, and most likely also result in the resignation or removal of some or all of our present officers and directors; and ● may adversely affect prevailing market prices for our common stock.

~~As EsoGuard~~The ~~was~~holder marketed prior to rule publication and is also NYS CLEP approved, hence, enforcement discretion is applicable for compliance with Stages 4 and 5. We will be implementing compliance with MDR requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files by March 31, 2025, well before the deadline of ~~May~~our ~~6, 2025.~~debt ~~Gap analysis~~ has ~~been~~certain ~~completed~~rights ~~and~~with werespect ~~are expecting our compliance activities~~ to ~~be completed for Stages 2 and 3 before~~ the ~~FDA’s~~shares ~~expected timeframes~~ in ~~2026~~Lucid ~~and~~Diagnostics ~~2027, respectively. We are confident~~ that ~~the~~we ~~proposed~~own, ~~final~~which ~~rule~~may ~~will not~~ have a ~~commercial~~material impact ason the ~~Company~~return already has a robust QS management platform for medical devices and EsoGuard will be able to easily transition to the platform to fulfill the QS requirements, as required by the FDA. However, there can be no assurance that Lucid will be able to successfully transition the platform to fulfill the QS requirements, as required by FDA, and its failure to do so could have a material impact on ~~Lucid’s~~any ~~ability~~investment toin ~~commercialize EsoGuard~~shares ~~and~~of on our ~~business~~common ~~as a whole~~stock.

~~Any future~~Under ~~products~~the orterms ~~services~~of wethe ~~may~~2026 ~~develop~~Note, the holder thereof has certain rights that may ~~not~~impact bethe ~~approved~~extent ~~for~~to ~~sale~~which our shareholders would participate in ~~the~~any Udisposition of our shares of Lucid Diagnostics.S. orFor inexample, any ~~other~~change ~~country~~of control of Lucid Diagnostics (so long as our shares of Lucid Diagnostics represent all or substantially all of our assets) requires the consent of such holder. InFurther, ~~order~~upon toany ~~obtain~~such ~~approval~~change of control of Lucid Diagnostics, we ~~may~~are ~~need~~obligated to ~~conduct~~use ~~clinical~~the ~~trials~~proceeds ~~necessary~~thereof to ~~support~~redeem the 2026 Note for a ~~FDA~~redemption ~~510~~price equal to the outstanding principal balance of the Note plus any interest that would accrue thereon through maturity (k)not ~~notice~~to orexceed ~~PMA~~two ~~application~~years ~~will~~of beinterest). ~~expensive~~Such ~~and~~redemption ~~will~~payment ~~require~~ in turn would substantially reduce the ~~enrollment~~proceeds available to holders of ~~large~~our ~~numbers~~common stock as a result of ~~patients,~~such ~~and~~transaction. ~~suitable~~Any ~~patients~~or ~~may~~all beof ~~difficult~~these toevents ~~identify~~could ~~and~~have ~~recruit~~a material impact on the return on any investment in shares of our common stock.

~~Our only~~A ~~products~~robust ~~for~~public which we have obtained approval or clearance from the FDA or a comparable foreign regulatory authority is our EsoCheck cell sample collection device and our CarpX minimally invasive surgical device. In certain limited circumstances, we also may market ~~our~~ ~~products without such approval or clearance, as is the case~~ for ~~the~~our ~~EsoGuard~~common ~~LDT.~~stock ~~Generally, however, neither we nor any future collaboration partner can commercialize any products we~~ may ~~develop~~not in the U.S. or in any foreign country without first obtaining regulatory approval for the product, where applicable, from the FDA or comparable foreign regulatory authorities. The approval route in the U.S. for any products we may develop may be ~~either via the PMA process~~sustained, awhich decould ~~novo~~affect ~~510(k)~~your ~~pathway,~~ability ~~or traditional 510(k). The PMA approval process is more complex, costly and time consuming than the 510(k) process. Additional randomized, controlled clinical trials may be necessary~~ to ~~obtain~~sell ~~approval.~~our ~~The~~common ~~approval~~stock process may take several years to complete and may never be obtained. Before obtaining regulatory approvals for the commercial sale of any product we may develop in the U.S., we must demonstrate with substantial evidence, gathered in preclinical and well-controlled clinical studies, that the planned products are safe and effective for use for that target indication. We may not conduct such a trial or ~~may~~depress ~~not successfully enroll or complete any such trial. Any products we may develop may not achieve~~ the ~~required primary~~market ~~endpoint~~price in the clinical trial and may not receive regulatory approval. We must also demonstrate that the manufacturing facilities, processes and controls for any products we may develop are adequate. Moreover, obtaining regulatory approval in one country for marketing of any products we may develop does not ensure we will be able to obtain regulatory approval in other countries, while a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in other countries. Failure to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our ~~products~~common ~~internationally~~stock.

~~Even if~~We weare orunable ~~any future collaboration partner were~~ to ~~successfully~~predict ~~obtain~~whether aan ~~regulatory~~active ~~approval~~trading ~~for~~market ~~any product we may develop, any approval might contain significant limitations related to use restrictions~~ for ~~specified~~our ~~age~~common ~~groups,~~stock ~~warnings,~~will ~~precautions or contraindications, or may~~ be ~~subject to burdensome post-approval study or risk management requirements~~sustained. If wean ~~are~~active ~~unable~~market tois ~~obtain~~not ~~regulatory~~sustained ~~approval~~ for ~~any~~ ~~products, we may develop in one or more jurisdictions, or~~ any ~~approval contains significant limitations~~reason, weit may ~~not~~ be ~~able~~difficult tofor ~~obtain sufficient~~you ~~revenue~~ to ~~justify~~sell ~~commercial~~your ~~launch.~~securities ~~Also,~~at ~~any~~the ~~regulatory~~time ~~approval~~you ofwish ato ~~product,~~sell ~~once obtained~~them, ~~may~~at bea ~~withdrawn.~~price Ifthat weis ~~are unable~~attractive to ~~successfully~~you, ~~obtain regulatory approval to sell any products we may develop in the U.S.~~ or ~~other~~at ~~countries, our business, financial condition, results of operations and growth prospects could be adversely affected~~all.

Initiating and completing clinical trials necessary to support a FDA 510(k) notice or a PMA application will be time-consuming and expensive and the outcome uncertain. Moreover, the results of early clinical trials are not necessarily predictive of future results, and any product the Company advances into clinical trials may not have favorable results in early or later clinical trials. Conducting successful clinical studies will require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Patient enrollment in clinical trials and completion of patient participation and follow-up depend on many factors, including the size of the patient population, the nature of the trial protocol, the attractiveness of, or the discomforts and risks associated with, the treatments received by patients enrolled as subjects, the availability of appropriate clinical trial investigators, support staff, and proximity of patients to clinical sites and ability to comply with the eligibility and exclusion criteria for participation in the clinical trial and patient compliance. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness of our products or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts. Patients may also not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive products. In addition, patients participating in clinical trials may die before completion of the trial or suffer adverse medical events unrelated to investigational products. Further, the FDA may require the Company to submit data on a greater number of patients than it originally anticipated and/or for a longer follow-up period or change the data collection requirements or data analysis for any clinical trials. Delays in patient enrollment or failure of patients to continue to participate in a clinical trial may cause an increase in costs and delays in the approval and attempted commercialization of our products or result in the failure of the clinical trial. Such increased costs and delays or failures could adversely affect our business, operating results and prospects.43

~~The results~~Our ofstock ~~the~~price ~~Company’s~~may ~~clinical~~be ~~trials~~volatile, ~~may~~and ~~not~~purchasers ~~support~~of our ~~product~~securities ~~candidate~~could ~~claims~~incur orsubstantial ~~may result in the discovery of adverse side effects~~losses.

~~As the~~Our ~~Company’s~~stock ~~clinical~~price ~~trials~~is ~~are~~likely ~~completed~~to ~~as planned, it cannot~~ be ~~certain~~volatile. ~~that~~The ~~study~~stock ~~results~~market ~~will support product candidate claims or that the FDA or foreign regulatory authorities will agree with our conclusions regarding them. Success~~ in ~~pre-clinical evaluation and early clinical trials does not ensure that later clinical trials will be successful~~general, and ~~we cannot be sure that~~ the ~~later~~market ~~trials will~~for ~~replicate~~life ~~the~~science ~~results~~companies, ~~of prior trials~~ and ~~pre-clinical~~medical ~~studies.~~device ~~The~~companies ~~clinical~~in ~~trial~~particular, ~~process~~have ~~may~~experienced ~~fail~~extreme tovolatility ~~demonstrate~~ that ~~our~~has ~~product candidates~~often ~~are~~been ~~safe~~unrelated ~~and effective for the proposed indicated uses or otherwise influence medical decisions in the manner we need~~ to ~~show to evidence~~ the ~~clinical~~operating ~~utility~~performance of ~~our~~particular ~~product candidates, which could cause us to abandon a product candidate and may delay development of others~~companies. InThe ~~addition,~~market ifprice ~~clinical~~for ~~data does not support~~ our ~~product~~common ~~candidate~~stock ~~claims,~~may the FDA could then bring legal or regulatory enforcement actions against the Company and/or its products including, but not limited to, recalls or requirements for pre-market 510(k) authorizations. The Company can give no assurance that its data will be ~~substantiated~~influenced inby ~~studies~~many ~~involving more patients. In such a case~~factors, ~~the~~ ~~Company~~including ~~may never achieve significant revenues or profitability. Any delay or termination of our clinical trials will delay~~ the filing of any related product submissions and, ultimately, our ability to commercialize our product candidates and generate revenues (in particular where evidence of clinical utility is a critical factor to payor’s decisions around reimbursement). It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.following:

~~Our principal~~● ~~ongoing~~factors ~~clinical~~in ~~trials~~the ~~are~~public ~~those~~trading market for our stock that ~~relate~~may toproduce ~~EsoGuard.~~price ~~For~~movements athat ~~summary~~may ofor may not comport with macro, industry or company-specific fundamentals, including, without limitation, the ~~status~~sentiment of retail investors (including as may be expressed on financial trading and ~~certain~~other ~~information~~social ~~concerning~~media sites and online forums), the ~~results~~ direct access by retail investors to broadly available trading platforms, the amount and status of ~~those~~short ~~trials~~interest in our securities, ~~please~~access ~~see~~to ~~above~~margin ~~under~~debt, ~~“Background~~trading in options and ~~Overview—EsoGuard~~other derivatives on our common stock and ~~EsoCheck—Clinical~~any ~~Utility~~ related hedging and ~~Clinical~~other ~~Trials”~~trading factors; ● speculation in the press or investment community about our company or industry; ● our ability to successfully commercialize, and realize revenues from sales of, any products we may develop; ● the performance, safety and side effects of any products we may develop; ● the success of competitive products or technologies; ● results of clinical studies of any products we may develop or those of our competitors; ● regulatory or legal developments in the U.S. and other countries, especially changes in laws or regulations applicable to any products we may develop;

~~Even if~~● weintroductions ~~receive~~and announcements of new products by us, our commercialization partners, or our competitors, and the timing of these introductions or announcements; ● actions taken by regulatory ~~approval~~agencies ~~for~~with ~~any~~respect ~~product~~to our products, clinical studies, manufacturing process or sales and marketing terms; ● variations in our financial results or those of companies that are perceived to be similar to us; ● the success of our efforts to acquire or in-license additional products or other products we may develop; ● developments concerning our collaborations, weincluding ~~will~~but benot ~~subject~~limited to ~~ongoing~~those ~~regulatory~~with ~~obligations~~our sources of manufacturing supply and ~~continued regulatory~~our ~~review,~~commercialization ~~which~~partners; ~~may~~● ~~result~~developments concerning our ability to bring our manufacturing processes to scale in a cost-effective manner; ● announcements by us or our competitors of significant ~~additional~~acquisitions, ~~expense~~strategic partnerships, joint ventures or capital commitments; ● developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and ~~subject~~our usability to ~~penalties~~obtain ifpatent weprotection ~~fail~~for our products; ● our ability or inability to ~~comply~~raise ~~with~~additional ~~applicable regulatory~~capital ~~requirements~~and the terms on which we raise it; ● the recruitment or departure of key personnel; ● changes in the structure of healthcare payment systems; ● market conditions in the medical device, pharmaceutical and biotechnology sectors; ● actual or anticipated changes in earnings estimates or changes in stock market analyst recommendations regarding our common stock, other comparable companies or our industry generally; ● trading volume of our common stock; ● sales of our common stock by us or our stockholders; ● general economic, industry and market conditions; and ● the other risks described in this “Risk Factors” section.

~~Once regulatory~~These ~~approval~~broad ~~has~~market ~~been obtained, the approved product~~ and ~~its~~industry ~~manufacturer~~factors ~~are subject to continual review by the FDA or non-U.S. regulatory authorities. Our regulatory approval for any products we~~ may ~~develop~~seriously ~~may~~harm ~~be subject to limitations on~~ the ~~indicated~~market ~~uses~~price ~~for which~~of ~~the~~our ~~product~~common ~~may~~stock, beregardless ~~marketed. Future approvals may contain requirements for potentially costly post-marketing follow-up studies to monitor the safety and efficacy~~ of ~~the~~our ~~approved~~operating ~~product~~performance. In ~~addition, we are subject to extensive and ongoing regulatory requirements by~~ the ~~FDA~~past, ~~and~~following ~~other~~periods ~~regulatory~~of ~~authorities~~volatility ~~with~~in ~~regard to~~ the ~~labeling~~market, ~~packaging,~~securities ~~adverse~~class ~~event~~action ~~reporting,~~litigation ~~storage,~~has ~~advertising,~~often ~~promotion and~~been ~~recordkeeping~~instituted ~~for~~against ~~our products~~companies. InSuch ~~addition~~litigation, weif ~~are~~instituted ~~required~~against ~~to comply with cGMP regulations regarding the manufacture of any products we may develop~~us, ~~which~~could ~~include~~result ~~requirements~~in ~~related~~substantial tocosts ~~quality control~~ and ~~quality~~diversion ~~assurance as well as the corresponding maintenance~~ of ~~records~~management’s attention and ~~documentation. Further~~resources, ~~regulatory~~which ~~authorities~~could ~~must~~materially ~~approve these manufacturing facilities before they can be used to manufacture drug products,~~ and ~~these~~adversely ~~facilities~~affect ~~are~~our subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP regulations. If we or a third party discover previously unknown problems with a productbusiness, ~~such~~financial ~~as adverse events of unanticipated severity or frequency~~condition, orresults ~~problems with the facility where the product is manufactured, a regulatory authority may impose restrictions on that product, the manufacturer or us, including requiring withdrawal~~ of ~~the~~operations ~~product~~and ~~from~~growth ~~the market or suspension of manufacturing~~prospects.

3344

~~Healthcare reform~~Our ~~measures,~~outstanding ~~including~~warrants ~~those~~and ~~targeting~~other ~~Medicare~~convertible orsecurities ~~Medicaid,~~may ~~could~~have ~~hinder~~an oradverse ~~prevent~~effect on the market price of our ~~products’~~common ~~commercial~~stock ~~success~~and the value of your investment in us.

~~There likely~~ ~~will~~As ~~be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost~~ of March ~~health care~~27, ~~including~~2026, ~~those~~there ~~targeting~~were ~~Medicare~~6,383,089 orshares ~~Medicaid.~~of Weour ~~cannot~~common ~~predict~~stock ~~the~~issued ~~initiatives~~and ~~that~~outstanding, ~~may~~and, beas ~~adopted in the future or their full impact. The continuing efforts~~ of ~~the~~such ~~government~~date, ~~insurance~~we ~~companies,~~also ~~managed~~had ~~care~~issued ~~organizations~~ and ~~other payors of healthcare services to contain or reduce costs of health care may adversely affect~~outstanding:

●(i) ~~our~~stock ~~ability~~options to ~~set~~purchase 84,315 shares of our common stock at a weighted average exercise price ~~that~~of we$197.02 ~~believe~~per isshare, ~~fair~~with ~~for~~such ~~our~~total ~~products~~number inclusive of both stock options granted under the PAVmed Inc. 2014 Long-Term Incentive Equity Plan (“PAVmed 2014 Equity Plan”); ●1,500,879 shares of our ~~ability~~common stock reserved for issuance, but not subject to ~~generate~~outstanding ~~revenue~~stock-based ~~and~~equity ~~achieve~~awards orunder ~~maintain~~the ~~profitability~~PAVmed 2014 Equity Plan; and ●15,774 ~~the~~shares ~~availability~~ of ~~capital~~our common stock reserved for issuance under the PAVmed Inc. Employee Stock Purchase Plan (“PAVmed ESPP”);

~~Further, changes~~(ii) ~~in regulatory requirements and guidance may occur~~1, ~~both in the United States and in foreign countries~~559,991 ~~and~~shares we may need to amend clinical study protocols to reflect these changes. Amendments may require us to resubmit our clinical study protocols to IRB’s for reexamination, which may impact the costs, timing or successful completion of aSeries ~~clinical~~B ~~study.~~Convertible InPreferred ~~light of widely publicized events concerning the safety risk of certain drug and medical device products~~Stock, ~~regulatory~~convertible ~~authorities,~~into ~~members of Congress~~3,467 ~~the~~shares ~~Governmental Accounting Office, medical professionals and the general public have raised concerns about potential safety issues. These events have resulted in the recall and withdrawal~~ of ~~medical~~our ~~device~~common ~~products,~~stock; ~~revisions to product labeling that further limit use of products~~ and establishment of risk management programs that may, for instance, restrict distribution of certain products or require safety surveillance or patient education. The increased attention to safety issues may result in a more cautious approach by the FDA or other regulatory authorities to clinical studies and the drug approval process. Data from clinical studies may receive greater scrutiny with respect to safety, which may make the FDA or other regulatory authorities more likely to terminate or suspend clinical studies before completion or require longer or additional clinical studies that may result in substantial additional expense and a delay or failure in obtaining approval or approval for a more limited indication than originally sought.

~~Given the~~(iii) ~~serious public health risks of high profile adverse safety events with certain products~~30,000 ~~the~~Series ~~FDA~~D orPreferred ~~other regulatory authorities may require~~Warrants, asrepresenting athe ~~condition~~right ofto ~~approval,~~purchase ~~costly risk evaluation and mitigation strategies~~4, ~~which may include safety surveillance~~615,393 ~~restricted distribution~~shares ~~and~~of ~~use,~~the ~~patient~~Company’s ~~education,~~common ~~enhanced~~stock ~~labeling,~~at ~~special~~an ~~packaging~~exercise orprice ~~labeling, expedited reporting~~ of ~~certain~~$6.50 ~~adverse~~per ~~events, preapproval~~whole ~~of promotional materials and restrictions on direct-to-consumer advertising~~share.

~~If we~~The ~~fail~~issuance toof ~~comply~~these ~~with~~shares ~~healthcare~~will ~~regulations~~dilute our other equity holders, wewhich could ~~face~~cause ~~substantial~~the ~~penalties~~price ~~and~~of our ~~business~~common stock to decline. These convertible securities will also reduce the proceeds distributable to our shareholders, ~~operations~~including ~~and~~any ~~financial~~distributions ~~condition could~~of bethe ~~adversely~~proceeds ~~affected~~of any sale of the shares of Lucid Diagnostics held by us or any other transaction involved a disposition of one of our subsidiaries.

~~Even though~~We we do not ~~and~~intend ~~will not control referrals of healthcare services or bill directly~~ to ~~Medicare,~~pay ~~Medicaid~~any orcash ~~other~~dividends ~~third-party~~on ~~payors, certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to~~ our ~~business.~~common Westock ~~could~~at bethis ~~subject to healthcare fraud and abuse and patient privacy regulation by both the federal government and the states in which we conduct our business~~time. ~~The regulations that may affect our ability to operate include, without limitation:~~

●We ~~the~~have ~~federal~~not ~~healthcare~~paid ~~program~~any ~~Anti-Kickback~~cash ~~Statute,~~dividends ~~which~~on ~~prohibits,~~our ~~among~~shares ~~other~~of ~~things,~~common ~~any~~stock ~~person~~to ~~from~~date. ~~knowingly~~The ~~and~~payment ~~willfully~~of ~~offering,~~cash ~~soliciting,~~dividends ~~receiving~~on orour ~~providing~~common ~~remuneration,~~stock ~~directly or indirectly,~~ in ~~exchange~~the ~~for~~future orwill tobe ~~induce~~dependent ~~either~~upon ~~the~~our ~~referral~~revenues ofand ~~an individual for~~earnings, orif ~~the purchase~~any, ~~order~~capital orrequirements ~~recommendation~~and ~~of,~~general ~~any~~financial ~~good~~condition orand ~~service~~will ~~for which payment may~~ be ~~made~~within ~~under federal healthcare programs, such as~~ the ~~Medicare~~discretion ~~and~~of ~~Medicaid~~our ~~programs;~~Board ●of ~~the U~~Directors.S. ~~Foreign~~It ~~Corrupt~~is ~~Practices Act, or FCPA, which prohibits payments or~~ the ~~provision~~present ofintention ~~anything~~ of ~~value~~our toBoard ~~foreign officials for the purpose~~ of ~~obtaining~~Directors ~~or keeping business; ● the federal False Claims Act, or FCA, which prohibits, among other things, individuals or entities from knowingly presenting, or causing~~ to beretain ~~presented,~~all ~~false claims~~earnings, orif ~~knowingly using false statements~~any, tofor ~~obtain~~use ~~payment~~in ~~from~~our ~~the~~business ~~federal~~operations ~~government,~~ and which may apply to entities like us which provide coding and billing advice to customers; ● federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● the federal transparency requirements under the Health Care Reform Law requires manufacturers of drugs, ~~devices~~accordingly, ~~biologics~~our ~~and~~Board ~~medical supplies to report to the Department~~ of ~~Health~~Directors ~~and~~does ~~Human~~not ~~Services~~anticipate ~~information~~declaring ~~related~~any todividends ~~physician~~on ~~payments~~our ~~and~~common ~~other~~stock ~~transfers~~in ~~of value and physician ownership and investment interests; ●~~ the ~~federal~~foreseeable ~~Health~~future. ~~Insurance~~As ~~Portability~~a ~~and Accountability Act of 1996~~result, asany ~~amended~~gain byyou ~~the~~will ~~Health~~realize ~~Information~~on ~~Technology~~our ~~for~~common ~~Economic~~stock ~~and~~(including ~~Clinical~~common ~~Health~~stock ~~Act,~~obtained ~~which~~upon ~~governs~~exercise ~~the conduct~~ of ~~certain~~our ~~electronic~~warrants) ~~healthcare~~will ~~transactions~~result ~~and~~solely ~~protects~~from the ~~security~~appreciation ~~and privacy~~ of ~~protected health information; and ● state law equivalents of each of the above federal laws,~~ such ~~as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers~~shares.

~~If our~~We ~~operations~~have ~~are~~made ~~found~~distributions ~~to be in violation~~ of ~~any~~shares of ~~the~~Lucid ~~laws~~common ~~described~~stock ~~above or any other governmental regulations that apply~~ to ~~us, we~~our ~~may~~shareholders bein ~~subject to penalties, including civil and criminal penalties, damages, fines and~~ the ~~curtailment or restructuring of our operations. Any penalties~~past, ~~damages,~~but ~~fines,~~there ~~curtailment~~is orno ~~restructuring~~assurance ~~of our operations could adversely affect our ability to operate our business and our financial results. Any action against us for violation of these laws, even if~~ we ~~successfully~~will ~~defend~~do ~~against~~so ~~it,~~in ~~could cause us to incur significant legal expenses and divert our management’s attention from~~ the ~~operation of our business~~future. ~~Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.~~

34On February 15, 2024, the Company distributed by special dividend to the Company stockholders 3,331,747 shares of Lucid Diagnostics common stock held by the Company. On such date, each PAVmed shareholder as of the January 15, 2024 record date received a stock dividend of approximately 38 shares of Lucid common stock for approximately every 3 shares of PAVmed common stock they held as of such date. However, our Board of Directors has no intention to make any further distributions of shares of Lucid common stock or other assets at this time.

~~The Company’s~~We ~~medical~~are ~~products~~subject ~~may~~to inevolving ~~the~~corporate ~~future~~governance beand ~~subject~~public todisclosure ~~product~~expectations ~~recalls~~and regulations that ~~could~~impact ~~harm~~compliance ~~its~~costs ~~reputation,~~and ~~business~~risks ~~and~~of ~~financial results~~noncompliance.

~~The FDA~~We ~~has~~are ~~the~~subject ~~authority~~ to ~~require~~changing ~~the~~rules ~~recall~~and ofregulations ~~commercialized~~promulgated ~~medical~~by ~~device~~a ~~products~~number ~~in the event~~ of ~~material~~governmental ~~deficiencies~~and orself-regulatory ~~defects in design or manufacture. In the case of the FDA~~organizations, ~~the~~including ~~authority to require a recall must be based on an FDA finding that there is a reasonable probability that~~ the ~~device~~SEC ~~would~~and ~~cause serious injury or death. Manufacturers may~~Nasdaq, ~~under~~as ~~their~~well ~~own initiative, recall a product if any material deficiency in a device is found. A government-mandated or voluntary recall by the Company or one of its distributors could occur~~ as aevolving ~~result~~investor ofexpectations ~~component~~around ~~failures,~~corporate ~~manufacturing~~governance ~~errors,~~and ~~design~~environmental orand ~~labeling~~social ~~defects~~practices ~~or other deficiencies~~ and ~~issues~~disclosures. ~~Recalls~~These ofrules ~~any of~~and ~~the~~regulations ~~Company’s~~continue ~~products~~to ~~would~~evolve ~~divert~~in ~~managerial~~scope and ~~financial~~complexity, ~~resources~~ and ~~have~~many annew ~~adverse~~requirements ~~effect~~have onbeen ~~its~~created ~~financial~~in ~~condition and~~response ~~results of operations. The FDA requires that certain classifications of recalls be reported~~ to ~~the~~laws ~~FDA~~enacted ~~within~~by ~~ten (10) working days after~~ the ~~recall is initiated~~U.S. ~~Companies~~and ~~are~~foreign ~~required to maintain certain records of recalls~~governments, ~~even~~making ifcompliance ~~they~~more ~~are~~difficult ~~not~~and ~~reportable to the FDA~~uncertain. The ~~Company~~increase ~~may initiate voluntary recalls involving its products~~ in ~~the~~costs ~~future~~to ~~that~~comply ~~the Company determines do not require notification of the FDA. If the FDA disagrees~~ with ~~the~~such ~~Company’s~~evolving ~~determinations~~expectations, ~~they~~rules ~~could~~and ~~require~~regulations, ~~the~~as ~~Company~~well ~~to report those actions~~ as ~~recalls. A~~any ~~future~~risk ~~recall~~of ~~announcement could harm the Company’s reputation with customers and negatively affect its sales. In addition~~noncompliance, ~~the FDA~~ could ~~take~~adversely ~~enforcement~~impact ~~action for failing to report the recalls when they were conducted~~us. ~~No recalls of the Company’s medical products that we are seeking to commercialize have been reported to the FDA.~~

If the Company’s medical products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.45

~~Under the~~We ~~FDA~~incur ~~medical~~significant ~~device~~costs ~~reporting~~as ~~regulations, medical device manufacturers are required to report to the FDA information that~~ a ~~device has~~result ~~or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury if the malfunction~~ of ~~the device or one of~~ our ~~similar~~and ~~devices~~Lucid ~~were~~Diagnostics tooperating recur. If the Company fails to report these events to the FDA within the required timeframes, or at all, the FDA could take enforcement action against the Company. Any such adverse event involving its products also could result in future voluntary corrective actions, such as ~~recalls~~a orpublic ~~customer notifications~~company, or ~~agency~~and ~~action,~~our ~~such~~management ~~as inspection or enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit,~~ will ~~require~~be ~~the~~required ~~dedication~~to ofdevote ~~the~~substantial ~~Company’s~~ time ~~and~~to ~~capital,~~compliance ~~distract management from operating our business, and may harm its reputation and financial results~~initiatives.

~~If the~~As ~~Company~~a public company, with a majority-owned subsidiary that is ~~found~~also a public company, we incur significant legal, accounting and other expenses. We are subject to bethe ~~promoting~~reporting requirements of the ~~use~~Exchange Act, the other rules and regulations of ~~its~~the ~~devices~~Securities ~~for~~and ~~unapproved~~Exchange Commission, or ~~“off-label”~~SEC, ~~uses~~and orthe ~~engaging~~rules inand regulations of Nasdaq or any other ~~noncompliant activities,~~national securities exchange on which our securities are then trading. Compliance with the ~~Company~~various ~~may~~reporting beand ~~subject~~other requirements applicable to ~~recalls,~~public ~~seizures,~~companies ~~fines,~~requires ~~penalties,~~considerable ~~injunctions,~~time ~~adverse~~and ~~publicity~~attention of management. For example, ~~prosecution~~the Sarbanes-Oxley Act and the rules of the SEC and Nasdaq have imposed various requirements on public companies, orincluding requiring establishment and maintenance of effective disclosure and financial controls. Our management and other ~~adverse~~ ~~actions,~~personnel ~~resulting~~devote ina ~~damage~~substantial amount of time to ~~its~~these ~~reputation~~compliance initiatives. These rules and ~~business~~regulations result in significant legal and financial compliance costs and make some activities more time-consuming and costlier.

The ~~Company’s~~ ~~labeling,~~Sarbanes-Oxley ~~advertising~~Act requires, ~~promotional~~among ~~materials~~other ~~and~~things, ~~user~~that ~~training~~we ~~materials~~maintain ~~must~~effective ~~comply~~internal ~~with~~control ~~the~~over ~~FDA~~financial reporting and ~~other~~disclosure ~~applicable laws~~controls and ~~regulations~~procedures. In particular, ~~including~~we ~~the~~must ~~prohibition~~perform ofsystem ~~the~~and ~~promotion~~process ofevaluation aand ~~medical~~testing ~~device~~of ~~for~~our ainternal ~~use~~control ~~that~~over ~~has~~financial ~~not~~reporting ~~been~~to ~~cleared~~allow ormanagement ~~approved by~~to report on the ~~FDA.~~effectiveness ~~Obtaining~~of ~~510(k)~~our ~~clearance~~internal orcontrol ~~PMA~~over ~~approval~~financial ~~only~~reporting, ~~permits~~as required by Section 404 of the ~~Company~~Sarbanes-Oxley toAct. ~~promote~~In ~~its~~addition, ~~products~~we ~~for~~will ~~the~~be ~~uses~~required ~~specifically~~to ~~cleared by~~have ~~the~~our ~~FDA.~~independent ~~Use~~registered ofpublic aaccounting ~~device~~firm ~~outside~~attest ~~its~~to ~~cleared~~the oreffectiveness ~~approved~~of ~~indications~~our isinternal ~~known~~control asover ~~“off-label”~~financial ~~use.~~reporting ~~Physicians~~beginning ~~and~~with ~~consumers may~~our ~~use~~annual ~~the~~report ~~Company’s~~on ~~products~~Form ~~off~~10-~~label~~K ~~because~~following the ~~FDA~~date ~~does~~on ~~not~~which ~~restrict~~we orare ~~regulate~~no longer a ~~physician’s~~smaller ~~choice~~reporting ofcompany. ~~treatment within~~Our ~~the~~compliance ~~practice~~with Section 404 of ~~medicine~~the ~~nor~~Sarbanes-Oxley isAct ~~there~~requires ~~oversight~~that onwe ~~patient~~incur ~~use~~substantial ofaccounting ~~over-the-counter~~expense ~~devices~~and expend significant management efforts. ~~Although~~We ~~the~~currently ~~Company~~do ~~may~~not ~~request~~have ~~additional cleared~~an ~~indications~~internal ~~for~~audit group, and as our ~~current~~business ~~products~~expands, ~~the~~we ~~FDA~~will ~~may~~need ~~deny~~to ~~those~~hire ~~requests,~~additional ~~require~~accounting ~~additional~~and ~~expensive~~financial ~~clinical~~staff ~~data~~with toappropriate ~~support any~~public ~~additional~~company ~~indications~~experience orand ~~impose~~technical ~~limitations~~accounting onknowledge. ~~the~~If ~~intended~~we ~~use~~are ofnot ~~any~~able ~~cleared~~to ~~product~~comply aswith athe ~~condition~~requirements of ~~clearance.~~Section ~~Even~~404 in a timely manner, or if ~~regulatory clearance~~we or ~~approval~~our ofindependent aregistered ~~product~~public isaccounting ~~granted,~~firm ~~such~~identify ~~clearance~~deficiencies orin ~~approval~~our ~~may~~internal becontrol ~~subject~~over tofinancial ~~limitations~~reporting onthat ~~the~~are ~~intended~~deemed ~~uses~~to ~~for~~be ~~which~~ material weaknesses, the ~~product~~market ~~may~~price beof ~~marketed~~our stock could decline and ~~reduce~~we ~~our~~could ~~potential~~be subject to ~~successfully~~sanctions ~~commercialize~~or investigations by the ~~product~~SEC ~~and~~or ~~generate~~other ~~revenue~~regulatory ~~from~~authorities, ~~the~~which ~~product~~would require additional financial and management resources.

~~If the~~Our ~~FDA~~ability ~~determines~~to ~~that~~successfully ~~the~~implement ~~Company’s~~our ~~labeling,~~business ~~advertising,~~plan ~~promotional~~and ~~materials,~~comply orwith ~~user~~Section ~~training~~404 ~~materials,~~requires orus ~~representations made~~to bybe ~~Company~~able ~~personnel,~~to ~~include~~prepare ~~the~~timely ~~promotion~~and ofaccurate anfinancial ~~off-label~~statements. ~~use~~We ~~for~~expect ~~the device, or~~ that ~~the~~we ~~Company~~will ~~has~~need ~~made~~to ~~false~~continue orto ~~misleading or~~improve ~~inadequately substantiated promotional claims~~existing, orand ~~claims~~implement ~~that~~new ~~could~~operational ~~potentially change the regulatory status of the product, the agency could take the position that these materials have misbranded the Company’s devices~~ and ~~request~~financial ~~that the Company modifies its labeling~~systems, ~~advertising,~~ orprocedures ~~user training or promotional materials~~ and~~/or~~ ~~subject~~controls ~~the~~to ~~Company~~manage toour ~~regulatory~~business oreffectively. ~~legal~~Any ~~enforcement~~delay ~~actions,~~in ~~including~~ the ~~issuance~~implementation of ~~an Untitled Letter or a Warning Letter~~, ~~injunction, seizure, recall, adverse publicity, civil penalties, criminal penalties,~~ or ~~other~~disruption ~~adverse~~in ~~actions. It is also possible that other federal, state, or foreign enforcement authorities might take action if they consider~~ the ~~Company’s~~transition ~~labeling~~to, ~~advertising,~~new ~~promotional,~~ or ~~user~~enhanced ~~training materials to constitute promotion of an unapproved use~~systems, ~~which~~procedures ~~could result in significant fines, penalties,~~ or ~~other adverse actions under other statutory authorities~~controls, ~~such~~may ascause ~~laws~~our ~~prohibiting false~~operations ~~claims for reimbursement. In that event, we would be subject~~ to ~~extensive~~suffer ~~fines~~ and ~~penalties~~we ~~and~~may ~~the Company’s reputation could~~ be ~~damaged~~unable ~~and adoption of the products would be impaired. Although the Company intends~~ to ~~refrain~~conclude ~~from statements~~ that ~~could~~our ~~be considered~~internal ~~off-label~~control ~~promotion~~over offinancial ~~its~~reporting ~~products,~~is ~~the~~effective ~~FDA or another regulatory agency could disagree~~ and ~~conclude~~to ~~that~~obtain ~~the~~an ~~Company~~unqualified ~~has engaged~~report inon ~~off-label~~internal ~~promotion.~~controls ~~For~~from ~~example,~~our ~~the~~auditors ~~Company~~if ~~has~~required ~~made~~under ~~statements~~Section ~~regarding~~404 ~~some~~ of ~~its devices that~~ the ~~FDA may view as off~~Sarbanes-~~label promotion~~Oxley Act. ~~In addition~~This, ~~any such off-label use of the Company’s products may increase the risk of injury to patients, and,~~ in turn, ~~the~~ ~~risk~~could ofhave ~~product~~an ~~liability~~adverse ~~claims,~~impact ~~and~~on ~~such~~trading ~~claims~~prices ~~are~~for ~~expensive~~our tocommon ~~defend~~stock, and could ~~divert~~adversely ~~the~~affect ~~Company’s~~our ~~management’s attention~~ability ~~and~~to ~~result~~access ~~in substantial damage awards against~~ the ~~Company~~capital markets.

35Under our management services agreement with Lucid Diagnostics, many of our personnel and other resources are devoted to ensuring Lucid Diagnostics complies with the above requirements applicable to public companies. This further exhausts management and other personnel resources that could be used for other revenue-generating activities.

~~Risks Associated with Ownership of Our Common Stock~~46

~~We may~~If ~~issue~~we ~~shares~~experience ofmaterial weaknesses in our ~~common~~internal ~~and~~control ~~/or~~over ~~preferred~~financial ~~stock~~reporting in the future, ~~which could reduce the equity interest of~~ our ~~stockholders~~business ~~and~~may ~~might cause~~be ~~a change in control of our ownership~~harmed.

Our ~~certificate~~ ofmanagement ~~incorporation~~is ~~authorizes~~responsible ~~the~~for ~~issuance~~establishing ofand upmaintaining toadequate ~~250,000,000~~internal ~~shares~~control ofover ~~common~~financial ~~stock,~~reporting ~~par~~and ~~value~~for ~~$.001~~evaluating ~~per~~and ~~share,~~reporting ~~and~~on ~~20,000,000 shares~~the effectiveness of ~~preferred~~our ~~stock,~~system ~~par~~of ~~value~~internal $control.~~001~~ ~~per~~Our ~~share.~~internal Wecontrol ~~may~~over ~~issue~~financial reporting is a ~~substantial~~process ~~number~~designed to provide reasonable assurance regarding the reliability of ~~additional~~financial ~~shares~~reporting and the preparation of ~~our~~financial ~~common~~statements ~~stock~~for orexternal ~~preferred stock,~~reporting orpurposes ain ~~combination~~accordance ofwith ~~common~~U.S. ~~and~~GAAP. ~~preferred~~As ~~stock~~a public company, we are required to ~~raise~~comply ~~additional~~with ~~funds~~the orSarbanes-Oxley inAct ~~connection~~and ~~with~~other ~~any~~rules ~~strategic~~that ~~acquisition~~govern public companies. ~~The issuance~~In ofparticular, ~~additional~~we ~~shares~~are ofrequired ~~our~~to ~~common~~certify ~~stock~~our orcompliance ~~any~~with ~~number~~Section 404 of ~~shares~~the Sarbanes-Oxley Act, which requires us to furnish annually a report by management on the effectiveness of our ~~preferred~~internal ~~stock:~~control over financial reporting.

●Although ~~may~~our ~~significantly~~management ~~reduce~~determined ~~the~~that ~~equity~~our ~~interest~~internal control over financial reporting was effective as of ~~investors;~~December ●31, 2025, we may ~~subordinate~~experience material weaknesses in our internal control over financial reporting in the ~~rights~~future. ofAny ~~holders~~necessary ofremediation ~~common~~efforts ~~stock~~would ifplace ~~preferred~~a ~~stock~~significant isburden ~~issued~~on ~~with~~management ~~rights~~and ~~senior~~add increased pressure to ~~those~~our ~~afforded~~financial resources and processes. If we were are unable to successfully remediate any material weaknesses in our ~~common~~internal ~~stockholders;~~control ●over ~~may~~financial ~~cause~~reporting athat ~~change~~may be identified in ~~control~~the iffuture in a ~~substantial~~timely ~~number~~manner, the accuracy and timing of our ~~shares~~financial ofreporting ~~common~~may ~~stock~~be ~~are~~adversely ~~issued~~affected; our liquidity, ~~which~~our ~~may~~access ~~affect~~to capital markets, ~~among~~the ~~other~~perceptions ~~things,~~of our ~~ability~~creditworthiness tomay ~~use~~be ~~our~~adversely ~~net~~affected; ~~operating~~we ~~loss~~may ~~carryforwards,~~be ifunable ~~any,~~to ~~and~~maintain ~~most~~or ~~likely~~regain ~~also~~compliance ~~result~~with inapplicable ~~the~~securities ~~resignation~~laws, orthe ~~removal~~listing requirements of ~~some~~the orNasdaq ~~all~~Stock ofMarket; ~~our~~we ~~present~~may ~~officers~~be ~~and~~subject ~~directors;~~to regulatory investigations and ●penalties; investors may ~~adversely~~lose

Filing Compare · PAVmed Inc.