UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-K

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

For the fiscal year ended December 31, ~~2021~~2022

☐ 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: 000-54586

NANOMIX CORPORATION

(Exact name of registrant as specified in its charter)

Delaware		27-0801073
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

2121 Williams Street San Leandro, CA		94577
(Address of principal executive offices)		(Zip Code)

(510) 428-5300

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act: None

Securities registered pursuant to Section 12(g) of the Act: Common Stock, par value $0.001 per share

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 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 every 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 filer	☐
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(a) 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 Act). Yes ☐ No ☒

The aggregate market value of the ~~registrant’s~~voting and non-voting common ~~stock~~equity held by non-affiliates of the registrant ~~was~~on ~~approximately~~June ~~$58.3~~30, ~~million~~2022, onthe ~~June~~last business day 30of the registrant’s most recently completed second fiscal quarter, ~~2021~~was approximately $28.8 million based on the closing price ~~for~~ of the registrant’s common stock on ~~the~~OTCQB ~~Pink Open Market~~ on ~~June~~that ~~30, 2021~~date.

As of April 126, ~~2022~~2023, a total of 46 48,~~203~~996,~~866~~763 shares of common stock, par value $0.001 per share, were issued and outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

None.

TABLE OF CONTENTS

		Page
PART I		1
Item 1.	Business	1
Item 1A.	Risk Factors	10
Item 1B.	Unresolved Staff Comments	4740
Item 2.	Properties	4740
Item 3.	Legal Proceedings	4740
Item 4.	Mine Safety Disclosures	4740
PART II		48
Item 5.	Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	4841
Item 6.	[Reserved]	4842
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	4942
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	5547
Item 8.	Financial Statements and Supplementary Data	5547
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	5647
Item 9A.	Controls and Procedures	5647
Item 9B.	Other Information	5748
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	5748
PART III		58
Item 10.	Directors, Executive Officers and Corporate Governance	5849
Item 11.	Executive Compensation
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	6354
Item 13.	Certain Relationships and Related Transactions, and Director Independence	6556
Item 14.	Principal Accounting Fees and Services	6656
PART IV		67
Item 15.	Exhibits, Financial Statement Schedules	6757
Item 16.	Form 10-K Summary	7061

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain statements contained in this Annual Report on Form 10-K, which reflect our current views with respect to future events and financial performance, and any other statements of a future or forward-looking nature, constitute “forward-looking statements” for the purpose of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section titled “Risk Factors”. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements.

Any forward-looking statement in this Annual Report on Form 10-K reflects our current view with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our business, results of operations, industry and future growth. Given these uncertainties, you should not place undue reliance on these forward-looking statements. No forward-looking statement is a guarantee of future performance. You should read this Annual Report on Form 10-K and the documents that we reference herein and therein and have filed as exhibits hereto and thereto completely and with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

This Annual Report on Form 10-K also contain or may contain estimates, projections and other information concerning our industry, our business and the markets for our products, including data regarding the estimated size of those markets and their projected growth rates. We obtained the industry and market data in this prospectus from our own research as well as from industry and general publications, surveys and studies conducted by third parties. This data involves a number of assumptions and limitations and contains projections and estimates of the future performance of the industries in which we operate that are subject to a high degree of uncertainty, including those discussed in “Risk Factors.” We caution you not to give undue weight to such projections, assumptions and estimates. Further, industry and general publications, studies and surveys generally state that they have been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe that these publications, studies and surveys are reliable, we have not independently verified the data contained in them. In addition, while we believe that the results and estimates from our internal research are reliable, such results and estimates have not been verified by any independent source.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements as predictions of future results. Our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

Throughout this report the terms “Nanomix,” “we,” “our” or “us,” refer to Nanomix Corporation and its subsidiaries on a consolidated basis, unless stated or the context implies otherwise.

RISK FACTOR SUMMARY

Our business is subject to significant risks and uncertainties that make an investment in us speculative and risky. Below we summarize what we believe are the principal risk factors but these risks are not the only ones we face, and you should carefully review and consider the full discussion of our risk factors in the section titled “Risk Factors,” together with the other information in this Annual Report on Form 10-K. If any of the following risks actually occurs (or if any of those listed elsewhere in this Annual Report on Form 10-K occur), our business, reputation, financial condition, results of operations, revenue, and future prospects could be seriously harmed. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business. These risks include, among others:

●

We have incurred significant losses since inception and expect to incur losses in the future. We cannot be certain that we will achieve or sustain profitability.

●

Our financial situation creates doubt whether we will continue as a going concern.

●

We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.

●

Our obligations to the holders of our Notes are secured by a security interest in substantially all of our assets. We are currently in default on the Notes and as a result, the note holders could foreclose on our assets.

●

Our obligations under the Notes are secured by a security interest in substantially all of our assets. We are currently in default on the Notes and, as a result, , the holders of the notes, acting through their appointed agent, could foreclose on their security interests and liquidate some or all of these assets, which would harm our business, financial condition and results of operations and could require us to curtail or cease operations.

●

If we cannot successfully develop, maintain, commercialize, or obtain regulatory approvals for new and existing diagnostic assays, our financial results will be harmed and our ability to compete will be harmed.

●

We are subject to many laws and governmental regulations and any adverse regulatory action may materially adversely affect our financial condition and business operations.

●

Disruptions at the FDA and other government agencies caused by funding shortages, or other agency policy concerns could shift their priorities or hinder their ability to hire, retain or deploy key leadership and other personnel. This could result in delays or may prevent new or modified products from being developed, cleared, approved, authorized, or commercialized in a timely manner or at all, which could negatively impact our business.

●

Our diagnostic products have not been manufactured in significant volume and are subject to unforeseen scale-up risks.

●

We utilize third-party, single-source suppliers for some components and materials used in our products and product candidates, and the loss of any of these suppliers could have an adverse impact on our business.

●

Our products may not be able to compete with new diagnostic products or existing products developed by well-established competitors, which would negatively affect our business.

●

If we are unable to recruit, train and retain key personnel, we may not achieve our goals.

●

New technologies, techniques or assays could emerge that might offer better combinations of price and performance than our current or future assays.

●

We have limited experience in marketing and selling our products, and if we are unable to expand, manage and maintain our direct sales and marketing organizations, or otherwise commercialize our products, our business may be adversely affected.

●

We have a limited operating history and may face difficulties encountered by companies early in their commercialization in competitive and rapidly evolving markets.

●

We have limited commercial scale capabilities. If we are unable to successfully implement commercial capabilities and manage our growth, our business will be harmed.

●

Customers may not adopt our products quickly, or at all.

●

There has been a limited public market for our common stock, and we do not know whether one will develop to provide you adequate liquidity. Furthermore, the trading price for our common stock, should an active trading market develop, may be volatile and could be subject to wide fluctuations in per-share price.

iii

PART I

ITEM 1. BUSINESS.

Overview

On June 6, 2021, ~~Boston Therapeutics and~~ Nanomix, Inc., or Nanomix, and Boston Therapeutics completed a reverse merger, or the Merger, resulting in the formation of Nanomix Corporation (the “Company”).. As consideration for the Merger, ~~The Company issued to~~ the shareholders of Nanomix, Inc. received 1,000,000 shares of ~~a newly created~~ Series C Convertible Preferred Stock of the Company (the “Preferred Stock”). On March 2, 2022 upon completion of a previously approved 173:1 reverse stock split, all such shares of Preferred Stock issued to Nanomix, Inc. shareholders automatically converted into approximately 35,644,997 shares of common stock of the Company, the warrants assumed at closing may be exercisable into approximately 2,124,687 shares of common stock of the Company and the options ~~and restricted stock units~~ assumed at closing may be exercisable into approximately 5,718,838 shares of common stock of the Company. The shares of common stock issued upon conversion of the Preferred Stock together with warrants, restricted stock units and options assumed on the closing date ~~represent~~represented approximately 80% of the outstanding shares of Common Stock of the Company upon closing of the Merger. After the merger, the Company changed its name to Nanomix Corporation and its ticker symbol to NNMX. ~~A previously approved 173:1 reverse stock split was effective on March 2, 2022.~~

~~After the~~Our ~~Merger, our~~ primary focus is on the development and commercialization of Nanomix’s advanced mobile Point-of-Care, or POC, diagnostic system that can be used in performing a wide range of in vitro diagnostic tests in many environments. Nanomix’s goal is to provide laboratory quality testing for time sensitive medical conditions, at the first point of contact that a patient has with the healthcare system, no matter where that occurs. The Nanomix eLab® system isand the initial two assays are CE Marked, and a 510(k) application is currently in development~~, and Emergency Use Application (EUA) for COVID antigen testing has been submitted to the FDA~~. Nanomix intends to market and sell this system for the detection and diagnosis of a variety of time sensitive medical conditions. Nanomix ceased all operations of the predecessor company.

~~Prior~~Nanomix toeLab the Merger, we were a pre-clinical and clinical-stage pharmaceutical development company focused on the clinical development, outsourced contract manufacture and test marketing for commercialization of carbohydrate-based patented formulation of investigative materials as medical food, supplements, drug and drug combination, and other clinical exploratory outsourced exploratory peptide therapeutic options. Due to limited funding and the merger, our activity including any drug development during year ended December 31, 2021 was severely limited. Following the closing of the Merger, the Company intends to conduct a comprehensive review of strategic alternatives for our legacy products and product candidates pertaining to the commercialization of our therapeutic drugs including SUGARDOWN®, BTI-320 and IPOXYN. The Company does not expect to receive any form of material consideration in connection with such alternatives. In the event it is not able to dispose of these assets, the Company expects to cease all operations in connection therewith in order to avoid incurring any further associated expense.System

Nanomix believes that quality healthcare should ~~eLab~~be ~~System~~available to consumers anywhere and anytime. The foundation of quality healthcare is timely information supporting a proper diagnosis and associated treatment. Our vision is to make healthcare accessible to patients without compromise, by delivering the highest quality, fastest, most cost-effective and portable detection systems that bring the patient and caregiver closer together.

The Nanomix ~~believes~~ ~~that~~eLab ~~quality~~System ~~healthcare~~is ~~should~~a beproprietary ~~available~~diagnostic platform developed by Nanomix to ~~consumers~~meet ~~anywhere~~the ~~and~~growing ~~anytime.~~need ~~The~~for ~~foundation~~decentralized ofmedical ~~quality~~diagnostic ~~healthcare~~solutions. The platform is ~~timely~~designed to provide ~~information~~rapid ~~supporting~~test results in a ~~proper~~handheld ~~diagnosis~~device ~~and~~at ~~associated~~the ~~treatment.~~first ~~Our~~point ~~vision~~of ispatient tocontact ~~make~~in ~~healthcare~~locations ~~accessible~~that torange ~~patients~~from ~~without~~Emergency ~~compromise~~Departments, to long byterm ~~delivering~~and ~~the~~assisted ~~highest~~care ~~quality~~facilities, ~~fastest,~~to ~~most~~urgent ~~cost-effective~~care and ~~portable~~emergency ~~detection~~medical ~~systems~~response ~~that~~settings. ~~bring~~The ~~the~~eLab ~~patient~~System ~~and~~may ~~caregiver~~also ~~closer~~be used as a research-use-only ~~together~~device by certain CLIA approved laboratories after internal evaluations.

The Nanomix eLab ~~System~~system is a ~~proprietary~~rapid, ~~diagnostic~~easy-to-use, quantitative detection platform ~~developed~~that byperforms ~~Nanomix~~a torange ~~meet~~of ~~the~~in ~~growing~~vitro ~~need~~diagnostic ~~for~~assays, ~~decentralized~~such ~~medical~~as ~~diagnostic~~electrochemical immunoassay and enzymatic ~~solutions~~assays. The platform isconsists ~~designed~~of a hand-held analyzer and a disposable cartridge. The eLab System utilizes a proprietary nano-biosensor with multiple detection electrodes to ~~provide~~generate ~~rapid~~multiple ~~test~~electrochemical assay results infrom a ~~handheld~~single ~~device~~patient atsample. ~~the~~Specificity ~~first~~is ~~point~~generated by functionalizing each of ~~patient~~the ~~contact~~electrodes inon ~~locations that~~the ~~range~~sensor ~~from~~for ~~Emergency~~particular ~~Departments,~~biomarkers. toThe ~~long~~sensor ~~term~~is ~~and~~incorporated ~~assisted~~into ~~care~~a ~~facilities,~~single-use toconsumable microfluidics ~~urgent~~cartridge ~~care~~that processes the biological sample and ~~emergency~~reports ~~medical~~its ~~response~~results ~~settings~~through the handheld eLab System.

1The eLab system is designed to be operated by medical and non-medically trained persons. An assay is run by inserting the cartridge into the eLab Analyzer. Following the prompts on the Analyzer interface, the user identifies the subject, scans a barcode on the consumable package, loads the test sample into the cartridge, and presses start. Assay results generally take between 10 and 15 minutes, from sample collection to answer. A wide variety of biomolecules with varying chemistries can be tested on a single device in one operation. The electrochemical detection system eliminates the need for ongoing instrument calibration and maintenance commonly associated with optical systems. Wireless connectivity provides for transmission of patient results to other devices for data sharing, management, and EMR integration.

~~The Nanomix~~Compared ~~eLab~~with ~~system~~other isPOC atesting ~~rapid~~systems, ~~easy-to-use,~~the ~~quantitative~~Nanomix eLab ~~detection~~system ~~platform~~provides ~~that~~testing ~~performs a range of~~ in ~~vitro~~traditional ~~diagnostic~~laboratories ~~assays, such~~ as ~~electrochemical~~well ~~immunoassay~~as ~~and enzymatic assays. The platform consists of a hand~~non-~~held~~traditional ~~analyzer~~decentralized ~~and~~environments awith ~~disposable~~enhanced ~~cartridge. The eLab~~sensitivity ~~System~~and ~~utilizes~~specificity, aadvanced ~~proprietary~~multiplexing ~~nano-biosensor~~and ~~with~~multimodal ~~multiple~~capabilities, ~~detection~~quantitative ~~electrodes~~results, toBluetooth ~~generate~~communication ~~multiple~~of ~~electrochemical~~results ~~assay~~and ~~results~~an ~~from~~on aboard ~~single~~electronic ~~patient~~data ~~sample.~~base ~~Specificity is generated by functionalizing each~~ of ~~the~~testing ~~electrodes~~activities. onThe ~~the~~Nanomix ~~sensor~~eLab® ~~for~~system ~~particular biomarkers. The sensor~~ is ~~incorporated~~CE ~~into~~Marked, a ~~single-use~~510(k) ~~consumable~~is ~~microfluidics~~currently ~~cartridge~~in ~~that~~development, ~~processes~~and a ~~the~~COVID-19 ~~biological~~Antigen ~~sample~~test ~~and~~has ~~reports~~been ~~its results~~submitted ~~through~~to the ~~handheld~~FDA ~~eLab~~for ~~System~~Emergency Use Authorization.

~~The eLab~~Our ~~system~~strategy is ~~designed~~ to bedevelop ~~operated~~a bymenu ~~medical~~of ~~and non-medically trained persons. An assay is run by inserting the cartridge into~~diagnostic ~~the~~tests ~~eLab~~for ~~Analyzer. Following~~ the ~~prompts~~detection onand ~~the~~diagnosis ~~Analyzer~~of ~~interface,~~time ~~the~~sensitive ~~user~~medical ~~identifies~~conditions ~~the subject, scans a barcode~~ on the ~~consumable package,~~Nanomix ~~loads~~eLab ~~the~~Analyzer ~~test~~and ~~sample~~to ~~into the cartridge~~sell, ~~and~~market ~~presses start. Assay results generally take between 10~~ and ~~15 minutes, from sample~~distribute ~~collection to answer. A wide variety of biomolecules with varying chemistries can be tested on a single device in one operation. The electrochemical detection system eliminates~~ the ~~need~~eLab ~~for~~Analyzer ~~ongoing instrument calibration~~ and ~~maintenance commonly~~ associated ~~with~~tests ~~optical systems.~~on ~~Wireless~~a ~~connectivity~~worldwide ~~provides for transmission of patient results to other devices for data sharing, management, and EMR integration~~basis.

Compared with other POC testing systems, the Nanomix eLab system provides testing in traditional laboratories as well as non-traditional decentralized environments with enhanced sensitivity and specificity, advanced multiplexing and multimodal capabilities, quantitative results, Bluetooth communication of results and an on board electronic data base of testing activities. The Nanomix eLab® system is CE Marked, a 510(k) is currently in development, and a COVID-19 Antigen test has been submitted to the FDA for Emergency Use Authorization.1

Our strategy is to develop a menu of diagnostic tests for the detection and diagnosis of time sensitive medical conditions on the Nanomix eLab Analyzer and to sell, market and distribute the eLab Analyzer and associated tests on a worldwide basis.Products

~~Products~~The Nanomix eLab is an in vitro diagnostic test platform for the quantitative determination of analytes in biological samples that include plasma, whole blood, and nasal swab specimens. The eLab system consists of a handheld analyzer, a sample transfer device and a disposable cartridge. The Nanomix eLab is a platform technology and Nanomix intends to develop a range of test cartridges compatible with Nanomix eLab analyzer. The key advantages of our approach are:

~~The Nanomix~~● ~~eLab~~Laboratory isquality an in vitro diagnostic test platform for the quantitative determination of analytes in biological samples that include plasma, whole blood, and nasal swab specimens. The eLab system consists of a handheld analyzer, a sample transfer device and a disposable cartridge. The Nanomix eLab is a platform technology and Nanomix intends to develop a range of test cartridges compatible with Nanomix eLab analyzer. The key advantages of our approach are:results;

● ~~Laboratory~~Multiplexing ~~quality~~and ~~results~~multimodal testing;

● ~~Multiplexing~~Quantitative ~~and~~determination ~~multimodal~~of ~~testing~~test results;

● ~~Quantitative~~Operates ~~determination~~in ofdistributed ~~test results~~environments; and

● ~~Operates~~Electronic inrecord ~~distributed~~storage ~~environments;~~with ~~and~~Bluetooth communication of results.

●The ~~Electronic~~eLab ~~record~~has ~~storage~~been ~~with~~shown ~~Bluetooth~~to ~~communication~~be ofeasily ~~results~~operated by non-medically trained personnel. The platform performs immunoassays and enzymatic assays. All tests run on the eLab Analyzer utilize the same disposable cartridge format.

~~The~~Nanomix’s first product, the S1 Panel Assay ~~eLab~~for ~~has~~use ~~been~~in ~~shown~~aiding tothe bediagnosis ~~easily~~of ~~operated~~critical byinfections, ~~non-medically~~received ~~trained~~CE ~~personnel.~~marking ~~The~~for ~~platform~~the ~~performs~~eLab ~~immunoassays~~Analyzer and ~~enzymatic~~the ~~assays.~~assay using plasma samples in ~~All~~November ~~tests~~of ~~run~~2019. onCE marking of the ~~eLab~~assay ~~Analyzer~~using ~~utilize~~whole blood samples was received in 2022. Preparation of a 510(k) for the ~~same~~S1 ~~disposable~~Panel ~~cartridge~~using plasma ~~format~~samples is currently in process.

~~Nanomix’s first product, the S1 Panel Assay for use in aiding the diagnosis of critical infections, received CE marking for the assay and the~~ eLab ~~Analyzer~~ in November of 2019. Filing of a 510(k) was started in 2020 through a third-party reviewer for the CRP assay. With the advent of the Coronavirus pandemic, Nanomix shifted to developing COVID-19 testing products in April of 2020. Preparation of a 510(k) is currently in process.Analyzer

2The eLab Analyzer is a handheld portable instrument that operates via a touch screen using a simple instruction menu. The analyzer works from a rechargeable battery or wall power and can be operated during recharging. The eLab Analyzer contains electronics, a pneumatic system, a barcode scanner, data storage, USB connections, and Bluetooth communications. To use the eLab system, an operator signs into the system and then follows the prompts on the eLab screen to run an assay, run controls, or review past test results. To run a test, the operator scans or enters a patient ID and scans the consumable test package using the built-in bar code scanner. The barcode contains information about the test including manufacturing lot codes and expiration dating for the consumable. The operator loads the patient sample into the disposable cartridge and inserts the cartridge into the eLab analyzer. The operator is then prompted on the screen to activate the assay. The eLab automatically runs through to completion using the programmed test protocol specific for that assay. At conclusion of the test protocol, results are displayed on the screen and can be sent electronically via Bluetooth as selected by the operator. All test information is recorded in the onboard database. The instrument includes a robust control system and, if there are errors in processing, the eLab displays an error code on the screen.

~~eLab Analyzer~~COVID-19 Rapid IgG/IgM Test Panel

The ~~eLab~~ ~~Analyzer~~Nanomix is a handheld portable instrument that operates via a touch screen using a simple instruction menu. The analyzer works from a rechargeable battery or wall power and can be operated during recharging. The eLab Analyzer contains electronics, a pneumatic system, a barcode scanner, data storage, USB connections, and Bluetooth communications. To use the eLab system, an operator signs into the system and then follows the prompts on the eLab screen to run an assay, run controls, or review past test results. To run a test, the operator scans or enters a patient ID and scans the consumable test package using the builtCOVID-in19 ~~bar~~Rapid ~~code~~IgG/IgM ~~scanner. The barcode contains~~Panel information about the test including manufacturing lot codes and expiration dating for the consumable. The operator loads the patient sample into the disposable cartridge and inserts the cartridge into the eLab analyzer. The operator is ~~then~~an ~~prompted~~electrochemical onimmunoassay ~~the screen to activate the assay. The eLab automatically runs through to completion using the programmed~~ test ~~protocol~~intended ~~specific~~ for ~~that~~qualitative ~~assay.~~detection ~~At conclusion~~ of ~~the~~IgG ~~test protocol, results are displayed on the screen~~ and ~~can~~IgM beantibodies ~~sent~~(without ~~electronically~~differentiation) ~~via~~to ~~Bluetooth as selected by the~~SARS-CoV-2 ~~operator. All test information is recorded~~ in ~~the~~human ~~onboard~~venous ~~database.~~whole ~~The~~blood ~~instrument~~and ~~includes~~plasma a(K2EDTA, ~~robust control system and~~lithium-heparin, ~~if there are errors in processing~~sodium-heparin, ~~the~~sodium ~~eLab displays an error code on the screen~~citrate).

~~COVID~~Venous whole blood or plasma samples are collected and using a provided transfer device the sample is transferred to the single-19use, microfluidic cartridge. The cartridge is then run on ~~Rapid~~Nanomix ~~IgG/IgM~~eLab ~~Test~~Analyzer, ~~Panel~~which will display results after about 10 minutes. The presence of SARS-CoV-2 antibodies is determined using a quantitative electrochemical reading which is then compared to a cutoff level to report a qualitative result of positive or negative.

~~The Nanomix~~An ~~eLab~~EUA for the COVID-19 Rapid IgG/IgM Test Panel was isfiled anwith ~~electrochemical~~the ~~immunoassay~~FDA ~~test~~in ~~intended~~July ~~for~~2020. ~~qualitative~~In ~~detection~~April of ~~IgG~~2021, ~~and~~the ~~IgM~~FDA ~~antibodies~~notified us that given the volume of EUA requests the Agency had received, ~~(without~~FDA ~~differentiation)~~is having to ~~SARS-CoV-2~~prioritize inEUA ~~human~~requests ~~venous~~and ~~whole~~they ~~blood~~will not be reviewing our product as filed. Nanomix is currently tracking use cases and ~~plasma~~reviewing ~~(K2EDTA,~~alternative ~~lithium-heparin,~~approaches ~~sodium~~to market the COVID antibody test but at this time does not expect to actively market the COVID-~~heparin,~~19 Rapid ~~sodium~~IgG/IgM ~~citrate)~~Test Panel.

~~Venous whole blood or plasma samples are collected and using a provided transfer device the sample is transferred to the single~~COVID-~~use,~~19 ~~microfluidic cartridge.~~Rapid ~~The~~Antigen ~~cartridge~~Test is then run on Nanomix eLab Analyzer, which will display results after about 10 minutes. The presence of SARS-CoV-2 antibodies is determined using a quantitative electrochemical reading which is then compared to a cutoff level to report a qualitative result of positive or negative.Panel

~~An EUA~~The ~~for~~Nanomix ~~the~~eLab COVID-19 Rapid ~~IgG/IgM~~Antigen ~~Test~~ Panel is ~~was~~an ~~filed~~electrochemical ~~with~~immunoassay ~~the~~test ~~FDA~~intended infor ~~July 2020. In April of 2021,~~ the ~~FDA~~qualitative ~~notified~~detection ~~us that given the volume~~ of ~~EUA~~nucleocapsid ~~requests~~antigens ~~the~~from ~~Agency~~SARS-CoV-2 ~~had~~in ~~received,~~nasal ~~FDA is having to prioritize EUA requests and they will not be reviewing our product as~~(anterior ~~filed. Nanomix~~nares) isswabs ~~currently~~from ~~tracking~~individuals ~~use~~who ~~cases~~are ~~and~~suspected ~~reviewing~~of ~~alternative approaches to market the~~ COVID ~~antibody test~~-19.

~~COVID-19 Antigen Test Panel~~2

~~The~~Nasal swab samples are collected using a provided ~~Nanomix~~swab ~~eLab~~and ~~COVID~~sample collection tube, then transferred to the single-19use, ~~Rapid~~microfluidic ~~Antigen~~cartridge. ~~Panel~~The cartridge is anthen ~~electrochemical~~run ~~immunoassay~~on ~~test~~Nanomix ~~intended~~eLab Analyzer, ~~for~~which ~~the~~will ~~qualitative~~display ~~detection~~results ofafter ~~nucleocapsid antigens~~about ~~from~~15 minutes. The presence of SARS-CoV-2 inantigen ~~nasal~~is ~~(anterior~~determined ~~nares)~~using ~~swabs~~a ~~from~~quantitative ~~individuals~~electrochemical reading ~~who~~which ~~are~~is ~~suspected~~then compared to a cutoff level to report a qualitative result of ~~COVID-19~~positive or negative.

~~Nasal swab~~The ~~samples~~COVID-19 ~~are~~Rapid ~~collected~~Antigen ~~using~~Test aPanel ~~provided~~is ~~swab~~CE ~~and~~marked. An ~~sample~~EUA ~~collection~~for ~~tube,~~the ~~then~~COVID-19 ~~transferred~~Antigen Test panel was submitted to the ~~single-use,~~FDA ~~microfluidic~~in ~~cartridge~~February of 2021. The ~~cartridge~~Company isreceived ~~then~~comments ~~run~~from onthe ~~Nanomix~~FDA ~~eLab~~in May ~~Analyzer,~~and ~~which~~conducted ~~will~~further ~~display~~clinical ~~results~~and ~~after~~analytical ~~about~~work 15identified ~~minutes~~by the FDA. The ~~presence~~EUA offor ~~SARS~~the COVID-~~CoV-2~~19 ~~antigen~~Antigen Test panel was resubmitted isto ~~determined~~the ~~using~~FDA ain ~~quantitative~~November ~~electrochemical~~of ~~reading~~2021. ~~which~~The isFDA ~~then~~requested ~~compared~~additional todata aprimarily ~~cutoff~~from ~~level~~clinical testing sites prior to ~~report~~beginning atheir ~~qualitative~~formal review. ~~result~~Given reductions in COVID-19 infection rates and related testing volumes, and the current pricing of COVID-19 tests, the Company ~~positive~~is ornot ~~negative~~pursuing further development of this assay and doesn’t expect significant revenue to be produced by the COVID-19 Antigen Test panel.

~~An EUA~~S1 ~~for~~Assay the COVID-19 Antigen Test panel was submitted to the FDA in February of 2021. The Company received comments from the FDA in May and conducted further clinical and analytical work identified by the FDA. The EUA for the COVID-19 Antigen Test panel was resubmitted to the FDA in November. The FDA has requested additional data primarily from clinical testing sites prior to beginning their formal review. Given reductions in COVID-19 infection rates and the timing of any potential EUA, the Company doesn’t expect significant revenue to be produced by the COVID-19 Antigen Test panel..Panel

The S1 Assay ~~Panel~~panel was developed as an aid in rapidly diagnosing critical infections including sepsis. The panel provides quantitative tests results for Lactate (LAC), C-Reactive Protein (CRP) and Procalcitonin (PCT) from a single patient sample. The assay runs on the eLab Analyzer with results available in approximately 12 minutes, providing information rapidly versus the current diagnostic solutions which can take hours to provide a test result.

The S1 ~~Assay~~Nanomix ~~panel~~S1 ~~was~~Panel ~~developed~~Cartridge asquantitatively measures antwo ~~aid~~biomarkers, inCRP, ~~rapidly~~and ~~diagnosing~~PCT ~~critical~~and ~~infections~~the ~~including~~metabolite ~~sepsis. The panel provides quantitative tests results for~~ Lactate (LAC), ~~C-Reactive~~in ~~Protein~~lithium ~~(CRP)~~heparinized ~~and Procalcitonin~~ (~~PCT~~Li-heparinized) ~~from a single~~ plasma ~~sample~~specimens. A venous whole blood sample type is expected to be added to the S1 Assay in 2022. The assay runs on the eLab Analyzer with results available in approximately 11 minutes, providing information rapidly versus the current diagnostic solutions which can take hours to provide a test result.

~~The Nanomix~~CRP S1test ~~Panel~~results ~~Cartridge~~can ~~quantitatively~~be ~~measures~~used ~~two~~to ~~biomarkers~~evaluate infection, tissue ~~CRP~~injury, and ~~PCT~~inflammatory ~~and the metabolite Lactate (LAC) in lithium heparinized (Li-heparinized) plasma specimens~~disorders.

~~CRP~~ PCT test results can be used ~~to evaluate infection, tissue injury, and inflammatory disorders.~~:

3● To aid in decision making on antibiotic therapy for patient with suspected or confirmed lower respiratory tract infections (LRTI) defined as community acquired pneumonia (CAP) acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in an inpatient setting or Emergency Department.

~~PCT test~~● ~~results~~To ~~can~~aid bein ~~used:~~antibiotic decision making from therapy to discontinuation of treatment for patients with suspected or confirmed sepsis.

● To aid in ~~decision~~the ~~making~~risk onassessment ~~antibiotic~~of ~~therapy~~critically ~~for~~ill ~~patient~~patients ~~with~~on ~~suspected~~their orfirst ~~confirmed~~day ~~lower~~of ~~respiratory~~ICU ~~tract~~admission ~~infections~~for ~~(LRTI)~~progression ~~defined~~of assevere ~~community~~sepsis ~~acquired pneumonia (CAP) acute bronchitis,~~ and ~~acute~~septic ~~exacerbation of chronic obstructive pulmonary disease (AECOPD) in an inpatient setting or Emergency Department~~shock.

● To aid in ~~antibiotic~~assessing ~~decision~~the ~~making~~cumulative ~~from~~28-day ~~therapy~~risk ~~to discontinuation~~ of ~~treatment~~all-cause mortality for patients diagnosed with ~~suspected~~severe sepsis or ~~confirmed~~septic ~~sepsis~~shock in the ICU or when obtained in the emergency department of other medical wards prior to ICU admission, using a change in PCT level over time.

●LAC Totest ~~aid~~results can be used in the ~~risk~~diagnosis and ~~assessment~~treatment of ~~critically~~lactic ~~ill~~acidosis, ~~patients~~monitoring ontissue ~~their~~hypoxia, ~~first~~and ~~day~~diagnosis of ~~ICU~~hyperlactatemia ~~admission for progression of severe sepsis~~ and ~~septic shock~~septicemia.

●Each Toof ~~aid~~the inthree ~~assessing~~tests ~~the~~provides ~~cumulative~~important ~~28-day~~information about ~~risk~~a ofpatient’s ~~all-cause~~condition. ~~mortality~~Having ~~for~~all ~~patients~~three ~~diagnosed~~of ~~with~~these ~~sever~~answers ~~sepsis~~in ora ~~septic~~short ~~shock~~time inperiod ~~the~~provides ~~ICU~~a orhealthcare ~~when~~provider ~~obtained~~with inimportant information about the ~~emergency~~patient’s ~~department~~status ofwithin ~~other~~the ~~medical~~clinical ~~wards~~window ~~prior~~for toinfection ~~ICU~~diagnosis. ~~admission,~~All ~~using~~of athe ~~change~~test results are used in ~~PCT~~the context ~~level~~of ~~over~~other ~~time~~information about the patient.

~~LAC test~~S1 ~~results~~Assay ~~can~~Panel beuse ~~used~~ in ~~the diagnosis and treatment of lactic acidosis, monitoring tissue hypoxia, and diagnosis of hyperlactatemia and septicemia.~~Sepsis

~~Each of~~One ~~the~~potential ~~three~~use ~~tests~~of ~~provides~~the ~~important~~S1 ~~information~~Assay ~~about~~panel ais ~~patient’s~~in the ~~condition.~~diagnosis ~~Having all three~~ of ~~these~~Sepsis. ~~answers~~Sepsis inhas abeen ~~short~~highlighted ~~time period~~as ~~provides~~ a ~~healthcare~~global ~~provider~~health ~~with~~crisis ~~important~~and ~~information~~there ~~about~~is ~~the~~intense ~~patient’s~~pressure ~~status~~to ~~within~~improve ~~the~~management ~~clinical window for infection~~of ~~diagnosis.~~sepsis ~~All~~from ofearly ~~the~~identification ~~test~~to ~~results~~administration ~~are~~of ~~used~~antimicrobial intherapy, ~~the~~monitoring ~~context~~and de-escalation of ~~other information about the patient~~therapy.

~~Initial~~Sepsis is the body’s overwhelming and life-threatening ~~customer~~response ~~evaluation~~to infection that can lead to tissue damage, organ failure, and death. There are more than 49 million cases of Sepsis annually with more the S16 ~~Assay~~million ~~Panel~~associated deaths. Sepsis is ~~underway~~the #1 cost of hospitalization in the ~~United~~U.S ~~Kingdom~~with costs for acute sepsis hospitalization and skilled nursing estimated to be $62 billion annually. ~~Additional~~As ~~customer~~many ~~evaluations~~as ~~are~~87% ~~scheduled~~of ~~for~~sepsis ~~Madrid~~cases start in the community. According to the Sepsis Alliance, mortality from sepsis increases 8% every hour that treatment is delayed. As many as 80% of sepsis deaths could be prevented ~~Spain~~with rapid diagnosis and treatment.

~~S1 Assay Panel use in Sepsis~~3

~~One potential~~Sepsis ~~use~~testing ofand ~~the S1 Assay panel is in the~~ diagnosis ofcan ~~Sepsis.~~be ~~Sepsis~~viewed ~~has been highlighted~~ as a ~~global health crisis and there is intense pressure to improve management of sepsis from early identification to administration of antimicrobial therapy, monitoring and de~~2-~~escalation~~stage ~~of therapy.~~process:

~~Sepsis is~~● ~~the~~Immediate ~~body’s~~patient ~~overwhelming~~testing and ~~life-threatening~~assessment ~~response~~focused toon ~~infection~~emergency ~~that~~treatment ~~can lead to tissue damage~~decisions, ~~organ failure,~~ and death. There are more than 49 million cases of Sepsis annually with more the 6 million associated deaths. Sepsis is the #1 cost of hospitalization in the U.S with costs for acute sepsis hospitalization and skilled nursing estimated to be $62 billion annually. As many as 87% of sepsis cases start in the community. According to the Sepsis Alliance, Mortality from sepsis increases 8% every hour that treatment is delayed. As many as 80% of sepsis deaths could be prevented with rapid diagnosis and treatment.

~~Sepsis testing~~● ~~and~~Specific diagnosis ~~can~~of bebacterial ~~viewed~~or asfungal ~~a 2-stage process:~~pathogen

●The ~~Immediate~~Nanomix S1 test panel focuses on the first phase, the need for rapid screening or patients suspected of sepsis. The S1 test panel provides an easy to use, rapid test at the first point of patient ~~testing~~contact to deliver important information about the patient’s condition. The panel includes Lactate, the current tool most used in sepsis screening, and ~~assessment~~adds ~~focused~~two onother ~~emergency~~tests ~~treatment~~(CRP ~~decisions~~and PCT) that are currently used to confirm a diagnosis. By using our multiplexing and multimodal technology, we are able to bring all three of these test results from a single sample to healthcare providers in a 12-minute test providing clinicians with host response diagnostics at the time of initial evaluation, in any care setting, and may help assess the following questions and advance standards of care: 1) is there an infection or not? 2) is the infection viral or bacterial? 3) what is the severity and deficit of tissue perfusion?

●Once ~~Specific~~hospitalized, ~~diagnosis~~a sepsis patient spends on average 8 days in an ICU. The S1 panel can also be used to monitor the progress of ~~bacterial~~a patient and to support modification or ~~fungal~~discontinuation of ~~pathogen~~antibiotic therapy.

~~The Nanomix~~Partnerships S1 test panel focuses on the first phase, the need for rapid screening or patients suspected of sepsis. The S1 test panel provides an easy to use, rapid test at the first point of patient contact to deliver important information about the patient’s condition. The panel includes Lactate, the current tool most used in sepsis screening, and adds two other tests (CRP and PCT) that are currently used to confirm a diagnosis. By using our multiplexing and multimodal technology, we are able to bring all three of these test results from a single sample to healthcare providers in an 11-minute test providing clinicians with host response diagnostics at the time of initial evaluation, in any care setting, may help assess the following questions and advance standards of care: 1) is there an infection or not? 2) is the infection viral or bacterial? 3) what is the severity and deficit of tissue perfusion?Licensees

~~Once~~RedPharm ~~hospitalized,~~(Beijing) aBiotechnology ~~sepsis~~Co., ~~patient~~Ltd. ~~spends~~(RedPharm) has onthe ~~average~~right 8to ~~days~~produce ineLab ancartridges ~~ICU.~~for ~~The~~the S1 Assay panel ~~can~~in ~~also~~the bePRC ~~used~~and has the right to ~~monitor~~ sell and distribute the ~~progress~~S1 ofAssay apanel in ~~patient~~the ~~and~~PRC, toJapan, ~~support~~Korea, ~~modification~~and orother ~~discontinuation~~countries ofin ~~antibiotic~~Southeast ~~therapy~~Asia.

4Sales Channels

~~Partnerships~~We recently established our sales and marketing function. We intend our products to be sold globally, both directly and ~~Licensees~~through distributors, to hospitals and clinics, clinical laboratories, and other healthcare entities such as assisted living, extended care, and other non-hospital based care facilities. We have focused product distribution efforts in those territories where a CE mark is required for commercial sales. We have successfully developed numerous distribution partnerships that will provide product distribution capabilities in key markets including Europe, the Middle East, and Southeast Asia. To support our distributor’s efforts, we plan to build a distribution sales and technical support capability within the company.

~~RedPharm (Beijing)~~Currently ~~Biotechnology Co., Ltd. (~~RedPharm) has ~~the~~rights ~~right~~ to ~~produce~~distribute ~~eLab cartridges for the S1 Assay panel in the PRC and has the right~~our toproducts ~~sell and distribute the S1 Assay panel~~ in ~~the~~ PRC, Japan, Korea, and ~~other~~ countries in Southeast Asia..

~~Sales~~The Company is also exploring the sale of our ~~Channels~~products as Research Use Only to CLIA laboratories.

We recently established our sales and marketing function. We intend our products to be sold globally, both directly and through distributors, to hospitals and clinics, clinical laboratories, and other healthcare entities such as assisted living, extended care, and other non-hospital-based care facilities. We have limited product distribution, and our new sales and marketing team is working to build our product distribution capabilities in key markets such as North America, Europe, and Southeast Asia.Manufacturing

~~Currently~~We currently have limited manufacturing capacity ~~RedPharm~~for ~~has~~our ~~rights~~consumable test cartridges and plan to ~~distribute~~implement ~~our~~automated ~~products~~production processes in ~~PRC,~~the ~~Japan,~~U.S. ~~Korea,~~ and ~~countries~~bring inon ~~Southeast~~additional ~~Asia~~manufacturing resources to expand consumable test cartridge manufacturing capacity. We ~~are~~depend ~~also~~on ~~actively~~several ~~developing distribution~~single ~~partners~~source invendors ~~the~~to ~~United~~supply ~~Kingdom,~~components for ~~European~~our ~~Union~~disposable test cartridge and ~~Southeast~~a ~~Asia.~~US-based Tocontract ~~support~~manufacturer for our ~~distributor’s~~eLab ~~efforts,~~analyzer. weWe plan to bring on additional component ~~build~~suppliers to add supply chain capacity as well as backup. We have completed the purchase of a ~~distribution~~significant ~~sales~~supply of printed electrodes from a former vendor and ~~technical~~plan ~~support~~to ~~capability~~qualify ~~within~~a ~~the~~new ~~company~~vendor of electrodes.

~~Manufacturing~~Sensor functionalization (converting raw electrodes into a biosensor) is currently done by Nanomix using a robotic system and final cartridge assembly is done by Nanomix manually. We plan to invest significantly in increasing capacity of sensor manufacturing processes and to automate portions of the cartridge assembly processes. The costs of our products are expected to decline significantly with volume growth as well as process automation.

~~We currently~~RedPharm ~~have~~has ~~limited~~the ~~manufacturing~~right ~~capacity for our consumable test cartridges and plan~~ to ~~implement~~produce ~~automated~~eLab ~~production processes~~cartridges in the UPRC.S. and bring on additional manufacturing resources to expand consumable test cartridge manufacturing capacity. We depend on several single source vendors to supply components for our disposable test cartridge and a US-based contract manufacturer for our eLab analyzer. We plan to bring on additional component suppliers to add supply chain capacity as well as backup. We have completed the purchase of a significant supply of printed electrodes from a former vendor and plan to qualify a new vendor of electrodes.

~~Sensor functionalization~~The ~~(converting~~Nanomix ~~raw~~eLab ~~electrodes~~analyzer ~~into~~is produced by a ~~biosensor)~~contract manufacturer located in the United States. While this is ~~currently~~not ~~done~~an byexclusive ~~Nanomix~~supply ~~using~~arrangement, ait ~~robotic~~would ~~system~~be ~~and~~difficult ~~final~~to ~~cartridge~~transfer production ~~assembly~~or add an additional supplier. The production of instruments is done byon ~~Nanomix~~a ~~manually~~purchase order basis. WeNanomix ~~plan~~purchases toand ~~invest~~consigns ~~significantly~~the inmaterials for ~~increasing~~the ~~capacity~~quantity of ~~sensor~~instruments ~~manufacturing~~on ~~processes~~the purchase order. The contract manufacturer builds, tests, and toships the units and invoices Nanomix ~~automate~~based ~~portions~~on ofthe units shipped less the ~~cartridge~~cost ~~assembly~~of ~~processes.~~the ~~The~~consigned ~~costs~~materials. Some of ~~our~~the ~~products~~components ~~are~~used ~~expected~~in tothe ~~decline~~eLab ~~significantly~~analyzer ~~with~~have ~~volume~~long ~~growth~~lead times asand ~~well~~Nanomix asplans ~~process~~to ~~automation~~purchase many of those components in quantities beyond the current purchase order.

~~RedPharm has the right to produce eLab cartridges in the PRC.~~4

~~The Nanomix eLab analyzer is produced by a contract manufacturer located in the United States. While this is not an exclusive supply arrangement~~Collaboration, it ~~would~~License ~~be difficult to transfer production or add an additional supplier. The production of instruments is done on a purchase order basis. Nanomix purchases~~ and ~~consigns~~Quality the materials for the quantity of instruments on the purchase order. The contract manufacturer builds, tests, and ships the units and invoices Nanomix based on the units shipped less the cost of the consigned materials. Some of the components used in the eLab analyzer have long lead times and Nanomix will purchase many of those components in quantities beyond the current purchase order.Agreements

5To support the development and commercialization of our eLab system and products, in September 2017 we entered into a development and license agreement with RedPharm (Beijing) Biotechnology Co., Ltd., or the RedPharm License. Pursuant to the RedPharm License, we granted an exclusive license to the technology know-how, data and regulatory documents for our eLab technology to RedPharm that will support the development of our eLab analyzer in both humans and animals.

~~Collaboration~~Under the agreement, ~~License~~RedPharm has the rights to produce the eLab cartridges in China for specific assays that are transferred by Nanomix to RedPharm. RedPharm is responsible for any clinical and ~~Quality~~regulatory ~~Agreements~~activities necessary to register the products for sale in their territories. To date, Nanomix has transferred the S1 Critical Infections test to RedPharm and RedPharm has paid Nanomix $200,000 in license fees related to the transfer of that specific assay. RedPharm is obligated to pay a royalty on the sales of S1 test cartridges. There are limited activities in China on registration of the S1 Assay panel, no current regulatory approvals, and no commercial sales activity.

~~To support~~RedPharm ~~the~~also ~~development~~has ~~and~~the rights ~~commercialization~~to ofproduce ~~our~~the eLab ~~system~~Analyzer ~~and products,~~ in ~~September~~China ~~2017~~for wesale ~~entered~~in ~~into a development and license agreement with RedPharm (Beijing) Biotechnology Co., Ltd., or~~ the RedPharm ~~License.~~territories ~~Pursuant~~upon to the ~~RedPharm~~payment ~~License,~~of wean ~~granted~~up anfront ~~exclusive~~ license tofee. ~~the~~Each ~~technology~~eLab analyzer ~~know-how,~~placed ~~data~~by ~~and~~RedPharm ~~regulatory~~with ~~documents~~a ~~for~~customer ~~our~~carries ~~elab~~a ~~technology~~per tounit ~~RedPharm~~royalty ~~that~~in ~~will support~~ the ~~development~~ range of ~~our~~a ~~eLab~~low ~~analyzer~~hundred ~~in both humans and animals~~dollars.

~~Under the~~We ~~agreement,~~retain ~~RedPharm~~exclusive ~~has~~rights to ~~the~~commercialize ~~rights~~our toproducts ~~produce~~throughout the ~~eLab~~world, ~~cartridges~~except in ~~China~~Australia, ~~for~~New ~~specific~~Zealand, ~~assays~~Singapore, ~~that~~China, ~~are~~Japan, ~~transferred~~Korea, byVietnam, ~~Nanomix to~~Indonesia, ~~RedPharm.~~Malaysia ~~RedPharm~~and isthe ~~responsible~~Philippines, ~~for~~where ~~any~~RedPharm ~~clinical~~will ~~and~~have ~~regulatory~~exclusive ~~activities~~rights ~~necessary~~ to ~~register~~commercialize ~~the~~our ~~products~~eLab ~~for sale in their territories~~technology. To ~~date,~~We ~~Nanomix~~retain ~~has~~rights ~~transferred the S1 Critical Infections test~~ to ~~RedPharm~~participate in ~~and~~the RedPharm ~~has~~markets ~~paid~~depending ~~Nanomix~~on ~~$200~~their ~~thousand~~progress in ~~license~~each ~~fees related~~of to the ~~transfer of that specific assay~~countries. With RedPharm, iswe ~~obligated~~have toestablished ~~pay~~ a ~~royalty~~collaboration onfor the management ~~sales~~ of S1the ~~test~~development ~~cartridges.~~of ~~There~~any ~~are limited~~product ~~activities~~that inutilizes ~~China~~our ontechnology, ~~registration~~including ofany ~~the S1 Assay panel~~joint, nocross-territory ~~current~~studies ~~regulatory~~that ~~approvals,~~may ~~and~~be noundertaken by ~~commercial~~the ~~sales~~parties, ~~activity~~if any.

Under the RedPharm License, ~~also~~RedPharm ~~has~~are ~~the~~obligated ~~rights~~ to ~~produce~~pay ~~the~~us ~~eLab~~future ~~Analyzer~~milestone inpayments ~~China~~up ~~for~~to ~~sale~~an inaggregate ~~the~~of ~~RedPharm~~$6.4 million. ~~territories~~Further, ~~upon~~sales ~~the~~of ~~payment~~test cartridges bear royalties of ana uplow ~~front~~single-digit ~~license fee.~~percentage ~~Each~~based ~~eLab~~on ~~analyzer~~net ~~placed~~sales byand ~~RedPharm~~sales ~~with~~of aeLab ~~customer~~Analyzers ~~carries~~carry a per unit royalty in the ~~range~~low hundreds of ~~a low hundred~~ dollars.

~~We retain~~The ~~exclusive~~RedPharm ~~rights~~License continues toin ~~commercialize~~effect ~~our~~until ~~products~~the ~~throughout~~expiration ~~the~~of ~~world,~~all ~~except~~payment inobligations ~~Australia,~~thereunder ~~New~~(including ~~Zealand,~~royalty ~~Singapore,~~payments ~~China,~~and ~~Japan, Korea,~~licensee ~~Vietnam,~~revenue) ~~Indonesia,~~on ~~Malaysia~~a product-by-product and ~~the~~country-by-country ~~Philippines~~basis, ~~where~~unless ~~RedPharm~~earlier ~~will~~terminated ~~have~~by ~~exclusive~~the ~~rights~~parties. Pursuant to ~~commercialize~~the ~~our~~terms ~~elab~~of ~~technology.~~the RedPharm License, Wein ~~retain~~addition ~~rights~~to each party’s right to ~~participate~~terminate inthe agreement upon the ~~RedPharm~~other ~~markets~~party’s ~~depending~~material onbreach ~~their~~(if ~~progress~~not incured ~~each~~within ofa specified ~~the~~period ~~countries.~~after ~~With~~receipt ~~RedPharm~~of notice) or insolvency, (i) we also have ~~established~~ aunilateral ~~collaboration~~termination ~~for~~rights ~~the~~in ~~management of~~ the ~~development~~event ofRedPharm commences any ~~product~~court ~~that~~action ~~utilizes~~to invalidate any our ~~technology~~intellectual property, ~~including~~and ~~any~~(ii) ~~joint,~~RedPharm ~~cross-territory studies~~has ~~that~~unilateral ~~may~~termination berights ~~undertaken~~to bycancel ~~the~~this ~~parties,~~agreement upon ifsix ~~any~~(6) months prior written notice.

~~Under the~~There ~~RedPharm~~is ~~License,~~no ~~RedPharm~~current ~~are obligated to pay us future milestone payments up to an aggregate of $6.4 million. Further, sales~~business ofactivity ~~test~~with ~~cartridges bear royalties of a low single-digit percentage based on net sales and sales of eLab Analyzers carry a per unit royalty in the low hundreds of dollars~~RedPharm.

~~The RedPharm~~Technology ~~License~~& continues in effect until the expiration of all payment obligations thereunder (including royalty payments and licensee revenue) on a product-by-product and country-by-country basis, unless earlier terminated by the parties. Pursuant to the terms of the RedPharm License, in addition to each party’s right to terminate the agreement upon the other party’s material breach (if not cured within a specified period after receipt of notice) or insolvency, (i) we also have unilateral termination rights in the event RedPharm commences any court action to invalidate any our intellectual property., and (ii) RedPharm has unilateral termination rights to cancel this agreement upon six (6) months prior written notice.Development

~~Technology~~Our products are based on the Nanomix eLab electrochemical &detection ~~Development~~technology. Current and planned products will operate on the eLab Analyzer using the current microfluidic disposable test cartridge form. New product development will be largely focused on expanding the menu of tests that operate on the eLab Analyzer. Our initial focus will be on testing for medical conditions that require rapid results for patient management and benefit from the mobile capabilities of our system. Future developments will expand the menu to tests that support other decentralized healthcare needs.

Our products are based on the Nanomix eLab electrochemical detection technology. Current and planned products will operate on the eLab Analyzer using the current microfluidic disposable test cartridge form. New product development will be largely focused on expanding the menu of tests that operate on the eLab Analyzer. Our initial focus will be on testing for medical conditions that require rapid results for patient management and benefit from the mobile capabilities of our system. Future developments will expand the menu to tests that support other decentralized healthcare needs.Competition

~~Competition~~Many of our competitors are significantly larger and have greater financial, research, manufacturing, and marketing resources. Important competitive factors include product quality, performance, ease of use, price, customer service and reputation. Industry competition is based on these and the following additional factors:

~~Many of~~● ~~our~~patent competitors are significantly larger and have greater financial, research, manufacturing, and marketing resources. Important competitive factors include product quality, performance, ease of use, price, customer service and reputation. Industry competition is based on these and the following additional factors:protection;

● ~~patent~~technology ~~protection~~expertise;

● ~~technology~~ability ~~expertise~~to develop and market products and processes;

● ability to ~~develop~~obtain ~~and~~required ~~market~~regulatory ~~products and processes~~approvals;

● ability to ~~obtain~~manufacture ~~required~~cost-effective products that meet applicable regulatory ~~approvals~~requirements;

~~● ability to manufacture cost-effective products that meet applicable regulatory requirements;~~5

●

access to adequate capital; and,

●

ability to attract and retain qualified personnel.

6We believe our technical capabilities and proprietary know-how relating to our eLab system are strong, particularly for the development of tests for critical care conditions in decentralized care environments. However, there are a number of competitive technologies used and/or seeking to be used by others in point-of-care settings.

~~We believe~~Although ~~our~~we ~~technical~~have ~~capabilities~~no ~~and~~specific ~~proprietary~~knowledge ~~know-how~~of ~~relating~~any other tocompetitors’ ~~our~~products ~~eLab~~that ~~system~~could ~~are~~render ~~strong,~~our ~~particularly~~products ~~for~~obsolete, ~~the~~if ~~development of~~we ~~tests~~fail ~~for~~to ~~critical~~maintain ~~care~~and ~~conditions~~enhance inour ~~decentralized~~competitive ~~care~~position or ~~environments.~~fail ~~However,~~to ~~there~~introduce ~~are~~new aproducts ~~number~~and ofproduct ~~competitive~~features, ~~technologies~~our ~~used and/or~~customers ~~seeking~~may decide to beuse ~~used~~the products developed by ~~others~~our competitors, which could result in ~~point-~~a loss of~~-care~~ ~~settings~~revenues and cash flow.

Although we have no specific knowledge of any other competitors’ products that could render our products obsolete, if we fail to maintain and enhance our competitive position or fail to introduce new products and product features, our customers may decide to use the products developed by our competitors, which could result in a loss of revenues and cash flow.Employees

~~Employees~~As of December 31, 2022, we had 30 full-time equivalent employees, of whom 6 were in administration, 10 in research and development and engineering, 11 in manufacturing and quality, and 3 in sales and marketing. The majority of our employees are located in San Leandro, California.

~~As of~~We ~~December~~have ~~31,~~never ~~2021, we~~ had 25a ~~full-time~~work ~~equivalent employees~~stoppage, ofand ~~whom~~none 3of our ~~were~~employees inare ~~administration,~~represented 11by ina ~~research~~labor ~~and~~organization ~~development~~or ~~and engineering,~~subject 8to inany ~~manufacturing~~collective ~~and~~bargaining ~~quality, and 3 in sales and marketing~~arrangements. ~~The~~We ~~majority~~consider of our ~~employees~~employee ~~are~~relations to ~~located~~be ~~in San Leandro, California~~good.

~~We have~~Governmental ~~never had a work stoppage, and none of our employees are represented by a labor organization or subject to any collective bargaining arrangements. We consider our employee relations to be good.~~Regulation

~~Governmental~~Certain of our activities are subject to regulatory ~~Regulation~~oversight by the FDA under provisions of the Federal Food, Drug, and Cosmetic Act and regulations thereunder, including regulations governing the development, marketing, labeling, promotion, manufacturing, and export of diagnostic products. Our clinical laboratory customers are subject to oversight by Centers for Medicare and Medicaid Services, or CMS, pursuant to CLIA, as well as agencies in various states. Failure to comply with applicable requirements can lead to sanctions, including withdrawal of products from the market, recalls, refusal to authorize government contracts, product seizures, civil money penalties, injunctions, and criminal prosecution.

~~Certain of our activities are subject to regulatory oversight by the~~ FDA ~~under~~Approval/Clearance provisions of the Federal Food, Drug, and Cosmetic Act and regulations thereunder, including regulations governing the development, marketing, labeling, promotion, manufacturing, and export of diagnostic products. Our clinical laboratory customers are subject to oversight by Centers for Medicare and Medicaid Services, or CMS, pursuant to CLIA, as well as agencies in various states. Failure to comply with applicable requirements can lead to sanctions, including withdrawal of products from the market, recalls, refusal to authorize government contracts, product seizures, civil money penalties, injunctions, and criminal prosecution.Requirements

~~FDA~~Unless an exemption applies, each medical device that we wish to market in the United States must receive 510(k) clearance or Premarket Approval~~/Clearance~~ ~~Requirements~~(PMA). Medical devices that receive 510(k) clearance are “cleared” by the FDA to market, distribute, and sell in the United States. Medical devices that obtain a PMA by the FDA are “approved” to market, distribute and sell in the United States. We cannot be certain that 510(k) clearance or PMA approval will ever be obtained for any products that we develop. Descriptions of the PMA and 510(k) clearance processes are provided below.

~~Unless an~~The ~~exemption~~FDA ~~applies,~~decides ~~each~~whether ~~medical~~a device must undergo either the 510(k) clearance or PMA based on statutory criteria that weutilize ~~wish~~a torisk-based ~~market~~classification insystem. PMA is the ~~United~~FDA ~~States~~process of ~~must~~scientific ~~receive~~and ~~510(k)~~regulatory ~~clearance~~review orto ~~Premarket~~evaluate ~~Approval~~the safety and effectiveness of Class III medical devices and, in many cases, Class II ~~(PMA)~~medical devices. ~~Medical~~Class III devices are those that ~~receive~~support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. The FDA uses these criteria to decide whether a PMA or a 510(k) ~~clearance~~is ~~are~~appropriate, ~~“cleared”~~including bythe level of risk that the ~~FDA~~agency toperceives ~~market,~~is ~~distribute,~~associated with the device and ~~sell~~a indetermination by the ~~United States.~~agency ~~Medical~~of ~~devices~~whether ~~that~~the ~~obtain~~product is a ~~PMA~~type byof ~~the~~device ~~FDA~~that is similar to devices that are ~~“approved”~~already legally marketed. Devices deemed to ~~market,~~pose ~~distribute~~relatively ~~and~~less ~~sell~~risk are placed in ~~the~~either ~~United~~Class ~~States~~I or II. We ~~cannot~~In bemany ~~certain~~cases, ~~that~~the FDA requires the manufacturer to submit a 510(k) requesting clearance or(also ~~PMA~~referred ~~approval~~to ~~will~~as ~~ever~~a bepremarket ~~obtained~~notification), ~~for~~unless ~~any~~an ~~products~~exemption ~~that~~applies. weThe ~~develop.~~510(k) ~~Descriptions~~must ofdemonstrate that the manufacturer’s ~~PMA~~proposed device is “substantially equivalent” in intended use and ~~510(k)~~in ~~clearance~~safety ~~processes~~and ~~are~~effectiveness ~~provided~~to ~~below~~a legally marketed predicate device. A “predicate device” is a pre-existing medical device to which equivalence can be drawn, that is either in Class I or Class II or is a Class III device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for submission of a PMA application.

~~The FDA~~Device ~~decides~~classification ~~whether~~depends aon ~~device must undergo either~~ the ~~510(k)~~device’s intended ~~clearance~~use orand ~~PMA~~its ~~based~~indications onfor ~~statutory~~use. ~~criteria~~In ~~that~~addition, ~~utilize~~classification ais risk-based ~~classification system. PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices and~~, ~~in many cases, Class II medical devices. Class III devices are those~~ that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. The FDA uses these criteria to decide whether a PMA or a 510(k) is ~~appropriate~~, ~~including~~ the ~~level of~~ risk ~~that~~ the ~~agency~~device ~~perceives~~poses isto ~~associated with~~ the ~~device~~patient and/or ~~a determination by~~ the ~~agency~~user ~~of whether the product~~ is a ~~type~~major offactor ~~device~~in ~~that~~determining isthe ~~similar~~class to ~~devices~~which ~~that~~it ~~are~~is ~~already legally marketed~~assigned. ~~Devices~~ ~~deemed to pose relatively less risk are placed in either~~ Class I orincludes ~~II.~~devices Inwith ~~many cases,~~ the ~~FDA~~lowest ~~requires~~risk the manufacturer to submit a 510(k) requesting clearance (also referred to as a premarket notification), unless an exemption applies. The 510(k) must demonstrate that the manufacturer’s proposed device is “substantially equivalent” in intended use and ~~in safety and effectiveness~~ ~~to a legally marketed predicate device. A “predicate device” is a pre-existing medical device to which equivalence can be drawn, that is either in~~ Class ~~I or Class II or is a Class~~ III ~~device~~includes ~~that~~those ~~was~~with ~~in commercial distribution before May 28, 1976, for which~~ the ~~FDA~~greatest ~~has not yet called for submission of a PMA application~~risk.

7Class I devices are those for which safety and effectiveness can be assured by adherence to the FDA’s general regulatory controls for medical devices, or the General Controls, which include compliance with the applicable portions of the FDA’s quality system regulations, facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials. Some Class I devices also require premarket clearance by the FDA through the 510(k) process.

Device classification depends on the device’s intended use and its indications for use. In addition, classification is risk-based, that is, the risk the device poses to the patient and/or the user is a major factor in determining the class to which it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.6

Class I II devices are ~~those~~subject ~~for~~to ~~which~~the ~~safety~~FDA’s General Controls, and ~~effectiveness~~any ~~can~~other bespecial ~~assured~~controls byas ~~adherence~~deemed tonecessary by the FDA’s ~~general~~to ~~regulatory~~ensure ~~controls for~~the ~~medical~~safety ~~devices,~~and oreffectiveness of the ~~General~~device. ~~Controls,~~Premarket ~~which~~review ~~include~~and clearance ~~compliance~~by ~~with~~ the ~~applicable~~FDA ~~portions~~for ofClass ~~the~~II ~~FDA’s~~devices ~~quality~~is ~~system regulations,~~accomplished ~~facility~~through ~~registration~~the ~~and~~510(k) ~~product~~process. ~~listing,~~Pursuant ~~reporting~~to ofthe ~~adverse~~Medical ~~medical~~Device ~~events,~~User Fee and ~~appropriate~~Modernization Act of 2002, ~~truthful~~unless ~~and~~a ~~non-misleading labeling,~~specific ~~advertising~~exemption applies, ~~and~~510(k) ~~promotional~~submissions ~~materials.~~are ~~Some~~subject ~~Class~~to Iuser ~~devices~~fees. ~~also~~Certain ~~require~~Class ~~premarket~~II ~~clearance~~devices byare ~~the~~exempt ~~FDA~~from this ~~through~~premarket ~~the~~review ~~510(k)~~ process.

Class II ~~devices~~III ~~are~~includes ~~subject~~devices towith the ~~FDA’s~~greatest risk. ~~General~~Devices ~~Controls,~~in ~~and~~this ~~any~~class ~~other~~must ~~special~~meet ~~controls~~all asof ~~deemed necessary by~~ the ~~FDA~~requirements toin ~~ensure the~~Classes ~~safety~~I and ~~effectiveness of the device. Premarket review and clearance by the FDA for Class~~ II ~~devices is accomplished through the 510(k) process~~. ~~Pursuant~~In ~~to the Medical Device User Fee and Modernization Act of 2002~~addition, ~~unless a specific exemption applies, 510(k) submissions are subject to user fees. Certain~~ Class IIIII devices ~~are~~cannot ~~exempt~~be ~~from~~marketed ~~this~~until they ~~premarket~~receive ~~review~~Premarket ~~process~~Approval.

The safety and effectiveness of Class III ~~includes~~ devices cannot ~~with~~be assured solely by the ~~greatest~~General ~~risk.~~Controls ~~Devices~~and inthe ~~this~~other ~~class~~requirements ~~must~~described ~~meet~~above. ~~all~~These ofdevices ~~the~~require ~~requirements~~formal inclinical ~~Classes~~studies to Idemonstrate safety and IIeffectiveness. InUnder ~~addition~~Medical Device User Fee and Modernization Act of 2002, PMA applications (and supplemental ~~Class~~premarket ~~III~~approval ~~devices~~applications) ~~cannot~~are besubject ~~marketed~~to ~~until~~significantly higher user fees than 510(k) applications, and they ~~receive~~also ~~Premarket~~require ~~Approval~~considerably more time and resources.

The safety and effectiveness of Class III devices cannot be assured solely by the General Controls and the other requirements described above. These devices require formal clinical studies to demonstrate safety and effectiveness. Under Medical Device User Fee and Modernization Act of 2002, PMA applications (and supplemental premarket approval applications) are subject to significantly higher user fees than 510(k) ~~applications,~~ ~~and~~Clearance ~~they also require considerably more time and resources.~~Pathway

We are currently developing products that either will or are likely to require an FDA 510(k) clearance. We anticipate submitting a 510(k) for each such product to demonstrate that such ~~Clearance~~proposed ~~Pathway~~device is substantially equivalent to a previously cleared 510(k) device or a device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for the submission of a 510(k). The FDA’s 510(k) clearance pathway usually takes from three to twelve months but could take longer. In some cases, the FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence.

~~We are~~If ~~currently~~a ~~developing~~device ~~products~~receives ~~that either will or are likely to require an FDA~~ 510(k) clearance., Weany ~~anticipate~~modification that ~~submitting~~could asignificantly ~~510(k) for~~affect ~~each~~its ~~such~~safety ~~product~~or toeffectiveness, ~~demonstrate~~or that ~~such~~would ~~proposed~~constitute ~~device~~a isnew ~~substantially~~or ~~equivalent~~major tochange ain ~~previously~~its ~~cleared~~intended use, will require a new 510(k) ~~device~~clearance or, ~~a device~~depending ~~that~~on ~~was~~the inmodification, ~~commercial~~a ~~distribution~~PMA. ~~before~~The ~~May~~FDA ~~28,~~requires ~~1976,~~each ~~for~~device ~~which~~manufacturer ~~the~~to ~~FDA~~determine ~~has~~whether the ~~not~~proposed ~~yet~~change ~~called~~requires ~~for the~~ submission of a new 510(k)~~. The~~ ~~FDA’s~~or ~~510(k)~~a ~~clearance~~PMA, ~~pathway~~but ~~usually~~the ~~takes~~FDA ~~from~~can ~~three~~review toany ~~twelve~~such ~~months~~decision ~~but~~and, ~~could~~if ~~take~~it ~~longer.~~disagrees Inwith ~~some~~the manufacturer’s ~~cases~~determination, can require the ~~FDA~~manufacturer ~~may require~~to ~~additional~~cease ~~information,~~marketing ~~including~~and/or ~~clinical~~recall ~~data,~~the tomodified ~~make~~device auntil ~~determination~~510(k) ~~regarding~~clearance or ~~substantial~~PMA ~~equivalence~~of the modified device is obtained.

~~If a~~Clinical ~~device~~Laboratory ~~receives~~Improvement ~~510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute~~Amendments a new or major change in its intended use, will require a new 510(k) clearance or, depending on the modification, a PMA. The FDA requires each device manufacturer to determine whether the proposed change requires submission of a new 510(k) or a PMA, but the FDA can review any such decision and, if it disagrees with the manufacturer’s determination, can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or PMA of the modified device is obtained.1988

~~Clinical~~A manufacturer of a test categorized as moderately ~~Laboratory~~complex ~~Improvement~~may ~~Amendments~~request that categorization of ~~1988~~the test be waived through a CLIA Waiver (CW) by Application submission to the FDA. When a test is categorized as waived, it may be performed by laboratories with a Certificate of Waiver, such as a physician’s office or other outreach setting. In a CW submission, the manufacturer provides evidence to the FDA that a test meets the CLIA statutory criteria for waiver CLIA, a walk-in clinic or an emergency room provides CMS authority over all laboratory testing, except research that is performed on humans in the United States. The Division of Laboratory Services, within the Survey and Certification Group under the CMS, has the responsibility for implementing the CLIA program.

~~A manufacturer~~The ofCLIA aprogram ~~test~~is ~~categorized~~designed asto ~~moderately~~establish ~~complex~~quality laboratory ~~may~~testing ~~request~~by ~~that~~ensuring ~~categorization~~the accuracy, reliability and timeliness of ~~the~~patient test beresults. ~~waived~~Under ~~through~~CLIA, a ~~CLIA~~laboratory ~~Waiver (CW)~~is bya ~~Application~~facility that ~~submission~~does tolaboratory ~~the~~testing ~~FDA.~~on ~~When~~specimens aderived ~~test~~from ishumans ~~categorized~~and asused ~~waived,~~to itprovide ~~may~~information befor ~~performed~~the bydiagnosis, ~~laboratories~~prevention ~~with~~or ~~a Certificate~~treatment of ~~Waiver~~disease, ~~such~~or asimpairment aof, ~~physician’s office~~ or ~~other~~assessment ~~outreach~~of ~~setting~~health. InUnder athe CWCLIA ~~submission~~program, ~~the~~unless ~~manufacturer~~waived, ~~provides~~laboratories ~~evidence~~must tobe ~~the FDA~~certified ~~that~~by ~~a test meets~~ the ~~CLIA~~government, satisfy ~~statutory~~governmental ~~criteria~~quality ~~for~~and ~~waiver~~personnel ~~CLIA~~standards, aundergo ~~walk-in~~proficiency ~~clinic or an emergency room provides CMS authority over all laboratory~~ testing, ~~except~~be ~~research~~subject ~~that~~to isinspections ~~performed~~and onpay ~~humans in the United States~~fees. ~~The~~We ~~Division of Laboratory Services, within~~anticipate ~~the~~requesting ~~Survey~~CLIA ~~and~~Waiver ~~Certification Group under the CMS, has the responsibility~~ for ~~implementing~~ the ~~CLIA~~tests ~~program~~we develop.

~~The CLIA~~Pervasive ~~program is designed to establish quality laboratory testing by ensuring the accuracy, reliability~~ and ~~timeliness~~Continuing ofFDA patient test results. Under CLIA, a laboratory is a facility that does laboratory testing on specimens derived from humans and used to provide information for the diagnosis, prevention or treatment of disease, or impairment of, or assessment of health. Under the CLIA program, unless waived, laboratories must be certified by the government, satisfy governmental quality and personnel standards, undergo proficiency testing, be subject to inspections and pay fees. We anticipate requesting CLIA Waiver for the tests we develop.Regulation

8A host of regulatory requirements apply to our approved devices, including: the quality system regulation, which requires manufacturers to follow elaborate design, testing, control, documentation and other quality assurance procedures; the Medical Reporting Regulations, which require manufacturers to report to the FDA specified types of adverse events involving their products; labeling regulations; and the FDA’s general prohibition against promoting products for unapproved or “off-label” uses. Some Class II devices are subject to special controls-such as performance standards, post-market surveillance, patient registries, and FDA guidelines-that do not apply to Class I devices.

~~Pervasive~~The regulatory requirements that apply to our ~~and~~approved ~~Continuing~~products ~~FDA~~classified ~~Regulation~~as medical devices include:

~~A host~~● ofproduct ~~regulatory~~listing ~~requirements~~and ~~apply~~establishment ~~to our approved devices~~registration, ~~including: the quality system regulation,~~ which ~~requires~~helps ~~manufacturers to~~facilitate ~~follow~~FDA ~~elaborate~~inspections ~~design, testing, control, documentation~~ and other ~~quality~~regulatory ~~assurance procedures~~action; the Medical Reporting Regulations, which require manufacturers to report to the FDA specified types of adverse events involving their products; labeling regulations; and the FDA’s general prohibition against promoting products for unapproved or “off-label” uses. Some Class II devices are subject to special controls-such as performance standards, post-market surveillance, patient registries, and FDA guidelines-that do not apply to Class I devices.

~~The regulatory requirements that apply to our approved products classified as medical devices include:~~7

● ~~product~~QSR, ~~listing~~which ~~and~~require ~~establishment~~manufacturers, ~~registration~~including third-party manufacturers, ~~which~~to ~~helps~~follow ~~facilitate~~stringent ~~FDA~~design, ~~inspections~~testing, control, documentation and other ~~regulatory~~quality ~~action~~assurance procedures during all aspects of the development and manufacturing process;

● ~~QSR,~~labeling ~~which~~regulations ~~require~~and ~~manufacturers,~~FDA ~~including~~prohibitions ~~third-party~~against ~~manufacturers,~~the topromotion ~~follow~~of ~~stringent~~products ~~design,~~for ~~testing~~uncleared, ~~control,~~unapproved ~~documentation~~or ~~and~~off-label ~~other~~use ~~quality~~or ~~assurance procedures during all aspects of the development and manufacturing process~~indication;

● ~~labeling~~clearance ~~regulations~~of ~~and~~product ~~FDA~~modifications ~~prohibitions~~that ~~against~~could ~~the~~significantly ~~promotion~~affect ofsafety ~~products~~or ~~for~~efficacy ~~uncleared,~~or ~~unapproved~~that orwould ~~off-label~~constitute a major change in intended use orof ~~indication~~one of our cleared devices;

● ~~clearance~~approval of product modifications that ~~could significantly~~ affect the safety or ~~efficacy~~effectiveness ~~or that would constitute a major change in intended use~~ of one of our cleared devices;

● ~~approval~~medical ofdevice ~~product~~reporting ~~modifications~~regulations, which require that ~~affect~~manufacturers ~~the~~comply ~~safety~~with FDA requirements to report if their device may have caused or ~~effectiveness~~contributed ofto ~~one~~a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of ~~our~~the ~~cleared~~device ~~devices~~or a similar device were to recur;

● ~~medical~~post-approval ~~device~~restrictions ~~reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may have caused~~ or ~~contributed to a death or serious injury~~conditions, orincluding ~~has~~post-approval ~~malfunctioned~~study ~~in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur~~commitments;

● post-~~approval~~market ~~restrictions~~surveillance regulations, which apply when necessary to protect the public health or ~~conditions,~~to ~~including~~provide ~~post-approval~~additional ~~study~~safety ~~commitments~~and effectiveness data for the device;

● ~~post-market~~the ~~surveillance~~FDA’s ~~regulations~~recall authority, ~~which~~whereby ~~apply~~it ~~when~~can ~~necessary~~ask, toor ~~protect~~under ~~the~~certain ~~public~~conditions ~~health~~order, ordevice manufacturers to ~~provide~~recall ~~additional~~from ~~safety~~the ~~and~~market ~~effectiveness~~a ~~data~~product ~~for~~that ~~the~~is ~~device~~in violation of governing laws and regulations;

● ~~the~~regulations ~~FDA’s~~pertaining ~~recall authority, whereby it can ask, or under certain conditions order, device manufacturers~~ to ~~recall~~voluntary ~~from~~recalls; ~~the market a product that is in violation of governing laws~~ and ~~regulations;~~,

● ~~regulations~~notices ~~pertaining~~of tocorrections ~~voluntary~~or ~~recalls; and,~~removals.

●Our ~~notices~~Emeryville, CA facility was licensed by the State of ~~corrections~~California. We have moved to a new facility and will need to transfer or ~~removals~~obtain a State of California license for the new facility [once we are manufacturing products for sale in the United States?]. We and any third-party manufacturers are subject to announced and unannounced inspections by the State or the FDA to determine our compliance with QSR and other regulations.

~~Our Emeryville,~~21st CACentury ~~facility~~Cures was licensed by the State of California. We have moved to a new facility and will need to transfer or obtain a State of California license for the new facility. We and any third-party manufacturers are subject to announced and unannounced inspections by the State or the FDA to determine our compliance with QSR and other regulations.Act

The 21st Century Cures Act, enacted in December 2016, contains several sections specific to medical device innovations. We believe that implementation of the 21st Century Cures Act may have a positive impact on its businesses by facilitating innovation and/or reducing the regulatory burden imposed on medical device manufacturers.

~~The 21st~~Environmental Century Cures Act, enacted in December 2016, contains several sections specific to medical device innovations. We believe that implementation of the 21st Century Cures Act may have a positive impact on its businesses by facilitating innovation and/or reducing the regulatory burden imposed on medical device manufacturers.Laws

9We believe that we are in compliance in all material respects with all foreign, federal, state, and local environmental regulations applicable to our manufacturing facilities. The cost of ongoing compliance with such regulations does not have a material effect on our operations.

~~Environmental Laws~~Intellectual Property

~~We believe~~Intellectual ~~that~~Property we are in compliance in all material respects with all foreign, federal, state, and local environmental regulations applicable to our manufacturing facilities. The cost of ongoing compliance with such regulations does not have a material effect on our operations.Strategy

~~Intellectual~~Our intellectual property strategy is to: (1) ~~Property~~build our own intellectual property portfolio around our eLab and electrochemical detection system; (2) pursue licenses, trade secrets and know-how within the area of rapid point-of-care testing; and, (3) develop and acquire proprietary positions to certain biomarkers.

eLab and Electrochemical Detection System Intellectual Property ~~Strategy~~

~~Our intellectual~~We ~~property~~have ~~strategy~~obtained ispatent ~~to:~~coverage ~~(1)~~on ~~build~~eLab ~~our~~and ~~own~~Electrochemical detection ~~intellectual~~technology, ~~property~~including ~~portfolio~~numerous ~~around~~patents ~~our~~in ~~eLab~~the ~~and~~United ~~electrochemical~~States, ~~detection system;~~China, ~~(2) pursue licenses~~Japan, ~~trade~~and ~~secrets~~the ~~and~~European ~~know-how~~Union. ~~within~~Additional ~~the~~patent ~~area~~applications are ofpending ~~rapid~~in ~~point-of-care~~the ~~testing;~~United ~~and~~States, ~~(3)~~as ~~develop~~well ~~and~~as ~~acquire proprietary~~in ~~positions~~the toEuropean ~~certain biomarkers~~Union.

~~eLab and Electrochemical Detection System Intellectual Property~~8

We have obtained patent coverage on eLab and Electrochemical detection technology, including numerous patents in the United States, China, Japan, and the European Union. Additional patent applications are pending in the United States, as well as in the European Union.Trademarks

~~Trademarks~~We have filed and obtained trademarks for our products, including the Nanomix eLab System. Our trademarks have been obtained in the United States and certain other countries around the world.

~~We have~~Trade ~~filed~~Secrets and ~~obtained trademarks for our products, including the Nanomix eLab System. Our trademarks have been obtained in the United States and certain other countries around the world.~~Know-How

~~Trade~~We have developed a substantial body of trade ~~Secrets~~secrets and ~~Know~~know-~~How~~how relating to the development and manufacture of our eLab and electrochemical test system, including the production of sensors, the design and production of microfluidics contained in the disposable test cartridge, the sourcing and optimization of materials for such tests, and methods to maximize sensitivity, speed-to-result, specificity, stability and reproducibility of our tests. These trade secrets and know-how provide us with an important competitive advantage.

~~We have~~Properties developed a substantial body of trade secrets and know-how relating to the development and manufacture of our eLab and electrochemical test system, including the production of sensors, the design and production of microfluidics contained in the disposable test cartridge, the sourcing and optimization of materials for such tests, and methods to maximize sensitivity, speed-to-result, specificity, stability and reproducibility of our tests. These trade secrets and know-how provide us with an important competitive advantage.

~~ITEM~~We do not own real properties. Our principal executive 1Aoffices recently relocated to 2121 Williams Street, San Leandro, CA, 94577. ~~RISK~~We ~~FACTORS~~lease our office pursuant to a 5-year lease which terminates on March 31, 2027. We believe that our existing facilities are suitable and adequate to meet our current needs. However, we may need to add or expand as we increase production levels or add employees. We believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations.

~~An investment~~Legal in our securities involves a high degree of risk. Before making an investment decision, you should give careful consideration to the following risk factors, in addition to the other information included in this prospectus, including our financial statements and related notes, before deciding whether to invest in our securities. The occurrence of any of the adverse developments described in the following risk factors could materially and adversely harm our business, financial condition, results of operations or prospects. In that case, the trading price of our common stock could decline, and you may lose all or part of your investment.Proceedings

~~Risks~~The Company is subject to claims and legal proceedings ~~Related~~that arise in the ordinary course of business. Such matters are inherently uncertain, and there can be no guarantee that the outcome of any such matter will be decided favorably to ~~Our~~the Company or that the resolution of any such matter will not have a material adverse effect upon the Company’s Consolidated Financial ~~Position~~Statements. The Company does not believe that any of such pending claims and ~~Need~~legal proceedings will have a material adverse effect on its Consolidated Financial Statements. The Company records a liability in its Consolidated Financial Statements for ~~Additional~~these ~~Capital~~matters when a loss is known or considered probable and the amount can be reasonably estimated. The Company reviews these estimates each accounting period as additional information is known and adjusts the loss provision when appropriate. If a matter is both probable to result in a liability and the amounts of loss can be reasonably estimated, the Company estimates and discloses the possible loss or range of loss to the extent necessary for its Consolidated Financial Statements not to be misleading. If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in its Consolidated Financial Statements.

~~The COVID-19~~Set ~~pandemic~~forth ~~could~~below ~~materially~~is ~~adversely~~a ~~affect~~description ~~our~~of ~~business,~~the ~~financial~~Company’s Legal ~~condition and results of operations~~Proceedings.

~~The COVID-19~~In ~~pandemic~~March 2019, ~~the~~we ~~measures~~were ~~attempted~~served towith ~~contain~~notification of ~~and~~complaint ~~mitigate~~filed by CureDM Inc. as agent for the ~~effects~~members of ~~the~~CureDM ~~virus~~Group Holdings, ~~including~~LLC ~~travel~~filed ~~bans~~with ~~and~~the ~~restrictions,~~Supreme ~~shelter-in-place,~~Court of the State of ~~quarantine~~New York County of New York regarding breach of contract and other ~~similar~~matters ~~governmental~~relating ~~orders~~to ~~and~~their ~~restrictions~~desire onto ~~trade~~unwind ~~put~~the inacquisition ~~place~~of ~~around~~CureDM Group Holdings LLC according to the ~~world~~original ~~have~~Contribution ~~caused~~Agreement. ~~widespread~~The ~~disruption in~~complaint ~~global~~was ~~economies~~withdrawn by CureDM, ~~productivity~~Inc. ~~and~~in ~~financial~~December ~~markets~~2019. ~~and~~The Company ~~have~~is ~~materially~~continuing ~~altered~~to ~~the~~work ~~way~~with inthe ~~which~~representatives wefrom ~~conduct~~CureDM ~~our~~Inc. ~~day-~~to~~-day~~ ~~business~~settle this claim and unwind the Contribution Agreement.

10In addition to the above matter, we are also in a dispute with Level Brands, Inc. regarding a License Agreement dated June 21, 2018 (JAMS Ref. No.: 1220061261). The Company filed an Answer to Complaint and Counter-complaint on June 25, 2019. Both parties are claiming non-performance under the License Agreement. The matter was scheduled for arbitration in October 2019. In October 2019, the arbitration was dismissed without prejudice.

~~The full~~On ~~extent~~October to16, ~~which~~2019 the ~~COVID-19~~Company ~~pandemic~~received ~~and~~a ~~the various responses to it impact our business, operations and financial results will~~Summons ~~depend on numerous evolving factors that we may not be able to accurately predict, including: the duration~~ and ~~scope~~Complaint offiled ~~the~~by ~~pandemic, including~~Microcap ~~any~~Headlines ~~potential~~Inc. ~~future~~against ~~waves of~~ the ~~pandemic;~~Company ~~governmental, business and individuals’ actions that have been and continue to be taken~~ in ~~response to~~ the ~~pandemic;~~Supreme ~~disruptions~~Court orof ~~restrictions on our employees’ ability to work and travel; and potential impact on~~ the ~~timeliness~~United ofStates ~~FDA and other regulatory bodies review and approval~~ of ~~our~~New ~~products.~~York ~~While~~County ~~some~~ of ~~our business operations~~Suffolk ~~can~~claiming bedamages ~~performed remotely, our product development and production activities need to be conducted on-site. Additionally, many~~ of ~~our employees are juggling additional work-related and personal challenges~~$18,000 ~~including adjusting communication~~ and ~~work~~the ~~practices~~costs ~~to collaborate remotely with work colleagues~~ and ~~business~~disbursements ~~partners, managing technical and communication challenges~~ of ~~working from home, balancing~~ the ~~need~~action. toDuring beJanuary ~~on-site for many activities~~2021, ,the ~~looking~~Company ~~after~~settled ~~children~~this asclaim awith ~~result of remote-learning and school closures, making plans~~Microcap ~~for childcare and caring for themselves~~Headlines, ~~family members or other dependents who are or may become ill~~Inc. Wefor ~~will continue to actively monitor the issues raised by the COVID-19 pandemic and may take further actions that alter our business operations~~$10, ~~including as may be required by federal, state, local or foreign authorities or that we determine are in the best interests of our employees, potential business partners and stockholders~~000.

~~The duration~~Corporate and extent of the impact from the COVID-19 pandemic depends on future developments that cannot be accurately predicted at this time, such as the severity and transmission rate of the virus, the existence of any additional waves of the pandemic, the extent and effectiveness of containment actions, treatment and prevention measures, including vaccines, and the impact of these and other factors on our employees and potential customers and business partners. If we are not able to respond to and manage the impact of such events effectively, our business may be harmed.Information

We were formed as a Delaware corporation on August ~~have~~24, ~~incurred~~2009, ~~significant~~under ~~losses~~the ~~since~~name ~~inception~~Avanyx ~~and~~Therapeutics, ~~expect~~Inc. On November 15, 2021, we changed our name to ~~incur~~“Nanomix ~~losses~~Corporation” inIn connection with the ~~future~~acquisition of Nanomix Inc., Wea ~~cannot~~California corporation. Our principal executive offices are located at 2121 Williams Street, San Leandro, CA 94577, and our telephone number is (510) 428-5300. Our website address is nanomixdx.com. Information contained on or accessible through our website is not, and should not be ~~certain~~considered, ~~that~~part weof, ~~will~~or ~~achieve~~incorporated by reference into, this Annual Report on Form 10-K and you should not consider any information contained on, or ~~sustain~~that ~~profitability~~can be accessed through, our website as part of this Annual Report in deciding whether to purchase our securities.

~~We have~~Available incurred significant losses since inception through December 31, 2021 and expect to incur losses in the future. Our accumulated deficit as of December 31, 2021 and December 31, 2020 was approximately $106.8 million and $97.3 million, respectively, and we incurred net losses each year since inception. We expect that our losses may continue for at least the next few years as we will be required to invest significant additional funds toward the continued development and commercialization of our technology. Our ability to achieve or sustain profitability depends on numerous factors, many of which are beyond our control, including the market acceptance of our products and future product candidates, future product development, our ability to achieve marketing clearance from the FDA and international regulatory clearance for future product candidates, our ability to compete effectively against an increasing number of competitors and new products, and our market penetration and margins. In spite of efforts to ramp sales of our products, we may never be able to generate sufficient revenue to achieve or sustain profitability.Information

~~Our~~We make our filings with the SEC, including our ~~financial~~Annual ~~situation~~Report ~~creates~~on ~~doubt~~Form ~~whether~~10-K, weQuarterly ~~will~~Reports ~~continue~~on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports, available free of charge on our website as soon as reasonably practicable after we file such reports with, or furnish such reports to, the SEC. The public may read and copy the materials we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. Additionally, the SEC maintains an internet site that contains reports, proxy and information statements and other information. The address of the SEC’s website is www.sec.gov. The information contained in the SEC’s website is not intended to be a ~~going~~part ~~concern~~of this filing.

Our independent registered public accounting firm has issued a report for our financial statements at December 31, 2021 that includes an explanatory paragraph referring to our recurring losses from operations, which raises substantial doubt about our ability to continue as a going concern. We have not generated substantial revenues to date. For the years ended December 31, 2021 and 2020, the Company had losses of $9.5 million and $6.2 million, respectively. There can be no assurances that we will be able to achieve a level of revenues adequate to generate sufficient cash flow from operations or additional financing through private placements, public offerings and/or bank financing necessary to support our working capital requirements. To the extent that funds generated from any private placements, public offerings and/or bank financing are insufficient, we will have to raise additional working capital. No assurance can be given that additional financing will be available, or if available, will be on acceptable terms. These conditions raise substantial doubt about our ability to continue as a going concern. If adequate working capital is not available, we may be forced to discontinue operations, which would cause investors to lose their entire investment. Our auditors have indicated that these conditions raise substantial doubt about the Company’s ability to continue as a going concern.

11ITEM 1A. RISK FACTORS.

WeAn investment in our securities involves a ~~will~~high ~~need~~degree toof ~~raise~~risk. ~~additional~~Before ~~funding~~making an investment decision, ~~which~~you ~~may~~should ~~not~~give becareful ~~available~~consideration onto ~~acceptable~~the ~~terms~~following risk factors, orin ataddition to ~~all.~~the ~~Failure~~other toinformation ~~obtain~~included in this ~~necessary~~prospectus, ~~capital when~~including ~~needed~~our ~~may~~financial ~~force~~statements usand related notes, before deciding whether to invest ~~delay~~in our securities. The occurrence of any of the adverse developments described in the following risk factors could materially and adversely harm our business, ~~limit~~financial condition, results of operations or ~~terminate~~prospects. In that case, the trading price of our ~~product~~common ~~development~~stock could ~~efforts~~decline, and you may lose all or ~~other~~part ~~operations~~of your investment.

~~We will~~Risks ~~need~~Related to ~~continue~~Our toFinancial ~~seek~~Position ~~capital from time to time to continue development of our advanced mobile POC diagnostic system~~ and ~~to acquire~~ ~~and~~Need ~~develop other products. Once approved~~ for ~~commercialization,~~Additional we cannot provide any assurances that any revenues it may generate in the future will be sufficient to fund our ongoing operations. We expect that our current cash position will be sufficient to fund our current operations for at least the next 4 months. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or a combination of these approaches. In any event, we will require additional capital to obtain regulatory approval for, and to commercialize, our product candidates. Raising funds in the current economic environment may present additional challenges. Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations.Capital

~~Any additional~~We ~~fundraising~~have ~~efforts~~incurred ~~may~~significant ~~divert~~losses ~~our~~since ~~management~~inception ~~from their day-to-day activities, which may adversely affect our ability to develop~~ and ~~commercialize our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient~~expect ~~amounts or on terms acceptable~~ to ~~us,~~incur iflosses atin ~~all. Moreover,~~ the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to declinefuture. ~~The~~We ~~sale~~cannot ~~of additional equity or convertible securities may dilute our existing stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and we may~~ be ~~required to agree to~~ certain ~~restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions~~ that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we ~~may~~will beachieve ~~required to relinquish rights to some of our technologies~~ or ~~product~~sustain ~~candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects~~profitability.

IfWe have incurred significant losses since inception through December we31, ~~are~~2022 ~~unable~~and expect to ~~obtain~~incur ~~funding~~losses onin athe ~~timely~~future. ~~basis~~Our accumulated deficit as of December 31, 2022 and December 31, 2021 was approximately $119.3 million and $106.8 million, respectively, and we incurred net losses each year since inception. We expect that our losses may continue for at least the next few years as we will be required to ~~significantly~~invest ~~curtail,~~significant ~~delay~~additional orfunds ~~discontinue~~toward ~~one~~the orcontinued ~~more~~development and commercialization of our ~~research~~ ortechnology. ~~development~~Our ~~programs~~ability to achieve or ~~the~~sustain ~~commercialization~~profitability ofdepends ~~any~~on ~~product~~numerous ~~candidate~~factors, ormany beof ~~unable~~which toare ~~expand~~beyond our ~~operations~~control, including orthe ~~otherwise capitalize~~market onacceptance of our ~~business~~products ~~opportunities~~and future product candidates, asfuture ~~desired~~product development, ~~which~~our ~~could~~ability ~~materially~~to ~~affect~~achieve marketing clearance from the FDA and international regulatory clearance for future product candidates, our ~~business~~ability to compete effectively against an increasing number of competitors and new products, ~~financial~~and ~~condition~~our market penetration and ~~results~~margins. In spite of efforts to ramp sales of our ~~operations~~products, we may never be able to generate sufficient revenue to achieve or sustain profitability.

Our ~~inability~~ tofinancial ~~raise~~situation ~~capital~~creates ondoubt ~~acceptable~~whether ~~terms~~we inwill ~~the future may cause us to delay, diminish, or curtail certain operational activities~~continue as we have done during the fiscal year ended December 31, 2021, including research and development activities, sales and marketing, and other operations, in order to reduce costs and sustain the business, and such inability would have a ~~material~~going ~~adverse effect on our business and financial condition~~concern.

WeOur independent registered public accounting firm has issued ~~expect~~a ~~capital~~report ~~outlays~~for ~~and~~our ~~operating~~financial ~~expenditures~~statements at December 31, 2022 that includes an explanatory paragraph referring to ~~increase~~our ~~over~~recurring ~~the~~losses ~~next~~from operations, ~~several~~which ~~years~~raises substantial doubt about our ability to continue as wea ~~work~~going concern. We have not generated substantial revenues to ~~expand~~date. ~~our~~For ~~commercial~~the ~~activities~~years ended December 31, ~~expand~~ ~~our~~2022 ~~development~~and ~~activities~~2021, ~~expand~~the ~~manufacturing~~Company had losses of $12.3 million and $9.5 million, respectively. There can be no assurances that we will be able to achieve a level of revenues adequate to generate sufficient cash flow from operations or additional financing through private placements, public offerings and/or ~~expand~~bank financing necessary to support our ~~infrastructure~~working capital requirements. To Wethe ~~may~~extent ~~need~~that funds generated from any private placements, public offerings and/or bank financing are insufficient, we will have to raise additional working capital. No assurance can be given that additional financing will be available, or if available, will be on acceptable terms. These conditions raise substantial doubt about our ability to continue as a going concern. If adequate working capital is not available, ~~among~~we ~~other~~may ~~things:~~be forced to discontinue operations, which would cause investors to lose their entire investment. Our auditors have indicated that these conditions raise substantial doubt about the Company’s ability to continue as a going concern.

●We ~~sustain~~will ~~and~~need ~~expand~~to ~~the~~raise ~~commercialization~~additional offunding, ~~our~~which ~~commercialized~~may ~~assays~~not ~~and~~be ~~assays~~available on ~~under~~acceptable ~~development~~terms, or ~~review~~at byall. ~~various~~Failure ~~regulatory~~to ~~agencies;~~obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.

●We ~~expand~~will ~~and~~need ~~automate~~to continue to seek capital from time to time to continue development of our ~~manufacturing~~advanced ~~capabilities~~mobile POC diagnostic system and ~~reduce~~to acquire and develop other products. Once approved for commercialization, we cannot provide any assurances that any revenues it may generate in the future will be sufficient to fund our ~~cost~~ongoing operations. We expect that our current cash position is insufficient to fund our operations beyond the current period. However, our operating plan may change as a result of ~~sales;~~many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or a combination of these approaches. In any event, we will require additional capital to obtain regulatory approval for, and to commercialize, our product candidates. Raising funds in the current economic environment may present additional challenges. Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations.

~~● increase our sales and marketing efforts to drive market adoption and address competitive developments;~~10

●Any ~~finance~~additional ~~capital~~fundraising ~~expenditures~~efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our ~~general~~product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and ~~administrative~~the ~~expenses;~~issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. The sale of additional equity or convertible securities may dilute our existing stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

● If ~~develop~~we ~~new~~are ~~assays~~unable to ~~expand~~obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any product ~~offerings~~candidate or be unable to expand our operations or otherwise capitalize on our ~~eLab~~business ~~system;~~opportunities, as desired, which could materially affect our business, financial condition and results of operations.

●Our ~~maintain~~inability to raise capital on acceptable terms in the future may cause us to delay, ~~expand~~diminish, or curtail certain operational activities as we have done during the fiscal year ended December 31, 2022, including research and ~~protect~~development activities, sales and marketing, and other operations, in order to reduce costs and sustain the business, and such inability would have a material adverse effect on our ~~intellectual~~business ~~property~~and ~~portfolio;~~financial condition.

●We ~~add~~expect ~~operational,~~capital ~~financial~~outlays and ~~management~~operating ~~information~~expenditures ~~systems;~~to increase over the next several years as we work to expand our commercial activities, expand our development activities, expand manufacturing operations and expand our infrastructure. We may need to raise additional capital to, among other things:

● ~~hire~~sustain ~~additional~~and ~~research~~expand ~~and~~the ~~development,~~commercialization ~~quality~~of ~~control,~~our ~~scientific,~~commercialized assays and ~~general~~assays ~~and~~under ~~administrative~~development ~~personnel.~~or review by various regulatory agencies;

12● expand and automate our manufacturing capabilities and reduce our cost of sales;

~~Our present~~● ~~and~~increase ~~future~~our ~~funding~~sales ~~requirements~~and ~~will~~marketing ~~depend~~efforts onto ~~many~~drive ~~factors,~~market ~~including~~adoption ~~but~~and ~~not~~address ~~limited~~competitive ~~to:~~developments;

● ~~the~~finance ~~progress~~capital expenditures and ~~timing~~our ofgeneral and administrative expenses; ● develop new assays to expand the product offerings on our ~~clinical~~eLab ~~trials~~system;

● ~~the~~maintain, ~~level~~expand ~~of research~~ and ~~development~~protect ~~investment required to maintain and improve~~ our ~~technology~~intellectual ~~position~~property portfolio;

● ~~the~~add ~~cost of filing~~operational, ~~prosecuting,~~financial ~~defending~~ and ~~enforcing~~management ~~patent~~information ~~claims~~systems; and ~~other intellectual property rights, if any;~~

● ~~our~~hire ~~efforts~~additional toresearch ~~acquire~~and ordevelopment, ~~license~~quality ~~complementary~~control, ~~technologies~~scientific, orand ~~acquire~~general ~~complementary~~and ~~businesses;~~administrative personnel.

●Our ~~changes~~present inand ~~product~~future ~~development~~funding ~~plans~~requirements ~~needed~~will todepend ~~address~~on ~~any~~many ~~difficulties~~factors, including inbut ~~commercialization~~not orlimited ~~changing market conditions;~~to:

● ~~competing~~the ~~technological~~progress and ~~market~~timing ~~developments~~of our clinical trials;

● ~~changes~~the inlevel ~~regulatory~~of ~~policies~~research orand ~~laws~~development ~~that~~investment ~~may~~required ~~affect~~to maintain and improve our ~~operations;~~technology ~~and~~position;

● ~~changes~~the incost ~~physician~~of ~~acceptance~~filing, orprosecuting, ~~medical~~defending ~~society~~and ~~recommendations~~enforcing ~~that~~patent ~~may~~claims ~~affect~~and ~~commercial~~other ~~efforts.~~intellectual property rights, if any;

~~Raising additional~~● ~~capital~~our ~~will~~efforts ~~cause dilution~~ to ~~our~~acquire ~~existing~~or ~~stockholders~~license ~~and~~complementary ~~may~~technologies ~~restrict our operations~~ or ~~require~~acquire uscomplementary ~~to relinquish certain intellectual property rights.~~businesses;

~~We will~~● ~~seek~~changes additional capital through a combination of public and private equity offerings, debt financings, strategic partnerships and alliances, licensing arrangements and grants. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders may be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt and receivables financings may be coupled with an equity component, such as warrants to purchase shares, which could also result in dilution of our existing stockholders’ ownership. The incurrence of indebtedness would result in increased fixed payment obligations and could also result in certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our product ~~candidates,~~development orplans ~~grant~~needed ~~licenses on terms that are not favorable~~ to ~~us.~~address Aany ~~failure~~difficulties ~~to obtain adequate funds may cause us to curtail certain operational activities, including research and development, regulatory trials, sales and marketing, and manufacturing operations,~~ in ~~order~~commercialization toor ~~reduce~~changing ~~costs~~market ~~and sustain the business, and would have a material adverse effect on our business and financial condition.~~conditions;

~~We may~~● becompeting attechnological ~~risk~~and ofmarket ~~securities class action litigation.~~developments;

~~We may~~● bechanges atin ~~risk of securities class action litigation. This risk is especially relevant for us due to our dependence on~~ regulatory ~~approvals of~~policies ~~our~~or ~~diagnostic~~laws ~~tests.~~that Inmay ~~the~~affect ~~past, life science companies have experienced significant stock price volatility, particularly when associated with binary events such as clinical trials and product approvals. Additionally, due to~~ our ~~price volatility and our high demand for cash to fund~~ operations,; ~~we have had to conduct a number of reverse stock splits~~ and highly dilutive financings to continue as a going concern which exposes us to additional risk of securities class action litigation. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business and result in a decline in the market price of our common stock. If such lawsuits were successful we may not be able to pay awarded damages and we may be forced into bankruptcy which would likely result in the complete loss of your investment.

13● changes in physician acceptance or medical society recommendations that may affect commercial efforts.

~~Market and economic conditions may negatively impact our business, financial condition and share price.~~11

~~In recent~~Raising ~~years,~~additional ~~concerns~~capital ~~over~~will ~~inflation,~~cause ~~energy~~dilution ~~costs, geopolitical issues, the U.S. mortgage market and a declining real estate market, unstable global credit markets and financial conditions, and volatile oil prices have led~~ to ~~periods~~our ~~of significant economic instability,~~existing ~~diminished~~stockholders ~~liquidity~~ and credit availability, declines in consumer confidence and discretionary spending, diminished expectations for the global economy and expectations of slower global economic growth going forward, increased unemployment rates, and increased credit defaults. Our general business strategy may berestrict ~~adversely~~our ~~affected~~operations ~~by any such economic downturns, volatile business environments and unstable~~ or unpredictable economic and market conditions. If these conditions occur, deteriorate or do not improve, it may make any necessary debt or equity financing more difficult to complete, more costly, and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance, and share price and could require us to ~~delay~~relinquish orcertain ~~abandon~~intellectual ~~development~~property ~~or commercialization plans~~rights. In addition, there is a risk that one or more of our current and future service providers, manufacturers, suppliers, hospitals and other medical facilities, our third party payors, and other partners could be negatively affected by these difficult economic times, which could adversely affect our ability to attain our operating goals on schedule and on budget or meet our business and financial objectives.

~~The~~We will seek additional capital through a combination of public and ~~small~~private ~~size~~equity offerings, debt financings, strategic partnerships and alliances, licensing arrangements and grants. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ~~Company’s~~ownership ~~accounting~~interest ~~staff~~of ~~has~~our ~~limited~~existing ~~segregation~~stockholders may be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of ~~financial~~our ~~duties~~stockholders. Debt and receivables financings may be coupled with an equity component, such as warrants to purchase shares, which could also result in ~~material~~dilution of ~~misstatements~~our existing stockholders’ ownership. The incurrence of indebtedness would result in increased fixed payment obligations and could also result in certain restrictive covenants, such as limitations on our ~~financial~~ability ~~statements~~to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, or grant licenses on terms that are not favorable to us. A failure to obtain adequate funds may cause us to curtail certain operational activities, including research and development, regulatory trials, sales and marketing, and manufacturing operations, in ~~future~~order ~~periods~~to reduce costs and sustain the business, and would have a material adverse effect on our business and financial condition.

~~The Company’s~~We CEO and Controller have identified control deficiencies regarding the lack of segregation of duties and the need for a stronger internal control environment. The small size of the Company’s accounting staff may ~~prevent~~be ~~adequate~~at ~~controls~~risk ~~in the future, such as segregation~~ of ~~duties,~~securities ~~due~~class toaction ~~the cost/benefit of such remediation~~litigation.

~~Although~~We may be at risk of securities class action litigation. This risk ~~the~~is ~~Company~~especially ~~has~~relevant ~~hired~~for aus ~~Controller~~due to ~~work~~our dependence on ~~SEC~~regulatory ~~reporting~~approvals ~~and~~of ~~accounting~~our ~~matters~~diagnostic tests. In the past, welife ~~expect~~science ~~that~~companies have ~~the~~experienced ~~Company~~significant ~~will~~stock ~~need~~price tovolatility, ~~hire~~particularly ~~accounting personnel~~when associated with ~~the~~binary ~~requisite~~events ~~knowledge~~such toas ~~improve~~clinical ~~the~~trials ~~levels~~and ofproduct approvals. ~~review~~Additionally, ofdue ~~accounting~~to our price volatility and ~~financial~~our ~~reporting~~high ~~matters.~~demand ~~The~~for ~~Company~~cash ~~may experience~~to ~~delays~~fund inoperations, ~~doing~~we sohave ~~and~~had ~~any~~to ~~such~~conduct ~~additional~~a ~~employees~~number of ~~would~~reverse ~~require~~stock ~~time~~splits and ~~training~~highly dilutive financings to ~~learn~~continue ~~the~~as ~~Company’s~~a ~~business and~~going ~~operating~~concern ~~processes~~which ~~and~~exposes ~~procedures.~~us ~~For~~to ~~the~~additional ~~near-term~~risk ~~future,~~of ~~until~~securities class ~~such~~action ~~personnel~~litigation. ~~are~~If inwe ~~place~~face such litigation, ~~this~~it ~~will~~could ~~continue~~result toin besubstantial costs and a ~~weakness in~~diversion ~~the~~of ~~Company~~management’s ~~internal~~attention and ~~control~~resources, ~~over~~which ~~financial~~could ~~reporting~~harm ~~that~~our ~~could~~business and result in ~~material~~a ~~misstatements~~decline in the ~~Company’s~~market ~~financial~~price of our common stock. If such lawsuits were successful ~~statements~~we may not ~~being~~be ~~prevented~~able orto ~~detected~~pay awarded damages and we may be forced into bankruptcy which would likely result in the complete loss of your investment.

~~In addition,~~Market ~~other~~and ~~control~~economic ~~weaknesses~~conditions ~~or deficiencies~~ may benegatively ~~identified~~impact ~~in the future. If we are unable to correct such weaknesses or deficiencies in internal controls in a timely manner,~~ our ~~ability to record~~business, ~~process, summarize and report financial information accurately and within~~ ~~the time periods specified in the rules and forms of the SEC will be adversely affected, and could result in material misstatements in our~~ financial ~~statements~~condition ~~in future periods. This failure could negatively affect the market price~~ and ~~trading~~share liquidity of our common stock, cause investors to lose confidence in our reported financial information, subject us to civil and criminal investigations and penalties, and generally materially and adversely impact our business and financial conditionprice.

~~Risks~~In recent years, concerns over inflation, energy costs, geopolitical ~~Related~~issues, the U.S. mortgage market and a declining real estate market, unstable global credit markets and financial conditions, and volatile oil prices have led to periods of significant economic instability, diminished liquidity and credit availability, declines in consumer confidence and discretionary spending, diminished expectations for the ~~Private~~global ~~Placement~~economy and expectations of slower global economic growth going forward, increased unemployment rates, and increased credit defaults. Our general business strategy may be adversely affected by any such economic downturns, volatile business environments and unstable or unpredictable economic and market conditions. If these conditions occur, deteriorate or do not improve, it may make any necessary debt or equity financing more difficult to complete, more costly, and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance, and share price and could require us to delay or abandon development or commercialization plans. In addition, there is a risk that one or more of our current and future service providers, manufacturers, suppliers, hospitals and other medical facilities, our third party payors, and other partners could be negatively affected by these difficult economic times, which could adversely affect our ability to attain our operating goals on schedule and on budget or meet our business and financial objectives.

~~Our obligations~~The tosmall ~~the~~size ~~holders~~ of ~~our~~the ~~Notes~~Company’s ~~are~~accounting ~~secured~~staff byhas alimited segregation ~~security interest in substantially all~~ of ~~our~~financial ~~assets,~~duties sowhich ifcould weresult ~~default~~in onmaterial ~~those obligations,~~misstatements ~~the~~in ~~note~~our ~~holders~~financial ~~could~~statements ~~foreclose~~in onfuture ~~our assets~~periods.

~~Our obligations~~The ~~under~~Company’s ~~the~~CEO ~~Notes~~and ~~are~~CFO ~~secured~~have byidentified acontrol ~~security~~deficiencies regarding ~~interest~~the inlack ~~substantially~~of ~~all~~segregation of ~~our~~duties ~~assets.~~and Asthe aneed ~~result,~~for ifa westronger ~~default~~internal incontrol ~~our obligations~~environment. ~~under~~The ~~the~~small ~~Notes,~~size ~~the holders~~ of the ~~notes, acting through their appointed agent, could foreclose on their security interests~~Company’s ~~and~~accounting ~~liquidate~~staff ~~some~~may orprevent ~~all~~adequate ofcontrols ~~these~~in ~~assets,~~the ~~which would harm our business~~future, ~~financial~~such ~~condition~~as ~~and~~segregation ~~results~~ of ~~operations~~duties, ~~and~~due ~~could require us~~ to ~~curtail~~the orcost/benefit ~~cease~~of ~~operations~~such remediation.

IfAlthough the Company has hired a Controller to work on SEC reporting and accounting matters, we expect that the ~~holders~~Company will need to hire accounting personnel with the requisite knowledge to improve the levels of ~~our~~review ~~Notes~~of ~~elect~~accounting and financial reporting matters. The Company may experience delays in doing so and any such additional employees would require time and training to ~~convert~~learn the ~~principal~~Company’s business and ~~interest~~operating ~~due~~processes ~~under~~and procedures. For the ~~Notes~~near-term future, ~~our~~until ~~stockholders~~such personnel are in place, this will ~~experience~~continue ~~substantial~~to be a weakness in the Company’s internal control over financial ~~dilution~~reporting that could result in ~~their~~material ~~investment~~misstatements in the Company’s financial statements not being prevented or detected.

~~The~~In addition, other control weaknesses or deficiencies may be identified ~~total~~in ~~remaining~~the ~~principal~~future. ~~amount~~If we ~~owe~~are unable to ~~the~~correct ~~holders~~such ofweaknesses ~~our~~or ~~Notes~~deficiencies isin ~~approximately~~internal ~~$8.4~~controls ~~million~~in asa oftimely ~~December 31~~manner, ~~2021.~~our Ifability ~~the~~to ~~holders~~record, ofprocess, ~~these~~summarize ~~Notes~~and ~~were~~report tofinancial ~~elect~~information toaccurately ~~convert~~and ~~all~~within the time periods specified in the rules and forms of the ~~principal~~SEC will ~~amount~~be (adversely affected, and ~~assuming~~could noresult ~~interest~~in ~~has~~material ~~accrued~~misstatements onin ~~the~~our ~~principal~~financial ~~amount)~~statements ~~into shares~~in offuture ~~our~~periods. ~~common~~This ~~stock~~failure atcould negatively affect the ~~Conversion~~market ~~Price~~price and trading liquidity of ~~$2.0587,~~our wecommon ~~would~~stock, because ~~required~~investors to ~~issue~~lose ~~approximately~~confidence ~~4.1~~in ~~million~~our ~~shares.~~reported ~~These~~financial ~~conversions~~information, ~~would~~subject ~~result~~us into ~~significant~~civil ~~dilution~~and tocriminal ~~the~~investigations ~~investments~~and ofpenalties, and generally materially and adversely impact our ~~existing~~business and ~~stockholders~~financial condition.

1412

~~The holders~~Risks ofRelated ~~our~~to ~~Notes have certain rights upon an event of default under the Notes which could harm~~ our ~~business, financial condition and results of operations and could require us to curtail or cease or operations.~~Indebtedness

~~Under our~~Our ~~Notes,~~obligations to the holders of ~~the~~our Notes ~~may require us to redeem all or any portion of the Notes (including all accrued and unpaid interest~~ ~~thereon),~~are insecured ~~cash,~~by at a ~~price~~security ~~equal~~interest ~~to the greater of (i) 115% of the amount to be redeemed and (ii) the product of (X) the Conversion Rate (as defined~~ in ~~the~~substantially ~~Notes)~~all ~~multiplied by (Y) the product~~ of ~~(1)~~our ~~120%~~assets ~~multiplied~~We byare ~~(2)~~currently the greatest Closing Sale Price of the Common Stock on any Trading Day during the period commencing on the Trading Day immediately preceding such Event of Default (or deemed Event of Default disregarding any cure period in ~~such~~default ~~Event of Default above) and ending~~ on the ~~date the Company makes the entire payment required to be made. It is unlikely that we would have the cash to redeem the~~ Notes and, as ~~required.~~a ~~Furthermore~~result, ~~if we default on the payment of the notes~~, ~~interest on~~ the ~~notes will accrue at the rate of 18% per annum. If we were unable to come to an agreement with the holders~~ ofnote ~~the Notes regarding payment, the~~ holders could foreclose on ~~their security interest, which could harm~~ our ~~business, financial condition and results of operations and could require use to curtail or cease our operations~~assets.

~~Risks~~Our obligations under the Notes are secured by ~~Related~~a tosecurity ~~Product~~interest ~~Development~~in substantially all of our assets. As a result, ~~Regulatory~~if ~~Approval~~we default in our obligations under the Notes, ~~Manufacturing~~the holders of the notes, acting through their appointed agent, could foreclose on their security interests and ~~Commercialization~~liquidate some or all of these assets, which would harm our business, financial condition and results of operations and could require us to curtail or cease operations.

If we ~~cannot~~the ~~successfully~~holders ~~develop,~~of ~~maintain,~~our ~~commercialize,~~Notes orelect ~~obtain~~to ~~regulatory~~convert the ~~approvals~~principal ~~for~~and ~~new~~interest ~~and~~due ~~existing~~under ~~diagnostic~~the ~~assays~~Notes, our ~~financial results~~stockholders will beexperience ~~harmed~~substantial ~~and~~dilution ~~our~~in ~~ability~~their ~~to compete will be harmed~~investment.

~~Our financial~~The ~~performance~~total ~~depends~~remaining inprincipal ~~part~~amount ~~upon~~we ~~our~~owe ~~ability~~ to the ~~successfully~~holders ~~develop~~of ~~and~~our ~~market~~Notes ~~new~~is ~~assays~~approximately in$14.6 amillion ~~rapidly~~as ~~changing~~of ~~technological and~~December ~~economic environment~~31, ~~and~~2022. toIf ~~maintain~~the ~~and~~holders ~~successfully~~of ~~commercialize~~these ~~previously~~Notes ~~cleared~~were ~~assays.~~to Ifelect ~~we fail~~ to ~~successfully introduce~~convert ~~new~~all ~~assays~~of orthe doprincipal ~~not~~amount ~~maintain approval for previously FDA-cleared assays, we could lose customers~~ (and ~~market~~assuming ~~share.~~no Weinterest ~~could~~has ~~also~~accrued ~~lose market~~on ~~share~~the ifprincipal ~~our~~amount) ~~competitors~~into ~~introduce~~shares ~~new~~of ~~assays or technologies that render~~ our ~~assays~~common ~~less~~stock ~~competitive~~at orthe ~~obsolete. In addition,~~Conversion ~~delays~~Price ~~in the introduction~~ of ~~new assays due to regulatory~~$1.1717, ~~developmental~~we orwould ~~other~~be ~~obstacles~~required ~~could~~to ~~negatively~~issue ~~impact~~approximately ~~our~~11.5 ~~revenue~~million ~~and market share, as well as our earnings~~shares. ~~Factors~~These ~~that~~conversions ~~can~~would ~~influence~~result ~~our~~in ~~ability~~significant dilution to ~~introduce new assays,~~ the ~~timing~~investments ~~associated with new product approvals and commercial success~~ of ~~these~~our ~~assays~~existing ~~include:~~stockholders.

●The ~~the~~holders ~~scope~~of our Notes have certain rights upon an event of ~~and~~default ~~progress~~under ~~made~~the inNotes which could harm our ~~research~~business, financial condition and ~~development~~results ~~activities;~~of operations and could require us to curtail or cease or operations.

●Under our ~~ability~~Notes, the holders of the Notes may require us to ~~successfully~~redeem ~~initiate~~all or any portion of the Notes (including all accrued and ~~complete~~unpaid ~~clinical~~interest ~~trial~~thereon), ~~studies;~~in cash, at a price equal to the greater of (i) 115% of the amount to be redeemed and (ii) the product of (X) the Conversion Rate (as defined in the Notes) multiplied by (Y) the product of (1) 120% multiplied by (2) the greatest Closing Sale Price of the Common Stock on any Trading Day during the period commencing on the Trading Day immediately preceding such Event of Default (or deemed Event of Default disregarding any cure period in such Event of Default above) and ending on the date the Company makes the entire payment required to be made. It is unlikely that we would have the cash to redeem the Notes as required. Furthermore, if we default on the payment of the notes, interest on the notes will accrue at the rate of 18% per annum. If we were unable to come to an agreement with the holders of the Notes regarding payment, the holders could foreclose on their security interest, which could harm our business, financial condition and results of operations and could require use to curtail or cease our operations.

●Risks ~~timely~~Related ~~expansion~~to ofProduct ~~our~~Development, ~~menu~~Regulatory ofApproval, ~~assays;~~Manufacturing and Commercialization

●If ~~the~~we ~~results~~cannot ofsuccessfully ~~clinical~~develop, ~~trials~~maintain, ~~needed~~commercialize, toor obtain ~~support any~~ regulatory approvals offor ~~our~~new and existing diagnostic assays;, our financial results will be harmed and our ability to compete will be harmed.

●Our financial performance depends in part upon our ability to ~~obtain~~successfully develop and market new assays in a rapidly changing technological and economic environment, and to maintain ~~requisite~~and successfully commercialize previously cleared assays. If we fail to successfully introduce new assays or do not maintain approval for previously FDA-cleared assays, we could lose customers and market share. We could also lose market share if our competitors introduce new assays or ~~other~~technologies ~~regulatory~~that render ~~clearances~~our assays less competitive or ~~approvals~~obsolete. ~~for~~In addition, delays in the introduction of new assays due to regulatory, developmental or other obstacles could negatively impact our revenue and market share, as well as our earnings. Factors that can influence our ability to introduce new assays, onthe atiming ~~timely~~associated ~~basis;~~with new product approvals and commercial success of these assays include:

● ~~demand~~the ~~for~~scope ~~the~~of ~~new~~and ~~assays~~progress wemade ~~introduce~~in our research and development activities;

● ~~product~~our ~~offerings~~ability ~~from~~to ~~our~~successfully ~~competitors;~~initiate and complete clinical trial studies;

● ~~the~~timely ~~functionality~~expansion of ~~new~~our ~~assays~~menu ~~that~~of ~~address market requirements and customer demands.~~assays;

~~We are~~● ~~subject~~the toresults ~~many~~of ~~laws~~clinical ~~and~~trials ~~governmental~~needed ~~regulations~~to ~~and~~support any ~~adverse~~ regulatory ~~action~~approvals ~~may~~of ~~materially adversely affect~~ our ~~financial condition and business operations.~~assays;

~~The assays~~● ~~that~~our weability ~~develop and commercialize in the future are subject~~ to ~~regulation~~obtain ~~by numerous government agencies, including the FDA~~ and ~~comparable~~ ~~foreign~~maintain ~~agencies.~~requisite To varying degrees, each of these agencies requires us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of our assays. In particular, FDA ~~regulations~~or ~~govern~~other ~~activities such~~regulatory asclearances ~~product development, product testing, product labeling, product storage, premarket clearance~~ or ~~approval,~~approvals ~~manufacturing,~~for ~~advertising, promotion,~~our ~~product sales, reporting of certain product failures and distribution. Our~~ assays ~~will~~on ~~require~~a ~~510(k)~~timely ~~clearance from the FDA prior to marketing.~~basis;

15● demand for the new assays we introduce;

~~We may~~● beproduct ~~unable~~offerings tofrom ~~obtain marketing clearance for~~ our ~~assays~~competitors; ~~in development. If such approval is obtained, it may:~~and

● ~~take~~the afunctionality ~~significant~~of ~~amount~~new ofassays ~~time;~~that address market requirements and customer demands.

~~● require the expenditure of substantial resources;~~13

●We ~~involve~~are ~~stringent~~subject ~~clinical~~to many laws and ~~pre-clinical~~governmental ~~testing;~~regulations and any adverse regulatory action may materially adversely affect our financial condition and business operations.

● The ~~involve~~assays ~~modifications~~that we develop and commercialize in the future are subject to regulation by numerous government agencies, ~~repairs~~including the FDA and comparable foreign agencies. To varying degrees, each orof ~~replacements~~these agencies requires us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of our assays;. ~~and/~~In particular, FDA regulations govern activities such as product development, product testing, product labeling, product storage, premarket clearance or approval, manufacturing, advertising, promotion, product sales, reporting of certain product failures and distribution. Our assays will require 510(k) clearance from the FDA prior to marketing.

●We ~~result~~may inbe ~~limitations~~unable onto ~~the~~obtain ~~proposed~~marketing ~~uses~~clearance offor our assays in development. If such approval is obtained, it may:

~~Since 2009,~~● ~~the~~take FDA has significantly increased its oversight of companies subject to its regulations, including medical device companies, by hiring new investigators and stepping up inspections of manufacturing facilities. The FDA has recently also significantly increased the number of warning letters issued to companies. If the FDA were to conclude that we are not in compliance with applicable laws or regulations, or that any of our medical devices are ineffective or pose an unreasonable health risk, the FDA could ban such medical devices, detain or seize adulterated or misbranded medical devices, order a ~~recall,~~significant ~~repair,~~amount ~~replacement, or refund~~ of such devices, refuse to grant pending pre-market approval applications or require certificates of foreign governments for exports, and/or require us to notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health. The FDA may also impose operating restrictions on a company-wide basis, enjoin and restrain certain violations of applicable law pertaining to medical devices and assess civil or criminal penalties against our officers, employees or us. The FDA may also recommend prosecution to the U.S. Department of Justice. Any adverse regulatory action, depending on its magnitude, may restrict us from effectively marketing and selling our diagnostic tests.time;

~~Foreign governmental~~● ~~regulations~~require ~~have become increasingly stringent and more common, and we may become subject to more rigorous regulation by foreign governmental authorities in~~ the ~~future.~~expenditure ~~Penalties for a company’s non-compliance with foreign governmental regulation could be severe, including revocation or suspension~~ of asubstantial ~~company’s business license and criminal sanctions. Any domestic or foreign governmental law or regulation imposed in the future may have a material adverse effect on us.~~resources;

~~Our current~~● ~~and~~involve ~~potential~~stringent ~~customers~~clinical ~~in the United States~~ and ~~elsewhere may also be subject, directly or indirectly, to applicable anti~~pre-~~kickback, fraud~~clinical and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.testing;

~~The life~~● ~~sciences~~involve ~~industry~~modifications, isrepairs, ~~highly~~or ~~competitive~~replacements ~~and~~of ~~subject to rapid technological change. If~~ our ~~competitors and potential competitors develop superior~~ assays; and ~~technologies, our competitive position and results of operations would suffer.~~/or

~~We face~~● ~~intense~~result ~~competition from a number of companies that offer assays~~ in ~~our~~limitations ~~target~~on markets, many of which have substantially greater financial resources and larger, more established marketing, sales and service operations than we do. The life sciences industry is characterized by rapid and continuous technological innovation. We may need to develop new technologies for our existing product and our assays to be competitive. One or more of our current or future competitors could render our existing products or assays under development obsolete or uneconomical by technological advances. We may also encounter other problems in the ~~process~~proposed ofuses ~~delivering new assays to the marketplace, such as problems related to FDA clearance or regulations, design, development or manufacturing~~ of ~~such assays, and as a result we may be unsuccessful in selling such assays. Our future success depends on~~ our ~~ability to compete effectively against current technologies, as well as to respond effectively to technological advances by developing and marketing~~ assays ~~that are competitive in the continually changing technological landscape~~.

16Since 2009, the FDA has significantly increased its oversight of companies subject to its regulations, including medical device companies, by hiring new investigators and stepping up inspections of manufacturing facilities. The FDA has recently also significantly increased the number of warning letters issued to companies. If the FDA were to conclude that we are not in compliance with applicable laws or regulations, or that any of our medical devices are ineffective or pose an unreasonable health risk, the FDA could ban such medical devices, detain or seize adulterated or misbranded medical devices, order a recall, repair, replacement, or refund of such devices, refuse to grant pending pre-market approval applications or require certificates of foreign governments for exports, and/or require us to notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health. The FDA may also impose operating restrictions on a company-wide basis, enjoin and restrain certain violations of applicable law pertaining to medical devices and assess civil or criminal penalties against our officers, employees or us. The FDA may also recommend prosecution to the U.S. Department of Justice. Any adverse regulatory action, depending on its magnitude, may restrict us from effectively marketing and selling our diagnostic tests.

IfForeign governmental regulations have become increasingly stringent ~~our~~and ~~assays~~more docommon, ~~not~~and ~~perform~~we asmay ~~expected~~become orsubject ~~the~~to ~~reliability~~more ofrigorous regulation by foreign governmental authorities in the ~~technology~~future. onPenalties ~~which~~for a ~~our~~company’s ~~assays~~non-compliance ~~are~~with ~~based~~foreign isgovernmental ~~questioned~~regulation could be severe, weincluding ~~could~~revocation ~~experience~~or suspension of a company’s ~~delayed~~business license and criminal sanctions. Any domestic or ~~reduced~~foreign ~~market~~governmental ~~acceptance~~law ofor ~~our~~regulation ~~assays,~~imposed ~~increased~~in ~~costs~~the ~~and~~future ~~damage~~may tohave ~~our~~a ~~reputation~~material adverse effect on us.

Our ~~success~~ ~~depends~~current onand ~~the~~potential ~~market’s~~customers ~~confidence~~in ~~that~~the weUnited ~~can~~States ~~provide reliable, high-quality analyzers~~ and ~~diagnostic program. We believe~~elsewhere ~~that~~may ~~customers~~also inbe ~~our~~subject, ~~target~~directly ~~markets~~or ~~are~~indirectly, ~~likely~~ to beapplicable ~~particularly~~anti-kickback, ~~sensitive~~fraud ~~to product defects~~ and ~~errors.~~abuse, ~~Our~~false ~~reputation~~claims, ~~and~~transparency, ~~the~~health ~~public~~information ~~image~~privacy ofand ~~our~~security ~~assays~~and orother ~~technologies~~healthcare ~~may~~laws beand ~~impaired~~regulations, ifwhich ~~our~~could ~~assays~~expose ~~fail~~us to ~~perform~~criminal assanctions, ~~expected~~civil orpenalties, ~~our assays are perceived as difficult~~contractual todamages, ~~use.~~reputational ~~Despite quality control testing~~harm, ~~defects~~administrative orburdens ~~errors~~and ~~could~~diminished ~~occur~~profits inand ~~our~~future ~~assays or technologies~~earnings.

~~In the~~The ~~future,~~life ifsciences ~~our~~industry ~~assays~~is ~~experience~~highly acompetitive ~~material~~and ~~defect or error, this could result in loss or delay of revenues, delayed market acceptance,~~subject ~~product~~to ~~recalls,~~rapid ~~damaged~~technological ~~reputation,~~change. ~~diversion~~If ofour ~~development~~competitors ~~resources, legal claims, increased insurance costs or increased service~~ and ~~warranty~~potential ~~costs,~~competitors ~~any~~develop ofsuperior ~~which could harm our business. Such defects or errors could also prompt us to amend certain warning labels or narrow the scope of the use of our~~ assays, ~~either~~and ~~of which could hinder our success in the market. Even after any underlying concerns or problems are resolved~~technologies, ~~any widespread concerns regarding~~ our ~~technology or any manufacturing defects or performance errors in our~~competitive ~~assays~~position ~~could result in lost revenue, delayed market acceptance, damaged reputation, increased service~~ and ~~warranty~~results ~~costs~~of ~~and~~operations ~~claims~~would ~~against us~~suffer.

~~COVID-19~~We face intense competition from a number of companies that offer assays ~~diagnostic~~in ~~tests~~our ~~are~~target ~~subject~~markets, many of which have substantially greater financial resources and larger, more established marketing, sales and service operations than we do. The life sciences industry is characterized by rapid and continuous technological innovation. We may need to ~~changes~~develop new technologies for our existing product and our assays to be competitive. One or more of our current or future competitors could render our existing products or assays under development obsolete or uneconomical by technological advances. We may also encounter other problems in ~~CLIA~~the process of delivering new assays to the marketplace, such as problems related to FDA clearance or regulations, design, development or manufacturing of such assays, and ~~other~~as ~~regulatory~~a ~~requirements~~result we may be unsuccessful in selling such assays. Our future success depends on our ability to compete effectively against current technologies, as well as to respond effectively to technological advances by developing and marketing assays that are competitive in the continually changing technological landscape.

Our COVID-19 tests are subject to regulations of the FDA, International Organization for Standards and other regulatory requirements. The regulations regarding the manufacture and sale of COVID-19 tests may be unclear and are subject to change. Newly promulgated regulations could require changes to our COVID-19 diagnostic tests, necessitate additional procedures, or make it impractical or impossible for us to market our tests for certain uses, in certain markets, or at all. The FDA and other regulatory authorities also have the ability to impose new or additional requirements relating to COVID-19 tests. The implementation of such changes or new or additional requirements may result in substantial additional costs and could delay or make it more difficult or complicated to sell our products. Further, our COVID-19 tests, if approved, will be marketed under an Emergency Use Authorization (EUA) from the FDA. The FDA may decide to withdraw EUA designation for the SARS CoV-2 pandemic, resulting in the need for us to apply for clearance to market under a 510(k) or other regulatory process. This could result in substantial additional costs and time to develop the necessary data and information for such clearance.14

~~Disruptions at~~If ~~the~~our ~~FDA~~assays ~~and~~do ~~other~~not ~~government~~perform ~~agencies~~as ~~caused~~expected ~~by funding shortages, COVID-19~~ or ~~other~~the ~~global~~reliability ~~health~~of the ~~concerns~~technology ~~could~~on ~~shift~~which ~~their~~our ~~priorities or~~assays ~~hinder~~are ~~their~~based ~~ability~~is ~~to hire~~questioned, ~~retain~~we ~~or deploy key leadership and other personnel. This~~ could ~~result~~experience indelayed ~~delays~~ or ~~may~~reduced ~~delay,~~market oracceptance ~~otherwise prevent~~of ~~new~~our ~~or modified products from being developed~~assays, ~~cleared, approved, authorized, or commercialized in a timely manner or at all,~~increased ~~which~~costs ~~could~~and ~~negatively~~damage ~~impact~~to our ~~business~~reputation.

~~The ability~~Our ofsuccess ~~the~~depends ~~FDA~~on ~~to review and clear, approve, or authorize new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes,~~ the ~~FDA~~market’s ~~ability~~confidence ~~to hire and retain key personnel and accept the payment of user fees, and other events~~ that ~~may~~we ~~otherwise~~can ~~affect the FDA’s ability to perform routine functions. Average review~~provide ~~times at the agency have fluctuated in recent years as a result. In addition~~reliable, ~~government~~high-quality ~~funding~~analyzers ~~of other government agencies that fund research~~ and ~~development~~diagnostic ~~activities is subject to the political process, which is inherently fluid and unpredictable~~program. ~~Disruptions~~We ~~at the~~believe ~~FDA~~that ~~and~~customers ~~other~~in ~~agencies~~our ~~may~~target ~~also~~markets ~~slow~~are ~~the~~likely ~~time necessary for medical devices or modifications~~ to be ~~cleared or approved, medical devices~~particularly tosensitive be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including for 35 days beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to ~~furlough~~product ~~critical~~defects ~~FDA employees~~ and ~~stop critical activities~~errors. ~~Separately,~~Our inreputation ~~response to the global COVID-19 pandemic, on March 10, 2020 the FDA announced its intention to postpone most foreign inspections of manufacturing facilities~~ and ~~products, and subsequently, on March 18, 2020,~~ the ~~FDA~~public ~~announced~~image ~~its intention to temporarily postpone routine surveillance inspections~~ of ~~domestic~~our ~~manufacturing~~assays ~~facilities.~~or ~~Further,~~technologies ~~the FDA’s response to COID-19 has delayed and~~ may ~~continue~~be toimpaired ~~delay~~if ~~reviews~~our ~~of non-COVID~~assays ~~products~~fail ~~which in turn would impact our ability~~ to ~~bring~~perform ~~products~~as toexpected ~~market. Regulatory authorities outside the United States may adopt similar restrictions~~ or ~~other~~our ~~policy~~assays ~~measures~~are inperceived ~~response~~as difficult to ~~the COVID-19 pandemic~~use. IfDespite aquality ~~prolonged~~control ~~government shutdown occurs~~testing, ordefects ~~if global health concerns continue to prevent the FDA~~ or ~~other~~errors ~~regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it~~ could ~~significantly impact the ability of the FDA or other regulatory authorities to timely review~~ ~~and~~occur ~~process~~in our ~~regulatory~~assays ~~submissions,~~or ~~which could have a material adverse effect on our business~~technologies.

17In the future, if our assays experience a material defect or error, this could result in loss or delay of revenues, delayed market acceptance, product recalls, damaged reputation, diversion of development resources, legal claims, increased insurance costs or increased service and warranty costs, any of which could harm our business. Such defects or errors could also prompt us to amend certain warning labels or narrow the scope of the use of our assays, either of which could hinder our success in the market. Even after any underlying concerns or problems are resolved, any widespread concerns regarding our technology or any manufacturing defects or performance errors in our assays could result in lost revenue, delayed market acceptance, damaged reputation, increased service and warranty costs and claims against us.

~~If our~~Disruptions S1at ~~Assay~~the ~~Panel,~~FDA ~~COVID-19~~and ~~Antigen~~other ~~Panel~~government agencies caused by funding shortages, ~~our~~or ~~COVID-19~~other ~~IgG/IgM~~agency ~~Antibody~~policy ~~panel~~concerns ~~products~~could orshift ~~any~~their ofpriorities ~~our~~or ~~other~~hinder ~~product~~their ~~candidates~~ability ~~fail~~ to ~~achieve~~hire, retain or deploy key leadership and ~~sustain~~other ~~sufficient~~personnel. ~~market~~This ~~acceptance~~could result in delays or may delay, weor ~~will~~otherwise ~~not~~prevent ~~generate~~new ~~expected~~or ~~revenue~~modified ~~and~~products ~~our~~from ~~growth~~being ~~prospects~~developed, cleared, ~~operating~~approved, ~~results and~~authorized, ~~financial~~or ~~condition~~commercialized ~~may~~in bea ~~harmed~~timely manner or at all, which could negatively impact our business.

The ~~commercialization~~ ability of ~~our~~the S1FDA ~~Assay~~to ~~Panel~~review and clear, approve, or authorize new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the ~~future~~FDA’s ~~commercialization~~ability to hire and retain key personnel and accept the payment of ~~our~~user fees, and other ~~product~~events ~~candidates~~that inmay otherwise affect the ~~United~~FDA’s ~~States~~ability to perform routine functions. Average review times at the agency have fluctuated in recent years as a result. ~~and~~In addition, government funding of other ~~jurisdictions~~government inagencies that fund research and development activities is subject to the political process, which weis ~~intend~~inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for medical devices or modifications to ~~pursue~~be ~~marketing~~cleared ~~clearance~~or ~~are~~approved, ~~key~~medical ~~elements~~devices ofto be reviewed and/or approved by necessary government agencies, which would adversely affect our ~~strategy~~business. IfFor weexample, ~~are~~over ~~not~~the ~~successful~~last inseveral years, including for 35 days beginning on December 22, 2018, the ~~conveying~~U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to ~~hospitals~~furlough critical FDA employees and ~~other~~stop ~~customers~~critical ~~that~~activities. ~~our~~Separately, ~~current~~in response to the global COVID-19 pandemic, on March 10, 2020 the FDA announced its intention to postpone most foreign inspections of manufacturing facilities and products, and ~~future~~subsequently, ~~product~~on ~~candidates~~March ~~provide~~18, ~~equivalent~~2020, orthe ~~superior~~FDA ~~diagnostic~~announced ~~information~~its inintention ato ~~shorter~~temporarily ~~period~~postpone routine surveillance inspections of ~~time~~domestic ~~compared~~manufacturing facilities. Further, the FDA’s response to ~~existing~~COID-19 ~~technologies,~~has ordelayed ~~that~~and ~~these~~may continue to delay reviews of non-COVID products ~~and~~which ~~future~~in ~~product~~turn ~~candidates~~would ~~improve~~impact our ability to bring ~~patient~~products ~~outcomes~~to market. Regulatory authorities outside the United States may adopt similar restrictions or ~~decrease~~other ~~healthcare~~policy ~~costs~~measures in response to the COVID-19 pandemic. If a prolonged government shutdown occurs, weor ~~may~~if ~~experience~~global ~~reluctance~~health concerns continue to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or ~~refusal~~other regulatory activities, onit could significantly impact the ~~part~~ability of ~~hospitals~~the toFDA ~~order,~~or ~~and~~other ~~third-party payors~~regulatory authorities to ~~pay~~timely ~~for~~review ~~performing~~and aprocess ~~test~~our inregulatory submissions, which ~~our~~could ~~product~~have isa ~~utilized~~material adverse effect on our business.

~~These hurdles~~If ~~may~~our ~~make~~S1 itAssay ~~difficult~~Panel, toCOVID-19 ~~demonstrate~~Antigen toPanel, ~~hospitals~~COVID-19 ~~and~~IgG/IgM Antibody ~~other~~panel ~~healthcare~~products ~~providers~~or ~~that~~any of our ~~current~~other ~~diagnostic~~product ~~products~~candidates ~~and~~fail ~~future product~~to ~~candidates~~achieve ~~are~~and ~~appropriate~~sustain ~~options~~sufficient ~~for~~market ~~testing~~acceptance, ~~may~~we bewill ~~superior~~not togenerate expected ~~available~~revenue ~~tests~~ and ~~may~~our begrowth ~~more~~prospects, ~~cost-effective~~operating ~~than~~results ~~alternative technologies~~and financial condition may be harmed.

~~If we~~The ~~fail~~commercialization toof ~~successfully~~our ~~commercialize~~S1 ~~our~~Assay Panel products and the future commercialization of our other product candidates, wein ~~may~~the ~~never~~United ~~receive~~States aand ~~return~~other onjurisdictions ~~the~~in ~~significant~~which ~~investments~~we intend to pursue marketing clearance are key elements of our strategy. If we are not successful in ~~product~~conveying ~~development,~~to ~~sales~~hospitals and ~~marketing,~~other ~~regulatory,~~customers ~~manufacturing~~that our current products and ~~quality~~future ~~assurance~~product wecandidates ~~have~~provide ~~made~~equivalent or superior diagnostic information in a shorter period of time compared to existing technologies, or that these products and ~~further~~future ~~investments~~product candidates improve patient outcomes or decrease healthcare costs, we may experience reluctance, ~~intend~~or refusal, on the part of hospitals to ~~make~~order, and ~~may~~third-party ~~fail~~payors to ~~generate~~pay ~~revenue~~for ~~and~~performing ~~gain~~a ~~economies~~test ofin ~~scale~~which ~~from~~our ~~such~~product ~~investments~~is utilized.

~~If any~~These ofhurdles ~~our~~may ~~products,~~make orit ~~the~~difficult ~~malfunctioning~~to ofdemonstrate ~~our~~to ~~products,~~hospitals ~~causes~~and other orhealthcare ~~contributes~~providers tothat aour ~~death~~current ordiagnostic aproducts ~~serious~~and ~~injury,~~future weproduct ~~will~~candidates beare ~~subject to~~appropriate ~~medical~~options ~~device~~for ~~reporting regulations~~testing, ~~which~~may be ~~can~~superior ~~result~~to inavailable ~~voluntary~~tests ~~corrective~~and ~~actions~~may orbe ~~agency~~more ~~enforcement~~cost-effective ~~actions~~than alternative technologies.

~~Under the~~If ~~FDA~~we ~~medical~~fail ~~device reporting regulations, medical device manufacturers are required~~ to ~~report~~successfully tocommercialize ~~the~~our ~~FDA~~products ~~information~~and ~~that~~product ~~a device~~candidates, ~~has~~we or may ~~have~~never ~~caused~~receive ~~or contributed to~~ a ~~death~~return oron ~~serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury if~~ the ~~malfunction~~significant ofinvestments the device were to recur. If we fail to report these events to the FDA within the required timeframes, or at all, FDA could take enforcement action against us. Any such adverse event involving our assays could also result in ~~future~~ ~~voluntary~~product ~~corrective actions~~development, ~~such~~sales asand ~~recalls or customer notifications~~marketing, ~~or agency action~~regulatory, ~~such~~manufacturing ~~as inspection or enforcement action.~~and ~~Any~~quality ~~corrective~~assurance ~~action,~~we ~~whether~~have ~~voluntary~~made orand ~~involuntary,~~further asinvestments ~~well~~we asintend ~~defending~~to ~~ourselves~~make inand amay ~~lawsuit,~~fail ~~will~~to ~~require~~generate ~~the~~revenue ~~dedication of our time~~ and ~~capital,~~gain ~~distract~~economies ~~management~~of scale from ~~operating~~such ~~our business, and may harm our reputation and financial results~~investments.

Our assays may in the future be subject to product recalls. A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, including a third-country authority, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.15

~~The FDA~~If ~~and~~any ~~similar foreign governmental authorities have the authority to require the recall~~ of ~~commercialized~~our products ~~in the event of material deficiencies or defects in design or manufacture. In the case of the FDA~~, ~~the authority to require a recall must be based on an FDA finding that there is reasonable probability that the device would cause serious injury~~ or ~~death. In addition, foreign governmental bodies have~~ the ~~authority~~malfunctioning ~~to require the recall~~ of our products ~~in the event of material deficiencies or defects in design or manufacture. Manufacturers may~~, ~~under their own initiative, recall a product if any material deficiency in a device is found. The FDA requires that~~ ~~certain~~causes ~~classifications~~or ofcontributes ~~recalls be reported~~ to ~~the~~a ~~FDA~~death ~~within ten working days after the recall is initiated. A government-mandated~~ or ~~voluntary recall by us or one of our international distributors could occur as~~ a ~~result~~serious ~~of an unacceptable risk to health~~injury, ~~component failures,~~we ~~malfunctions,~~will manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our assays would divert managerial and financial resources and have an adverse effect on our reputation, results of operations and financial condition, which could impair our ability to produce our products in a cost-effective and timely manner in order to meet our customers’ demands. We may also be subject to ~~liability~~medical ~~claims,~~device bereporting ~~required to bear other costs~~regulations, orwhich ~~take~~can ~~other~~result ~~actions that may have a negative impact on~~in our future sales and our ability to generate profits. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA or another third-country competent authority. We may initiate voluntary ~~recalls~~corrective ~~involving~~actions ~~our products in the future that we determine do not require notification of the FDA~~ or ~~another~~agency ~~third-country~~enforcement ~~competent authority. If the FDA disagrees with our determinations, it could require us to report those~~ actions ~~as recalls~~. A future recall announcement could harm our reputation with customers and negatively affect our sales. In addition, the FDA could take enforcement action for failing to report the recalls when they occur.

18Under 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 were to recur. If we fail to report these events to the FDA within the required timeframes, or at all, FDA could take enforcement action against us. Any such adverse event involving our assays could also 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 our time and capital, distract management from operating our business, and may harm our reputation and financial results.

~~We are~~Our ~~also~~assays ~~required~~may toin ~~follow~~the ~~detailed~~future ~~recordkeeping~~be ~~requirements~~subject ~~for~~to ~~all~~product ~~Company-initiated medical device corrections and removals~~recalls. InA ~~addition,~~recall inof ~~December~~our ~~2012~~products, ~~the~~either ~~FDA~~voluntarily ~~issued~~or aat ~~draft~~the ~~guidance~~direction ~~intended~~of ~~to assist~~ the FDA ~~and~~or ~~industry~~another ingovernmental ~~distinguishing medical device recalls from product enhancements. Per the guidance~~authority, ifincluding ~~any change or group of changes to~~ a ~~device that addresses a violation of the~~third-country ~~FDCA~~authority, ~~that~~or ~~change~~the ~~would~~discovery ~~generally~~of ~~constitute~~serious asafety ~~medical~~issues ~~device~~with ~~recall~~our ~~and~~products, ~~require~~could ~~submission~~have of a ~~recall~~significant ~~report~~adverse toimpact ~~the~~on ~~FDA~~us.

IfThe FDA and similar foreign governmental authorities have the authority weto ~~become~~require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture. In the case of the FDA, the authority to require a recall must be based on an FDA finding that there is reasonable probability that the device would cause serious injury or death. In addition, foreign governmental bodies have the authority to require the recall of our products in the event of material deficiencies or defects in design or manufacture. Manufacturers may, under their own initiative, recall a product if any material deficiency in a device is found. The FDA requires that certain classifications of recalls be reported to the FDA within ten working days after the recall is initiated. A government-mandated or voluntary recall by us or one of our international distributors could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our assays would divert managerial and financial resources and have an adverse effect on our reputation, results of operations and financial condition, which could impair our ability to produce our products in a cost-effective and timely manner in order to meet our customers’ demands. We may also be subject to liability claims, ~~relating~~be required to ~~improper~~bear ~~handling~~other costs, ~~storage~~or take other actions that may have a negative impact on our future sales and our ability to generate profits. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA or ~~disposal~~another third-country competent authority. We may initiate voluntary recalls involving our products in the future that we determine do not require notification of ~~hazardous~~the ~~materials~~FDA or another third-country competent authority. If the FDA disagrees with our determinations, weit could ~~incur~~require ~~significant~~us ~~cost~~to report those actions as recalls. A future recall announcement could harm our reputation with customers and ~~time~~negatively affect our sales. In addition, the FDA could take enforcement action for failing to ~~comply~~report the recalls when they occur.

We are ~~subject~~also required to ~~foreign,~~follow ~~federal,~~detailed ~~state~~recordkeeping ~~and local regulations governing the use, manufacture, storage, handling and disposal of materials~~requirements ~~and~~for ~~waste~~all ~~products.~~Company-initiated Wemedical ~~may~~device ~~incur~~corrections ~~significant costs complying with both existing~~ and ~~future environmental laws and regulations~~removals. In ~~particular~~addition, we ~~are~~in ~~subject~~December ~~to regulation by the Occupational Safety and Health Administration~~2012, ~~or OSHA, and~~ the ~~Environmental~~FDA ~~Protection~~issued ~~Agency, or~~a ~~EPA,~~draft ~~and~~guidance intended to ~~regulation~~assist ~~under~~ the ~~Toxic~~FDA ~~Substances Control Act~~ and ~~the~~industry ~~Resource~~in ~~Conservation~~distinguishing ~~and~~medical ~~Recovery~~device ~~Act~~recalls infrom ~~the~~product ~~United States~~enhancements. ~~OSHA~~ orPer the ~~EPA~~guidance, ~~may~~if ~~adopt~~any ~~additional~~change ~~regulations~~or group inof ~~the~~changes ~~future~~to ~~that~~a ~~may~~device ~~affect~~that ~~our~~addresses ~~research~~a ~~and~~violation ~~development programs. The risk~~ of ~~accidental contamination or injury from hazardous materials cannot be eliminated completely. In~~ the ~~event of an accident~~FDCA, wethat ~~could~~change bewould ~~held~~generally ~~liable for~~constitute ~~any~~a ~~damages~~medical ~~that~~device ~~result,~~recall and require ~~any~~submission ~~liability could exceed the limits or fall outside the coverage~~ of ~~our~~a ~~workers’~~recall ~~compensation insurance.~~report ~~We may not be able~~ to ~~maintain~~the ~~insurance on acceptable terms, if at all~~FDA.

~~Our~~If we become subject to claims relating to improper handling, ~~diagnostic~~storage ~~products~~or ~~have~~disposal ~~not~~of ~~been~~hazardous ~~manufactured~~materials, inwe could incur significant ~~volume~~cost and ~~are~~time ~~subject~~ to ~~unforeseen scale-up risks~~comply.

~~Although we~~We ~~have~~are ~~developed~~subject ato ~~process~~foreign, tofederal, state and local regulations governing the use, manufacture, ~~our~~storage, ~~diagnostic~~handling and disposal of materials and waste products,. ~~there~~We ~~can~~may beincur nosignificant ~~assurance~~costs ~~that~~complying with both existing and future environmental laws and regulations. In particular, we ~~can~~are ~~manufacture~~subject ~~our~~to ~~diagnostic~~regulation by the Occupational Safety and Health ~~products~~Administration, ator aOSHA, ~~scale~~and ~~that~~the isEnvironmental ~~adequate~~Protection ~~for~~Agency, ~~our~~or ~~future~~EPA, ~~commercial~~and ~~needs.~~to Weregulation ~~may~~under ~~face~~the ~~significant~~Toxic Substances Control Act and the Resource Conservation and Recovery Act in the United States. OSHA or ~~unforeseen~~the ~~difficulties~~EPA may adopt additional regulations in ~~manufacturing~~the future that may affect our ~~diagnostic~~research ~~products~~and development programs. The risk of accidental contamination or injury from hazardous materials cannot be eliminated completely. In the event of an accident, ~~including~~we ~~but~~could be held liable for any damages that result, and any liability could exceed the limits or fall outside the coverage of our workers’ compensation insurance. We may not ~~limited~~be able to: maintain insurance on acceptable terms, if at all.

~~● technical issues relating to manufacturing components of our diagnostic products on a high-volume commercial scale at reasonable cost, and in a reasonable time frame;~~16

●Our ~~difficulty~~diagnostic ~~meeting~~products ~~demand~~have ornot ~~timing~~been ~~requirements~~manufactured ~~for~~in ~~orders~~significant volume ~~due~~and toare ~~excessive~~subject ~~costs~~to orunforeseen ~~lack~~scale-up ~~of capacity for part or all of an operation or process;~~risks.

●Although ~~lack~~we ofhave ~~skilled~~developed ~~labor~~a orprocess ~~unexpected~~to ~~increases~~manufacture inour ~~labor~~diagnostic products, ~~costs~~there ~~needed~~can tobe ~~produce~~no orassurance ~~maintain~~that we can manufacture our ~~analyzers~~diagnostic products at a scale that is adequate for our future commercial needs. We may face significant or ~~perform~~unforeseen ~~certain~~difficulties ~~required~~in ~~operations;~~manufacturing our diagnostic products, including but not limited to:

● ~~changes~~technical inissues ~~government~~relating ~~regulations~~to ormanufacturing incomponents ~~quality~~of orour ~~other~~diagnostic ~~requirements~~products ~~that~~on ~~lead~~a tohigh ~~additional~~volume ~~manufacturing~~commercial ~~costs~~scale orat anreasonable ~~inability~~cost, toand ~~supply product~~ in a ~~timely~~reasonable ~~manner,~~time ~~if at all~~frame; ~~and~~

● ~~increases~~difficulty inmeeting ~~raw~~demand ~~material~~ or ~~component~~timing ~~supply~~requirements ~~cost~~for ororders andue ~~inability~~ to ~~obtain~~excessive ~~supplies~~costs or lack of ~~certain~~capacity ~~critical~~for ~~components~~part or ~~supplies~~all ~~needed~~of toan ~~complete~~operation ~~our~~or ~~manufacturing processes.~~process;

~~These and~~● ~~other~~lack ~~difficulties~~of ~~may~~skilled ~~only~~labor ~~become~~or ~~apparent~~unexpected ~~when~~increases ~~scaling~~in uplabor tocosts ~~the~~needed ~~manufacturing process of our diagnostic products~~ to aproduce ~~more~~or ~~substantive commercial~~maintain ~~scale. If~~ our ~~diagnostic~~analyzers ~~products cannot be manufactured in sufficient commercial quantities~~ or ~~manufacturing~~perform iscertain ~~delayed, our~~required ~~future prospects could be significantly impacted and our financial prospects would be materially harmed.~~operations;

~~We or~~● ~~our~~changes ~~suppliers~~in ~~may~~government ~~experience~~regulations ~~development~~or in quality or other requirements that lead to additional manufacturing ~~problems~~costs or ~~delays~~an ~~that~~inability ~~could~~to ~~limit~~supply ~~the~~product ~~growth~~in ofa ~~our~~timely ~~revenue~~manner, orif ~~increase our~~at ~~losses.~~all; and

~~We may~~● ~~encounter~~increases ~~unforeseen situations~~ in ~~the~~raw ~~manufacturing~~material ~~of our diagnostic products that could result in delays~~ or ~~shortfalls~~component insupply ~~our production.~~cost ~~Our suppliers may also face similar delays~~ or ~~shortfalls.~~an Ininability ~~addition, our or our suppliers’ production processes may have~~ to ~~change~~obtain tosupplies ~~accommodate any significant future expansion~~ of ~~our~~certain ~~manufacturing~~critical ~~capacity,~~components ~~which may increase our~~ or ~~our~~supplies ~~suppliers’ manufacturing~~needed ~~costs, delay production of our diagnostic products, reduce our product gross margin and adversely impact our business. If we are unable~~ to ~~satisfy~~complete ~~demand for~~ our ~~diagnostic products by successfully~~ manufacturing and shipping our diagnostic products in a timely manner, our revenue could be impaired, market acceptance for our assays could be adversely affected and our customers might instead purchase our competitors’ assays. In addition, developing manufacturing procedures for assays under development may require developing specific production processes ~~for those assays~~. ~~Developing such processes could be time consuming and any unexpected difficulty in doing so can delay the introduction of a product.~~

19These and other difficulties may only become apparent when scaling up to the manufacturing process of our diagnostic products to a more substantive commercial scale. If our diagnostic products cannot be manufactured in sufficient commercial quantities or manufacturing is delayed, our future prospects could be significantly impacted and our financial prospects would be materially harmed.

We ~~utilize~~ ~~third-party,~~or ~~single-source~~our suppliers ~~for~~may ~~some~~experience ~~components~~development ~~and~~or ~~materials~~manufacturing problems ~~used~~or indelays ~~our~~that ~~products~~could ~~and~~limit ~~product candidates, and~~ the ~~loss of~~growth ~~any~~ of ~~these~~our ~~suppliers~~revenue ~~could~~or ~~have~~increase ~~an adverse impact on~~ our ~~business~~losses.

We ~~rely~~ onmay ~~single-source~~encounter ~~suppliers~~unforeseen ~~for~~situations ~~some~~in ~~components~~the ~~and~~manufacturing ~~materials~~of ~~used in~~ our diagnostic products ~~and~~that ~~product~~could ~~candidates.~~result ~~Our~~in ~~ability~~delays toor ~~supply~~ shortfalls in our ~~products~~production. ~~commercially~~Our ~~and~~suppliers tomay ~~develop~~also ~~any~~face ~~future~~similar ~~products~~delays ~~depends,~~or inshortfalls. In ~~part~~addition, onour or our ~~ability~~suppliers’ toproduction ~~obtain~~processes ~~these~~may ~~components~~have into ~~accordance with~~change ~~regulatory~~to ~~requirements~~accommodate ~~and~~any insignificant ~~sufficient~~future ~~quantities~~expansion ~~for~~of ~~clinical~~our manufacturing ~~testing~~capacity, ~~and~~which ~~commercialization.~~may ~~While~~increase our ~~suppliers~~or ~~have generally met~~ our ~~demand~~suppliers’ ~~for~~manufacturing ~~their~~costs, ~~products~~delay onproduction aof ~~timely~~our ~~basis~~diagnostic ~~in the past~~products, reduce ~~these~~our ~~were~~product ~~with~~gross ~~limited~~margin ~~production quantities~~ and weadversely ~~cannot~~impact ~~assure~~our ~~that they~~business. ~~will~~If inwe ~~the~~are ~~future~~unable ~~be able~~ to ~~meet~~satisfy ~~our~~ demand for ~~their~~our diagnostic products, ~~either~~by ~~because~~successfully manufacturing weand doshipping ~~not~~our ~~have~~diagnostic ~~long-term~~products ~~agreements~~in ~~with~~a ~~those suppliers~~timely manner, our ~~relative~~revenue ~~importance~~could asbe aimpaired, ~~customer~~market toacceptance ~~those~~for ~~suppliers,~~our orassays could ~~their~~be ~~ability~~adversely toaffected ~~produce~~and ~~the~~our ~~components~~customers ~~used~~might ininstead purchase our ~~products~~competitors’ assays. ~~For~~ ~~example~~In addition, ~~our~~developing ~~supplier~~manufacturing procedures offor ~~printed~~assays ~~electrodes~~under ~~has~~development ~~exited~~may ~~the~~require ~~printing~~developing ~~business.~~specific Weproduction ~~purchased~~processes ~~safety~~for ~~stock~~those ~~from~~assays. ~~the~~Developing ~~supplier~~such ~~prior to~~processes ~~their~~could ~~discontinuing~~be ~~production~~time consuming and ~~have~~any ~~begun~~unexpected ~~qualification~~difficulty in doing so can delay the introduction of a ~~replacement supplier~~product.

~~While we~~We ~~believe~~utilize ~~replacement~~third-party, ~~suppliers exist for all components and materials we obtain from~~ single-source ~~sources, establishing additional or replacement~~ suppliers for ~~any~~some ~~of these~~ components and or materials, ifused ~~required,~~in ~~may~~our ~~not~~products beand ~~accomplished~~product ~~quickly. Even if we are able to find a replacement supplier~~candidates, ~~the replacement supplier would need to be qualified~~ and ~~may~~the ~~require~~loss ~~additional~~of ~~regulatory~~any ~~authority~~of ~~approval,~~these ~~which~~suppliers could ~~result in~~have ~~further~~an ~~delay.~~adverse ~~While~~impact weon ~~will seek to maintain adequate inventory of the single-source components and materials used in~~ our ~~products~~ ~~in the event of disruption, those inventories may not be sufficient~~business.

~~If our~~We ~~third~~rely on single-~~party~~source suppliers ~~fail~~for some components and materials used in our products and product candidates. Our ability to ~~deliver~~supply ~~the~~our ~~required~~products ~~commercial~~commercially and to develop any future products depends, in part, on our ability to obtain these components in accordance with regulatory requirements and in sufficient quantities offor ~~materials~~clinical testing and commercialization. While our suppliers have generally met our demand for their products on a timely basis ~~and~~in atthe ~~commercially~~past, ~~reasonable~~these ~~prices,~~were with limited production quantities and we ~~are~~cannot ~~unable~~assure that they will in the future be able to ~~find~~meet ~~one~~our ordemand ~~more~~for ~~replacement~~their ~~suppliers~~products, either ~~capable~~because ofwe ~~production~~do atnot ahave ~~substantially~~long-term ~~equivalent~~agreements ~~cost~~with inthose ~~substantially equivalent~~suppliers, ~~volumes~~our ~~and~~relative ~~quality~~importance onas a ~~timely~~customer ~~basis~~to those suppliers, or their ability to produce the ~~continued~~components ~~commercialization~~used ofin our products. For example, ~~the~~our ~~supply~~supplier of ~~our~~printed ~~products~~electrodes tohas ~~customers and~~exited the ~~development~~printing business. ofWe ~~any~~purchased ~~future~~safety ~~products~~stock ~~would~~from bethe ~~delayed,~~supplier ~~limited~~prior orto ~~prevented,~~their ~~which~~discontinuing ~~could~~production and have anbegun ~~adverse~~qualification ~~impact~~of ona ~~our business~~replacement supplier.

~~Manufacturing~~While we believe replacement suppliers exist for all components and ~~risks~~materials we obtain from single sources, establishing additional or replacement suppliers for any of these components or materials, if required, may ~~adversely~~not ~~affect~~be ~~our~~accomplished ~~ability~~quickly. Even if we are able to ~~manufacture~~find ~~products~~a replacement supplier, the replacement supplier would need to be qualified and may require additional regulatory authority approval, which could ~~reduce~~result ~~our~~in ~~gross~~further ~~margins~~delay. While we will seek to maintain adequate inventory of the single-source components and ~~negatively~~materials ~~affect~~used in our ~~operating~~products in the event of disruption, those inventories may ~~results~~not be sufficient.

~~Our~~If our third-party suppliers fail to deliver the required commercial ~~business~~quantities ~~strategy~~of ~~depends~~materials on ~~our~~a ~~ability~~timely tobasis ~~manufacture~~ and ~~assemble~~at ~~our~~commercially ~~current~~reasonable prices, and ~~proposed~~we ~~products~~are inunable ~~sufficient~~to ~~quantities~~find ~~and~~one onor more replacement suppliers acapable ~~timely~~of ~~basis~~production toat ~~meet~~a ~~consumer~~substantially ~~demand,~~equivalent ~~while~~cost ~~adhering~~in tosubstantially ~~product~~equivalent ~~quality~~volumes ~~standards,~~and ~~complying~~quality ~~with~~on ~~regulatory~~a ~~requirements~~timely ~~and~~basis, ~~managing~~the continued ~~manufacturing~~commercialization ~~costs.~~of Weour ~~are~~products, ~~subject~~the tosupply ~~numerous~~of ~~risks~~our ~~relating~~products to ~~our~~customers ~~manufacturing~~and ~~capabilities,~~the ~~including:~~development of any future

~~● quality or reliability defects in or changes in the composition of product components that we source from third party suppliers;~~17

●Manufacturing ~~our~~risks ~~inability~~may toadversely ~~secure~~affect ~~product~~our ~~components~~ability into amanufacture products ~~timely~~and ~~manner,~~could inreduce ~~sufficient~~our ~~quantities~~gross ormargins onand ~~commercially~~negatively ~~reasonable~~affect ~~terms;~~our operating results.

●Our business strategy depends on our ~~failure~~ability to ~~increase~~manufacture ~~production~~and ofassemble our current and proposed products in sufficient quantities and on a timely basis to meet consumer demand;, while adhering to product quality standards, complying with regulatory requirements and managing manufacturing costs. We are subject to numerous risks relating to our manufacturing capabilities, including:

● quality or reliability defects in or changes in the ~~challenge~~composition of ~~implementing~~product ~~and~~components ~~maintaining~~that ~~acceptable~~we ~~quality~~source ~~systems~~from ~~while~~third ~~experiencing~~party ~~rapid growth~~suppliers;

● our inability to ~~build~~secure ~~production~~product ~~lines~~components toin ~~enable~~a ustimely tomanner, ~~efficiently~~in ~~produce~~sufficient ~~products;~~quantities ~~and~~or on commercially reasonable terms;

● ~~difficulty~~our ~~identifying~~failure ~~and~~to ~~qualifying~~increase ~~alternative~~production ~~suppliers~~of ~~for~~products ~~components~~to inmeet ~~a timely manner.~~demand;

20● the challenge of implementing and maintaining acceptable quality systems while experiencing rapid growth;

~~As demand~~● ~~for~~ our ~~products~~inability ~~increases, we will need~~ to ~~invest~~build ~~additional resources to purchase components, hire and train employees, and enhance our manufacturing processes and implement manufacturing and quality systems. If we fail to increase our~~ production capacity efficiently while also maintaining quality requirements, our sales may not increase in line with our forecasts and our operating margins could fluctuate or decline. In addition, while we expect most new products will utilize the eLab instrument system and existing consumable cartridge, manufacturing of future products may require the modification of our production lines, ~~the~~to ~~hiring~~enable ~~of specialized employees, the identification of new suppliers for specific components, or the development of new manufacturing technologies. It may not be possible for~~ us to ~~manufacture these~~efficiently ~~products~~produce ~~at a cost or in quantities sufficient to make these~~ products; ~~commercially viable. Any future interruptions we experience in the manufacturing or shipping of our products could delay our ability to recognize revenues in a particular quarter~~ and ~~could also adversely affect our relationships with our customers.~~

~~We expect~~● todifficulty ~~rely~~identifying onand ~~third~~qualifying ~~parties~~alternative tosuppliers ~~conduct~~for ~~studies~~components ofin ~~our~~a ~~assays~~timely ~~under development that will be required by the FDA or other regulatory authorities and those third parties may not perform satisfactorily~~manner.

~~We do~~As ~~not~~demand ~~have~~for ~~the~~our ~~ability~~products toincreases, ~~independently~~we ~~conduct~~will ~~the~~need ~~field~~to ~~trial~~invest ~~studies~~additional resources orto ~~other~~purchase ~~studies~~components, ~~that~~hire ~~may~~and betrain ~~required~~employees, toand ~~obtain~~enhance ~~FDA~~our ~~and~~manufacturing ~~other regulatory~~processes ~~clearances~~and orimplement ~~approvals~~manufacturing ~~for~~and ~~our assays~~quality systems. ~~Accordingly,~~If we ~~expect~~fail to ~~rely~~increase onour ~~third~~production ~~parties,~~capacity ~~such~~efficiently aswhile ~~independent~~also ~~testing~~maintaining ~~laboratories and~~quality ~~hospitals~~requirements, ~~to conduct such studies. Our reliance on these third parties will reduce~~ our ~~control~~sales ~~over these activities. These third-party contractors~~ may not ~~complete activities on schedule or conduct studies~~ increase in ~~accordance~~line with ~~regulatory~~our ~~requirements~~forecasts orand our ~~study~~operating ~~design. We~~margins ~~cannot~~could ~~control~~fluctuate ~~whether~~or ~~they~~decline. ~~devote~~In ~~sufficient time~~addition, ~~skill~~while ~~and~~we ~~resources~~expect tomost ~~our~~new ~~studies.~~products ~~Our~~will ~~reliance~~utilize the oneLab ~~third~~instrument ~~parties~~system ~~that~~and weexisting doconsumable ~~not control~~cartridge, ~~will~~manufacturing ~~not relieve us~~ of ~~any~~future ~~applicable~~products ~~requirement~~may torequire ~~prepare,~~the ~~and~~modification ~~ensure~~of ~~compliance~~our ~~with~~production lines, ~~various~~the ~~procedures~~hiring ~~required~~of ~~under~~specialized ~~good clinical~~employees, ~~practices.~~the Ifidentification ~~these~~of ~~third~~new ~~parties~~suppliers dofor ~~not~~specific ~~successfully~~components, ~~carry out their contractual duties~~ or ~~regulatory~~the ~~obligations~~development orof ~~meet~~new ~~expected~~manufacturing ~~deadlines,~~technologies. ifIt ~~the~~may ~~third~~not ~~parties need to~~ be ~~replaced~~possible orfor ifus ~~the~~to ~~quality~~manufacture orthese ~~accuracy~~products ofat ~~the~~a ~~data~~cost ~~they~~or ~~obtain~~in isquantities ~~compromised~~sufficient ~~due~~ to ~~their~~make these products ~~failure~~commercially toviable. ~~adhere~~Any tofuture ~~our~~interruptions ~~clinical~~we ~~protocols~~experience orin ~~regulatory~~the ~~requirements~~manufacturing or ~~for~~shipping ~~other~~of ~~reasons,~~ our ~~studies~~products ~~may~~could bedelay ~~extended,~~our ~~delayed,~~ability ~~suspended~~to orrecognize ~~terminated,~~revenues ~~and~~in wea ~~may~~particular ~~not~~quarter beand ~~able~~could toalso ~~obtain~~adversely ~~regulatory~~affect ~~approval~~our ~~for~~relationships ~~additional~~with ~~assays~~our customers.

~~Any clinical~~We ~~trials~~expect ~~that~~to werely ~~may conduct may not begin~~ on ~~time,~~third orparties atto ~~all,~~conduct ~~may~~studies ~~not~~of beour assays ~~completed~~under ondevelopment ~~schedule,~~that orwill ~~at all, or may~~ be ~~more~~required ~~expensive than~~by wethe ~~expect,~~FDA ~~which could prevent~~ or ~~delay~~other regulatory ~~approval~~authorities ofand ~~our~~those ~~assays~~third orparties ~~impair~~may ~~our~~not ~~financial~~perform ~~position~~satisfactorily.

~~The~~We do not have the ability to independently conduct the field trial ~~commencement~~studies or ~~completion~~other ofstudies ~~any~~that ~~clinical~~may ~~trials~~be ~~that~~required to obtain FDA and other regulatory clearances or approvals for our assays. Accordingly, we ~~may~~expect to rely on third parties, such as independent testing laboratories and hospitals, to conduct such studies. Our reliance on these third parties will reduce our control over these activities. These third-party contractors may not complete activities on schedule or conduct studies in accordance with regulatory requirements or our study design. We cannot control whether they devote sufficient time, skill and resources to our studies. Our reliance on third parties that we do not control will not relieve us of any applicable requirement to prepare, and ensure compliance with, various procedures required under good clinical practices. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if the third parties need to be ~~delayed~~replaced or ~~halted~~if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our clinical protocols or regulatory requirements or for ~~numerous~~other reasons, ~~including~~our studies may be extended, ~~but~~delayed, suspended or terminated, and we may not ~~limited~~ be able to, ~~the~~obtain ~~following:~~regulatory approval for additional assays.

●Any ~~the~~clinical ~~FDA~~trials orthat ~~other~~we ~~regulatory~~may ~~authorities~~conduct ~~suspend~~may not begin on time, or ~~place~~at all, may not be completed on ~~hold~~schedule, aor ~~clinical~~at ~~trial~~all, or domay ~~not~~be ~~approve~~more aexpensive ~~clinical~~than ~~trial~~we ~~protocol~~expect, which could prevent or adelay ~~clinical~~regulatory approval ~~trial;~~of our assays or impair our financial position.

●The ~~the~~commencement ~~data~~or ~~and~~completion ~~safety~~of ~~monitoring~~any ~~committee~~clinical ortrials ~~applicable~~that ~~hospital~~we ~~institutional~~may conduct ~~ethics~~may ~~review~~be ~~board~~delayed ~~recommends~~or ~~that~~halted afor ~~trial~~numerous bereasons, ~~placed~~including, onbut ~~hold~~not orlimited ~~suspended;~~to, the following:

● ~~fewer~~the ~~patients~~FDA ~~meet~~or ~~our~~other regulatory authorities suspend or place on hold a clinical ~~study~~trial, ~~criteria~~or ~~and~~do ~~our~~not ~~enrollment~~approve ~~rate~~a isclinical ~~lower~~trial ~~than~~protocol weor ~~expected~~a clinical trial;

● ~~clinical~~the ~~trial~~data ~~sites~~and ~~decide~~safety ~~not~~monitoring tocommittee ~~participate~~ or ~~cease~~applicable ~~participation~~hospital ininstitutional aethics ~~clinical~~review board recommends that a trial be placed on hold or suspended;

● ~~third-party~~fewer ~~clinical~~patients ~~investigators~~meet ~~do not perform~~ our clinical ~~trials~~study oncriteria ~~schedule or consistent with the clinical trial protocol~~ and ~~good~~our ~~clinical~~enrollment ~~practices,~~rate oris ~~other~~lower ~~third-party~~than ~~organizations~~we ~~do not perform data collection and analysis in a timely or accurate manner~~expected;

● weclinical ~~fail~~trial ~~regulatory~~sites ~~inspections~~decide ofnot ~~our manufacturing facilities requiring us~~ to ~~undertake~~participate ~~corrective action~~ or ~~suspend~~cease orparticipation ~~terminate~~in ~~our~~a clinical ~~trials~~trial;

~~● interim results of the clinical trial are inconclusive or negative;~~18

● ~~pre~~third-party clinical investigators do not perform our clinical trials on schedule or consistent with the clinical ~~data~~trial ~~are~~protocol ~~interpreted~~and bygood clinical practices, or other third-party ~~parties~~organizations do not perform data collection and analysis in ~~unanticipated~~a ~~ways;~~timely or accurate manner;

● we fail regulatory inspections of our ~~trial~~manufacturing ~~design~~facilities isrequiring ~~inadequate~~us to ~~demonstrate~~undertake ~~safety~~corrective ~~and/~~action or ~~efficacy.~~suspend or terminate our clinical trials;

21● interim results of the clinical trial are inconclusive or negative;

~~Our clinical~~● ~~trial costs will increase if we have material delays in those trials or if we need to perform more or larger trials than planned. Adverse events during a~~ pre-clinical ~~trial could cause us to repeat a trial, terminate a trial~~ or ~~cancel an entire program. Should our~~ clinical ~~development~~ ~~plan~~data beare ~~delayed,~~interpreted ~~this~~by ~~could~~third ~~have~~parties ain ~~material~~unanticipated ~~adverse~~ways; ~~effect on our operations and financial condition.~~or

~~Product liability~~● ~~claims~~our ~~could~~trial ~~adversely~~design ~~impact~~is ~~our~~inadequate ~~financial~~to ~~condition~~demonstrate ~~and~~safety ~~our earnings~~ and/or ~~impair our reputation~~efficacy.

Our ~~business~~ ~~exposes~~clinical ustrial tocosts ~~potential~~will ~~product~~increase ~~liability~~if ~~risks~~we ~~that~~have ~~are~~material ~~inherent~~delays in ~~the design, manufacture and marketing of medical devices.~~ ~~Device~~those ~~failures,~~trials ~~manufacturing defects, design flaws,~~ or ~~inadequate~~if ~~disclosure~~we ofneed ~~product-related risks or product-related information with respect~~ to ~~our~~perform ~~assays~~more ~~could result in an unsafe condition regarding, injury to,~~ or ~~death~~larger ~~of,~~trials athan ~~patient~~planned. ~~The~~Adverse ~~occurrence~~events ofduring ~~such~~ a ~~problem~~ ~~could~~clinical ~~result~~trial incould ~~product~~cause ~~liability~~us ~~claims~~to or repeat a ~~recall of~~trial, orterminate ~~safety~~a ~~alert~~trial ~~relating to, one~~ or ~~more~~cancel ofan ~~our~~entire ~~assays~~program. ~~Product~~Should ~~liability claims~~our orclinical ~~product~~development ~~recalls~~plan inbe ~~the future~~delayed, ~~regardless~~this ~~of their ultimate outcome,~~ could have a material adverse effect on our ~~business~~operations and ~~reputation~~ ~~and~~financial ~~on our ability to attract and retain customers for our assays~~condition.

~~If our~~Product ~~diagnostic~~liability ~~products~~claims docould ~~not~~adversely ~~perform~~impact ~~as expected,~~ our ~~operating~~financial condition ~~results,~~and ~~reputation~~our earnings and ~~business~~impair ~~will~~our ~~suffer~~reputation.

Our ~~future~~ ~~success~~business ~~will~~exposes ~~depend~~us onto ~~the~~potential ~~market’s~~product ~~confidence~~liability risks that are ~~our~~inherent ~~technologies~~in ~~can~~the ~~provide reliable~~design, ~~high-quality~~manufacture ~~diagnostic~~and ~~results. We~~marketing ~~believe~~of ~~that~~medical ~~our~~devices. ~~customers~~Device ~~are~~failures, ~~likely~~manufacturing todefects, bedesign ~~particularly~~flaws, ~~sensitive~~or toinadequate disclosure ~~any~~of ~~defects~~product-related risks or ~~errors~~product-related ininformation ~~our~~with ~~products.~~respect Ifto our ~~technology~~assays ~~fails to~~could ~~perform~~result ain ~~clinical~~an ~~test~~unsafe condition regarding, injury ~~then~~to, weor ~~could~~death ~~face~~of, ~~claims~~a ~~against~~patient. usThe oroccurrence ~~our~~of ~~reputation~~such a problem could ~~suffer~~result asin aproduct ~~result~~liability ofclaims ~~such~~or ~~failures.~~a ~~The~~recall ~~failure~~ of, ~~our~~or ~~current~~safety alert ~~products~~relating to, one or ~~planned~~more ~~diagnostic~~of ~~product~~our ~~candidates~~assays. toProduct ~~perform~~liability ~~reliably~~claims or asproduct ~~expected~~recalls ~~could~~in ~~significantly~~the ~~impair~~future, ~~our~~regardless ~~reputation~~of their ultimate ~~and~~outcome, ~~the~~could ~~public~~have ~~image~~a ofmaterial adverse effect on our ~~products,~~business and wereputation ~~may~~and beon ~~subject~~our ability to ~~legal~~attract ~~claims~~and ~~arising~~retain ~~from~~customers ~~any~~for ~~defects or errors~~our assays.

~~Our products~~If ~~may~~our ~~not be able to compete with new~~ diagnostic products ordo ~~existing~~not ~~products~~perform ~~developed~~as byexpected, ~~well-established~~our ~~competitors~~operating results, ~~which would~~reputation ~~negatively~~and ~~affect~~business ~~our~~will ~~business~~suffer.

~~The diagnostic~~Our ~~industry~~future issuccess ~~focused~~will depend on the ~~testing~~market’s ofconfidence that ~~biological~~our ~~specimens~~technologies can provide reliable, high-quality diagnostic results. We believe that our customers are likely to be particularly sensitive to any defects or errors in our products. If our technology fails to perform a ~~laboratory~~clinical test, then we could face claims against us or atour ~~the~~reputation ~~point-of-care~~could ~~and~~suffer isas ~~highly~~a ~~competitive and~~result ~~rapidly~~of ~~changing~~such failures. ~~Important~~The ~~competitive~~failure ~~factors~~of ~~for~~ our current products ~~include~~or ~~price,~~planned ~~quality,~~diagnostic ~~performance,~~product ~~ease~~candidates to perform reliably or as expected could significantly impair our reputation and the public image of ~~use~~our products, and ~~customer~~we ~~service~~may be subject to legal claims arising from any defects or errors.

~~A few~~Our ~~large~~products ~~corporations~~may ~~produce~~not abe ~~wide~~able ~~variety~~to ~~of diagnostic tests and other medical devices and equipment. A larger number of mid-size companies generally~~ compete ~~only~~with innew ~~the~~ diagnostic ~~industry~~products or ~~and~~existing ~~a significant number of small companies produce only a few diagnostic~~ products. Asdeveloped aby ~~result~~well-established competitors, ~~the~~which ~~diagnostic~~would ~~test~~negatively ~~industry~~affect isour ~~highly fragmented and segmented~~business.

~~Some of~~The ~~our principal competitors may have considerably greater financial, technical and marketing resources than we do. Several companies produce~~ diagnostic ~~tests~~industry ~~that~~is ~~compete~~focused ~~directly~~on ~~with~~the ~~our~~ testing ~~product~~of ~~line,~~biological ~~including Abbott (Alere), Siemens, Becton Dickinson, and~~specimens ~~Danaher.~~in ~~Some~~a ~~competitors~~laboratory ~~offer~~or ~~broader~~at ~~product~~the ~~lines~~point-of-care and ~~may~~is ~~have~~highly ~~greater~~competitive ~~name~~and ~~recognition~~rapidly ~~than we have~~changing. ~~These~~Important ~~and~~competitive ~~other~~factors ~~companies~~for ~~have or~~our ~~may have~~ products include ~~incorporating~~price, ~~advanced~~quality, ~~technologies~~performance, ~~that~~ease ~~over~~of ~~time~~use, ~~could~~and ~~directly~~customer ~~compete with our testing product line~~service.

~~As new~~A ~~products~~few ~~incorporating~~large ~~new~~corporations ~~technologies~~produce ~~enter~~a ~~the~~wide ~~market,~~variety ~~our~~of ~~products~~diagnostic ~~may~~tests and ~~become~~other ~~obsolete~~medical ordevices aand ~~competitor’s~~equipment. ~~products~~A ~~may~~larger ~~be more~~number ~~effective~~of ormid-size ~~more~~companies ~~effectively~~generally ~~marketed~~compete ~~and~~only ~~sold.~~in Ifthe ~~our~~diagnostic ~~competitors’~~industry ~~products~~and ~~take~~a significant ~~market~~number ~~share~~of ~~from~~small ~~our~~companies ~~products~~produce ~~through more~~only ~~effective~~a ~~marketing~~few ordiagnostic ~~competitive~~products. ~~pricing,~~As ~~our~~a ~~revenues~~result, ~~margins~~the ~~and~~diagnostic ~~operating~~test ~~results~~industry ~~could~~is behighly ~~adversely~~fragmented and ~~affected~~segmented.

~~Our~~Some of our principal competitors may have considerably greater financial, ~~future~~technical ~~revenues~~and marketing resources than we do. Several companies produce diagnostic tests that compete directly with our testing product line, including Abbott (Alere), Siemens, Becton Dickinson, and ~~operating~~Danaher. ~~results~~Some competitors offer broader product lines and may behave ~~negatively~~greater name ~~affected~~recognition bythan ~~ongoing~~we ~~consolidation~~have. inThese ~~the~~and ~~healthcare~~other ~~industry~~companies have or may have products incorporating advanced technologies that over time could directly compete with our testing product line.

~~There has~~As ~~been~~new aproducts ~~significant~~incorporating ~~amount~~new oftechnologies ~~consolidation~~enter in the ~~healthcare~~market, ~~industry.~~our products ~~This~~may ~~consolidation~~become ~~has~~obsolete ~~increased~~or ~~the~~a ~~competition~~competitor’s toproducts ~~provide goods~~may ~~and~~be ~~services~~more toeffective ~~customers.~~or Inmore ~~addition,~~effectively ~~group~~marketed ~~purchasing organizations~~ and ~~integrated~~sold. ~~health~~If ~~delivery~~our ~~networks~~competitors’ products ~~have~~take ~~served~~market toshare ~~concentrate purchasing~~from ~~decisions~~our ~~for~~products ~~some~~through ~~customers,~~more ~~which~~effective ~~has~~marketing ~~also~~or ~~placed~~competitive pricing, ~~pressure~~our onrevenues, ~~medical~~margins ~~device~~and ~~suppliers. Due to ongoing consolidation,~~operating ~~there~~results could be ~~additional~~adversely ~~pressure on the prices of our products~~affected.

2219

~~Undetected errors~~Our orfuture ~~defects~~revenues inand ~~our~~operating ~~products~~results ormay ~~product~~be ~~candidates~~negatively ~~could~~affected by ~~harm~~ongoing ~~our~~consolidation ~~reputation,~~in ~~decrease~~the ~~market~~healthcare ~~acceptance of our products or expose us to product liability claims~~industry.

~~Our products~~There orhas ~~product~~been ~~candidates~~a ~~may~~significant ~~contain~~amount ~~undetected~~of ~~errors~~consolidation orin ~~defects~~the healthcare industry. ~~Disruptions~~This orconsolidation ~~other~~has ~~performance~~increased ~~problems~~the ~~with~~competition ~~our~~to ~~products or~~provide ~~product~~goods ~~candidates may damage our customers’ businesses~~ and ~~could~~services ~~harm~~to ~~our reputation~~customers. IfIn ~~that occurs~~addition, wegroup ~~may~~purchasing ~~incur significant~~organizations ~~costs,~~and ~~the~~integrated ~~attention~~health ofdelivery ~~our~~networks ~~key~~have ~~personnel~~served ~~could be diverted or other significant customer relations problems may arise. We may also be subject~~ to ~~warranty~~concentrate ~~and~~purchasing ~~liability~~decisions ~~claims~~ for ~~damages~~some ~~related~~customers, towhich ~~errors~~has oralso ~~defects~~placed inpricing pressure ~~our~~on ~~products~~medical ordevice ~~product candidates~~suppliers. ADue ~~material~~to ~~liability claim~~ongoing orconsolidation, ~~other~~there ~~occurrence~~could ~~that~~be ~~harms~~additional ~~our~~pressure ~~reputation~~on orthe ~~decreases~~prices ~~market acceptance~~ of our products ~~or product candidates could harm our business and operating results~~.

~~The sale~~Undetected ~~and~~errors ~~use of products~~ or ~~product~~defects ~~candidates~~in ~~or services based on~~ our ~~technologies, or activities related to our research and clinical studies, could lead to the filing of product liability claims if someone were to allege that one of our~~ products ~~contained a design~~ or ~~manufacturing~~ ~~defect. A~~ product ~~liability claim could result in substantial damages and be costly and time consuming to defend, either~~candidates ~~of which~~ could ~~materially~~ harm our ~~business~~reputation, ordecrease ~~financial~~market ~~condition.~~acceptance Weof ~~cannot assure you that~~ our ~~product~~products ~~liability~~or ~~insurance~~expose ~~would adequately protect our assets from the financial impact of defending a product liability claim. Any product liability claim brought against~~ us~~, with~~ orto ~~without merit, could increase our~~ product liability ~~insurance rates or prevent us from securing insurance coverage in the future~~claims.

WeOur products or product candidates may contain undetected errors or ~~currently~~defects. ~~develop,~~Disruptions ~~manufacture~~or ~~and~~other ~~test~~performance problems with our products ~~and~~or product candidates ~~and~~may ~~some~~damage ofour ~~their~~customers’ ~~components~~businesses and incould aharm ~~single~~our ~~facility~~reputation. If ~~these or~~that ~~any~~occurs, ~~future~~we ~~facility~~may orincur significant costs, the attention of our ~~equipment~~key ~~were~~personnel ~~damaged~~could orbe ~~destroyed,~~diverted or other ifsignificant wecustomer ~~experience~~relations aproblems ~~significant~~may ~~disruption~~arise. inWe ~~our~~may ~~operations~~also be subject to warranty and liability claims for damages related to ~~any~~errors ~~reason,~~or defects in our ~~ability~~products toor ~~continue~~product tocandidates. ~~operate~~A material liability claim or other occurrence that harms our ~~business~~reputation or decreases market acceptance of our products or product candidates could beharm ~~materially~~our ~~harmed~~business and operating results.

~~We currently~~The ~~develop,~~sale ~~manufacture~~ and ~~test~~use ~~our~~of products ~~and~~or product candidates ~~exclusively~~or inservices based aon ~~facility~~our intechnologies, ~~Emeryville~~or activities related to our research and clinical studies, ~~California.~~could Iflead ~~this or~~to ~~any~~the ~~future~~filing ~~facility~~of product liability claims if someone were to beallege ~~damaged,~~that ~~destroyed~~one orof ~~otherwise~~our ~~unable~~products tocontained ~~operate,~~a ~~whether~~design ~~due~~or tomanufacturing ~~fire,~~defect. ~~floods,~~A ~~hurricanes,~~product ~~storms,~~liability claim could result ~~tornadoes,~~in ~~other~~substantial ~~natural~~damages ~~disasters,~~and ~~employee~~be ~~malfeasance,~~costly ~~terrorist~~and ~~acts,~~time ~~power~~consuming ~~outages~~to defend, oreither ~~otherwise,~~of orwhich ifcould materially harm our business isor ~~disrupted~~financial condition. ~~for~~We ~~any~~cannot ~~other~~assure ~~reason,~~you wethat ~~may~~our ~~not~~product beliability ~~able~~insurance towould ~~develop~~adequately orprotect ~~test~~ our ~~products~~assets ~~and~~from the financial impact of defending a product ~~candidates~~liability asclaim. ~~promptly~~Any asproduct liability claim brought against us, with or without merit, could increase our ~~potential~~product ~~customers~~liability insurance ~~expect,~~rates or ~~possibly~~prevent ~~not~~us atfrom ~~all~~securing insurance coverage in the future.

~~The manufacture~~We ofcurrently ~~components~~develop, ofmanufacture and test our products and product candidates ~~involves complex processes, sophisticated equipment~~ and ~~strict~~some ~~adherence to~~of ~~specifications~~their ~~and~~components ~~quality~~in ~~systems~~a ~~procedures~~single facility. ~~Any~~If ~~unforeseen~~these ~~manufacturing~~or ~~problems,~~any ~~such~~future asfacility ~~contamination~~or of our ~~facility,~~ equipment ~~malfunction,~~ orwere ~~failure~~damaged ~~to strictly follow procedures~~ or ~~meet specifications~~destroyed, or ~~could~~if ~~result~~we inexperience ~~delays~~a orsignificant ~~shortfalls~~disruption in ~~production of~~ our ~~products.~~ ~~Identifying~~operations ~~and~~for ~~resolving the cause of~~ any manufacturing issues could require substantial time and resources. If we are unable to keep up with future demand for our products by successfully manufacturing and shipping our products in a timely mannerreason, our ~~revenue growth~~ability ~~could~~to becontinue ~~impaired~~to ~~and~~operate ~~market acceptance of~~ our ~~product~~business ~~candidates~~ could be materially ~~adversely affected~~harmed.

AsWe ofcurrently ~~March 31~~develop, ~~2022,~~manufacture weand ~~have~~test ~~entered~~our ~~into~~products aand ~~new~~product candidates exclusively in a facility ~~lease~~in ~~and~~San ~~have~~Leandro, ~~relocated~~California. ~~our~~If ~~operations~~this or any future facility were to ~~the~~be ~~new~~damaged, ~~location.~~destroyed ~~Moving~~or ~~our~~otherwise unable ~~manufacturing~~to ~~and~~operate, ~~development~~whether ~~facility~~due ~~requires~~to ~~revalidation~~fire, floods, hurricanes, storms, tornadoes, other natural disasters, employee malfeasance, terrorist ~~and~~acts, ~~startup~~power ofoutages, or otherwise, or if our ~~manufacturing~~business ~~equipment~~is ~~and~~disrupted ~~processes~~for ~~and~~any other reason, we may ~~interrupt~~not ~~our~~be ~~business~~able ~~resulting~~to indevelop ~~higher~~or ~~costs~~test our products and ~~potentially~~product ~~lost revenue~~candidates as promptly as our potential customers expect, or possibly not at all.

~~We maintain~~The ~~insurance~~manufacture ~~coverage~~of ~~against~~components ~~damage~~of to our ~~property~~products and ~~equipment~~product candidates involves complex processes, ~~subject~~sophisticated equipment and strict adherence to ~~deductibles~~specifications and ~~other~~quality ~~limitations~~systems ~~that~~procedures. weAny ~~believe~~unforeseen ismanufacturing ~~adequate.~~problems, Ifsuch weas ~~have~~contamination ~~underestimated~~of our ~~insurance~~facility, ~~needs~~equipment ~~with~~malfunction, ~~respect~~or failure to anstrictly ~~interruption~~follow procedures or meet specifications, could result in delays or ifshortfalls anin ~~interruption~~production isof ~~not~~our ~~subject~~products. Identifying and resolving the cause of any manufacturing issues could require substantial time and resources. If we are unable to ~~coverage~~keep up with future demand for our products by successfully manufacturing ~~under~~and shipping our ~~insurance~~products ~~policies~~in a timely manner, weour ~~may~~revenue ~~not~~growth could be ~~able~~impaired toand ~~cover~~market acceptance of our ~~losses~~product candidates could be adversely affected.

~~Third-Party~~We maintain insurance coverage against damage to our property and equipment, ~~reimbursement~~subject ~~policies~~to deductibles and ~~potential~~other ~~cost~~limitations ~~constraints~~that ~~could~~we ~~negatively~~believe ~~affect~~is adequate. If we have underestimated our ~~business~~insurance needs with respect to an interruption, or if an interruption is not subject to coverage under our insurance policies, we may not be able to cover our losses.

~~The list of our product end~~Third-~~users~~Party ~~includes~~reimbursement ~~hospitals~~policies and ~~other~~potential ~~healthcare providers. If these end-users do not receive adequate reimbursement for the~~ cost ~~of our products from their patients’ healthcare insurers or payors, the use of our products~~ constraints could be negatively ~~impacted. Furthermore,~~affect ~~the net sales of~~ our ~~products could also be adversely affected by changes in reimbursement policies of government or private healthcare payors~~business.

23The list of our product end-users includes hospitals and other healthcare providers. If these end-users do not receive adequate reimbursement for the cost of our products from their patients’ healthcare insurers or payors, the use of our products could be negatively impacted. Furthermore, the net sales of our products could also be adversely affected by changes in reimbursement policies of government or private healthcare payors.

Hospitals and other healthcare providers who purchase diagnostic products in the United States generally rely on third-party payors, such as private health insurance plans, Medicare and Medicaid, to reimburse all or part of the cost of the product. Due to the overall escalating cost of medical products and services, there is increased pressures on the healthcare industry, both foreign and domestic, to reduce the cost of products and services. Given the efforts to control and reduce healthcare costs in the United States, available levels of reimbursement may change for our existing products or products under development. Third-party reimbursement and coverage may not be available or adequate in either the United States or international markets, current reimbursement amounts may be decreased in the future and future legislation, and regulation or reimbursement policies of third-party payors, may reduce the demand for our products or our ability to sell our products on a profitable basis.

~~Ongoing changes in healthcare regulation could negatively affect our revenues, business and financial condition.~~20

~~There have~~Ongoing ~~been several proposed~~ changes in ~~the United States at the federal and state level for comprehensive reforms regarding the payment for, the availability of and reimbursement for~~ healthcare ~~services.~~regulation ~~These~~could ~~proposals~~negatively ~~have ranged from fundamentally changing federal and~~affect ~~state~~our ~~healthcare reimbursement programs~~revenues, ~~including~~business ~~providing comprehensive healthcare coverage to the public under government-funded programs, to minor modifications to existing programs. One example is the Patient Protection~~ and ~~Affordable~~financial ~~Care or the Affordable Care Act, the Federal healthcare reform law enacted in 2010~~condition.

~~Healthcare reform~~There ~~initiatives~~have ~~will~~been ~~continue~~several ~~to be~~ proposed ~~and~~changes ~~may~~in ~~reduce~~the ~~healthcare~~United ~~related~~States ~~funding~~at inthe federal anand ~~effort.~~state Itlevel isfor ~~impossible~~comprehensive toreforms ~~predict~~regarding the ~~ultimate~~ ~~content~~payment ~~and~~for, ~~timing~~the availability of ~~any~~and reimbursement for healthcare ~~reform~~services. These ~~legislation~~proposals ~~and~~have ~~its~~ranged ~~resulting~~from ~~impact~~fundamentally onchanging ~~us.~~federal Ifand ~~significant~~state ~~reforms~~healthcare ~~are~~reimbursement ~~made~~programs, toincluding ~~the~~providing comprehensive healthcare ~~system~~coverage into the ~~United~~public ~~States~~under government-funded programs, orto inminor ~~other~~modifications ~~jurisdictions,~~to ~~those~~existing ~~reforms~~programs. ~~may~~One ~~increase~~example ~~our~~is ~~costs~~the Patient Protection and Affordable Care or ~~otherwise~~the ~~negatively~~Affordable ~~effect on~~Care ~~our~~Act, ~~financial~~the ~~condition~~Federal ~~and~~healthcare ~~results~~reform oflaw ~~operations~~enacted in 2010.

~~In April~~Healthcare ~~2017,~~reform ~~the~~initiatives ~~European~~will ~~Parliament~~continue ~~passed~~to ~~the~~be ~~Medical~~proposed ~~Devices Regulation (Regulation 2017/745), which repeals~~ and ~~replaces the European~~may ~~Union~~reduce ~~Medical~~healthcare ~~Devices~~related ~~Directive~~funding ~~and~~in ~~the~~an ~~Active Implantable Medical Devices Directive~~effort. ~~Unlike~~It ~~directives,~~is ~~which~~impossible ~~must be implemented into the national laws of the European Economic Area, which we refer~~ to aspredict the ~~EEA,~~ultimate ~~member~~content ~~States,~~and ~~the~~timing ~~regulations~~of ~~would~~any behealthcare ~~directly~~reform ~~applicable,~~legislation ~~i.e.,~~and ~~without~~its ~~the~~resulting ~~need~~impact ~~for~~on ~~adoption~~us. ofIf ~~EEA~~significant ~~member~~reforms ~~State laws implementing them, in all EEA member States and~~ are ~~intended~~made to ~~eliminate current~~the ~~differences~~healthcare system in the ~~regulation~~United ~~of medical devices among EEA member~~ States~~. The Medical Devices Regulation~~, ~~among~~or in other ~~things~~jurisdictions, isthose ~~intended~~reforms tomay ~~establish~~increase aour ~~uniform,~~costs ~~transparent,~~or ~~predictable~~otherwise ~~and~~negatively ~~sustainable~~effect ~~regulatory~~on ~~framework~~our ~~across~~financial ~~the~~condition ~~EEA for medical devices~~ and ~~ensure~~results ~~a high level~~ of ~~safety and health while supporting innovation~~operations. ~~The Medical Devices Regulation will, however, only become fully applicable three years after publication (in May 2020). Once applicable, the Medical Devices Regulation will, among other things:~~

●In ~~strengthen~~April 2017, the ~~rules~~European onParliament ~~placing~~passed ~~devices~~the onMedical Devices Regulation (Regulation 2017/745), which repeals and replaces the ~~market~~European Union Medical Devices Directive and ~~reinforce~~the ~~surveillance~~Active ~~once~~Implantable ~~they~~Medical Devices Directive. Unlike directives, which must be implemented into the national laws of the European Economic Area, which we refer to as the EEA, member States, the regulations would be directly applicable, i.e., without the need for adoption of EEA member State laws implementing them, in all EEA member States and are ~~available;~~intended to eliminate current differences in the regulation of medical devices among EEA member States. The Medical Devices Regulation, among other things, is intended to establish a uniform, transparent, predictable and sustainable regulatory framework across the EEA for medical devices and ensure a high level of safety and health while supporting innovation. The Medical Devices Regulation will, however, only become fully applicable three years after publication (in May 2020). Once applicable, the Medical Devices Regulation will, among other things:

● ~~establish~~strengthen ~~explicit~~the ~~provisions~~rules on ~~manufacturers’~~placing ~~responsibilities~~devices ~~for~~on the ~~follow-up~~market ~~of the quality, performance~~ and ~~safety~~reinforce ofsurveillance ~~devices~~once ~~placed~~they onare ~~the market~~available;

● ~~improve~~establish ~~the~~explicit ~~traceability~~provisions ofon ~~medical~~manufacturers’ ~~devices~~responsibilities ~~throughout~~for the ~~supply~~follow-up ~~chain~~of to the ~~end-user~~quality, orperformance ~~patient~~and ~~through~~safety aof ~~unique~~devices ~~identification~~placed ~~number~~on the market;

● ~~set~~improve upthe atraceability ~~central~~of ~~database~~medical todevices ~~provide~~throughout ~~patients,~~the ~~healthcare~~supply ~~professionals~~chain ~~and~~to the ~~public~~end-user ~~with~~or ~~comprehensive~~patient ~~information~~through ona ~~products~~unique ~~available~~identification ~~in the EU~~number; ~~and~~

● ~~strengthen~~set ~~rules~~up ~~for~~a ~~the~~central ~~assessment~~database ofto ~~certain~~provide ~~high-risk devices~~patients, ~~such~~healthcare asprofessionals ~~implants,~~and ~~which~~the ~~may~~public ~~have~~with tocomprehensive ~~undergo~~information anon ~~additional~~products ~~check~~available byin ~~experts before they are placed on~~ the ~~market.~~EU; and

~~Expected to~~● bestrengthen ~~implemented~~rules infor ~~2022~~the assessment of certain high-risk devices, ~~the~~such ~~Medical~~as ~~Devices~~implants, ~~Regulation~~which may ~~impose~~have ~~increased~~to ~~compliance~~undergo ~~obligations~~an ~~for~~additional uscheck toby ~~access~~experts ~~the~~before EUthey are placed on the market.

24The Medical Devices Regulation was effective in 2022 and may impose increased compliance obligations for us to access the EU market.

Legislative and other regulatory changes could have an effect on our business.

Changes in regulatory or economic conditions or in the laws and policies governing foreign trade, taxes, manufacturing, and development in the United States could impact our business. Economic and regulatory changes could also affect foreign currency exchange rates which, in turn, could affect our reported financial results and our competitiveness on a worldwide basis.

Consolidation in the healthcare industry could have an adverse effect on our revenues and results of operations.

Many healthcare companies, including healthcare systems, are consolidating to create new companies with greater market power. As the healthcare industry consolidates, competition to provide goods and services to industry participants will become more intense. These industry participants may try to use their market power to negotiate price concessions or reductions for diagnostic tests. If we are forced to reduce our prices because of consolidation in the healthcare industry, our projected revenues would decrease and our earnings, financial condition, and/or cash flows would suffer.

If we or our distributors do not comply with the U.S. federal and state fraud and abuse laws, including anti-kickback laws for any products approved in the U.S., or with similar foreign laws where we market our products, we could face significant liability.

There are numerous United States federal and state laws pertaining to healthcare fraud and abuse, including anti-kickback laws, false claims, and physician transparency laws. Our relationships with physicians and surgeons, hospitals and our independent distributors are subject to scrutiny under these laws. Violations of these laws are punishable by criminal and civil sanctions, including significant fines, damages and monetary penalties and in some instances, imprisonment and exclusion from participation in federal and state healthcare programs, including the Medicare, Medicaid and Veterans Administration health programs.

Healthcare fraud and abuse regulations are complex, and even minor irregularities can potentially give rise to claims that a statute or prohibition has been violated. The laws that may affect our ability to operate include:21

●Healthcare ~~the~~fraud ~~federal~~and ~~healthcare~~abuse ~~program~~regulations ~~Anti-Kickback~~are ~~Statute~~complex, ~~which prohibits, among other things, persons from knowingly~~ and ~~willfully~~even ~~soliciting,~~minor irregularities ~~offering,~~can ~~receiving,~~potentially orgive ~~paying~~rise ~~remuneration, directly or indirectly, in cash or in kind,~~ to ~~induce~~claims orthat ~~reward~~a ~~the~~statute ~~purchasing, leasing, ordering~~ or ~~arranging~~prohibition ~~for~~has orbeen ~~recommending~~violated. ~~the~~The ~~purchase,~~laws ~~lease~~that ~~or order of any good or service for which payment~~ may beaffect ~~made~~our ~~under~~ability to ~~federal~~operate ~~healthcare programs such as Medicare and Medicaid;~~include:

● the federal ~~civil~~healthcare ~~False~~program ~~Claims~~Anti-Kickback ~~Act~~Statute, which prohibits, among other things, ~~knowingly~~persons ~~presenting,~~from orknowingly ~~causing~~and towillfully besoliciting, ~~presented~~offering, ~~claims~~receiving, ~~for~~or ~~payment~~paying ofremuneration, ~~government~~directly ~~funds~~or ~~that~~indirectly, ~~are~~in ~~false~~cash or ~~fraudulent~~in ~~or knowingly making~~kind, ~~using or causing~~ to beinduce ~~made~~ or ~~used~~reward athe ~~false~~purchasing, ~~record~~leasing, ordering or ~~statement~~arranging ~~material~~for toor anrecommending ~~obligation~~the topurchase, ~~pay~~lease ~~money~~or toorder ~~the~~of ~~government~~any orgood ~~knowingly concealing~~ or ~~knowingly~~service ~~and~~for ~~improperly~~which ~~avoiding,~~payment ~~decreasing~~may orbe ~~concealing~~made anunder ~~obligation~~federal tohealthcare ~~pay~~programs ~~money~~such toas ~~the~~Medicare ~~federal~~and ~~government~~Medicaid;

● ~~the~~ federal ~~Health~~civil ~~Insurance~~False ~~Portability~~Claims ~~and~~Act ~~Accountability~~prohibits, ~~Act~~among ofother ~~1996~~things, orknowingly ~~HIPAA~~presenting, asor ~~amended~~causing byto ~~the~~be ~~Health~~presented, ~~Information~~claims ~~Technology~~for ~~and~~payment ~~Clinical~~of ~~Health~~government ~~Act~~funds ofthat ~~2009,~~are ~~which,~~false ~~among~~or ~~other~~fraudulent ~~things~~or knowingly making, ~~imposes~~using ~~criminal~~or ~~and~~causing ~~civil~~to ~~liability~~be ~~for~~made ~~executing~~or used a ~~scheme~~false torecord ~~defraud~~or ~~any~~statement ~~healthcare~~material ~~benefit~~to ~~program~~an ~~and~~obligation ~~also~~to ~~imposes~~pay ~~obligations,~~money ~~including~~to ~~mandatory~~the ~~contractual~~government ~~terms,~~or ~~with~~knowingly ~~respect~~concealing toor ~~safeguarding~~knowingly ~~the~~and ~~privacy~~improperly avoiding, ~~security~~decreasing ~~and~~or ~~transmission~~concealing ofan ~~individually~~obligation ~~identifiable~~to ~~health~~pay ~~information~~money to the federal government;

● ~~HIPAA~~the ~~also created~~ federal ~~criminal~~Health ~~laws~~Insurance ~~that~~Portability ~~prohibit~~and ~~knowingly~~Accountability ~~and~~Act ~~willfully~~of ~~falsifying~~1996, ~~concealing~~ or ~~covering~~HIPAA, upas aamended ~~material~~by ~~fact~~the orHealth ~~making~~Information ~~any~~Technology ~~materially~~and ~~false,~~Clinical ~~fictitious~~Health orAct ~~fraudulent~~of ~~statement~~2009, ~~or representation~~which, oramong ~~making~~other orthings, ~~using~~imposes ~~any~~criminal ~~false~~and ~~writing~~civil orliability ~~document~~for ~~knowing~~executing ~~the~~a ~~same~~scheme to ~~contain~~defraud any ~~materially~~healthcare ~~false~~benefit ~~fictitious~~program orand ~~fraudulent~~also ~~statement~~imposes orobligations, ~~entry~~including inmandatory ~~connection~~contractual terms, with ~~the~~respect ~~delivery~~to ofsafeguarding orthe ~~payment~~privacy, ~~for~~security ~~healthcare~~and ~~benefits,~~transmission ~~items~~of orindividually ~~services~~identifiable health information;

● ~~the~~HIPAA ~~Federal~~also ~~Trade~~created ~~Commission~~federal ~~Act~~criminal laws that prohibit knowingly and ~~similar~~willfully ~~laws~~falsifying, ~~regulating~~concealing ~~advertisement~~or ~~and~~covering ~~consumer~~up ~~protections~~a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services;

● the ~~federal~~Federal ~~Foreign~~Trade ~~Corrupt~~Commission ~~Practices~~ Act ofand ~~1997,~~similar ~~which~~laws ~~makes~~regulating itadvertisement ~~illegal~~and toconsumer offer or provide money or anything of value to officials of foreign governments, foreign political parties, or international organizations with the intent to obtain or retain business or seek a business advantageprotections; ~~and~~

25● the federal Foreign Corrupt Practices Act of 1997, which makes it illegal to offer or provide money or anything of value to officials of foreign governments, foreign political parties, or international organizations with the intent to obtain or retain business or seek a business advantage; 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, and state laws governing the privacy of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. In addition, there has been a recent trend of increased federal and state regulation of payments made to physicians. Some states, such as California, Massachusetts, Nevada, and Vermont mandate implementation of commercial compliance programs and/or impose restrictions on device manufacturer marketing practices and tracking and reporting of gifts, compensation and other remuneration to physicians.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, exclusion from federal healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations. To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has recently increased its scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing with investigations can be time and resource consuming and can divert management’s attention from the business. In addition, settlements with the DOJ or other law enforcement agencies have forced healthcare providers to agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity agreement. Any violations of these laws, or any action against us for violation of these laws, even if we successfully defend against it, could have a material adverse effect on our reputation, business and financial condition.

Many foreign countries have enacted similar laws addressing fraud and abuse in the healthcare sector. The shifting commercial compliance environment and the need to build and maintain robust and expandable systems to comply with different compliance requirements in multiple jurisdictions increases the possibility that we may run afoul of one or more of the requirements.22

IfMany foreign countries have enacted similar laws addressing fraud and weabuse ~~are~~in ~~unable~~the healthcare sector. The shifting commercial compliance environment and the need to ~~recruit,~~build ~~train~~and maintain robust and ~~retain~~expandable systems ~~key~~to ~~personnel,~~comply with different compliance requirements in multiple jurisdictions increases the possibility that we may ~~not~~run ~~achieve~~afoul ~~our~~of one ~~goals~~or more of the requirements.

~~Our future~~If ~~success~~we ~~depends~~are onunable ~~our ability~~ to recruit, ~~develop,~~train ~~retain~~ and ~~motivate~~retain key personnel, ~~including individuals for our senior management,~~ ~~research and development, engineering, manufacturing and sales and marketing teams. Additionally,~~ we ~~will~~may ~~need to hire additional executive personnel including a Chief Financial Officer and other financial personnel in the future. We do~~ not ~~have~~achieve employment contracts with management personnel. Competition for qualified personnel is intense, particularly in the San Francisco Bay area. Our growth depends on attracting, retaining and motivating highly skilled personnel with the necessary technical or scientific background and ability to understand our ~~products~~ ~~at a technical and clinical level~~goals. In addition, we will need to hire assay developers, automation engineers and other manufacturing employees to build our product offerings and meet demand for our products as we scale up our sales and marketing operations. Because of the complex and technical nature of our products and the dynamic market in which we compete, any failure to attract, develop, retain and motivate qualified personnel could materially harm our operating results and growth prospects.

~~Changes~~Our future success depends on our ability to recruit, develop, retain and motivate key personnel, including individuals for our senior management, research and development, engineering, manufacturing and sales and marketing teams. We do not have employment contracts with management personnel. Competition for qualified personnel is intense, particularly in ~~tax~~the ~~laws~~San Francisco Bay area. Our growth depends on attracting, retaining and motivating highly skilled personnel with the necessary technical or ~~exposure~~scientific tobackground ~~additional~~and ~~income~~ability ~~tax~~to ~~liabilities~~understand ~~could~~our ~~have~~products at a ~~material~~technical ~~impact~~and onclinical level. In addition, we will need to hire assay developers, automation engineers and other manufacturing employees to build our ~~financial~~product ~~condition~~offerings and ~~results~~meet ofdemand for our products as we scale up our sales and marketing operations. Because of the complex and technical nature of our products and the dynamic market in which we compete, any failure to attract, develop, retain and motivate qualified personnel could materially harm our operating results and growth prospects.

~~We are subject to income taxes as well as non-income based taxes in both the United States and various foreign jurisdictions.~~ Changes in ~~existing~~ tax laws, ~~treaties, regulations~~ or ~~policies~~exposure orto ~~the~~additional ~~interpretation~~income ortax ~~enforcement thereof, or the enactment or adoption of new~~liabilities ~~tax~~could ~~laws,~~have ~~treaties,~~a ~~regulations~~material orimpact ~~policies~~on ~~could~~our ~~materially~~financial ~~impact~~condition ~~our~~and ~~effective~~results ~~tax~~of ~~rate~~operations.

IfWe are subject to income taxes as well as non-income based taxes in weboth dothe ~~not~~United ~~achieve~~States and various foreign jurisdictions. Changes in existing tax laws, ~~sustain~~treaties, regulations or ~~successfully~~policies ~~manage~~or ~~our~~the ~~anticipated~~interpretation or ~~growth~~enforcement thereof, ~~our~~or ~~business~~the ~~and~~enactment ~~prospects~~or ~~will~~adoption beof ~~harmed~~new tax laws, treaties, regulations or policies could materially impact our effective tax rate.

If we are unable to obtain or sustain adequate revenue growth, our financial results could suffer. Furthermore, significant growth will place strains on our management and our operational and financial systems and processes and our operating costs may escalate even faster than planned. If we ~~cannot effectively manage our expanding operations and our costs, we may not be able to grow effectively or we may grow at a slower pace. Additionally, if we~~ do not ~~successfully forecast the timing of regulatory authorization for our additional tests~~achieve, ~~marketing~~ ~~and~~sustain ~~subsequent demand for our diagnostic tests~~ or successfully manage our anticipated ~~expenses accordingly~~growth, our ~~operating~~business ~~results~~and prospects will be harmed.

26If we are unable to obtain or sustain adequate revenue growth, our financial results could suffer. Furthermore, significant growth will place strains on our management and our operational and financial systems and processes and our operating costs may escalate even faster than planned. If we cannot effectively manage our expanding operations and our costs, we may not be able to grow effectively or we may grow at a slower pace. Additionally, if we do not successfully forecast the timing of regulatory authorization for our additional tests, marketing and subsequent demand for our diagnostic tests or manage our anticipated expenses accordingly, our operating results will be harmed.

Other companies or institutions have commercial assays or may develop and market novel or improved methods for infectious disease diagnostics, which may make our diagnostic platform less competitive or obsolete.

The market for diagnostics is large and established, and our competitors may possess significantly greater financial resources and have larger development and commercialization capabilities than we do. We may be unable to compete effectively against these competitors either because their diagnostic platforms are superior or because they may have more expertise, experience, financial resources or stronger business relationships.

New technologies, techniques or assays could emerge that might offer better combinations of price and performance than our current or future assays.

It is critical to our success that we anticipate changes in technology and customer requirements and to successfully introduce, on a timely and cost-effective basis, new, enhanced and competitive technologies that meet the needs of current and prospective customers. If we do not successfully innovate and introduce new technology into our product lines or manage the transitions to new product offerings, our revenues, results of operations and business will be adversely impacted. Competitors may be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, standards or customer requirements. We anticipate that we will face increased competition in the future as existing companies and competitors develop new or improved diagnostic tests and as new companies enter the market with new technologies.

We could be exposed to liability if we experience security breaches or other disruptions, which could harm our reputation and business.

We may be subject to cyber-attacks whereby computer hackers may attempt to access our computer systems or our third-party IT service provider’s systems and, if successful, misappropriate personal or confidential information. In addition, a contractor or other third party with whom we do business may attempt to circumvent our security measures or obtain such information and may purposefully or inadvertently cause a breach involving sensitive information. We will continue to evaluate and implement additional protective measures to reduce the risk and detect cyber incidents, but cyber-attacks are becoming more sophisticated and frequent and the techniques used in such attacks change rapidly. Even though we take cyber-security measures that are continuously reviewed and updated, our information technology networks and infrastructure may still be vulnerable due to sophisticated attacks by hackers or breaches.

Even the most well protected IT networks, systems, and facilities remain potentially vulnerable because the techniques used in security breaches are continually evolving and generally are not recognized until launched against a target and, in fact, may not be detected. Any such compromise of our or our third party’s IT service providers’ data security and access, public disclosure, or loss of personal or confidential business information, could result in legal claims proceedings, liability under laws to protect, privacy of personal information, and regulatory penalties, disrupt our operations, require significant management attention and resources to remedy any damages that result, damage our reputation and customers willingness to transact business with us, any of which could adversely affect our business.23

WeEven ~~expect~~the tomost ~~generate~~well protected IT networks, systems, and facilities remain potentially vulnerable because the techniques used in security breaches are continually evolving and generally are not recognized until launched against a ~~portion~~target and, in fact, may not be detected. Any such compromise of our ~~revenue~~or our third party’s IT service providers’ ~~internationally~~data security and ~~are~~access, ~~subject~~public disclosure, or loss of personal or confidential business information, could result in legal claims proceedings, liability under laws to ~~various~~protect, ~~risks~~privacy ~~relating~~of personal information, and regulatory penalties, disrupt our operations, require significant management attention and resources to ~~those~~remedy ~~international~~any ~~activities~~damages that result, damage our reputation and customers willingness to transact business with us, any of which could adversely affect our ~~operating results~~business.

AWe expect to generate a portion of our revenue isinternationally and ~~expected~~are subject to ~~come~~various ~~from international~~risks ~~sources.~~relating ~~Engaging~~to inthose international ~~business~~activities ~~involves~~which acould ~~number~~adversely ofaffect ~~difficulties~~our ~~and~~operating ~~risks, including:~~results.

●A ~~required~~portion ~~compliance~~of ~~with~~our ~~existing~~revenue ~~and~~is ~~changing~~expected ~~foreign~~to ~~healthcare~~come ~~and~~from ~~other~~international ~~regulatory~~sources. Engaging ~~requirements~~in ~~and~~international ~~laws,~~business ~~such~~involves asa ~~those~~number ~~relating~~of todifficulties ~~patient~~and ~~privacy~~risks, ~~or handling of bio-hazardous waste;~~including:

● required compliance with ~~anti-bribery~~existing ~~laws,~~and ~~such~~changing asforeign ~~the~~healthcare ~~U.S.~~and ~~Foreign~~other ~~Corrupt~~regulatory ~~Practices~~requirements ~~Act~~ and ~~U.K.~~laws, ~~Bribery~~such ~~Act,~~as ~~data~~those ~~privacy~~relating ~~requirements,~~to ~~labor~~patient ~~laws~~privacy ~~and~~or ~~anti~~handling of bio-~~competition~~hazardous ~~regulations~~waste;

● ~~export~~required orcompliance ~~import~~with ~~restrictions~~anti-bribery laws, such as the U.S. Foreign Corrupt Practices Act and U.K. Bribery Act, data privacy requirements, labor laws and anti-competition regulations;

27● export or import restrictions;

●

various reimbursement and insurance regimes;

●

laws and business practices favoring local companies;

●

longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;

●

political and economic instability;

●

potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other trade barriers;

●

foreign exchange controls;

●

difficulties and costs of staffing and managing foreign operations;

●

difficulties protecting or procuring intellectual property rights; and

●

pandemics and public health emergencies, such as the coronavirus (COVID-19), could result in disruptions to travel and distribution in geographic locations where our products are sold.

As we expand internationally, our results of operations and cash flows will become increasingly subject to fluctuations due to changes in foreign currency exchange rates. Our expenses are generally ~~denominated~~ denominated in U.S. dollars. If the value of the U.S. dollar increases relative to foreign currencies in the future, in the absence of a corresponding change in local currency prices, our future revenue could be adversely affected as we convert future revenue from local currencies to U.S. dollars.

If we dedicate resources to our international operations and are unable to manage these risks effectively, our business, operating results and prospects will suffer.

Our employees, independent contractors, principal investigators, consultants, commercial partners, distributors and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.24

WeOur ~~are exposed to the risk of fraud or other misconduct by our~~ employees, independent contractors, principal investigators, consultants, commercial partners, distributors and vendors. ~~Misconduct by~~may ~~these~~engage parties could include intentional, reckless or negligent failures to: comply with the regulations of the FDA and other similar foreign regulatory bodies; provide true, complete and accurate information to the FDA and other similar regulatory bodies; comply with manufacturing standards we have established; comply with healthcare fraud and abuse laws and regulations in ~~the United States and similar foreign fraudulent~~ misconduct ~~laws;~~ or ~~report financial information or data accurately, or disclose unauthorized activities to us. These laws may impact, among~~ other ~~things,~~improper ~~our~~ activities ~~with principal investigators and research subjects~~, asincluding well as our sales, marketing and education programs. In particular, the promotion, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, selfnon-~~dealing and other abusive practices. These laws~~compliance ~~may~~with restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Such misconduct could also involve the improper use of information obtained in the course of clinical studies, which could result in regulatory ~~sanctions~~standards and ~~cause serious harm to our reputation~~requirements. We currently have a code of conduct applicable to all of our employees, but it is not always possible to identify and deter employee misconduct, and our code of conduct and the other precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses, or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations. Any of these actions or investigations could result in substantial costs to us, including legal fees, and divert the attention of management from operating our business.

28We are exposed to the risk of fraud or other misconduct by our employees, independent contractors, principal investigators, consultants, commercial partners, distributors and vendors. Misconduct by these parties could include intentional, reckless or negligent failures to: comply with the regulations of the FDA and other similar foreign regulatory bodies; provide true, complete and accurate information to the FDA and other similar regulatory bodies; comply with manufacturing standards we have established; comply with healthcare fraud and abuse laws and regulations in the United States and similar foreign fraudulent misconduct laws; or report financial information or data accurately, or disclose unauthorized activities to us. These laws may impact, among other things, our activities with principal investigators and research subjects, as well as our sales, marketing and education programs. In particular, the promotion, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Such misconduct could also involve the improper use of information obtained in the course of clinical studies, which could result in regulatory sanctions and cause serious harm to our reputation. We currently have a code of conduct applicable to all of our employees, but it is not always possible to identify and deter employee misconduct, and our code of conduct and the other precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses, or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations. Any of these actions or investigations could result in substantial costs to us, including legal fees, and divert the attention of management from operating our business.

Because we received CE-mark for our S1 Assay Panel in November of 2019 and began commercial sales activities in September 2020, we have limited experience marketing and selling our products. We began staffing our sales and marketing organization in 2021 and currently have a staff of 3. Our financial condition and operating results will be highly dependent upon the efforts of our sales and marketing organization. If we are unable to quickly build our sales and marketing team or if our sales and marketing efforts fail to adequately promote, market and sell our products, our sales may not increase at levels that are in line with our forecasts.

Our future sales growth will depend in large part on our ability to successfully build and expand the size and geographic scope of our sales and marketing team. Accordingly, our future success will depend largely on our ability to hire, train, retain and motivate skilled sales and marketing personnel. Because the competition for individuals with their skillset is high, there is no assurance we will be able to hire and retain personnel on commercially reasonable terms. If we are unable to build and expand our sales and marketing capabilities, we may not be able to effectively commercialize our products and our business and operating results may be adversely affected. Additionally, we will need to implement management information systems to support the sales and marketing operations. There is no assurance that these systems will be implemented and effective. Lack of these management information systems may negatively impact sales efforts.

Outside of the United States, we will sell our products through distribution partners and there is no guarantee that we will be successful in attracting or retaining desirable distribution partners for these markets or that we will be able to enter into such arrangements on favorable terms. Distributors may not commit the necessary resources to market and sell our products effectively or may choose to favor marketing the products of our competitors. If distributors do not perform adequately, or if we are unable to enter into effective arrangements with distributors in particular geographic areas, we may not realize our sales growth.

Our ability to grow our business will be limited if we fail to develop and maintain new and existing distribution channels.

Our plan to grow our business depends on third parties and distributors to sell our products. The sale of our products depends in large part on our ability to sell products to these customers and on the marketing and distribution abilities of the companies with which we collaborate.

Reliance on distributors and third-parties to market and sell our products could negatively impact our business for various reasons, including: (i) we may not be able to find suitable distributors for our products on satisfactory terms, or at all; (ii) agreements with distributors may prematurely terminate or may result in litigation between the parties; (iii) our distributors or other customers may not fulfill their contractual obligations and distribute our products in the manner or at the levels we expect; (iv) our distributors may prioritize other products or their own private label products that compete with our products; (v) Our existing distributor relationships or contracts may preclude or limit us from entering into arrangements with other distributors; and (vi) we may not be able to negotiate new or renew existing distribution agreements on acceptable terms, or at all.25

WeReliance ~~will~~on ~~try~~distributors and third-parties to ~~maintain~~market and ~~expand~~sell our products could negatively impact our business for various reasons, including: (i) we may not be able to find suitable distributors for our products on satisfactory terms, or at all; (ii) agreements with distributors ~~and~~may ~~third~~prematurely terminate or may result in litigation between the parties; ~~and~~(iii) ~~make~~our ~~every~~distributors ~~effort~~or toother ~~require~~customers ~~that~~may ~~they~~not fulfill their contractual obligations, ~~but~~and ~~there~~distribute ~~can~~our beproducts in the manner noor ~~assurance~~at ~~that~~the ~~such~~levels ~~companies~~we ~~will~~expect; do(iv) soour distributors may prioritize other products or their own private label products that ~~new~~compete ~~distribution~~with our ~~channels~~products; ~~will~~(v) beOur ~~available~~existing ondistributor ~~satisfactory~~relationships ~~terms.~~or Ifcontracts wemay ~~are~~preclude ~~unable~~or limit us from entering into arrangements with other todistributors; doand ~~so,~~(vi) ~~our~~we ~~business~~may ~~will~~not be ~~negatively~~able ~~impacted~~to negotiate new or renew existing distribution agreements on acceptable terms, or at all.

29We will try to maintain and expand our business with distributors and third parties and make every effort to require that they fulfill their contractual obligations, but there can be no assurance that such companies will do so or that new distribution channels will be available on satisfactory terms. If we are unable to do so, our business will be negatively impacted.

Potential customers may not adopt rapid Point-of-Care diagnostic testing.

Rapid point-of-care tests are beneficial because, among other things, they can be administered by healthcare providers in their own facilities or used by healthcare facilities without sending samples to central laboratories. But currently the majority of diagnostic tests used by healthcare providers in the U.S. are provided by clinical reference laboratories and hospital-based laboratories. In some international markets, such as Europe, diagnostic testing is performed primarily by centralized laboratories. Future sales of our products will depend, in part, on our ability to expand market acceptance of rapid point-of-care testing and successfully compete against laboratory testing methods and products. However, we expect that clinical reference and other hospital-based laboratories will continue to compete vigorously against our rapid point-of-care products. Even if we can demonstrate that our products are more cost effective, save time, or have better performance or other benefits, healthcare providers may resist changing to rapid point-of-care tests and instead may choose to obtain diagnostic results through laboratory tests. If we fail to achieve and expand market acceptance of our rapid point-of-care diagnostic tests with customers, it would have a negative effect on our future sales growth.

Even if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from their sales, if any, may be limited.

If approved for marketing, the commercial success of our product candidates will depend upon each product’s acceptance by the medical community, including physicians, patients and health care payors. The degree of market acceptance for any of our product candidates will depend on a number of factors, including:

	●	demonstration of clinical safety and efficacy;

	●	relative convenience, dosing burden and ease of administration;

	●	the prevalence and severity of any adverse effects;

	●	the willingness of physicians to prescribe our product candidates, and the target patient population to try new therapies;

	●	efficacy of our product candidates compared to competing products;

	●	the introduction of any new products that may in the future become available targeting indications for which our product candidates may be approved;

	●	new procedures or therapies that may reduce the incidences of any of the indications in which our product candidates may show utility;

	●	pricing and cost-effectiveness;

	●	the inclusion or omission of our product candidates in applicable therapeutic and vaccine guidelines;

	●	the effectiveness of our own or any future collaborators’ sales and marketing strategies;

	●	limitations or warnings contained in approved labeling from regulatory authorities;

	●	our ability to obtain and maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare and Medicaid, private health insurers and other third-party payors or to receive the necessary pricing approvals from government bodies regulating the pricing and usage of therapeutics; and

	●	the willingness of patients to pay out-of-pocket in the absence of third-party coverage or reimbursement or government pricing approvals.

3026

If any of our product candidates are approved, but do not achieve an adequate level of acceptance by physicians, health care payors, and patients, we may not generate sufficient revenues and we may not be able to achieve or sustain profitability. Our efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may never be successful.

In addition, even if we obtain regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize our product candidates successfully. For example, if the approval process takes too long, we may miss market opportunities and give other companies the ability to develop competing products or establish market dominance. Any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval ~~commitments~~ commitments that render our product candidates not commercially viable. For example, regulatory authorities may approve any of our product ~~candidates~~ candidates for fewer or more limited indications than we request, may grant approval contingent on the performance of costly post-marketing ~~clinical~~ clinical trials, or may approve any of our product candidates with a label that does not include the labeling claims necessary or desirable ~~for~~ for the successful commercialization for that indication. Further, the FDA or comparable foreign regulatory authorities may place conditions on approvals or require risk management plans or a Risk Evaluation and Mitigation Strategy (“REMS”) to assure the safe use of the drug. If the FDA or applicable foreign regulatory agency concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS; the regulatory agencies will not approve the BLA without an approved REMS, if required. A REMS could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The regulatory agencies may also require a REMS for an approved product when new safety information emerges. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of our product candidates. Moreover, product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following the initial marketing of the product. Any of the foregoing scenarios could materially harm the commercial success of our product candidates.

Adverse events involving our products may lead the FDA or applicable foreign regulatory agency to delay or deny clearance for our products or result in product recalls that could harm our reputation, business and financial results.

Once a product receives regulatory clearance or approval, the agency has the authority to require the recall of commercialized products in the event of adverse side effects, material deficiencies or defects in design or manufacture. The authority to require a recall must be based on a regulatory finding that there is a reasonable probability that the product would cause serious injury or death. Manufacturers may, under their own initiative, recall a product if any material deficiency in a product is found. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of adverse side effects, impurities or other product contamination, manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our financial condition and results of operations. The regulatory agencies require that certain classifications of recalls be reported to them within ten (10) working days after the recall is initiated. Companies are required to maintain certain records of recalls, even if they are not reportable to the regulatory agency. We may initiate voluntary recalls involving our products in the future that we determine do not require notification of the regulatory agencies. If the regulatory agency disagrees with our determinations, they could require us to report those actions as recalls. A future recall announcement could harm our reputation with customers and negatively affect our sales. In addition, the regulatory agency could take enforcement action for failing to report the recalls when they were conducted.

The in-licensing of technologies and the successful testing and early development of technologies in the laboratory may not be indicative of future results and may not result in commercially viable technologies or products. Further, our future products may have to be modified from their originally conceived versions in order to reach or be successful in the market.

Positive results from laboratory testing and early developmental successes, may not be predictive of future successful development, commercialization and sales results and should not be relied upon as evidence that products developed from our technologies will become commercially viable and successful. Further, the products we plan to develop in the future may have to be significantly modified from their originally conceived versions in order for us to control costs, compete with similar products, receive market acceptance, meet specific development and commercialization timeframes, avoid potential ~~infringement~~ infringement of the proprietary rights of others, or otherwise succeed in developing our business and earning ongoing revenues. This can be a costly and resource draining activity. What appear to be promising technologies when we license them may not lead to viable technologies or products, or to commercial success.

31We utilize third-party, single-source suppliers for some components and materials used in our products and product candidates, and the loss of any of these suppliers could have an adverse impact on our business.

We ~~utilize~~rely ~~third-party,~~on single-source suppliers for some components and materials used in our products and product candidates,. ~~and~~Our ~~the~~ability ~~loss~~to ofsupply our products commercially and to develop any offuture products depends, in part, on our ability to obtain these components in accordance with regulatory requirements and in sufficient quantities for clinical testing and commercialization. While our suppliers ~~could~~have generally met our demand for their products on a timely basis in the past, these were with limited production quantities and we cannot assure that they will in the future be able to meet our demand for their products, either because we do not have anlong-term ~~adverse~~agreements with those suppliers, our relative importance as a customer to those suppliers, or ~~impact~~their onability to produce the components used in our products. For example, our supplier of printed electrodes has exited the printing business. We purchased safety stock from the supplier prior to their discontinuing production and have begun qualification of a replacement supplier.

We rely on single-source suppliers for some components and materials used in our products and product candidates. Our ability to supply our products commercially and to develop any future products depends, in part, on our ability to obtain these components in accordance with regulatory requirements and in sufficient quantities for clinical testing and commercialization. While our suppliers have generally met our demand for their products on a timely basis in the past, these were with limited production quantities and we cannot assure that they will in the future be able to meet our demand for their products, either because we do not have long-term agreements with those suppliers, our relative importance as a customer to those suppliers, or their ability to produce the components used in our products. For example, our supplier of printed electrodes has exited the printing business. We purchased safety stock from the supplier prior to their discontinuing production and have begun qualification of a replacement supplier.27

While we believe replacement suppliers exist for all components and materials we obtain from single sources, establishing additional or replacement suppliers for any of these components or materials, if required, may not be accomplished quickly. Even if we are able to find a replacement supplier, the replacement supplier would need to be qualified and may require additional regulatory authority approval, which could result in further delay. While we will seek to maintain adequate inventory of the single-source components and materials used in our products in the event of disruption, those inventories may not be sufficient.

If our third-party suppliers fail to deliver the required commercial quantities of materials on a timely basis and at commercially reasonable prices, and we are unable to find one or more replacement suppliers capable of production at a substantially equivalent cost in substantially equivalent volumes and quality on a timely basis, the continued commercialization of our products, the supply of our products to customers and the development of any future products would be delayed, limited or prevented, which could have an adverse impact on our business.

Manufacturing risks may adversely affect our ability to manufacture products and could reduce our gross margins and negatively affect our operating results.

Our business strategy depends on our ability to manufacture and assemble our current and proposed products in sufficient quantities and on a timely basis to meet consumer demand, while adhering to product quality standards, complying with regulatory requirements and managing manufacturing costs. We are subject to numerous risks relating to our manufacturing capabilities, including:

●

quality or reliability defects in product components that we source from third party suppliers;

●

our inability to secure product components in a timely manner, in sufficient quantities or on commercially reasonable terms;

●

our failure to increase production of products to meet demand;

●

the challenge of implementing and maintaining acceptable quality systems while experiencing rapid growth;

●

our inability to build production lines to enable us to efficiently produce products; and

●

difficulty identifying and qualifying alternative suppliers for components in a timely manner.

As demand for our products increases, we will need to invest additional resources to purchase components, hire and train employees, and enhance our manufacturing processes and implement manufacturing and quality systems. If we fail to increase our production capacity efficiently while also maintaining quality requirements, our sales may not increase in line with our forecasts and our operating margins could fluctuate or decline. In addition, while we expect most new products will utilize the eLab instrument system and existing consumable cartridge, manufacturing of future products may require the modification of our production lines, the hiring of specialized employees, the identification of new suppliers for specific components, or the development of new manufacturing technologies. It may not be possible for us to manufacture these products at a cost or in quantities sufficient to make these products commercially viable. Any future interruptions we experience in the manufacturing or shipping of our products could delay our ability to recognize revenues in a particular quarter and could also adversely affect our relationships with our customers.

32Risks Related to Intellectual Property

~~Risks~~The ~~Related~~extent to ~~Intellectual~~which ~~Property~~we can protect our business and technologies through intellectual property rights that we own, acquire or license is uncertain.

~~The~~We ~~extent~~employ toa ~~which~~variety weof ~~can~~proprietary ~~protect~~and ~~our~~patented ~~business~~ technologies and methods in connection with the assays that we sell or are developing. We license some of these technologies ~~through~~from third parties. We cannot provide any assurance that the intellectual property rights that we own or license provide effective protection from competitive threats or that we would prevail in any litigation in which our intellectual property rights are challenged. In addition, ~~acquire~~we may not be successful in obtaining new proprietary or ~~license~~patented istechnologies ~~uncertain~~or methods in the future, whether through acquiring ownership or through licenses from third parties.

We employ a variety of proprietary and patented technologies and methods in connection with the assays that we sell or are developing. We license some of these technologies from third parties. We cannot provide any assurance that the intellectual property rights that we own or license provide effective protection from competitive threats or that we would prevail in any litigation in which our intellectual property rights are challenged. In addition, we may not be successful in obtaining new proprietary or patented technologies or methods in the future, whether through acquiring ownership or through licenses from third parties.28

Our currently pending or future patent applications may not result in issued patents, and we cannot predict how long it may take for a patent to issue on any of our pending patent applications, ~~assuming~~ assuming a patent does issue.

Other parties may challenge patents issued or exclusively licensed to us, or courts or administrative agencies may hold our patents or the patents we license on an exclusive basis to be invalid or unenforceable. We may not be successful in defending challenges made against our patents and other intellectual property rights. Any third-party challenge to any of our patents could result in the unenforceability or invalidity of some or all of the claims of such patents and could be time consuming and expensive.

The extent to which the patent rights of life sciences companies effectively protect their diagnostic tests and technologies is often highly uncertain and involves complex legal and factual questions for which important legal principles remain unresolved.

No consistent policy regarding the proper scope of allowable claims of patents held by life sciences companies has emerged to date in the United States. Various courts, including the U.S. Supreme Court, have rendered decisions that impact the scope of patentability of certain inventions or discoveries relating to diagnostic tests or genomic diagnostic testing. These decisions generally stand for the proposition that inventions that recite laws of nature are not themselves patentable unless they have sufficient additional features that provide practical assurance that the processes are genuine inventive applications of those laws rather than patent drafting efforts designed to monopolize a law of nature itself. What constitutes a “sufficient” additional feature for this purpose is uncertain. Although we do not generally rely on gene sequence patents, this evolving case law in the United States may adversely impact our ability to obtain new patents and may facilitate third-party challenges to our existing owned and exclusively licensed patents.

We cannot predict the breadth of claims that may be allowed or enforced in patents we own or in those to which we have exclusive license rights. For example:

●

the inventor(s) named in one or more of our patents or patent applications might not have been the first to have made the relevant invention;

●

the inventor (or his assignee) might not have been the first to file a patent application for the claimed invention;

●

others may independently develop similar or alternative diagnostic tests and technologies or may successfully replicate our product and technologies;

●

it is possible that the patents we own or in which have exclusive license rights may not provide us with any competitive advantages or may be challenged by third parties and found to be invalid or unenforceable;

33● any patents we obtain or exclusively license may expire before, or within a limited time period after, the assays and services relating to such patents are commercialized;

● ~~any patents~~ we ~~obtain or exclusively license~~ may ~~expire~~not ~~before,~~develop or ~~within~~acquire aadditional ~~limited~~proprietary ~~time period after, the~~ assays and ~~services~~technologies ~~relating~~that ~~to such patents~~ are ~~commercialized~~patentable; and

● weothers may ~~not~~acquire ~~develop~~patents orthat ~~acquire~~could ~~additional~~be ~~proprietary~~asserted ~~assays~~against ~~and~~us ~~technologies~~in a manner that ~~are~~could ~~patentable;~~have ~~and~~an adverse effect on our business.

●Changes ~~others~~in ~~may~~either ~~acquire~~the ~~patents~~patent ~~that~~laws ~~could~~or bein ~~asserted~~interpretations ~~against~~of uspatent laws in athe ~~manner~~United ~~that~~States ~~could~~or ~~have~~other ancountries ~~adverse~~may ~~effect~~diminish onthe value of our ~~business~~intellectual property rights.

~~Changes~~On inSeptember ~~either~~16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent ~~laws~~law. These include provisions that affect the way patent applications are prosecuted, redefine prior art, may affect patent litigation and switch the U.S. patent system from a “first-to-invent” system to a “first-to-file” system. Under a first-to-file system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to the patent on an invention regardless of whether another inventor had made the invention earlier. The U.S. Patent and Trademark Office, or inUSPTO, recently ~~interpretations~~developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law ~~laws~~associated with the Leahy-Smith Act, including the first-to-file provisions in particular, only became effective on March 16, 2013. Accordingly, it is not clear what, if any, impact the ~~United~~Leahy-Smith ~~States~~Act orwill ~~other~~have ~~countries~~on ~~may~~the ~~diminish~~operation of our business. However, the ~~value~~Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our ~~intellectual~~owned ~~property~~and ~~rights~~licensed patent applications and the enforcement or defense of issued patents that we own or license, all of which could have a material adverse effect on our business and financial condition.

On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art, may affect patent litigation and switch the U.S. patent system from a “first-to-invent” system to a “first-to-file” system. Under a first-to-file system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to the patent on an invention regardless of whether another inventor had made the invention earlier. The U.S. Patent and Trademark Office, or USPTO, recently developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, including the first-to-file provisions in particular, only became effective on March 16, 2013. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned and licensed patent applications and the enforcement or defense of issued patents that we own or license, all of which could have a material adverse effect on our business and financial condition.29

Patent applications in the United States and many foreign jurisdictions are not published until at least eighteen months after filing and it is possible for a patent application filed in the United States to be maintained in secrecy until a patent issues on the application. In addition, publications in the scientific literature often lag behind actual discoveries. We therefore cannot be certain that others have not filed patent applications that cover inventions that are the subject of pending applications that we own or exclusively license or that we were the first to invent the technology (if filed prior to the Leahy-Smith Act) or first to file (if filed after the Leahy-Smith Act). Our competitors may have filed, and may in the future file, patent applications covering technology that is similar to or the same as our technology. Any such patent application may have priority over patent applications that we own and, if a patent issues on such patent application, we could be required to obtain a license to such patent in order to carry on our business. If another party has filed a U.S. patent application covering an invention that is similar to, or the same as, an invention that we own, we may have to participate in an interference or other proceeding in the USPTO or a court to determine priority of invention in the United States, for applications and patents made prior to the enactment of the Leahy-Smith Act. For applications and patents made following the enactment of the Leahy-Smith Act, we may have to participate in a derivation proceeding to resolve disputes relating to inventorship. The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in our inability to obtain or retain any U.S. patent rights with respect to such invention.

In addition, the laws of foreign jurisdictions may not protect our rights to the same extent as the laws of the United States. For example, European patent law restricts the patentability of methods of treatment of the human body more than U.S. law does. Publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we or our licensors were the first to file for patent protection of such inventions. Moreover, the USPTO might require that the term of a patent issuing from a pending patent application be disclaimed and limited to the term of another patent that is commonly owned or names a common inventor. As a result, the issuance, scope, validity, term, enforceability and commercial value of our patent rights are highly uncertain.

34The patent prosecution process is expensive and time-consuming, is highly uncertain and involves complex legal and factual questions. Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

~~The~~Our ~~patent~~success ~~prosecution~~depends ~~process~~in islarge ~~expensive~~ part on our ability to obtain and ~~time-consuming,~~maintain patent isprotection ~~highly~~in ~~uncertain~~the United States and ~~involves~~other ~~complex~~countries ~~legal~~with respect to our proprietary technology and ~~factual~~product ~~questions~~candidates. ~~Recent~~We ~~patent~~seek to ~~reform~~protect ~~legislation~~our ~~could~~proprietary ~~increase~~ position by filing in the ~~uncertainties~~United States and ~~costs~~in ~~surrounding~~certain ~~the~~foreign ~~prosecution~~jurisdictions ofpatent applications related to our ~~patent~~novel ~~applications~~technologies and ~~the~~product ~~enforcement~~candidates orthat ~~defense~~are ofimportant to our ~~issued patents~~business.

~~Our~~The ~~success~~patent ~~depends~~prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in ~~large~~a ~~part~~timely onmanner. It is also possible that we will fail to identify patentable aspects of our ~~ability~~ research and development output before it is too late to obtain patent ~~and~~protection. ~~maintain~~In addition, we may not pursue or obtain patent protection in all major markets. Moreover, in some circumstances, we may not have the ~~United~~right ~~States~~to ~~and~~control ~~other~~the ~~countries~~preparation, ~~with~~filing ~~respect~~or prosecution of patent applications, or to ~~our~~maintain ~~proprietary~~the patents, covering technology ~~and~~that ~~product candidates~~we license from third parties. WeIn ~~seek~~some circumstances, our licensors may have the right to ~~protect~~enforce the licensed patents without our ~~proprietary~~involvement ~~position~~or byconsent, ~~filing~~or into decide not to enforce or to allow us to enforce the ~~United~~licensed ~~States~~patents. Therefore, these patents and patent applications may not be prosecuted and enforced in ~~certain~~a ~~foreign~~manner ~~jurisdictions~~consistent ~~patent~~with ~~applications~~the best interests of our business. If any of our ~~related~~licensors fail to maintain such patents, or lose rights to those patents, the rights that we have licensed may be reduced or eliminated and our ~~novel~~right ~~technologies~~to develop and commercialize any of our product candidates that are ~~important~~the tosubject ~~our~~of ~~business~~such licensed rights could be adversely affected.

~~The~~Our ~~patent~~pending ~~prosecution process is expensive~~ and ~~time-consuming,~~ ~~and~~future wepatent applications may not beresult ~~able~~in topatents being ~~file~~issued ~~and~~which ~~prosecute~~protect ~~all~~our ~~necessary~~technology or ~~desirable~~products, ~~patent~~in ~~applications~~whole ~~at a reasonable cost~~ or in a ~~timely~~part, ~~manner.~~or Itwhich iseffectively ~~also~~prevent ~~possible~~others ~~that~~from wecommercializing ~~will~~competitive technologies ~~fail to identify patentable aspects of our research~~ and ~~development output before it is too late to obtain patent protection~~products. In ~~addition~~particular, weduring ~~may~~prosecution ~~not~~of ~~pursue~~any ~~or obtain~~ patent ~~protection~~application, inthe ~~all~~issuance ~~major~~of ~~markets.~~any ~~Moreover,~~patents ~~in some~~based ~~circumstances,~~on wethe application may ~~not~~depend ~~have~~upon ~~the~~our ~~right~~ability to ~~control~~generate ~~the~~additional ~~preparation,~~nonclinical ~~filing~~ or ~~prosecution~~clinical ofdata ~~patent~~that ~~applications,~~support ~~or to maintain~~ the ~~patents,~~patentability ~~covering~~of ~~technology~~our ~~that~~proposed ~~we license from third parties~~claims. We ~~In some circumstances, our licensors~~ may ~~have~~not ~~the~~be ~~right~~able to ~~enforce the~~generate ~~licensed~~sufficient ~~patents~~additional ~~without~~data ~~our~~on ~~involvement~~a ortimely ~~consent~~basis, or toat ~~decide not to enforce or to allow us to enforce the licensed patents~~all. ~~Therefore~~Moreover, ~~these~~ ~~patents~~changes ~~and patent applications may not be prosecuted and enforced~~ in aeither ~~manner consistent with~~ the ~~best~~patent ~~interests~~laws ~~of our business.~~or Ifinterpretation ~~any~~ of ~~our~~the ~~licensors~~patent ~~fail~~laws toin ~~maintain~~the ~~such~~United ~~patents,~~States or ~~lose~~other ~~rights~~countries tomay ~~those~~diminish ~~patents,~~ the ~~rights~~value ~~that we have licensed may be reduced or eliminated and our right to develop and commercialize any~~ of our ~~product~~patents ~~candidates~~or ~~that~~narrow ~~are~~ the ~~subject~~scope of ~~such licensed rights could~~ beour ~~adversely~~patent ~~affected~~protection.

Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. In particular, during prosecution of any patent application, the issuance of any patents based on the application may depend upon our ability to generate additional nonclinical or clinical data that support the patentability of our proposed claims. We may not be able to generate sufficient additional data on a timely basis, or at all. Moreover, changes in either the patent laws or interpretation of the patent laws in the United States or other countries may diminish the value of our patents or narrow the scope of our patent protection.30

Moreover, we may be subject to a third-party pre-issuance ~~submission~~ submission of prior art to the USPTO, or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings or other patent office proceedings or litigation, in the United States or elsewhere, challenging ~~our~~ our patent rights or the patent rights of others. An adverse determination in any such submission or proceeding could reduce the scope of, or invalidate, our patent rights; allow third parties to commercialize our technology or products and compete directly with us, without payment to us; or result in our inability to manufacture or commercialize products without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our owned and licensed patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent prosecution process and following the issuance of a patent. There are situations in which noncompliance with these requirements can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case if our patent were in force.

Our intellectual property rights may not be sufficient to protect our competitive position and to prevent others from manufacturing, using or selling competing assays.

The scope of our owned and exclusively licensed intellectual property rights may not be sufficient to prevent others from manufacturing, using or selling competing assays. Competitors could purchase our product and attempt to replicate some or all of the competitive advantages we derive from our development efforts, willfully infringe our intellectual property rights, design around our protected technology or develop their own competitive technologies and thereby avoid infringing our intellectual property rights. If our intellectual property is not sufficient to effectively prevent our competitors from developing and selling similar diagnostic tests, our competitive position and our business could be adversely affected.

35We may become involved in disputes relating to our intellectual property rights, and may need to resort to litigation in order to defend and enforce our intellectual property rights.

WeExtensive ~~may~~litigation ~~become~~regarding ~~involved~~patents inand ~~disputes~~other ~~relating~~intellectual property rights has been common in the medical diagnostic testing industry. Litigation may be necessary to ~~our~~assert ~~intellectual~~infringement ~~property~~claims, ~~rights~~protect trade secrets or know-how and determine the enforceability, scope and validity of certain proprietary rights. Litigation may ~~need~~even be necessary to ~~resort~~resolve todisputes ~~litigation~~of ininventorship ~~order~~or toownership ~~defend~~of proprietary rights. The defense and ~~enforce~~prosecution ~~our~~of intellectual property ~~rights~~lawsuits, USPTO interference or derivation proceedings and related legal and administrative proceedings (e.g., a re-examination) in the United States and internationally involve complex legal and factual questions. As a result, such proceedings are costly and time consuming to pursue, and their outcome is uncertain.

~~Extensive~~Even ~~litigation~~if ~~regarding~~we ~~patents~~prevail ~~and~~in ~~other intellectual~~such ~~property~~a ~~rights~~proceeding ~~has~~in ~~been~~which ~~common~~we inassert ~~the~~our ~~medical~~intellectual property ~~diagnostic~~rights ~~testing~~against ~~industry.~~third ~~Litigation~~parties, ~~may~~the beremedy ~~necessary~~we toobtain ~~assert~~may ~~infringement claims,~~not ~~protect~~be ~~trade~~commercially ~~secrets~~meaningful or ~~know-how~~adequately ~~and~~compensate ~~determine~~us ~~the~~for ~~enforceability,~~any ~~scope~~damages we ~~and~~may ~~validity~~have ~~of certain proprietary rights~~suffered. ~~Litigation may~~If ~~even~~we bedo ~~necessary~~not toprevail ~~resolve~~in ~~disputes~~such ofa ~~inventorship~~proceeding, orour ~~ownership~~patents ofcould ~~proprietary~~potentially ~~rights.~~be ~~The~~declared ~~defense~~to ~~and~~be ~~prosecution~~invalid, ~~of intellectual~~unenforceable ~~property~~or ~~lawsuits,~~narrowed ~~USPTO~~in ~~interference~~scope, or ~~derivation~~we ~~proceedings~~could ~~and~~otherwise ~~related~~lose ~~legal~~valuable ~~and~~intellectual ~~administrative~~property rights. Similar proceedings ~~(e.g.,~~involving athe ~~re-examination)~~intellectual inproperty ~~the~~we ~~United~~exclusively ~~States~~license ~~and~~could ~~internationally~~also ~~involve~~have ~~complex~~an ~~legal~~impact ~~and~~on ~~factual~~our ~~questions~~business. AsFurther, aif ~~result,~~any ~~such~~of ~~proceedings~~our ~~are~~other ~~costly~~owned ~~and~~or ~~time~~exclusively licensed ~~consuming~~patents toare ~~pursue~~declared invalid, ~~and~~unenforceable ~~their~~or ~~outcome~~narrowed isin ~~uncertain~~scope, our competitive position could be adversely affected.

~~Even~~We ifcould weface ~~prevail~~claims inthat ~~such a proceeding in which we assert~~ our ~~intellectual~~activities ~~property~~or ~~rights against third parties,~~ the ~~remedy we obtain may not be commercially meaningful or adequately compensate us for any damages we may have suffered. If we do not prevail in such a proceeding~~manufacture, ~~our patents could potentially be declared~~ touse ~~be invalid, unenforceable~~ or ~~narrowed~~sale inof ~~scope,~~our orassays weinfringe ~~could~~the ~~otherwise lose valuable~~ intellectual property rights. ~~Similar~~of ~~proceedings involving~~others, ~~the~~which ~~intellectual property we exclusively license~~ could ~~also~~cause ~~have~~us anto ~~impact~~pay ondamages ~~our~~or ~~business.~~licensing ~~Further,~~fees ifand limit ~~any of~~ our ~~other~~ability ~~owned or~~to ~~exclusively~~sell ~~licensed~~some ~~patents are declared invalid, unenforceable~~ or ~~narrowed~~all inof ~~scope,~~ our ~~competitive~~assays ~~position~~and ~~could be adversely affected~~services.

WeOur ~~could~~research, ~~face~~development ~~claims~~and ~~that~~commercialization ~~our~~ activities may infringe or ~~the~~be ~~manufacture,~~claimed ~~use~~to infringe patents or ~~sale~~other intellectual property rights owned by other parties of ~~our~~which ~~assays~~we ~~infringe~~may be unaware because the relevant ~~intellectual~~patent ~~property~~applications ~~rights~~may have been filed but not yet published. Certain of ~~others,~~our ~~which~~competitors ~~could~~and ~~cause~~other uscompanies have substantial patent portfolios and may attempt to ~~pay~~use ~~damages~~ patent litigation as a means to obtain a competitive advantage or to extract licensing ~~fees~~revenue. In ~~and~~addition ~~limit~~to ~~our~~patent ~~ability~~infringement claims, we may also be subject to ~~sell~~other ~~some~~claims relating to the violation of intellectual property rights, such as claims that we have misappropriated trade secrets or ~~all~~infringed third party trademarks. The risks of being involved in such litigation may also increase as we gain greater visibility as a public company and as we gain commercial acceptance of our ~~assays~~diagnostic tests and ~~services~~move into new markets and applications for our assays.

Our research, development and commercialization activities may infringe or be claimed to infringe patents or other intellectual property rights owned by other parties of which we may be unaware because the relevant patent applications may have been filed but not yet published. Certain of our competitors and other companies have substantial patent portfolios and may attempt to use patent litigation as a means to obtain a competitive advantage or to extract licensing revenue. In addition to patent infringement claims, we may also be subject to other claims relating to the violation of intellectual property rights, such as claims that we have misappropriated trade secrets or infringed third party trademarks. The risks of being involved in such litigation may also increase as we gain greater visibility as a public company and as we gain commercial acceptance of our diagnostic tests and move into new markets and applications for our assays.31

Regardless of merit or outcome, our involvement in any litigation, interference or other administrative proceedings could cause us to incur substantial expense and could significantly divert the efforts of our technical and management personnel. Any public announcements related to litigation or interference proceedings initiated or threatened against us could cause our share price to decline. An adverse determination, or any actions we take or agreements we enter into in order to resolve or avoid disputes, may subject us to the loss of our proprietary position or to significant liabilities, or require us to seek licenses that may include substantial cost and ongoing royalties. Licenses may not be available from third parties or may not be obtainable on satisfactory terms. An adverse determination or a failure to obtain necessary licenses may restrict or prevent us from manufacturing and selling our diagnostic tests and offering our services. These outcomes could materially harm our business, financial condition and results of operations.

We may not be able to adequately protect our intellectual property outside of the United States.

The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States, and many companies have encountered significant problems in protecting and defending such rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to medical devices, diagnostic testing and biotechnology, which could make it difficult for us to stop the infringement of our patents and for licensors, if they were to seek to do so, to stop infringement of patents that are licensed to us. Proceedings to enforce our patent rights in foreign ~~jurisdictions~~ jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business. Additionally, prosecuting and maintaining intellectual property (particularly patent) rights are very costly endeavors, and for these and other reasons we may not pursue or obtain patent protection in all major markets. We do not know whether legal and government fees will increase substantially and therefore are unable to predict whether cost may factor into our global intellectual property strategy.

36In addition to the risks associated with patent rights, the laws in some foreign jurisdictions may not provide protection for our trade secrets and other intellectual property. If our trade secrets or other intellectual property are misappropriated in foreign jurisdictions, we may be without adequate remedies to address these issues. Additionally, we also rely on confidentiality and assignment of invention agreements to protect our intellectual property in foreign jurisdictions. These agreements may provide for contractual remedies in the event of misappropriation, but we do not know to what extent, if any, these agreements, and any remedies for their breach, will be enforced by a foreign court. If our intellectual property is misappropriated or infringed upon and an adequate remedy is not available, our future prospects will likely diminish. The sale of diagnostic tests that infringe our intellectual property rights, particularly if such diagnostic tests are offered at a lower cost, could negatively impact our ability to achieve commercial success and may materially and adversely harm our business.

InOur ~~addition~~failure to ~~the~~secure ~~risks~~trademark ~~associated~~registrations ~~with~~could ~~patent~~adversely ~~rights,~~affect ~~the laws in some foreign jurisdictions may not provide protection for~~ our ~~trade~~business ~~secrets~~ and ~~other intellectual property. If~~ our ~~trade~~ ~~secrets~~ability ~~or other intellectual property are misappropriated in foreign jurisdictions, we may be without adequate remedies~~ to ~~address these~~market ~~issues. Additionally, we also rely on confidentiality and assignment of invention agreements to protect~~ our ~~intellectual~~assays ~~property in foreign jurisdictions. These agreements may provide for contractual remedies in the event of misappropriation, but we do not know to what extent, if any, these agreements,~~ and ~~any~~product ~~remedies for their breach, will be enforced by a foreign court~~candidates. If our intellectual property is misappropriated or infringed upon and an adequate remedy is not available, our future prospects will likely diminish. The sale of diagnostic tests that infringe our intellectual property rights, particularly if such diagnostic tests are offered at a lower cost, could negatively impact our ability to achieve commercial success and may materially and adversely harm our business.

Our ~~failure~~trademark applications in the United States and any other jurisdictions where we may file may not be allowed for registration, and our registered trademarks may not be maintained or enforced. During trademark registration proceedings, we may receive rejections. Although we are given an opportunity to ~~secure~~respond to those rejections, we may be unable to overcome such rejections. In addition, in the USPTO and in corresponding foreign agencies, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our applications and/or registrations, and our applications and/or registrations may not survive such proceedings. Failure to secure such trademark registrations in the United States and in foreign jurisdictions could adversely affect our business and our ability to market our ~~assays~~diagnostic tests and product candidates.

~~Our~~We ~~trademark applications in the United States and any other jurisdictions where we~~ may ~~file may not~~ be allowed for registration, and our registered trademarks may not be maintained or enforced. During trademark registration proceedings, we may receive rejections. Although we are given an opportunity to respond to those rejections, we may be unable to ~~overcome~~adequately ~~such~~prevent ~~rejections.~~disclosure Inof ~~addition,~~trade ~~in the USPTO and in corresponding foreign agencies, third~~secrets ~~parties are given an opportunity to oppose pending trademark applications~~ and toother ~~seek~~proprietary ~~to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our applications and/or registrations~~information, ~~and our applications and/~~or ~~registrations~~the ~~may~~misappropriation ~~not~~of ~~survive such proceedings. Failure to secure such trademark registrations in~~ the ~~United~~intellectual ~~States~~property ~~and~~we inregard ~~foreign~~as ~~jurisdictions could adversely affect~~ our ~~business~~ ~~and our ability to market our diagnostic tests and product candidates~~own.

We ~~may~~rely beon ~~unable~~trade secrets to ~~adequately~~protect ~~prevent~~our ~~disclosure~~proprietary know how and technological ofadvances, particularly where we do not believe patent protection is appropriate or obtainable. Nevertheless, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, third party contractors, third party collaborators and other advisors to protect our trade secrets and other proprietary information,. These agreements generally require that the other party to the agreement keep confidential and not disclose to third parties all confidential information developed by us or made known to the other ~~misappropriation~~party by us during the course of the ~~intellectual~~other ~~property~~party’s relationship with us. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Monitoring unauthorized disclosure is difficult, and we ~~regard~~do not know whether the steps we have taken to prevent such disclosure are, or will be, adequate. If we were to seek to pursue a claim that a third party had illegally obtained and was using our trade secrets, it would be expensive and time consuming, and the outcome would be unpredictable. Further, courts outside the United States may be less willing to protect trade secrets. In addition, others may independently discover our trade secrets and proprietary information and therefore be free to use such trade secrets and proprietary information. Costly and time consuming litigation could be necessary to enforce and determine the scope of our proprietary rights. In addition, our trade secrets and proprietary information may be misappropriated as a result of breaches of our ~~own~~electronic or physical security systems in which case we may have no legal recourse. Failure to obtain, or maintain, trade secret protection could enable competitors to use our proprietary information to develop assays that compete with our assays or cause additional, material adverse effects upon our competitive business position.

We rely on trade secrets to protect our proprietary know how and technological advances, particularly where we do not believe patent protection is appropriate or obtainable. Nevertheless, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, third party contractors, third party collaborators and other advisors to protect our trade secrets and other proprietary information. These agreements generally require that the other party to the agreement keep confidential and not disclose to third parties all confidential information developed by us or made known to the other party by us during the course of the other party’s relationship with us. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Monitoring unauthorized disclosure is difficult, and we do not know whether the steps we have taken to prevent such disclosure are, or will be, adequate. If we were to seek to pursue a claim that a third party had illegally obtained and was using our trade secrets, it would be expensive and time consuming, and the outcome would be unpredictable. Further, courts outside the United States may be less willing to protect trade secrets. In addition, others may independently discover our trade secrets and proprietary information and therefore be free to use such trade secrets and proprietary information. Costly and time consuming litigation could be necessary to enforce and determine the scope of our proprietary rights. In addition, our trade secrets and proprietary information may be misappropriated as a result of breaches of our electronic or physical security systems in which case we may have no legal recourse. Failure to obtain, or maintain, trade secret protection could enable competitors to use our proprietary information to develop assays that compete with our assays or cause additional, material adverse effects upon our competitive business position.32

37We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

As is common in our industry, we employ individuals who were previously employed at other companies in our industry or in related industries, including our competitors or potential competitors. We may be subject to claims that ~~our~~we or these employees have ~~wrongfully~~inadvertently or otherwise used or disclosed ~~alleged~~ trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

AsThird isparties ~~common in our industry, we employ individuals who were previously employed at other companies in our industry or in related industries, including our competitors or potential competitors. We~~ may beinitiate ~~subject~~legal toproceedings ~~claims~~alleging that we ~~or these employees have inadvertently or otherwise used or disclosed trade secrets or other proprietary~~ ~~information~~are ofinfringing their ~~former~~intellectual ~~employers.~~property ~~Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims~~rights, ~~litigation~~the ~~could~~outcome ~~result~~of inwhich ~~substantial~~would ~~costs and~~ be ~~a distraction to management~~uncertain.

~~Third~~Our ~~parties~~commercial ~~may~~success ~~initiate~~depends ~~legal~~upon ~~proceedings~~our ability to develop, manufacture, ~~alleging~~market ~~that~~and wesell ~~are~~our product candidates without infringing ~~their~~the proprietary rights of third parties. There is considerable intellectual property litigation in the life sciences industry. We cannot guarantee that our product candidates will not infringe third-party patents or other proprietary rights. We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including inter partes review, interference, or derivation proceedings before the ~~outcome~~USPTO ofand ~~which~~similar ~~would~~bodies in other countries. Third parties may assert infringement claims against us based on existing intellectual property rights and intellectual property rights that may be ~~uncertain~~granted in the future.

~~Our~~If ~~commercial~~we ~~success~~are ~~depends~~found ~~upon~~to ~~our~~infringe ~~ability to~~a ~~develop,~~third ~~manufacture,~~party’s ~~market~~intellectual ~~and~~property rights, ~~sell~~we ~~our~~could ~~product~~be ~~candidates~~required ~~without~~to ~~infringing~~obtain ~~the~~a ~~proprietary~~license ~~rights~~from ofsuch third ~~parties.~~party ~~There~~to iscontinue ~~considerable intellectual~~developing ~~property~~and ~~litigation~~marketing inour ~~the~~products. ~~life~~However, ~~sciences~~we may ~~industry.~~not Webe ~~cannot~~able ~~guarantee~~to ~~that~~obtain ~~our~~any ~~product~~required ~~candidates~~license ~~will~~on ~~not~~commercially ~~infringe~~reasonable ~~third-party patents~~terms or ~~other~~at ~~proprietary rights~~all. WeEven ~~may~~if ~~become~~we ~~party~~were able to obtain a license, orit could ~~threatened~~be ~~with~~non-exclusive, ~~future~~thereby ~~adversarial~~giving ~~proceedings~~our orcompetitors ~~litigation~~access ~~regarding intellectual~~to ~~property~~the ~~rights~~same ~~with~~technologies ~~respect~~licensed to ~~our~~us. ~~products~~We ~~and~~could ~~technology~~be forced, including ~~inter~~ ~~partes review,~~by court ~~interference~~order, or ~~derivation~~to ~~proceedings~~cease ~~before~~commercializing the ~~USPTO~~infringing technology or product. In addition, we could be found liable for monetary damages, including treble damages and ~~similar~~attorneys’ ~~bodies~~fees inif ~~other~~we ~~countries.~~are ~~Third~~found ~~parties~~to ~~may~~have ~~assert~~willfully ~~infringement~~infringed ~~claims~~a ~~against~~patent. A finding of infringement could prevent us ~~based~~from oncommercializing ~~existing~~our ~~intellectual~~product ~~property~~candidates ~~rights~~or ~~and~~force ~~intellectual~~us ~~property~~to ~~rights~~cease ~~that~~some ~~may~~of beour ~~granted~~business inoperations, which could materially harm our business. Claims that we have misappropriated the ~~future~~confidential information or trade secrets of third parties could have a similar negative impact on our business.

IfObtaining ~~we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing~~ and ~~marketing~~maintaining our ~~products.~~ ~~However,~~patent weprotection ~~may~~depends ~~not be able to obtain any required license~~ on ~~commercially reasonable terms or at all. Even if we were able~~compliance towith ~~obtain~~various ~~a license~~procedural, itdocument ~~could be non-exclusive~~submission, ~~thereby~~fee ~~giving~~payment ~~our~~and ~~competitors~~other ~~access~~requirements toimposed ~~the same technologies licensed to us. We could be forced, including~~ by ~~court~~governmental ~~order,~~patent ~~to cease commercializing the infringing technology or product. In addition~~agencies, ~~we could be found liable for monetary damages, including treble damages~~ and ~~attorneys’~~our ~~fees if we are found to have willfully infringed a~~ own patent. Aprotection ~~finding of infringement~~ could ~~prevent~~be usreduced ~~from commercializing our product candidates~~ or ~~force~~eliminated usfor tononcompliance ~~cease~~with ~~some~~these ~~of our business operations, which could materially harm our business~~requirements. ~~Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.~~

~~Obtaining~~Periodic maintenance fees and ~~maintaining~~annuities ~~our~~on any issued patent ~~protection~~are due ~~depends~~to onbe paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with ~~various~~a number of procedural, ~~document submission~~documentary, fee payment and other ~~requirements~~similar ~~imposed~~provisions byduring ~~governmental~~the patent ~~agencies~~application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, ~~and~~there ~~our~~are ~~own~~situations in which noncompliance can result in abandonment or lapse of the patent ~~protection~~or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could beresult ~~reduced~~in abandonment or ~~eliminated~~lapse ~~for~~of ~~noncompliance~~a ~~with~~patent ~~these~~or ~~requirements~~patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, our competitors might be able to enter our markets, which could have a material adverse effect on our business.

~~Periodic~~Intellectual ~~maintenance~~property ~~fees~~litigation and annuities on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could ~~result~~cause inus ~~abandonment or lapse of a patent or patent application include, but are not limited~~ to, ~~failure~~spend ~~to respond to official~~substantial ~~actions~~resources ~~within prescribed time limits, non-payment of fees~~ and ~~failure~~distract ~~to properly legalize and submit formal documents. In such an event,~~ our ~~competitors~~personnel ~~might~~from betheir ~~able~~normal ~~to enter our markets, which could have a material adverse effect on our business~~responsibilities.

~~Intellectual~~Even ~~property~~if resolved in our favor, litigation ~~could~~or ~~cause~~other legal proceedings relating to intellectual property claims may cause us to ~~spend~~incur ~~substantial~~significant ~~resources~~expenses and could distract our ~~personnel~~technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have an adverse effect on the price of our common stock. Such litigation or proceedings could increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace.

~~Even~~We ~~if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims~~ may ~~cause~~spend usconsiderable toresources ~~incur~~developing ~~significant expenses~~ and ~~could distract our technical~~maintaining ~~and management personnel from their normal responsibilities. In addition~~patents, ~~there~~licensing ~~could~~agreements beand ~~public announcements of the results of hearings, motions or~~ other ~~interim~~intellectual ~~proceedings~~property orthat ~~developments~~may ~~and~~later ~~if securities analysts or investors perceive these results to~~ be ~~negative,~~abandoned ~~it could have an adverse effect on the price of our common stock. Such litigation~~ or ~~proceedings could increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We~~ may ~~not~~otherwise ~~have~~never ~~sufficient financial~~result orin ~~other~~products ~~resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the~~brought costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to ~~compete in the marketplace~~market.

38Not all technologies and candidate products that initially show potential as the basis for future products ultimately meet the rigors of our development process and as a result may be abandoned and/or never otherwise result in products brought to market. In some cases, prior to abandonment we may be required to incur significant costs developing and maintaining intellectual property and/or maintaining license agreements and our business could be harmed by such costs.

We may spend considerable resources developing and maintaining patents, licensing agreements and other intellectual property that may later be abandoned or may otherwise never result in products brought to market.33

~~Not~~We ~~all~~rely ~~technologies~~on ~~and~~information ~~candidate~~technology, ~~products~~and ~~that initially~~if ~~show~~we ~~potential~~are asunable ~~the~~to ~~basis~~protect against ~~for~~service ~~future~~interruptions, ~~products~~data ~~ultimately~~corruption, ~~meet~~cyber-based ~~the~~attacks ~~rigors of our development process and as a result may be abandoned and/~~or ~~never~~network ~~otherwise~~security ~~result in products brought to market. In some cases~~breaches, ~~prior~~our tooperations ~~abandonment~~could ~~we may~~ be ~~required~~disrupted, ~~to incur significant costs developing~~ and ~~maintaining intellectual property and/or maintaining license agreements and~~ our business could be ~~harmed~~negatively ~~by such costs~~affected.

We rely on information technology networks and systems to process, transmit and ifstore electronic and financial information; to coordinate our business; and to communicate within our Company and with customers, wesuppliers, ~~are~~partners ~~unable~~and other third parties. These information technology systems may be susceptible to ~~protect~~damage, ~~against~~disruptions ~~service~~or ~~interruptions~~shutdowns, hardware ~~data~~or ~~corruption~~software failures, power outages, computer viruses, cyber-~~based~~ attacks, telecommunication failures, user errors or ~~network~~catastrophic events. ~~security~~If ~~breaches~~our information technology systems suffer severe damage, disruption or shutdown, and our ~~operations~~business continuity plans do not effectively resolve the issues in a timely manner, our operations could be disrupted, and our business could be negatively affected. In addition, cyber-attacks could lead to potential unauthorized access and disclosure of confidential information, and data loss and corruption. There is no assurance that we will not experience these service interruptions or cyber-attacks in the future.

WeRisks ~~rely~~Related ~~on information technology networks and systems~~ to ~~process,~~the ~~transmit and store electronic and financial information; to coordinate our business; and to communicate within our~~ Company and with customers, suppliers, partners and other third parties. These information technology systems may be susceptible to damage, disruptions or shutdowns, hardware or software failures, power outages, computer viruses, cyber-attacks, telecommunication failures, user errors or catastrophic events. If our information technology systems suffer severe damage, disruption or shutdown, and our business continuity plans do not effectively resolve the issues in a timely manner, our operations could be disrupted, and our business could be negatively affected. In addition, cyber-attacks could lead to potential unauthorized access and disclosure of confidential information, and data loss and corruption. There is no assurance that we will not experience these service interruptions or cyber-attacks in the future.Business

~~Risks~~We ~~Related~~have toa ~~the~~limited ~~Company~~operating history and ~~our~~may ~~Business~~face difficulties encountered by companies early in their commercialization in competitive and rapidly evolving markets.

We ~~have~~received aCE-Mark ~~limited~~for ~~operating~~our ~~history~~eLab instrument and ~~may~~S1 Assay panel in November ~~face~~of ~~difficulties~~2019 ~~encountered~~and began commercializing these products in the fourth quarter of 2020. We have also developed products for COVID-19 with the intent to file for FDA EUA. The application for our COVID-19 antibody test was not reviewed by ~~companies~~the ~~early~~FDA due to the volume of EUA requests the Agency has received for similar tests. The EUA application for our COVID-19 antigen test was reviewed by the FDA and additional clinical and analytical information was requested. The Company conducted additional work and refiled the EUA in November 2021. The FDA has requested additional information primarily from clinical testing sites prior to initiating their ~~commercialization~~formal review. Given changes in ~~competitive~~COVID-19 testing volumes and ~~rapidly~~pricing, ~~evolving~~we ~~markets~~are not pursuing further development of the COVID-19 products.

WeAccordingly, ~~received~~we ~~CE-Mark~~have ~~for~~a ~~our~~relatively ~~eLab~~limited ~~instrument~~operating ~~and S1~~history ~~Assay~~upon ~~panel~~which to inevaluate ~~November~~our ofbusiness ~~2019~~ and ~~began~~forecast ~~commercializing~~our ~~these~~future ~~products~~sales inand ~~the~~operating ~~fourth quarter of 2020~~results. WeIn ~~have~~assessing ~~also developed products for COVID-19 with the intent to file for FDA EUA. The application for~~ our ~~COVID-19~~business ~~antibody~~prospects, ~~test~~you ~~was~~should ~~not reviewed by the FDA due to the~~consider ~~volume of EUA requests~~ the ~~Agency~~various ~~has~~risks ~~received~~and ~~for~~difficulties ~~similar~~frequently ~~tests.~~encountered ~~The~~by ~~EUA~~companies ~~application~~early ~~for~~in ~~our~~their ~~COVID-19~~commercialization ~~antigen~~in ~~test~~competitive ~~was~~and ~~reviewed~~rapidly ~~by the~~evolving ~~FDA~~markets, ~~and~~particularly ~~additional~~companies ~~clinical~~that ~~and~~develop ~~analytical information was requested. The Company conducted additional work~~ and ~~refiled~~sell ~~the~~medical ~~EUA in November 2021~~devices. ~~The~~These ~~FDA~~risks ~~has~~include ~~requested~~our ~~additional~~ability ~~information primarily from clinical testing sites prior~~ to ~~initiating their formal review.~~:

~~Accordingly,~~● weimplement ~~have a relatively limited operating history upon which to evaluate our business~~ and ~~forecast~~execute our ~~future sales and operating results. In assessing our~~ business prospects, you should consider the various risks and difficulties frequently encountered by companies early in their commercialization in competitive and rapidly evolving markets, particularly companies that develop and sell medical devices. These risks include our ability to:strategy;

● ~~implement~~establish a sales and ~~execute~~marketing infrastructure to grow sales of our ~~business~~products ~~strategy~~and product candidates;

● ~~establish~~implement acomputer ~~sales~~based ~~and~~systems ~~marketing~~for ~~infrastructure~~the tomanagement ~~grow~~of ~~sales~~orders, ofproduction, ~~our~~inventory, ~~products~~invoicing, and ~~product~~receivable ~~candidates~~collections;

● ~~implement~~increase ~~computer~~awareness ~~based systems for the management~~ of ~~orders,~~our ~~production, inventory, invoicing, and receivable collections~~brand;

● ~~increase~~manage ~~awareness~~expanding ~~of our brand;~~operations

● ~~manage~~expand ~~expanding~~our ~~operations~~manufacturing capabilities, including increasing production of current products efficiently while maintaining quality standards and adapting our manufacturing facilities to the production of new product candidates;

● ~~expand~~respond ~~our~~effectively ~~manufacturing~~to ~~capabilities,~~competitive ~~including~~pressures ~~increasing production of current products efficiently while maintaining quality standards~~ and ~~adapting our manufacturing facilities to the production of new product candidates~~developments;

39● enhance our existing product and develop new products;

● ~~respond~~obtain ~~effectively~~and maintain regulatory clearance or approval to ~~competitive~~commercialize ~~pressures~~product candidates and ~~developments~~enhance our existing products;

● ~~enhance~~effectively ~~our~~perform ~~existing~~clinical ~~product~~trials ~~and~~with ~~develop~~respect ~~new~~to our proposed products;

● ~~obtain~~attract, retain and ~~maintain~~motivate ~~regulatory~~qualified ~~clearance~~personnel orin ~~approval~~various toareas ~~commercialize~~of ~~product candidates and enhance~~ our ~~existing~~business: ~~products;~~and

● ~~effectively~~implement ~~perform~~and ~~clinical~~maintain ~~trials~~systems ~~with~~and ~~respect~~processes tothat ~~our~~are ~~proposed~~compliant ~~products;~~with applicable regulatory standards.

●We ~~attract~~may not have the institutional knowledge or experience to be able to effectively address these and other risks that may face our business. In addition, ~~retain~~we may not be able to develop insights into trends that could emerge and ~~motivate~~negatively ~~qualified~~affect ~~personnel~~our inbusiness ~~various~~and ~~areas~~may fail to respond effectively to those trends. As a result of these or other risks, we may not be able to execute key components of our business: strategy, and our business, financial condition and operating results may suffer.

~~● implement and maintain systems and processes that are compliant with applicable regulatory standards.~~34

WeSales ~~may~~cycles ~~not~~for ~~have the institutional knowledge or experience to be able to effectively address these and other risks that may face~~ our ~~business.~~products ~~In addition, we~~ may ~~not~~ be ~~able~~lengthy, towhich ~~develop~~can cause ~~insights~~variability ~~into trends that could emerge~~ and ~~negatively~~unpredictability ~~affect~~in our business ~~and may fail to respond effectively to those trends~~. ~~As a result of these or other risks, we may not be able to execute key components of our business strategy, and our business, financial condition and operating results may suffer.~~

~~Sales~~Some ~~cycles~~of ~~for~~ our products may berequire lengthy, and unpredictable sales cycles, which ~~can~~makes it more difficult to accurately forecast revenues and may cause ~~variability~~revenues and ~~unpredictability~~operating results to vary from period to period. Our products may involve sales to large public and private institutions which may require many levels of approval and may be dependent on economic or political conditions and the availability of funding from government or public health agencies which can vary from period to period. There can be no assurance that purchases or funding from these agencies will occur or continue. As a result, we may expend considerable resources on unsuccessful sales efforts or we may not be able to complete transactions at all or on a schedule and in an amount consistent with our ~~business~~objectives.

~~Some~~We ofhave ~~our~~limited ~~products~~commercial ~~may~~scale ~~require~~capabilities. ~~lengthy~~If ~~and~~we ~~unpredictable sales~~are ~~cycles, which makes it more difficult to accurately forecast revenues and may cause revenues and operating results to vary from~~unable ~~period~~ to ~~period.~~successfully ~~Our~~implement ~~products~~commercial ~~may~~capabilities ~~involve sales to large public~~ and ~~private~~manage ~~institutions~~our ~~which~~growth, ~~may~~our ~~require~~business many levels of approval and may be dependent on economic or political conditions and the availability of funding from government or public health agencies which can vary from period to period. There can be no assurance that purchases or funding from these agencies will ~~occur or continue. As a result, we may expend considerable resources on unsuccessful sales efforts or we may not~~ be ~~able to complete transactions at all or on a schedule and in an amount consistent with our objectives~~harmed.

We have ~~limited~~been ~~commercial~~a ~~scale~~development stage company and we will need to establish and significantly expand our operations and capabilities. We expect this expansion to occur rapidly and continue to an even greater degree Ifin the future as we ~~are~~continue ~~unable~~to commercialize our products, build a sales and marketing organization, and seek marketing clearance from the FDA and international regulatory bodies for our future product candidates. Our growth will place a significant strain on our management, operating and financial systems and our sales, marketing, manufacturing, engineering, product development, and administrative resources. As a result of our growth, operating costs may escalate even faster than planned, and some of our internal systems and processes, including those relating to ~~successfully~~manufacturing ~~implement~~our ~~commercial~~products, ~~capabilities~~will need to be established and ~~manage~~may need to be enhanced, updated or replaced. Additionally, our anticipated growth will increase demands placed on our suppliers, resulting in an increased need for us to manage our suppliers and monitor for quality assurance. If we cannot effectively manage our expanding operations, manufacturing capacity and costs, including scaling to meet increased demand and properly managing suppliers, we may not be able to grow or we may grow at a slower pace than expected and our business ~~will~~could be ~~harmed~~adversely affected.

We ~~have~~face ~~been~~substantial a development stage company and we will need to establish and significantly expand our operations and capabilities. We expect this expansion to occur rapidly and continue to an even greater degree in the future as we continue to commercialize our productscompetition, ~~build~~which amay sales and marketing organization, and seek marketing clearance from the FDA and international regulatory bodies for our future product candidates. Our growth will place a significant strain on our management, operating and financial systems and our sales, marketing, manufacturing, engineering, product development, and administrative resources. As a result ofin ~~our~~others ~~growth~~discovering, ~~operating costs may escalate even faster than planned, and some of our internal systems~~ ~~and~~developing ~~processes,~~or ~~including~~commercializing ~~those relating to manufacturing our~~ products, ~~will~~before ~~need to be established and may need to be enhanced, updated~~ or ~~replaced.~~more ~~Additionally,~~successfully ~~our~~than ~~anticipated growth will increase demands placed on our suppliers, resulting in an increased need for us to manage our suppliers and monitor for quality assurance. If~~ we cannot effectively manage our expanding operations, manufacturing capacity and costs, including scaling to meet increased demand and properly managing suppliers, we may not be able to grow or we may grow at a slower pace than expected and our business could be adversely affecteddo.

The development and commercialization of medical devices is highly competitive. We ~~face~~compete ~~substantial~~with ~~competition~~a variety of multinational pharmaceutical companies and specialized biotechnology companies, ~~which~~as ~~may~~well as products ~~result~~and inprocesses ~~others~~being ~~discovering~~developed at universities and other research institutions. Our competitors have developed, are developing or ~~commercializing~~will develop product candidates and processes competitive with our product candidates. Competitive therapeutic treatments include those that have already been approved and accepted by the medical community and any new treatments that may enter the market. We believe that a significant number of products ~~before~~are orcurrently ~~more~~available, ~~successfully~~under ~~than~~development, and may become commercially available in the future, for the treatment of indications for which we domay try to develop product candidates.

~~The~~More ~~development~~established ~~and~~companies ~~commercialization~~may ofhave ~~medical devices~~a ~~is highly~~ competitive. Weadvantage ~~compete~~over ~~with~~us due ato ~~variety~~their ofgreater ~~multinational~~size, ~~pharmaceutical~~cash ~~companies~~flows and ~~specialized~~institutional ~~biotechnology~~experience. ~~companies~~Compared to us, as ~~well~~many asof ~~products~~our ~~and~~competitors ~~processes~~may ~~being~~have ~~developed~~significantly atgreater financial, ~~universities~~technical and ~~other~~human ~~research institutions~~resources. ~~Our~~As ~~competitors~~a ~~have~~result ~~developed,~~of ~~are developing~~these orfactors, ~~will~~our ~~develop~~competitors ~~product~~may ~~candidates~~have ~~and~~an ~~processes~~advantage ~~competitive~~in ~~with~~marketing ~~our~~their ~~product~~approved products ~~candidates.~~and ~~Competitive~~may ~~therapeutic~~obtain ~~treatments include~~regulatory ~~those~~approval ~~that~~of ~~have~~their ~~already~~product ~~been~~candidates ~~approved~~before ~~and~~we ~~accepted~~are byable ~~the~~to, ~~medical~~which ~~community~~may ~~and~~limit ~~any~~our ~~new~~ability ~~treatments~~to ~~that~~develop or ~~may~~commercialize ~~enter~~our ~~the~~product ~~market~~candidates. We ~~believe~~Our ~~that~~competitors amay ~~significant~~also ~~number~~develop ofdrugs ~~products~~that are ~~currently available~~safer, ~~under~~more ~~development~~effective, ~~and~~more ~~may~~widely ~~become~~used ~~commercially~~and ~~available in~~less ~~the~~expensive ~~future~~than ours, ~~for~~and ~~the~~may ~~treatment~~also ofbe ~~indications~~more ~~for~~successful ~~which~~than weus ~~may~~in ~~try~~manufacturing toand ~~develop~~marketing ~~product~~their ~~candidates~~products.

40Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These companies compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

~~More~~Our ~~established~~technologies ~~companies may have a competitive advantage over us due to their greater size, cash flows~~ and ~~institutional~~products ~~experience.~~under ~~Compared to us~~development, ~~many of our competitors may have significantly greater financial, technical~~ and ~~human resources. As a result of these factors,~~ our ~~competitors may have an advantage in~~business, ~~marketing their approved products and~~ may ~~obtain~~fail ~~regulatory~~if ~~approval of their product candidates before~~ we are not able to, ~~which~~successfully ~~may limit our ability to develop or~~ commercialize ~~our~~them ~~product candidates. Our competitors may also develop drugs that are safer, more effective, more widely used~~ and ~~less~~ultimately ~~expensive~~generate ~~than~~significant ~~ours,~~revenues ~~and~~as ~~may~~a ~~also be more successful than us in manufacturing and marketing their products~~result.

~~Mergers~~Successful ~~and~~development ~~acquisitions~~of intechnologies ~~the pharmaceutical~~ and ~~biotechnology~~our ~~industries~~product ~~may~~candidates ~~result~~will require insignificant ~~even~~additional ~~more~~investment, ~~resources~~including ~~being~~costs ~~concentrated~~associated ~~among~~with aadditional ~~smaller~~development, ~~number~~completing oftrials ~~our~~and ~~competitors.~~obtaining ~~Smaller and~~regulatory ~~other~~approval, ~~early-stage~~as ~~companies~~well ~~may~~as ~~also~~the ~~prove~~ability to bemanufacture ~~significant~~or ~~competitors,~~have ~~particularly~~others ~~through~~manufacture ~~collaborative~~our ~~arrangements~~products ~~with~~in ~~large~~sufficient ~~and~~quantities at acceptable costs while ~~established~~also ~~companies.~~preserving ~~These~~product ~~companies~~quality. ~~compete~~Difficulties ~~with~~often usencountered in ~~recruiting~~scaling ~~and~~up ~~retaining~~production ~~qualified~~include ~~scientific~~problems involving production yields, quality ~~management~~control and ~~commercial~~assurance, shortage of qualified personnel, ~~establishing~~ ~~clinical~~production ~~trial~~costs ~~sites~~ and ~~subject~~process ~~registration~~controls. ~~for~~In ~~clinical trials~~addition, aswe ~~well~~are assubject into inherent ~~acquiring~~risks associated with new technologies ~~complementary~~and ~~to, or~~products. ~~necessary~~These ~~for,~~risks include the possibility that any of our ~~programs.~~technologies or future products may:

~~Our~~● ~~technologies~~be ~~and~~found ~~products under development, and our business, may fail if we are not able to successfully commercialize them and ultimately generate significant revenues as a result.~~unsafe;

~~Successful~~● ~~development~~be ofineffective technologies and our product candidates will require significant additional investment, including costs associated with additional development, completing trials and obtaining regulatory approval, as well as the ability to manufacture or ~~have~~less ~~others~~effective ~~manufacture~~than our products in sufficient quantities at acceptable costs while also preserving product quality. Difficulties often encountered in scaling up production include problems involving production yields, quality control and assurance, shortage of qualified personnel, production costs and process controls. In addition, we are subject to inherent risks associated with new technologies and products. These risks include the possibility that any of our technologies or future products may:anticipated;

● befail ~~found~~to ~~unsafe~~receive necessary regulatory approvals;

~~● be ineffective or less effective than anticipated;~~35

● ~~fail~~be difficult to ~~receive~~competitively ~~necessary~~price ~~regulatory~~relative ~~approvals~~to alternative solutions;

● be ~~difficult~~harmful to ~~competitively~~consumers ~~price~~or ~~relative~~the ~~to alternative solutions~~environment;

● be ~~harmful~~difficult to ~~consumers~~manufacture oron ~~the~~an ~~environment~~economically viable scale;

● be ~~difficult~~subject to ~~manufacture~~supply onchain anconstraints ~~economically~~for ~~viable~~raw ~~scale~~materials;

● fail to be ~~subject~~developed and accepted by the market prior to ~~supply~~the ~~chain~~successful ~~constraints~~marketing ~~for~~of ~~raw~~alternative ~~materials~~products by competitors;

● ~~fail to~~ be ~~developed~~difficult ~~and~~to ~~accepted~~market bybecause ~~the~~of ~~market~~infringement ~~prior~~on to the ~~successful~~proprietary ~~marketing~~rights of ~~alternative~~third ~~products by competitors~~parties; or

● be ~~difficult~~too toexpensive ~~market~~for ~~because~~commercial ~~of infringement on the proprietary rights of third parties; or~~use.

●Furthermore, we may be ~~too~~faced ~~expensive~~with lengthy market partner or distributor evaluation and approval processes. Consequently, we may incur substantial expenses and devote significant management effort in order to customize products for ~~commercial~~market ~~use~~partner or distributor acceptance, though there can be no assurance of such acceptance. As a result, we cannot accurately predict the volume or timing of any future sales.

~~Furthermore,~~Customers we may benot ~~faced~~adopt ~~with~~our ~~lengthy market partner or distributor evaluation and approval processes. Consequently, we may incur substantial expenses and devote significant management effort in order to customize~~ products ~~for market partner or distributor acceptance~~quickly, ~~though there can be no assurance of such acceptance. As a result, we cannot accurately predict the volume~~ or ~~timing~~at ~~of any future sales~~all.

41Customers in the sector in which we operate can be generally cautious in their adoption of new products and technologies. In addition, given the relative novelty of our future planned products, customers of those products may require education regarding their utility and use, which may delay their adoption. There can be no assurance that customers will adopt our products quickly, or at all.

~~Customers~~ The ~~may~~significant ~~not~~level ~~adopt~~of competition in the markets for our products ~~quickly~~developed in the future may result in pricing pressure, reduced margins or atthe ~~all~~inability of our future products to achieve market acceptance.

~~Customers~~The inmarkets ~~the~~for ~~sector~~our infuture ~~which~~products weare ~~operate~~intensely ~~can be~~competitive ~~generally cautious in their adoption of new products~~ and ~~technologies~~rapidly changing. InWe ~~addition,~~may ~~given~~be ~~the~~unable ~~relative~~to ~~novelty~~compete ~~of our future planned products~~successfully, ~~customers~~which ~~of those products~~ may ~~require~~result ~~education~~in ~~regarding~~price ~~their utility and use~~reductions, ~~which~~reduced ~~may~~margins ~~delay~~and ~~their~~the ~~adoption.~~inability ~~There~~to ~~can~~achieve bemarket noacceptance ~~assurance~~for ~~that customers will adopt~~ our products ~~quickly, or at all~~.

~~The~~Our ~~significant~~competitors ~~level~~may ofhave ~~competition~~longer inoperating histories, significantly ~~the~~greater ~~markets~~resources, ~~for~~greater ~~our~~brand ~~products~~recognition ~~developed~~and inlarge ~~the~~customer ~~future~~bases ~~may~~than ~~result~~we indo. ~~pricing~~As ~~pressure~~a result, ~~reduced~~they ~~margins~~may orbe able to devote greater resources to the ~~inability~~manufacture, ofpromotion ~~our~~or ~~future~~sale of their products to, ~~achieve~~receive greater resources and support from market ~~acceptance~~partners and independent distributors, initiate or withstand substantial price competition or more readily take advantage of acquisition or other opportunities.

~~The~~We ~~markets~~may rely on third parties for the production of our future products. ~~are~~If ~~intensely competitive~~these ~~and~~parties ~~rapidly~~do ~~changing.~~not Weproduce ~~may~~our beproducts ~~unable~~at toa ~~compete~~satisfactory ~~successfully~~quality, ~~which~~in ~~may~~a ~~result~~timely manner, in ~~price~~sufficient ~~reductions~~quantities or at an acceptable cost, ~~reduced~~our ~~margins~~sales and ~~the~~ ~~inability~~development toefforts ~~achieve~~could ~~market~~be ~~acceptance~~delayed ~~for~~or ~~our~~otherwise ~~products~~negatively affected.

~~Our~~We ~~competitors~~ may ~~have~~rely ~~longer~~on ~~operating~~third ~~histories, significantly~~parties ~~greater~~for ~~resources,~~the ~~greater~~manufacture ~~brand~~of ~~recognition~~our ~~and~~future ~~large customer bases than we do~~products. Our Asreliance aon ~~result,~~third ~~they~~parties ~~may be able~~ to ~~devote greater resources to the~~ manufacture, ~~promotion~~our orfuture ~~sale of their~~ products, ~~receive~~may ~~greater~~present ~~resources~~significant ~~and~~risks ~~support~~to ~~from market partners and independent distributors~~us, ~~initiate~~including orthe ~~withstand substantial price competition or more readily take advantage of acquisition or other opportunities.~~following:

We● ~~may~~reduced ~~rely~~control onover ~~third~~delivery ~~parties for the production of our future products. If these parties do not produce our products at a satisfactory quality~~schedules, inyields ~~a timely manner, in sufficient quantities or at an acceptable cost, our sales~~ and ~~development~~product ~~efforts could be delayed or otherwise negatively affected.~~reliability;

We● ~~may~~price ~~rely on third parties for the manufacture of our future products. Our reliance on third parties to manufacture our future products may present significant risks to us, including the following:~~increases;

● ~~reduced~~manufacturing ~~control~~deviations ~~over~~from ~~delivery~~internal ~~schedules, yields~~ and ~~product~~regulatory ~~reliability~~specifications;

● ~~price~~the ~~increases~~failure of a key manufacturer to perform as we require for technical, market or other reasons;

● ~~manufacturing~~difficulties ~~deviations~~in ~~from~~establishing ~~internal~~additional ~~and~~manufacturer ~~regulatory~~relationships ~~specifications~~if we are presented with the need to transfer our manufacturing process technologies to them;

● ~~the~~misappropriation ~~failure~~ of aour ~~key~~intellectual ~~manufacturer to perform as we require for technical, market or other reasons~~property; and

● ~~difficulties~~other risks in ~~establishing~~potentially ~~additional~~meeting ~~manufacturer~~our ~~relationships~~product ifdevelopment weschedule ~~are~~or ~~presented~~satisfying ~~with~~ the ~~need~~requirements toof ~~transfer~~ our ~~manufacturing~~market ~~process~~partners, ~~technologies~~distributors, todirect ~~them;~~customers and end users.

●If ~~misappropriation~~we need to enter into agreements for the manufacturing of our ~~intellectual~~future products, ~~property;~~there ~~and~~can be no assurance we will be able to do so on favorable terms, if at all.

~~● other risks in potentially meeting our product development schedule or satisfying the requirements of our market partners, distributors, direct customers and end users.~~36

If we ~~need~~are unable to ~~enter~~establish ~~into~~successful ~~agreements~~relations ~~for~~with ~~the manufacturing~~third-party ofmarket ~~our~~partners ~~future~~or ~~products~~distributors, ~~there~~or ~~can~~these bemarket nopartners ~~assurance~~or wedistributors ~~will~~do benot ~~able~~focus toadequate doresources so on ~~favorable~~selling ~~terms~~our products or are otherwise unsuccessful in selling them, ifsales atof ~~all~~our products may not develop.

42We anticipate relying on independent market partners and distributors to distribute and assist us with the marketing and sale of our products. Our future revenue generation and growth will depend in large part on our success in establishing and maintaining this sales and distribution channel. If our market partners and distributors are unable to sell our products, or receive negative feedback from end users, they may not continue to purchase or market our products. In addition, there can be no assurance that our market partners and distributors will focus adequate resources on selling our products to end users or will be successful in selling them. Many of our potential market partners and distributors are in the business of distributing and sometimes manufacturing other, possibly competing, products. As a result, these market partners and distributors may perceive our products as a threat to various product lines currently being distributed or manufactured by them. In addition, these market partners and distributors may earn higher margins by selling competing products or combinations of competing products. If we are unable to establish successful relationships with independent market partners and distributors, we will need to further develop our own sales and distribution capabilities, which would be expensive and time-consuming and might not be successful.

IfThe weuse ~~are~~of ~~unable~~our toproducts ~~establish~~may ~~successful relations~~be ~~with~~limited ~~third-party~~by ~~market partners or distributors~~regulations, orand ~~these market partners or distributors do not focus adequate resources on~~we ~~selling~~may ~~our~~be ~~products~~exposed orto ~~are~~product ~~otherwise~~liability ~~unsuccessful~~and inremediation ~~selling them, sales of our products may not develop~~claims.

WeThe ~~anticipate~~use ~~relying on independent market partners and distributors to distribute and assist us with the marketing and sale~~ of our planned products. ~~Our~~may ~~future~~be ~~revenue~~regulated ~~generation~~by ~~and~~various ~~growth will~~local, ~~depend~~state, infederal ~~large part on our success in establishing~~ and ~~maintaining~~foreign ~~this sales and distribution channel~~regulators. Even Ifif ~~our~~we ~~market partners and distributors~~ are ~~unable~~able to ~~sell~~comply ~~our~~with ~~products,~~all orsuch ~~receive~~regulations ~~negative~~and ~~feedback~~obtain ~~from~~all ~~end~~necessary ~~users~~registrations, ~~they may not continue to purchase or market our products.~~ Inwe ~~addition,~~cannot ~~there~~provide ~~can be no~~ assurance that our ~~market~~future ~~partners~~products ~~and distributors~~ will ~~focus~~not ~~adequate~~cause ~~resources~~injury ~~on selling our products~~ to ~~end~~the ~~users~~environment, people, or ~~will~~animals ~~be successful in selling them. Many of our potential market partners~~ and/or ~~distributors~~otherwise ~~are in the business of distributing~~have ~~and~~unintended ~~sometimes~~adverse ~~manufacturing other~~consequences, ~~possibly~~under ~~competing,~~all ~~products~~circumstances. As aFor ~~result~~example, ~~these market partners and distributors may perceive~~ our products asmay abe ~~threat~~improperly tocombined ~~various~~with ~~product~~other ~~lines~~chemicals ~~currently being distributed~~ or, even ~~manufactured~~when byproperly ~~them. In addition~~combined, ~~these~~our ~~market~~products ~~partners and~~may ~~distributors~~be ~~may~~blamed ~~earn~~for ~~higher~~damage ~~margins~~caused by ~~selling~~those ~~competing~~other ~~products~~chemicals. orThe ~~combinations~~costs of ~~competing~~remediation ~~products.~~or ~~If we are unable to establish~~products ~~successful~~liability ~~relationships~~could ~~with~~materially ~~independent~~adversely ~~market~~affect ~~partners and distributors, we will need to further develop~~ our ~~own sales and distribution capabilities~~results, ~~which~~financial ~~would~~condition ~~be expensive~~ and ~~time-consuming and might not be successful~~operations.

~~The~~We may be held liable for, or incur costs to settle, liability and remediation claims if any products we develop, or any products that use or incorporate any of our technologies, cause injury or are found unsuitable during product testing, manufacturing, marketing, sale or use. These risks exist even with respect to products that have received, or may bein ~~limited~~the ~~by regulations~~future receive, ~~and~~regulatory approval, registration or clearance for commercial use. We cannot guarantee that we ~~may~~will be ~~exposed~~able to avoid product liability ~~and remediation claims~~exposure.

~~The~~At ~~use~~the ofstage ~~our~~customary ~~planned~~to ~~products~~do ~~may~~so, bewe ~~regulated by~~expect ~~various~~to ~~local,~~maintain ~~state,~~product ~~federal~~liability insurance ~~and~~at ~~foreign~~levels ~~regulators. Even if~~ we believe are ~~able~~sufficient toand ~~comply~~consistent with ~~all~~industry ~~such~~standards ~~regulations~~for ~~and~~like ~~obtain~~companies ~~all~~and ~~necessary registrations~~products. However, we cannot guarantee ~~provide assurance~~ that our ~~future~~product ~~products~~liability insurance will ~~not~~be ~~cause~~sufficient ~~injury~~ to ~~the~~help ~~environment,~~us ~~people,~~avoid orproduct ~~animals~~liability-related ~~and/or otherwise~~losses. ~~have~~In ~~unintended~~the ~~adverse consequences~~future, ~~under~~it is ~~all~~possible ~~circumstances.~~that ~~For~~meaningful ~~example,~~insurance ~~our~~coverage ~~products~~ may not be ~~improperly~~available ~~combined~~on ~~with~~commercially ~~other chemicals~~reasonable terms or, ~~even~~at ~~when~~all. ~~properly~~In ~~combined~~addition, ~~our~~a ~~products~~product liability ~~may~~claim becould ~~blamed~~result ~~for~~in ~~damage~~liability ~~caused~~to byus ~~those~~greater ~~other~~than ~~chemicals~~our assets or insurance coverage. ~~The~~Moreover, ~~costs~~even ofif ~~remediation~~we have adequate insurance orcoverage, ~~products~~product liability claims or recalls could ~~materially~~result ~~adversely~~in ~~affect~~negative ~~our~~publicity ~~results,~~or ~~financial~~force ~~condition~~us to devote significant time and ~~operations~~attention to these matters, which could harm our business.

WeThere may be ~~held~~limitations ~~liable~~on ~~for,~~the oreffectiveness ~~incur~~of ~~costs to~~our ~~settle~~internal controls, ~~liability~~ and ~~remediation~~a ~~claims~~failure ~~if any products we develop, or any products that use or incorporate any~~ of our ~~technologies, cause~~control ~~injury~~systems ~~or are found unsuitable during product testing, manufacturing, marketing, sale or use. These risks exist even with respect~~ to ~~products~~prevent ~~that~~error ~~have received,~~ or fraud may inmaterially ~~the~~harm ~~future~~our ~~receive, regulatory approval, registration or clearance for commercial use~~Company. ~~We cannot guarantee that we will be able to avoid product liability exposure.~~

AtWe ~~the~~do ~~stage~~not ~~customary~~expect tothat dointernal ~~so,~~control weover ~~expect~~financial toaccounting and ~~maintain~~disclosure, ~~product~~even ~~liability~~if ~~insurance~~timely atand ~~levels~~well weestablished, ~~believe~~will ~~are~~prevent ~~sufficient~~all error and ~~consistent~~all ~~with~~fraud. ~~industry~~A ~~standards~~control ~~for~~system, ~~like~~no ~~companies~~matter how well designed and ~~products.~~operated, ~~However~~can provide only reasonable, wenot ~~cannot~~absolute, ~~guarantee~~assurance that ~~our~~the ~~product~~control ~~liability~~system’s ~~insurance~~objectives will be ~~sufficient~~met. toFurther, ~~help~~the ~~us avoid product liability-related~~design ~~losses.~~of Ina ~~the~~control ~~future,~~system itmust isreflect ~~possible~~the fact that ~~meaningful~~there ~~insurance~~are ~~coverage~~resource ~~may~~constraints, ~~not~~and bethe ~~available~~benefits onof ~~commercially~~controls ~~reasonable~~must ~~terms~~be orconsidered ~~at all.~~relative Into ~~addition,~~their acosts. ~~product~~Because ~~liability~~of ~~claim~~the ~~could~~inherent ~~result~~limitations in ~~liability~~all tocontrol ussystems, ~~greater~~no ~~than~~evaluation ~~our~~of ~~assets~~controls orcan ~~insurance~~provide ~~coverage.~~absolute ~~Moreover,~~assurance ~~even if~~that weall ~~have~~control ~~adequate~~issues ~~insurance~~and ~~coverage,~~instances ~~product~~of ~~liability~~fraud, ~~claims~~if orany, ~~recalls~~have ~~could~~been ~~result~~detected. inFailure ~~negative~~of ~~publicity~~our orcontrol ~~force~~systems us to ~~devote~~prevent ~~significant time~~error ~~and~~or ~~attention~~fraud ~~to these matters, which~~ could materially ~~harm~~adversely affect our business.

~~There~~Risks ~~may~~Related ~~be limitations on the effectiveness of our internal controls, and a failure of our control systems~~ to ~~prevent~~Our ~~error~~Common ~~or fraud may materially harm our Company.~~Stock

WeThere dohas ~~not~~been ~~expect~~a ~~that~~limited ~~internal~~public ~~control~~market ~~over~~for ~~financial accounting~~our ~~and~~common ~~disclosure~~stock, ~~even if timely and well established, will prevent all error and all fraud. A control system, no matter how~~ ~~well designed~~ and ~~operated,~~we ~~can~~do ~~provide only reasonable,~~ not ~~absolute,~~know ~~assurance~~whether ~~that~~one ~~the~~will ~~control~~develop ~~system’s~~to ~~objectives~~provide ~~will~~you beadequate ~~met~~liquidity. ~~Further~~ Furthermore, the ~~design~~trading ofprice afor ~~control~~our ~~system~~common ~~must reflect the fact that there are resource constraints~~stock, ~~and the benefits of controls must be~~should ~~considered~~an ~~relative~~active totrading ~~their~~market ~~costs. Because of the inherent limitations in all control systems~~develop, nomay ~~evaluation~~be ofvolatile ~~controls can provide absolute assurance that all control issues~~ and ~~instances~~could ofbe ~~fraud,~~subject ~~if any, have been detected. Failure of our control systems~~ to ~~prevent error~~wide orfluctuations ~~fraud~~in ~~could~~per-share ~~materially adversely affect our business~~price.

43Our common stock is quoted on the OTCQB under the trading symbol “NNMX”; historically, however, there has been a limited public market for our common stock and we cannot assure you that an active trading market for our common stock will develop or be sustained. The liquidity of any market for the shares of our common stock will depend on a number of factors, including:

~~Risks~~● ~~Related~~the tonumber ~~Our~~of ~~Common Stock~~stockholders;

~~Our~~● ~~common stock is quoted on the Pink Open Market under the trading symbol “NNMX”; historically, however, there has been a limited public market for~~ our ~~common~~operating ~~stock.~~performance ~~Although we~~and ~~have~~financial applied to list our Common Stock on the Nasdaq Stock Market, we cannot assure you that an active trading market for our common stock will develop or be sustained. The liquidity of any market for the shares of our common stock will depend on a number of factors, including:condition;

● the ~~number~~market offor ~~stockholders~~similar securities;

● ~~our~~the ~~operating~~extent ~~performance~~of ~~and~~coverage ~~financial~~of ~~condition~~us by securities or industry analysts; and

● the interest of securities dealers in making a market ~~for~~in ~~similar~~the ~~securities;~~shares of our common stock.

●Even if an active trading market develops, the ~~extent~~market price for our common stock may be highly volatile and could be subject to wide fluctuations. In addition, the price of ~~coverage~~shares of usour bycommon ~~securities~~stock could decline significantly if our future operating results fail to meet or ~~industry~~exceed the expectations of market analysts; and investors and actual or anticipated variations in our quarterly operating results could negatively affect our share price.

●The volatility of the ~~interest~~price of ~~securities~~our ~~dealers~~common instock ~~making~~may aalso ~~market~~be inimpacted by the ~~shares~~risks ofdiscussed ~~our~~under ~~common~~this ~~stock.~~“Risk Factors” section, in addition to other factors, including:

~~Even~~● ifdevelopments anin ~~active trading market develops,~~ the ~~market~~ ~~price~~financial ~~for~~markets ~~our common stock may be highly volatile~~ and ~~could~~worldwide ~~be subject to wide fluctuations. In addition, the price of shares of our common stock could decline significantly if our future operating results fail to meet~~ or ~~exceed~~regional ~~the expectations of market analysts and investors and actual or anticipated variations in our quarterly operating results could negatively affect our share price.~~economies;

~~The~~● ~~volatility~~announcements of ~~the~~innovations ~~price~~or ofnew ~~our~~products ~~common~~or ~~stock may~~services ~~also be impacted~~ by ~~the~~us ~~risks~~or ~~discussed~~our ~~under this “Risk Factors” section, in addition to other factors, including:~~competitors;

● ~~developments~~announcements inby the ~~financial~~government ~~markets~~relating ~~and~~to ~~worldwide~~regulations orthat ~~regional~~govern ~~economies~~our industry;

● ~~announcements~~significant sales of ~~innovations~~our orcommon ~~new~~stock ~~products~~ or ~~services~~other bysecurities usin orthe ~~our~~open ~~competitors~~market;

● ~~announcements~~variations byin ~~the~~interest ~~government relating to regulations that govern our industry~~rates;

● ~~significant~~changes ~~sales~~in ofthe ~~our~~market ~~common~~valuations ~~stock~~of or other ~~securities~~comparable ~~in the open market~~companies; and

● ~~variations~~changes in ~~interest~~accounting ~~rates;~~principles.

●Our ~~changes~~outstanding inwarrants and preferred stock may affect the market price ~~valuations~~and liquidity of ~~other~~the ~~comparable~~common ~~companies; and~~stock.

●As ~~changes~~of December 31, 2022, we had approximately 15,738,147 shares of common stock warrants for the purchase of up to approximately an additional 15,738,147 shares of common stock outstanding. There are 500 shares of series D preferred outstanding that are convertible into approximately 243,000 shares of common stock. In February 2022, 963,964 shares of our series B preferred stock outstanding, were converted into approximately 5.6 million shares of common stock, as well as 1,000,000 shares of our series C preferred stock which were converted into approximately 35.6 million shares of common stock. As of December 31, 2022, the remaining 377 shares of Preferred stock C are still outstanding. The amount of common stock reserved for issuance may have an adverse impact on our ability to raise capital and may affect the price and liquidity of our common stock in ~~accounting~~the public ~~principles~~market. In addition, the issuance of these shares of common stock will have a dilutive effect on current stockholders’ ownership.

~~Our~~The ~~outstanding~~conversion ~~warrants~~of ~~and~~outstanding ~~preferred~~convertible ~~stock may~~notes ~~affect~~into ~~the~~shares ~~market~~of common ~~price~~stock ~~and~~could ~~liquidity~~materially ofdilute ~~the~~our ~~common~~current ~~stock~~stockholders.

As of ~~April~~December 1231, 2022, we had approximately ~~6,827,956 shares of common~~ ~~stock~~$13.4 ~~warrants~~million ~~for~~aggregate ~~the~~principal ~~purchase~~amount of upconvertible tonotes ~~approximately~~outstanding, anconvertible ~~additional~~into ~~6,827,956~~ shares of our common stock ~~outstanding.~~at ~~There~~a ~~are~~fixed ~~500 shares~~price of ~~series~~$1.1717 Dper ~~preferred~~share. ~~outstanding~~The ~~that~~conversion ~~are~~prices ~~convertible~~of ~~into~~these ~~approximately~~notes ~~243~~may ~~thousand~~be ~~shares~~less ofthan ~~common~~the ~~stock.~~market Inprice ~~February 2022, 963,964 shares~~ of our ~~series~~common ~~B preferred~~ stock ~~outstanding,~~at ~~were~~the ~~converted~~time ~~into approximately 5.6 million shares~~ of ~~common stock~~conversion, ~~as well as 1,000,000~~ ~~shares~~and ofwhich ~~our~~may ~~series~~be Csubject ~~preferred~~to ~~stock~~future ~~which~~adjustment ~~were~~due ~~converted~~to ~~into~~certain ~~approximately~~events, ~~35.6~~including ~~million~~our ~~shares~~issuance of common stock. Asor ~~described~~common ~~more~~stock equivalents ~~fully~~at ~~below,~~an ~~holders~~effective ofprice ~~our~~per ~~notes~~share ~~and~~lower ~~warrants~~than ~~may~~the ~~elect~~conversion torate ~~receive~~then ain ~~substantial~~effect. ~~number~~If ofthe ~~shares~~entire ofprincipal ~~common~~amount ~~stock~~of ~~upon~~all ~~conversion of~~ the outstanding convertible notes ~~and/or~~is ~~exercise~~converted ofinto ~~the~~shares ~~warrants. The amount~~ of common stock, ~~reserved~~we ~~for~~would ~~issuance~~be ~~may~~required ~~have an adverse impact on our ability~~ to ~~raise~~issue ~~capital~~an ~~and~~aggregate ~~may~~of ~~affect~~no ~~the~~less ~~price~~than ~~and~~approximately ~~liquidity~~11.5 million shares of ~~our~~ common stock ~~in the public market~~. InIf ~~addition,~~we ~~the~~issue ~~issuance~~all of these shares ~~of common~~, ~~stock~~the ~~will~~ownership ~~have~~of aour ~~dilutive effect on~~ current stockholders’ ~~ownership~~will be diluted.

~~The~~Because ~~conversion~~our ofcommon ~~outstanding~~stock ~~convertible~~may be deemed a low-priced “penny” ~~notes~~stock, ~~into~~an ~~shares~~investment ofin our common stock ~~could~~should ~~materially~~be ~~dilute~~considered ~~our~~high-risk ~~current~~and ~~stockholders~~subject to marketability restrictions.

~~As of April 12~~Historically, ~~2022,~~the wetrading ~~had~~price ~~approximately $9.1 million aggregate principal amount~~ of ~~convertible notes outstanding, convertible into shares of~~ our common stock athas abeen ~~fixed price of~~ $25.~~0587~~ 00 per share. ~~The~~or ~~conversion prices~~lower, ofand ~~these~~deemed ~~notes~~a ~~may~~penny bestock, ~~less~~as ~~than~~defined ~~the~~in ~~market~~Rule ~~price~~3a51-1 ofunder ~~our common stock at~~ the ~~time~~Exchange ~~of conversion~~Act, and ~~which may be~~ subject to ~~future adjustment~~the ~~due~~penny ~~to certain events, including our issuance of common~~ stock orrules ~~common stock equivalents at an effective price per share lower~~of ~~than~~ the ~~conversion~~Exchange ~~rate~~Act ~~then~~specified in ~~effect.~~rules If15g-1 ~~the~~through ~~entire~~15g-100. ~~principal~~Those ~~amount~~rules ofrequire ~~all~~broker–dealers, ~~the~~before ~~outstanding~~effecting ~~convertible~~transactions ~~notes is converted into shares~~in ofany ~~common~~penny stock, ~~we would be required~~ to ~~issue an aggregate of no less than approximately 4.4 million shares of common stock. If we issue all of these shares, the ownership of our current stockholders will be diluted.~~:

44● deliver to the customer, and obtain a written receipt for, a disclosure document;

~~Because~~● ~~our~~disclose ~~common~~certain ~~stock~~price ~~may~~information beabout ~~deemed~~the ~~a low-priced “penny”~~ stock~~, an investment in our common stock should be considered high-risk and subject to marketability restrictions.~~;

Historically, the trading price of our common stock has been $5.00 per share or lower, and deemed a penny stock, as defined in Rule 3a51-1 under the Exchange Act, and subject to the penny stock rules of the Exchange Act specified in rules 15g-1 through 15g-100. Those rules require broker–dealers, before effecting transactions in any penny stock, to:38

● ~~deliver~~disclose to the ~~customer,~~amount ~~and~~of ~~obtain~~compensation areceived ~~written~~by ~~receipt~~the ~~for,~~broker-dealer aor ~~disclosure~~any ~~document~~associated person of the broker-dealer;

● ~~disclose~~send ~~certain~~monthly statements to customers with market and price information about the penny stock; and

● ~~disclose~~in some circumstances, approve the ~~amount~~purchaser’s ofaccount ~~compensation~~under ~~received~~certain bystandards ~~the~~and ~~broker-dealer~~deliver orwritten ~~any~~statements ~~associated~~to ~~person~~the ofcustomer with information specified in the ~~broker-dealer;~~rules.

●Consequently, ~~send~~the ~~monthly~~penny ~~statements~~stock rules may restrict the ability or willingness of broker-dealers to ~~customers~~sell ~~with~~the ~~market~~common stock and ~~price~~may ~~information~~affect ~~about~~ the ~~penny~~ability of holders to sell their common stock; in the secondary market and the price at which such holders can sell any such securities. These additional procedures could also limit our ability to raise additional capital in the future.

●Financial inIndustry ~~some~~Regulatory ~~circumstances,~~Authority ~~approve~~(“FINRA”) sales ~~the~~practice ~~purchaser~~requirements may also limit a stockholder’s ~~account~~ability ~~under~~to ~~certain~~buy ~~standards~~ and ~~deliver~~sell ~~written~~our ~~statements~~common tostock, ~~the~~which ~~customer~~could ~~with~~depress ~~information~~the ~~specified~~price of inour ~~the~~common ~~rules~~stock.

~~Consequently,~~In addition to the “penny stock” rules ~~may~~described ~~restrict~~above, ~~the~~FINRA ~~ability~~has oradopted ~~willingness~~rules ofthat require a broker-~~dealers~~dealer to ~~sell~~have reasonable grounds for believing that the ~~common~~investment ~~stock~~is ~~and~~suitable ~~may~~for ~~affect~~that customer ~~the~~before ~~ability~~recommending ofan ~~holders~~investment to ~~sell~~a ~~their~~customer. ~~common~~Prior ~~stock~~to recommending speculative low-priced securities to their non-institutional incustomers, broker-dealers must make reasonable efforts to obtain information about the ~~secondary~~customer’s ~~market~~financial status, tax status, investment objectives and ~~the~~other ~~price~~information. atUnder ~~which~~interpretations ~~such~~of ~~holders~~these ~~can~~rules, ~~sell~~FINRA ~~any~~believes ~~such~~that there is a high probability that speculative low-priced securities will not be suitable for at least some customers. ~~These~~Thus, ~~additional~~the ~~procedures~~FINRA ~~could~~requirements ~~also~~make ~~limit~~it more difficult for broker-dealers to recommend that their customers buy our common stock, which may limit your ability to ~~raise~~buy ~~additional~~and ~~capital~~sell inour shares of common stock, have an adverse effect on the ~~future~~market for our shares of common stock, and thereby depress our price per share of common stock.

~~Financial~~If ~~Industry~~securities ~~Regulatory~~or ~~Authority~~industry analysts do not publish research or ~~(“FINRA”)~~reports ~~sales~~about ~~practice~~our ~~requirements~~business, ~~may~~or ~~also~~if ~~limit~~they aissue ~~stockholder’s~~an ~~ability~~adverse toor ~~buy~~misleading ~~and~~opinion ~~sell~~regarding our ~~common~~ stock, ~~which could~~our ~~depress~~stock ~~the~~ price ofand ~~our~~trading ~~common~~volume could ~~stock~~decline.

InThe ~~addition~~trading tomarket ~~the~~for ~~“penny~~our common stock” ~~rules described~~may ~~above,~~be ~~FINRA~~influenced ~~has~~by ~~adopted~~the ~~rules~~research and reports that ~~require~~industry aor ~~broker-dealer~~securities toanalysts ~~have~~publish ~~reasonable~~about ~~grounds~~us ~~for~~or ~~believing~~our ~~that~~business. ~~the~~We ~~investment~~do ~~is suitable~~not ~~for~~currently ~~that~~have, ~~customer~~and ~~before~~may ~~recommending~~never anobtain, ~~investment~~research coverage toby asecurities ~~customer.~~and ~~Prior~~industry toanalysts. ~~recommending~~If ~~speculative~~no ~~low-priced~~or few securities ~~to their~~or ~~non-institutional~~industry ~~customers,~~analysts ~~broker-dealers~~commence ~~must~~coverage ~~make~~of ~~reasonable~~us, ~~efforts~~the totrading ~~obtain~~price for ~~information~~our ~~about~~common ~~the~~stock ~~customer’s~~may ~~financial status,~~be ~~tax~~negatively ~~status,~~affected. ~~investment~~In ~~objectives~~the ~~and~~event ~~other~~that ~~information.~~we ~~Under~~receive ~~interpretations~~securities ofor ~~these~~industry ~~rules~~analyst coverage, ~~FINRA~~if ~~believes~~any ~~that~~of ~~there~~the ~~is a~~analysts ~~high~~who ~~probability~~cover ~~that~~us ~~speculative~~issue ~~low-priced~~an ~~securities~~adverse ~~will~~or ~~not~~misleading beopinion ~~suitable~~regarding ~~for~~us, atour ~~least~~business ~~some~~model, ~~customers.~~our ~~Thus,~~intellectual ~~the~~property ~~FINRA~~or ~~requirements~~our stock performance, ~~make~~or itif ~~more~~our ~~difficult~~operating ~~for~~results ~~broker-dealers~~fail to ~~recommend~~meet ~~that~~the ~~their~~expectations ~~customers~~of ~~buy~~analysts, our ~~common~~ stock, ~~which~~price ~~may~~would ~~limit~~likely ~~your~~decline. ~~ability~~If toone ~~buy and~~or ~~sell~~more ~~our~~of ~~shares~~these analysts cease coverage of ~~common~~us ~~stock,~~or ~~have~~fail anto ~~adverse~~publish ~~effect~~reports on ~~the~~us ~~market~~regularly, ~~for~~we ~~our~~could ~~shares~~lose ofvisibility ~~common~~in ~~stock~~the financial markets, ~~and~~which ~~thereby~~in ~~depress~~turn could cause our stock price ~~per~~ ~~share~~or oftrading ~~common~~volume ~~stock~~to decline.

45Certain provisions of our certificate of incorporation and Delaware law make it more difficult for a third party to acquire us and make a takeover more difficult to complete, even if such a transaction were in stockholders’ interest.

IfOur ~~securities~~certificate orof ~~industry~~incorporation ~~analysts~~and dothe ~~not~~Delaware General Corporation ~~publish~~Law ~~research~~contain certain provisions that may have the effect of making it more difficult or ~~reports~~delaying ~~about~~attempts by others to obtain control of our ~~business~~Company, oreven ifwhen ~~they~~these ~~issue~~attempts anmay ~~adverse~~be orin ~~misleading~~the ~~opinion~~best ~~regarding~~interests of our ~~stock~~stockholders. We also are subject to the anti-takeover provisions of the Delaware General Corporation Law, ~~our~~which ~~stock~~prohibits ~~price~~us from engaging in a “business combination” with an “interested stockholder” unless the business combination is approved in a prescribed manner and ~~trading~~prohibits ~~volume~~the ~~could~~voting ~~decline~~of shares held by persons acquiring certain numbers of shares without obtaining requisite approval. The statutes and our certificate of incorporation have the effect of making it more difficult to effect a change in control of our Company.

~~The trading market for our common stock may be influenced by the research and reports that industry or securities analysts publish about us or our business.~~ We do not currently ~~have, and may never obtain, research coverage by securities and industry analysts. If no~~ or ~~few securities or industry analysts commence coverage of us, the trading price~~ for ~~our common stock may be negatively affected. In~~ the ~~event~~foreseeable ~~that~~future weintend receive securities or industry analyst coverage, if any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectual property or our stock performance, or if our operating results fail to ~~meet the expectations of analysts, our stock price would likely~~pay ~~decline.~~dividends ~~If one or more of these analysts cease coverage of us or fail to publish reports~~ on ~~us regularly, we could lose visibility in the financial markets, which in turn could cause~~ our ~~stock~~common ~~price or trading volume to decline~~stock.

~~Certain~~We ~~provisions~~have ofnever declared or paid any cash dividends on our ~~certificate~~common ofstock. ~~incorporation~~We ~~and~~currently ~~Delaware~~anticipate ~~law~~that ~~make~~we itwill ~~more~~retain ~~difficult~~future earnings for athe ~~third~~development, ~~party~~operation toand ~~acquire~~expansion usof our business and ~~make~~do anot ~~takeover~~anticipate declaring ~~more~~or ~~difficult~~paying toany ~~complete, even~~cash ifdividends ~~such~~for the foreseeable future. As a ~~transaction~~result, ~~were~~any return on your investment in ~~stockholders’~~our ~~interest~~common stock will be limited to the appreciation in the price of our common stock, if any.

Our certificate of incorporation and the Delaware General Corporation Law contain certain provisions that may have the effect of making it more difficult or delaying attempts by others to obtain control of our Company, even when these attempts may be in the best interests of our stockholders. We also are subject to the anti-takeover provisions of the Delaware General Corporation Law, which prohibits us from engaging in a “business combination” with an “interested stockholder” unless the business combination is approved in a prescribed manner and prohibits the voting of shares held by persons acquiring certain numbers of shares without obtaining requisite approval. The statutes and our certificate of incorporation have the effect of making it more difficult to effect a change in control of our Company.39

WeITEM do1B. ~~not~~UNRESOLVED ~~currently~~STAFF ~~or for the foreseeable future intend to pay dividends on our common stock.~~COMMENTS

~~We have never declared or paid any cash dividends on our common stock~~None. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. As a result, any return on your investment in our common stock will be limited to the appreciation in the price of our common stock, if any.

46ITEM 2. PROPERTIES

~~ITEM~~We 1Bdo not own real properties. ~~UNRESOLVED~~Our ~~STAFF~~principal ~~COMMENTS~~executive offices recently relocated to 2121 Williams Street, San Leandro, CA, 94577. We lease our office pursuant to a 5-year lease which terminates on March 31, 2027. We believe that our existing facilities are suitable and adequate to meet our current needs. However, we may need to add or expand as we increase production levels or add employees. We believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations.

None.

ITEM 2. PROPERTIES

We do not own real properties. Our principal executive offices recently relocated to 2121 Williams Street, San Leandro, CA, 94577. We lease our office pursuant to a 5-year lease which terminates on March 31, 2027. We believe that our existing facilities are suitable and adequate to meet our current needs. However, we may need to add or expand as we increase production levels or add employees. We believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations.

ITEM 3. LEGAL PROCEEDINGS

The Company is subject to claims and legal proceedings that arise in the ordinary course of business. Such matters are inherently uncertain, and there can be no guarantee that the outcome of any such matter will be decided favorably to the Company or that the resolution of any such matter will not have a material adverse effect upon the Company’s Consolidated Financial Statements. The Company does not believe that any of such pending claims and legal proceedings will have a material adverse effect on its Consolidated Financial Statements. The Company records a liability in its Consolidated Financial Statements for these matters when a loss is known or considered probable and the amount can be reasonably estimated. The Company reviews these estimates each accounting period as additional information is known and adjusts the loss provision when appropriate. If a matter is both probable to result in a liability and the amounts of loss can be reasonably estimated, the Company estimates and discloses the possible loss or range of loss to the extent necessary for its Consolidated Financial Statements not to be misleading. If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in its Consolidated Financial Statements.

Set forth below is a description of the Company’s Legal Proceedings.

In March 2019, we were served with notification of complaint filed by CureDM Inc. as agent for the members of CureDM Group Holdings, LLC filed with the Supreme Court of the State of New York County of New York regarding breach of contract and other matters relating to their desire to unwind the acquisition of CureDM Group Holdings LLC according to the original Contribution Agreement. The complaint was withdrawn by CureDM, Inc. in December 2019. ~~The Company is continuing to work with the representatives from CureDM Inc. to settle this claim and unwind the Contribution Agreement.~~

In addition to the above matter, we are also in a dispute with Level Brands, Inc. regarding a License Agreement dated June 21, 2018 (JAMS Ref. No.: 1220061261). The Company filed an Answer to Complaint and Counter-complaint on June 25, 2019. Both parties are claiming non-performance under the License Agreement. The matter was scheduled for arbitration in October 2019. In October 2019, the arbitration was dismissed without prejudice.

On October 16, 2019 the Company received a Summons and Complaint filed by Microcap Headlines Inc. against the Company in the Supreme Court of the United States of New York County of Suffolk claiming damages of $18,000 and the costs and disbursements of the action. During January 2021, the Company settled this claim with Microcap Headlines, Inc. for $10,000.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

4740

PART II

Market Information

Our common stock is quoted to trade in the over-the-counter securities market through the ~~Pink~~OTCQB ~~Open Market~~ under the symbol “NNMX”. We have been eligible to participate in on the over-the-counter markets since February 28, 2012. Any over-the-counter market quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not necessarily represent actual transactions.

Holders

As of ~~April~~March 1231, ~~2022,~~2023 there were 1,~~947~~962 holders of record of our common stock. This number does not include “street name,” or beneficial holders, whose shares are held of record by banks, brokers, financial institutions and other nominees. The transfer agent for ~~Madison~~the Company’s Common Stock is Worldwide Stock Transfer, LLC, One University Plaza, Suite 505, Hackensack, NJ 07601 and their telephone number is (201) 820-2008.

Dividends

We have not declared any dividends since incorporation and do not anticipate that we will do so in the foreseeable future. Our intention is to retain future earnings for use in our operations and the expansion of our business.

Recent Sales of Unregistered Securities; ~~Use~~ Use of Proceeds from Registered Offerings

We did not sell any of our equity securities during the year ended December 31, ~~2021~~2022 that were not registered under the Securities Act and were not previously reported on a Current Report on Form 8-K filed by us.

Purchases of Equity Securities by the Issuer and Affiliate Purchasers

None.

Securities Authorized for Issuance Under Equity Compensation Plans

The following table includes the information as of the end of ~~2021~~2022 for our equity compensation plans:

Plan category	Number of securities to be issued upon exercise of outstanding options (a)		Weighted average exercise price of outstanding options (b)		Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c)
Equity compensation plans approved by security holders (1)		535,~~104~~570,850	$	820.29382		52,~~497~~232,~~977~~377
Equity compensation plans not approved by security holders		--	$	--		--
Total (2)		535,~~104~~570,850	$	0.382		52,~~497~~232,~~977~~377

(1) Consists of our Amended and Restated 2010 Stock Plan (the “2010 Plan”) and our 2021 Omnibus Equity Incentive Plan (the “2021 Plan”). See Note 12 -“Stock-Based Compensation” of the Notes to the Financial Statements included in this Annual Report on Form 10-K.

(1)

Consists of our stock options assumed in the merger from the Nanomix, Inc. Amended and Restated 2010 Stock Plan (the “2010 Plan”) and our 2021 Omnibus Equity Incentive Plan (the “2021 Plan”). See Note 12 -“Stock-Based Compensation” of the Notes to the Financial Statements included in this Annual Report on Form 10-K.

(2)

Does not include 3,415,891 stock options at an average exercise price of $0.229 approved and unissued subject to shareholder approval of amendments to the 2021 Plan.

~~(2) Does not include restricted stock units and stock options that were assumed as part of the merger with Nanomix and not issued under an equity compensation plan.~~41

ITEM 6. ~~[Reserved]~~

Not applicable.

48ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

~~ITEM~~You 7should read the following discussion and analysis of our financial condition and plan of operations together with “Selected Financial Data” and our financial statements and the related notes appearing elsewhere in this prospectus. ~~MANAGEMENT’S~~In ~~DISCUSSION~~addition ~~AND~~to historical information, this discussion and analysis contains ~~ANALYSIS~~forward-looking OFstatements ~~FINANCIAL~~that ~~CONDITION~~involve ~~AND~~risks, ~~RESULTS~~uncertainties OFand ~~OPERATIONS~~assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included elsewhere in this prospectus. All amounts in this report are in U.S. dollars, unless otherwise noted.

You should read the following discussion and analysis of our financial condition and plan of operations together with “Selected Financial Data” and our financial statements and the related notes appearing elsewhere in this prospectus. In addition to historical information, this discussion and analysis contains forwardFORWARD-~~looking~~LOOKING statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included elsewhere in this prospectus. All amounts in this report are in U.S. dollars, unless otherwise noted.STATEMENTS

~~FORWARD~~This report, including exhibits that are being filed as part of this report, as well as other statements made by Nanomix Corporation (the “Company”, “we”, “us”, and “our”), contain “forward-~~LOOKING~~looking ~~STATEMENTS~~statements” that include information relating to future events, future financial performance, strategies, expectations, competitive environment and regulation. Words such as “may,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements.

~~This~~These ~~report,~~forward-looking ~~including exhibits~~statements ~~that~~include ~~are~~such things ~~being filed~~ as: ~~part~~investment ofobjectives ~~this~~and ~~report,~~the asCompany’s ~~well~~ability asto ~~other~~make ~~statements~~investments ~~made~~in bya ~~Nanomix~~timely ~~Corporation~~manner ~~(the~~on ~~“Company”, “we”,~~acceptable ~~“us”,~~terms; ~~and “our”), contain “forward-looking statements” that include information~~references ~~relating~~ to future ~~events,~~success ~~future~~of ~~financial~~the ~~performance,~~Company’s ~~strategies,~~products; ~~expectations,~~the ~~competitive~~Company’s ~~environment~~business ~~and~~strategy; ~~regulation.~~estimated ~~Words~~future ~~such as~~capital ~~“may,”~~expenditures; ~~“should,” “could,” “would,” “predicts,” “potential,”~~sales ~~“continue,”~~of ~~“expects,”~~the ~~“anticipates,”~~Company’s ~~“future,”~~products; ~~“intends,”~~competitive ~~“plans,” “believes,”~~strengths ~~“estimates,”~~ and ~~similar~~goals; ~~expressions,~~and asother ~~well~~similar ~~as statements in future tense, identify forward-looking statements~~matters.

These forward-looking statements ~~include~~reflect ~~such~~the Company’s ~~things~~current ~~as:~~beliefs ~~investment~~and ~~objectives~~expectations with respect to future events and are based on assumptions and are subject to risks and uncertainties and other factors outside the Company’s control that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, the following: ability to ~~make~~develop, ~~investments~~commercialize inand amarket ~~timely~~new ~~manner~~products; onability ~~acceptable~~to market ~~terms~~and sell products, whether through an internal, direct sales force or third parties; ~~references~~ability to ~~future~~manufacture ~~success~~products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of ~~the~~obtaining, ~~Company’s~~necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the ~~Company’s~~FDA ~~business~~or ~~strategy~~other regulatory entities; ~~estimated~~changes ~~future~~in ~~capital~~relationships, ~~expenditures~~including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; competing products and technology changes; ~~sales~~reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; market acceptance of our products; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the ~~Company’s~~Centers for Disease Control and Prevention and other agencies; ability to fund research and development and other products and operations; ~~competitive~~ability ~~strengths~~to obtain and ~~goals~~maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; ability to reach and maintain sustained profitability; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other ~~similar~~types ~~matters~~of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; changes in laws or regulations; global and regional economic conditions; and general political, business and market conditions.

~~These~~Although ~~forward-looking statements reflect~~ the Company’s ~~current~~believes ~~beliefs~~the ~~and~~ expectations reflected ~~with~~in ~~respect~~such toforward-looking ~~future~~statements ~~events and~~ are based onupon ~~assumptions~~reasonable ~~and are subject to risks and uncertainties and other factors outside the Company’s control that may cause actual results to differ materially from those projected. Such factors include~~assumptions, ~~but~~these are ~~not~~only ~~limited to~~assumptions, ~~the following: ability to develop, commercialize~~ and ~~market~~forward-looking ~~new products;~~statements ~~ability~~should tonot ~~market~~be ~~and~~read ~~sell~~as ~~products,~~a ~~whether~~guarantee ~~through~~of anfuture ~~internal,~~performance ~~direct sales force~~ or ~~third~~results ~~parties; ability to manufacture products in accordance with applicable specifications, performance standards~~ and ~~quality~~will ~~requirements;~~probably ~~ability~~not tobe ~~obtain,~~accurate ~~and~~indications ~~timing and cost~~ of ~~obtaining,~~ ~~necessary~~when ~~regulatory~~such ~~approvals for new products~~ performance or ~~new~~results ~~indications~~will orbe ~~applications~~achieved. ~~for~~Investors ~~existing~~are ~~products;~~cautioned ~~ability~~that toforward-looking ~~comply with~~statements ~~applicable~~may ~~regulatory~~not ~~requirements;~~be ~~ability~~reliable ~~to effectively resolve warning letters, audit observations~~ and ~~other~~speak ~~findings~~only oras ~~comments from~~of the ~~FDA or other regulatory entities; changes in relationships, including disputes or disagreements, with strategic partners or other~~date ~~parties~~they ~~and~~are ~~reliance~~made ~~on strategic partners for the performance of critical activities under collaborative arrangements; competing products~~ and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; market acceptance of our products; changes in market acceptance of products based on product performance or other factorsthat, ~~including~~ ~~changes~~except inas ~~testing~~required ~~guidelines, algorithms or other recommendations~~ by law, the ~~Centers~~Company ~~for~~undertakes ~~Disease~~no ~~Control~~obligation ~~and Prevention and other agencies; ability~~ to ~~fund~~update ~~research~~these ~~and~~forward-looking ~~development~~statements ~~and other products and operations; ability~~ to reflect ~~obtain~~any ~~and~~future ~~maintain~~events ~~new~~ or ~~existing~~circumstances. ~~product distribution~~All ~~channels;~~subsequent ~~reliance~~written on sole supply sources for critical products and components; ability to reach and maintain sustained profitability; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or ~~other~~oral ~~technology;~~forward-looking ~~obstacles~~statements toattributable ~~international marketing and manufacturing of products; ability~~ to ~~sell products internationally, including~~ the ~~impact~~Company ~~of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss~~ or ~~impairment of sources of capital; ability~~ to ~~attract and retain qualified~~ ~~personnel;~~individuals ~~exposure~~acting toon ~~product~~its ~~liability~~behalf ~~and~~are ~~other~~expressly ~~types~~qualified ~~of litigation; changes~~ in ~~international,~~their ~~federal~~entirety orby ~~state~~this laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; changes in laws or regulations; global and regional economic conditions; and general political, business and market conditionssection.

4942

~~Although~~Investors ~~the~~should ~~Company believes~~also ~~the~~be ~~expectations~~aware ~~reflected~~that inwhile ~~such~~we do, ~~forward-looking~~from ~~statements~~time ~~are~~to ~~based upon reasonable assumptions~~time, ~~these~~communicate ~~are~~with ~~only~~securities ~~assumptions~~analysts, ~~and~~ ~~forward-looking~~it ~~statements~~is ~~should~~against ~~not~~our bepolicy ~~read~~to asdisclose aany ~~guarantee~~material ofnon-public ~~future performance~~ information or ~~results~~other ~~and~~confidential ~~will~~commercial ~~probably~~information ~~not~~to besecurities ~~accurate~~analysts ~~indications of~~unless ~~when~~and ~~such~~until ~~performance~~we orhave ~~results~~made ~~will~~it bepublicly ~~achieved~~available. ~~Investors~~Accordingly, stockholders ~~are~~should ~~cautioned~~not assume that ~~forward-looking~~we ~~statements~~agree ~~may~~with ~~not~~any bestatement ~~reliable~~or ~~and speak~~report ~~only~~issued asby ofany ~~the~~analyst ~~date~~irrespective ~~they~~of ~~are~~the ~~made~~content ~~and~~of ~~that,~~the ~~except~~statement or asreport. ~~required by law~~Furthermore, ~~the~~we ~~Company~~have ~~undertakes~~a nopolicy ~~obligation~~against toissuing ~~update~~or ~~these~~confirming ~~forward-looking statements~~financial toforecasts ~~reflect~~or ~~any~~projections ~~future~~issued ~~events~~by ~~or circumstances~~others. ~~All~~Thus, ~~subsequent~~to ~~written~~the extent orthat ~~oral~~reports ~~forward-looking~~issued ~~statements~~by ~~attributable~~securities toanalysts ~~the Company~~contain orany toprojections, ~~individuals~~forecasts ~~acting~~or onopinions, ~~its~~such ~~behalf~~reports are ~~expressly~~not ~~qualified~~the inresponsibility of ~~their~~the ~~entirety by this section~~Company.

Investors should also be aware that while we do, from time to time, communicate with securities analysts, it is against our policy to disclose any material non-public information or other confidential commercial information to securities analysts unless and until we have made it publicly available. Accordingly, stockholders should not assume that we agree with any statement or report issued by any analyst irrespective of the content of the statement or report. Furthermore, we have a policy against issuing or confirming financial forecasts or projections issued by others. Thus, to the extent that reports issued by securities analysts contain any projections, forecasts or opinions, such reports are not the responsibility of the Company.Overview

~~Overview~~This discussion and analysis should be read in conjunction with the accompanying Consolidated Financial Statements and related notes. The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of any contingent liabilities at the financial statement date and reported amounts of revenue and expenses during the reporting period. On an ongoing basis, we review our estimates and assumptions. Our estimates are based on our historical experience and other assumptions that we believe to be reasonable under the circumstances. Actual results are likely to differ from those estimates under different assumptions or conditions, but we do not believe such differences will materially affect our financial position or results of operations. Our critical accounting policies, the policies we believe are most important to the presentation of our financial statements and require the most difficult, subjective and complex judgments, are outlined below in ‘‘Critical Accounting Policies,’’.

This ~~discussion~~management’s ~~and analysis should be read in conjunction with the accompanying Consolidated Financial Statements and related notes. The~~ discussion and analysis of ~~our~~of financial condition and results of operations ~~are based upon our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States~~ (“~~U.S. GAAP~~MD&A”). ~~The~~is ~~preparation~~intended ~~of financial statements in conformity with U.S. GAAP requires us~~ to ~~make~~help ~~estimates~~you ~~and~~understand ~~assumptions that affect~~ the ~~reported~~business ~~amounts~~operations ~~of assets~~ and ~~liabilities,~~ ~~disclosure of any contingent liabilities at the~~ financial ~~statement~~condition ~~date and reported amounts~~ of ~~revenue and expenses during~~ the ~~reporting period.~~Company Onas an ongoing basis, we review our estimates and assumptions. Our estimates are based on our historical experience and other assumptions that we believe to be reasonable under the circumstances. Actual results are likely to differ from those estimates under different assumptions or conditions, but we do not believe such differences will materially affect our financial position or results of ~~operations.~~December ~~Our critical accounting policies~~31, the policies we believe are most important to the presentation of our financial statements and require the most difficult, subjective and complex judgments, are outlined below in “Critical Accounting Policies,’’2022.

~~This~~Our ~~management’s discussion and analysis of financial condition and results of operations (“~~MD&A”) is ~~intended~~presented toin ~~help~~six ~~you understand the business operations and financial condition of the Company as of December 31, 2021.~~sections:

~~Our~~● ~~MD&A~~Executive ~~is presented in six sections:~~Overview

● ~~Executive~~Consolidated ~~Overview~~Results of Operations

● ~~Consolidated~~Liquidity ~~Results~~and ofCapital ~~Operations~~Resources

● ~~Liquidity~~Recent ~~and Capital Resources~~Developments

● ~~Recent~~Significant ~~Developments~~Accounting Policies and Critical Accounting Estimates

● ~~Significant~~Recently ~~Accounting~~Issued ~~Policies and Critical~~ Accounting ~~Estimates~~Pronouncements

●Executive ~~Recently Issued Accounting Pronouncements~~Overview

~~Executive~~On ~~Overview~~June 6, 2021, Nanomix, Inc., or Nanomix, and Boston Therapeutics completed a reverse merger, or the Merger, resulting in the formation of Nanomix Corporation (the “Company”). As consideration for the Merger, the shareholders of Nanomix received 1,000,000 shares of Series C Convertible Preferred Stock of the Company (the “Preferred Stock”). On March 2, 2022 upon approval of a previously approved 173:1 reverse stock split, all such shares of Preferred Stock issued to Nanomix shareholders automatically converted into approximately 35,644,997 shares of common stock of the Company, the warrants assumed at closing may be exercisable into approximately 2,124,687 shares of common stock of the Company and the options assumed at closing may be exercisable into approximately 5,718,838 shares of common stock of the Company. The shares of common stock issued upon conversion of the Preferred Stock together with warrants, restricted stock units and options assumed on the closing date represent approximately 80% of the outstanding shares of Common Stock of the Company upon closing of the Merger. After the merger, the Company changed its name to Nanomix Corporation and its ticker symbol to NNMX.

OnOur ~~June 6, 2021, Boston Therapeutics and Nanomix, Inc., or Nanomix, completed a reverse merger, or the Merger, resulting in the formation of Nanomix Corporation (the “Company”).~~Business

50Nanomix, Inc, is a development stage company that seeks to develop, manufacture, and commercialize point-of-care diagnostic tests that are used to detect or monitor diseases. The Company’s product development efforts are focused on our proprietary technology, a novel point-of-care diagnostic platform that offers certain customer advantages as compared to other point-of-care diagnostic technologies. Nanomix, Inc. was originally formed in 2001 as a nanotechnology sensor company. In 2009, ownership changed, and the business was redirected to development and commercialization of a mobile point-of-care diagnostic platform.

The Company issued to the shareholders of Nanomix 1,000,000 shares of a newly created Series C Convertible Preferred Stock of the Company (the “Preferred Stock”). Upon the effectiveness of the amendment to our Certificate of Incorporation to effectuate the reverse stock split of one-for-173, all such shares of Preferred Stock issued to Nanomix shareholders automatically converted into approximately 35,644,997 shares of common stock of the Company, the warrants to be assumed at closing may be exercisable into approximately 2,124,687 shares of common stock of the Company and the options and restricted stock units assumed at closing may be exercisable into approximately 5,718,838 shares of common stock of the Company. The shares of common stock issuable upon conversion of the Preferred Stock together with warrants, restricted stock units and options to be assumed on the closing date represented approximately 80% of the outstanding shares of Common Stock of the Company upon closing of the Merger. 43

~~The~~Business Closing of the merger effectuated a change in control of the Company. As a result of the Closing, the Nanomix shareholders own approximately 80.0% of the Company’s issued and outstanding common stock on a fully diluted basis assuming full conversion of the Series C Preferred Stock. As Nanomix is now the controlling management party, financial statements are consolidated based on the historical results of operations for Nanomix and the combined balance sheets of the entities. The Company’s name change to “Nanomix Corporation” and the symbol change to “NNMX” were effective November 15, 2021. The previously approved 173:1 reverse stock split was effective on March 3, 2022.Strategy

~~Our~~The ~~Business~~healthcare market is rapidly evolving to incorporate a decentralized system of care delivery within a broad spectrum of environments: the emergency department, skilled nursing facilities, elderly homes, urgent care centers, ambulances, and remote locations. While hospital central laboratories currently are the gold standard of clinical testing, a mobile diagnostic platform offering high-quality testing results at affordable prices is needed to serve the decentralized testing requirements. The Nanomix eLab System is specifically designed to meet this evolving market need. The system includes a durable, handheld, rechargeable battery powered instrument and a disposable multiplex, microfluidic test cartridge. Proprietary biosensors deliver laboratory-quality performance wherever the patient or healthcare provider needs it, including a wide range of testing environments outside the hospital. The Nanomix eLab System is well suited for markets that include pre-hospital assessment, chronic medical care, and post-hospital disease management, as well as use in remote locations far from traditional centers of health care delivery. Whether in an Emergency Department, an Urgent Care facility, a skilled nursing facility or on an ambulance, the Nanomix eLab System is designed to help mobile health providers to quickly assess a patient’s condition and intervene with a higher level of care when necessary.

~~Nanomix~~Our ~~Corporation~~initial ~~is a~~product development ~~stage~~focus ~~company~~is ~~that~~on ~~seeks~~testing for tocritical ~~develop,~~medical ~~manufacture,~~conditions ~~and~~where ~~commercialize~~rapidly ~~point-of-care~~available ~~diagnostic~~information ~~tests~~is ~~that~~needed ~~are~~to ~~used~~help toinform ~~detect or~~clinical ~~monitor~~decision ~~diseases~~making. The ~~Company’s~~Nanomix ~~product development efforts are focused on our proprietary technology, a novel point-of-care~~S1 ~~diagnostic~~Assay ~~platform~~Panel ~~that~~is ~~offers~~designed ~~certain customer advantages as compared~~ to ~~other~~provide ~~point-of-care~~information ~~diagnostic~~about ~~technologies.~~critical ~~Nanomix~~infections, ~~Inc. was~~including ~~originally~~sepsis, ~~formed~~ in ~~2001~~less asthan a15 ~~nanotechnology sensor company~~minutes. InThe ~~2009,~~S1 ~~ownership~~Assay ~~changed~~Panel has ~~and~~received ~~the~~CE ~~business~~marking. ~~was~~Future ~~redirected~~product to development ~~and~~ ~~commercialization~~efforts offor aother ~~mobile~~critical ~~point-of-care~~conditions ~~diagnostic~~are ~~platform~~planned for development.

~~Business~~Results ~~Strategy~~of Operations

~~The~~Results ~~healthcare market is rapidly evolving to incorporate a decentralized system~~ of ~~care~~operations ~~delivery~~for ~~within a broad spectrum of environments:~~ the ~~emergency~~years ~~department,~~ended ~~skilled~~December ~~nursing facilities~~31, ~~elderly~~2022 ~~homes, urgent care centers, ambulances,~~ and remote locations. While hospital central laboratories currently are the gold standard of clinical testing, a mobile diagnostic platform offering high-quality testing results at affordable prices is needed to serve the decentralized testing requirements. The Nanomix eLab System is specifically designed to meet this evolving market need. The system includes a durable, handheld, rechargeable battery powered instrument and a disposable multiplex, microfluidic test cartridge. Proprietary biosensors deliver laboratory-quality performance wherever the patient or healthcare provider needs it, including a wide range of testing environments outside the hospital. The Nanomix eLab System is well suited for markets that include pre-hospital assessment, chronic medical care, and post-hospital disease management, as well as use in remote locations far from traditional centers of health care delivery. Whether in an Emergency Department, an Urgent Care facility, a skilled nursing facility or on an ambulance, the Nanomix eLab System is designed to help mobile health providers to quickly assess a patient’s condition and intervene with a higher level of care when necessary.2021

~~Our~~The ~~initial~~results ~~product~~of ~~development focus~~operations ~~is on testing~~ for ~~critical~~the ~~medical~~years ~~conditions where rapidly available information is needed to help inform clinical decision making.~~ended ~~The~~December ~~Nanomix S1 Assay Panel is designed to provide information about critical infections~~31, ~~including~~2022 ~~sepsis,~~and in2021 ~~approximately~~were 11as ~~minutes. The S1 Assay Panel has received CE marking. Future product development efforts for other critical conditions are planned for development.~~follows:

51NANOMIX CORPORATION

~~Results~~CONSOLIDATED ofSTATEMENTS OF ~~Operations~~OPERATIONS

Results of operations for the year ended December 31, 2021 and 2020

	December 31,
	2022			2021

Revenues	$	15,450		$	141,778

Operating costs and expenses:
Research and development		3,159,239			3,017,263
Selling, general and administrative expenses		5,293,379			2,849,666
Total operating expenses		8,452,618			5,866,929
Loss from operations		(8,437,168	)		(5,725,151	)

Other income (expense):
Interest income		3			2
Interest expense		(3,716,544	)		(1,644,829	)
Interest expense, related, party		(391,757	)		(572,347	)
Other income		212,490			-
Change in fair value of derivative liability		-			15,282
Change in fair value of warrant liability		-			438,972
Forgiveness of PPP loan and accrued interest		-			408,242
Loss on debt modification		-			(2,385,204	)
Total income (expense)		(3,895,808	)		(3,739,882	)

Loss before income taxes		(12,332,976	)		(9,465,033	)
Provision for income taxes		-			-
Net loss	$	(12,332,976	)	$	(9,465,033	)

~~The results of operations for the years ended December 31, 2021 and 2020 were as follows:~~44

	December 31,
	2021			2020
Revenues	$	141,778		$	513,244
Operating costs and expenses:
Research and development		3,017,263			4,184,820
Selling, general and administrative expenses		2,849,666			1,234,784
Total operating expenses		5,866,929			5,419,604
Loss from operations		(5,725,151	)		(4,906,360	)
Other income (expense):
Interest income		2			6
Interest expense		(1,644,829	)		(209,538	)
Interest expense, related, party		(572,347	)		(1,076,478	)
Change in fair value of derivative liability		15,282			-
Change in fair value of warrant liability		438,972			-
Forgiveness of PPP loan and accrued interest		408,242
Loss on debt modification		(2,385,204	)		-
Total income (expense)		(3,739,882	)		(1,286,010	)
Loss before income taxes		(9,465,033	)		(6,192,370	)
Provision for income taxes		-			-
Net loss	$	(9,465,033	)	$	(6,192,370	)

Total Revenues

Total net revenues during twelve months ended December 31, 2022 were $15 thousand, a decrease of $126 thousand compared to year 2021. Revenues in 2022 were from product sales while revenues in 2021 were related to completion of a BARDA product development contract.

~~Total~~Research net revenues during the year ended December 31, 2021 were $142 thousand, a decrease of $371 thousand compared to the same period in 2020. The decrease in total net revenues was attributable to a reduction of COVID-19 development funding received from BARDA. The BARDA funding began in 2020 and ~~the project funding was completed earlier in 2021. There was no appreciable product related revenue in either period.~~Development

~~Research~~This category includes costs incurred for product and ~~Development~~process development, and clinical & regulatory affairs. Costs for year ended December 31, 2022 of $3.2 million were largely related to further development of the Company’s S-1 Assay Panel for critical infections and for regulatory filing and related activities for an assay for the detection of COVID-19. Costs of $3.0 million in the year ended December 31, 2021 were related to the development of the S1 Assay Panel and development work on the COVID-19 program. All development efforts were for development of the eLab platform.

~~This category includes costs incurred for product and process development~~Selling, ~~and~~General ~~clinical & regulatory affairs. Costs for the year ended December 31, 2021 were largely related to the development~~ and ~~clinical~~Administrative trials of two assays for COVID-19. Costs in the year ended December 31, 2020 were related to the development of the S1 Assay Panel and development work on the COVID-19 program. All development efforts were for development of the eLab platform.Expense

Selling, ~~General~~general and administrative expense (“SG&A”) ~~Administrative~~for ~~Expense~~the year ended December 31, 2022 increased by $2.4 million from the same period in 2021. The increase was due to establishment of a sales and marketing function in 2021 and increased general and administrative costs in 2022 mainly from legal and accounting costs related to the merger and subsequent regulatory filings, insurance, and warrant expense recorded in year of 2022.

~~Selling,~~Other ~~general~~Income ~~and administrative expense~~ (~~“SG&A”~~Expense) for the year ended December 31, 2021 increased by $1,615 thousand from the same period in 2020. The increase was due to establishment of a sales and marketing function in 2021 and increased general and administrative costs in 2021 mainly from legal and accounting costs related to the merger and subsequent regulatory filings.

52Other Expense in 2022 was $3,896 thousand, an increase in expense of $156 thousand compared to 2021. Other expense in 2022 was primarily composed of amortization of the previously recorded debt discount for the year ended December 31, 2022. Other expense in 2021 is primarily composed of loss on debt modification of $2,385 thousand for the year ended December 31, 2021 resulting from the exchange of a Nanomix secured Note and related accrued interest for a Senior Secured Convertible Note as part of the merger. These Notes and accrued interest were converted to Preferred Series C stock in 2021 as part of the merger. Other income of $212,490 in 2022 is from sale of the domain rights for nano.com to a third party for $250,000 net of escrow fees.

~~Other~~Net ~~Income (Expense)~~Loss

~~Other~~The ~~Income~~Net ~~(Expense) in~~Loss 2021 was $3,740 thousand, an increase in expense of $2,454 compared to 2020. Other expense in 2021 was primarily composed of loss on debt modification of $2,385 thousand and interest expense of $2,217 thousand for the year ended December 31, ~~2021. Interest expense of~~2022 ~~$2,217~~was ~~thousand in 2021 and~~ $~~1,286~~12.3 ~~thousand~~million inversus ~~2020 are primarily related to issued Secured Notes and Unsecured Convertible Notes used to fund the Company’s operations~~$9.5 ~~The~~million ~~Secured~~for ~~Notes and accrued interest were exchanged into senior secured convertible notes and~~ the ~~unsecured~~same ~~Notes~~period ~~and Accrued interest were converted to Preferred Series C stock~~ in 2021. asThe ~~part~~increased loss of ~~the merger~~$2.8 ~~Boston~~million ~~Therapeutics notes~~was ~~and~~largely ~~related~~due ~~accrued~~to ~~interest, predating~~ the ~~merger,~~increase in ~~were~~operating ~~converted~~expenses ~~into~~and ~~common stock or remain on~~ the ~~balance~~decrease ~~sheet~~in revenue.

~~Other~~Liquidity ~~expense in 2021 was reduced by $408 thousand in forgiveness of the PPP loan received in 2020~~ and ~~by a gain in the fair value of derivative and warrant~~Capital ~~liabilities in the amount of $454 thousand.~~Resources

~~Net Loss~~ Overview

~~The~~Our ~~Net~~liquidity ~~Loss~~requirements ~~for~~are ~~the year~~primarily ~~ended~~to ~~December~~fund our 31business operations, ~~2021~~including ~~was~~capital ~~$9.465~~expenditures ~~million~~and ~~versus~~working ~~$6.192~~capital ~~million for the same period in 2020~~requirements. ~~The~~Our ~~increased~~primary ~~loss~~sources of ~~$3.273~~liquidity ~~million was~~are ~~largely due to the loss on debt modification, an increase in interest expense, offset by the PPP loan forgiveness and the change in~~additional ~~the~~capital ~~fair~~investment ~~value of warrant~~ and ~~derivative liabilities~~debt.

~~Liquidity~~On ~~and~~June ~~Capital~~25, 2021, the Company entered into a securities ~~Resources~~purchase agreement with accredited investors pursuant to which the Company issued senior secured convertible notes in an aggregate principal amount of approximately $8.4 million for an aggregate purchase price of approximately $7.9 million. Immediately prior to the execution of the agreement described above, we entered into exchange agreements with the holders of outstanding promissory notes with an aggregate principal amount, together with accrued but unpaid interest, of approximately $2.1 million. The holders of the outstanding promissory notes were issued senior secured notes in the financing described above for an aggregate principal amount of $2.1 million. In connection with the issuance of the Notes, we issued to the Investors warrants to purchase an aggregate of approximately 4.1 million shares of Common Stock (collectively, the “Warrants”). The Company received approximately $5.8 million in funding from the transaction. In 2022, an additional $5,122 thousand of Notes were issued to investors bringing the total senior secured convertible notes issued to $13.4 million. We issued additional warrants to purchase an aggregate of approximately 6,1 million shares of common stock.

~~Overview~~In March of 2022, the Company entered into a Convertible Preferred stock arrangement and issued 500 shares of Preferred D stock for $500 thousand. The Preferred D investment agreement was to provide an additional $2.5 million in funding over the next 6 months. The Company is in discussions to potentially terminate or amend the agreement.

~~Our~~In ~~liquidity~~the ~~requirements are~~4th ~~primarily~~quarter toof ~~fund our business operations~~2022, ~~including~~the ~~capital~~Company issued ~~expenditures~~common ~~and~~stock ~~working~~to ~~capital~~a ~~requirements.~~distribution ~~Our~~partner ~~primary~~in ~~sources~~return ~~of liquidity~~for ~~are~~a ~~additional~~$500,000 ~~capital~~ investment ~~and debt~~.

On June 25, 2021, the Company entered into a securities purchase agreement with accredited investors pursuant to which the Company issued senior secured convertible notes in an aggregate principal amount of approximately $8.4 million for an aggregate purchase price of approximately $7.9 million. Immediately prior to the execution of the agreement described above, we entered into exchange agreements with the holders of outstanding promissory notes with an aggregate principal amount, together with accrued but unpaid interest, of approximately $2.1 million. The holders of the outstanding promissory notes were issued senior secured notes in the financing described above for an aggregate principal amount of $2.1 million. In connection with the issuance of the Notes, we issued to the Investors warrants to purchase an aggregate of approximately 4.1 million shares of Common Stock (collectively, the “Warrants”). The Company received approximately $5.8 million in funding from the transaction. 45

Cash Flows

As of December 31, ~~2021~~2022, the Company had cash and equivalents of $~~297~~17 thousand compared to $15297 thousand as of December 31, ~~2020~~2021 and outstanding debt of $814.46 million compared to $9.3 6 million asin of the ~~end~~same quarter of ~~2020~~2021.

Cash used in operating activities during the year ended December 31, ~~2021~~2022 was $6.~~318~~1 million. The net loss of $912.~~465~~3 million for ~~2021~~the year 2022 was increased by ~~non-cash gains~~amortization of ~~$408~~the ~~thousand~~discount from inthe ~~forgiveness~~issue of ~~the~~promissory ~~PPP~~notes ~~loan and accrued interest received in 2020 and a change~~ of $~~454~~4.0 ~~thousand in the fair value of derivative and warrant liabilities~~million, ~~offset~~services compensated by astock ~~loss~~issuance ~~on debt modification~~ of $~~2,385~~1.0 ~~thousand~~million, ~~and~~change ~~amortization~~in ofaccounts ~~the discount~~payable ~~from~~of ~~the~~$0.5 ~~issue~~million ofand ~~promissory~~stock-based ~~notes~~compensation of $~~1,478~~0.5 ~~thousand~~million, which were the significant non-cash expense items.

Cash ~~used~~provided by investing activities during ~~2021~~the year ended December 31, 2022 of $~~273~~186 thousand was primarily ~~for~~from ~~investing~~domain insale ~~of manufacturing equipment offset by cash received in the merger~~proceeds.

Cash provided by financing activities during ~~2021~~year 2022 of $65.96 million was primarily related to proceeds from the sale of ~~Senior~~convertible ~~Secured~~debt ~~Convertible~~issuances ~~notes~~for ~~and~~the ~~convertible~~amount $4.6 million, $500 thousand ~~debt~~of ~~issuances~~common stock sales, and $500 thousand proceeds from issuance of Preferred D stock used to fund company operations.

53Off-Balance Sheet Arrangements

~~Off~~The Company does not have any off-~~Balance~~balance ~~Sheet~~sheet ~~Arrangements~~arrangements, as defined in Item 303(a)(4)(ii) of Regulation S-K under the Securities Exchange Act of 1934, as amended.

~~The~~Recent ~~Company does not have any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of Regulation S-K under the Securities Exchange Act of 1934, as amended.~~Developments

~~Recent~~In ~~Developments~~June 2021, the Company completed a merger with Boston Therapeutics, a publicly held entity. The Company is the majority shareholder of the resulting entity. As part of the merger agreement, substantially all of the Company’s debt has been converted to equity in the merged entity. In addition, and in conjunction with the merger, the Company entered into a Convertible Equity arrangement and as of December 31, 2022 has issued $13.426 million in secured Notes and a received a related cash investment of $10.4 million.

InSignificant ~~June 2021, the Company~~Accounting ~~completed~~Policies a merger with Boston Therapeutics, a publicly held entity. The Company is the majority shareholder of the resulting entity. As part of the merger agreement, substantially all of the Company’s debt has been converted to equity in the merged entity. In addition, and inCritical ~~conjunction~~Accounting ~~with the merger, Boston Therapeutics entered into a Convertible Equity arrangement, issuing $8.3 million in secured Notes and a related cash investment of $5.8 million.~~Estimates

Significant ~~Accounting~~accounting policies are described in Note 3 – Significant Accounting Policies to the audited consolidated financial statements included herein. Certain of our accounting policies require the application of significant judgment by management in selecting the appropriate assumptions for calculating financial estimates. By their nature, these judgments are subject to an inherent degree of uncertainty. These judgments are based on our historical experience, terms of existing contracts, our evaluation of trends in the industry, information provided by our customers and ~~Critical~~information available ~~Accounting~~from ~~Estimates~~other outside sources, as appropriate. We consider an accounting estimate to be critical if:

~~Significant~~● ~~accounting policies~~It ~~are~~requires ~~described~~us ~~in Note 3 – Significant Accounting Policies~~ to ~~the~~make ~~audited~~assumptions ~~consolidated~~about ~~financial~~matters ~~statements~~that ~~included~~were ~~herein. Certain~~uncertain ofat ~~our accounting policies require~~ the ~~application~~time ofwe ~~significant~~were ~~judgment~~making ~~by management in selecting~~ the ~~appropriate assumptions for calculating financial estimates. By their nature~~estimate, these judgments are subject to an inherent degree of uncertainty. These judgments are based on our historical experience, terms of existing contracts, our evaluation of trends in the industry, information provided by our customers and ~~information available from other outside sources, as appropriate. We consider an accounting estimate to be critical if:~~

● ItChanges ~~requires~~in usthe toestimate ~~make~~or ~~assumptions~~different ~~about~~estimates ~~matters~~ that ~~were~~we ~~uncertain~~could athave ~~the~~selected ~~time~~would wehave ~~were~~had ~~making~~a ~~the~~material ~~estimate,~~impact ~~and~~on our financial condition or results of operations.

●The ~~Changes~~following listing is not intended to be a comprehensive list of all of our accounting policies. In many cases, the accounting treatment of a particular transaction is specifically dictated by accounting principles generally accepted in the ~~estimate~~United orStates ~~different~~of ~~estimates~~America, ~~that~~with weno ~~could~~need ~~have~~for ~~selected~~management’s judgment in their application. There are also areas in which management’s judgment in selecting any viable alternative would ~~have~~not ~~had~~produce a ~~material~~materially different ~~impact~~result. onThere have been no significant changes in our ~~financial~~critical ~~condition~~accounting orestimates ~~results~~during ofthe ~~operations~~year ended December 31, 2022.

~~The~~Revenue following listing is not intended to be a comprehensive list of all of our accounting policies. In many cases, the accounting treatment of a particular transaction is specifically dictated by accounting principles generally accepted in the United States of America, with no need for management’s judgment in their application. There are also areas in which management’s judgment in selecting any viable alternative would not produce a materially different result. There have been no significant changes in our critical accounting estimates during the year ended December 31, 2021.Recognition

~~Revenue~~For certain contracts, we recognize revenue from R&D, milestone and grant revenues when earned. Grants are invoiced after expenses are incurred, as that is the depiction of the timing of the transfer of services. Performance obligations generally follow the major phases of product development processes: design feasibility & planning, product development & design optimization, design verification, design validation & process validation, and pivotal studies. Further details regarding revenue recognition are document at Note 3(b) – Summary of Significant Accounting Policies: Revenue Recognition to the Unaudited Condensed Consolidated Financial Statements.

~~For~~Stock-Based certain contracts, we recognize revenue from R&D, milestone and grant revenues when earned. Grants are invoiced after expenses are incurred, as that is the depiction of the timing of the transfer of services. Performance obligations generally follow the major phases of product development processes: design feasibility & planning, product development & design optimization, design verification, design validation & process validation, and pivotal studies. Further details regarding revenue recognition are document at Note 3(b) – Summary of Significant Accounting Policies: Revenue Recognition to the Unaudited Condensed Consolidated Financial Statements.Compensation

~~Stock~~We recognize the fair value of equity-~~Based~~based ~~Compensation~~awards as compensation expense in our statement of operations. The fair value of our stock option awards was estimated using a Black-Scholes option valuation model. This valuation model’s computations incorporate highly subjective assumptions, such as the expected stock price volatility and the estimated life of each award. The fair value of the options, after considering the effect of expected forfeitures, is then amortized, generally on a straight-line basis, over the related vesting period of the option.

We recognize the fair value of equity-based awards as compensation expense in our statement of operations. The fair value of our stock option awards was estimated using a Black-Scholes option valuation model. This valuation model’s computations incorporate highly subjective assumptions, such as the expected stock price volatility and the estimated life of each award. The fair value of the options, after considering the effect of expected forfeitures, is then amortized, generally on a straight-line basis, over the related vesting period of the option.46

54Research & Development Costs

Research &and ~~Development~~development activities consist primarily of new product development, continuing engineering for existing products, and regulatory and clinical trial costs. Costs related to research and development efforts on existing or potential products are expensed as incurred.

~~Research~~Income and development activities consist primarily of new product development, continuing engineering for existing products, and regulatory and clinical trial costs. Costs related to research and development efforts on existing or potential products are expensed as incurred.Taxes

~~Accounts~~Income ~~Receivable~~taxes are accounted for under ASC 740 authoritative guidance (“Guidance”), which requires the asset and liability method of accounting for deferred income taxes. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities. Deferred tax assets or liabilities at the end of each period are determined using the tax rate expected to be in effect when taxes are actually paid or recovered.

NoThe ~~allowance~~Guidance ~~has~~also ~~been~~requires that a valuation allowance ~~provided~~be ~~for~~established ~~uncollectible~~when ~~accounts~~it is more likely than not that all or a portion of a deferred tax asset will not be realized. AsA review of ~~December~~all 31available positive and negative evidence needs to be considered, ~~2021~~including a company’s current and ~~2020~~past performance, the market environment in which the company operates, length of carryback and carryforward periods and existing contracts that will result in future profits. The Company ~~has~~believes $0that it is more likely than not that it will not be able to utilize its net operating loss carryforwards and ~~$821~~maintains a ~~accounts~~full ~~receivable~~valuation ~~balance,~~allowance. ~~respectively~~The Company maintains a full valuation allowance on research and development tax credits.

~~Income~~The ~~Taxes~~Guidance also prescribes a comprehensive model for recognizing, measuring, presenting and disclosing in the consolidated financial statements tax positions taken or expected to be taken on a tax return, including a decision whether to file or not to file in a particular jurisdiction.

~~Income~~ITEM ~~taxes are accounted for under ASC 740 authoritative guidance (“Guidance”), which requires the asset and liability method of accounting for deferred income taxes~~7A. ~~Deferred~~QUANTITATIVE ~~tax~~AND ~~assets~~QUALITATIVE ~~and~~DISCLOSURES ~~liabilities~~ABOUT ~~are~~MARKET ~~determined based on the difference between the financial statement and tax bases of assets and liabilities~~RISK. ~~Deferred tax assets or liabilities at the end of each period are determined using the tax rate expected to be in effect when taxes are actually paid or recovered.~~

~~The~~We ~~Guidance~~are ~~also requires that~~ a ~~valuation~~smaller ~~allowance~~reporting be established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence needs to be considered, including a company’s ~~current~~as ~~and past performance,~~defined ~~the~~by ~~market~~Rule ~~environment~~12b-2 inof ~~which~~ the ~~company~~Exchange ~~operates,~~Act ~~length of carryback~~ and ~~carryforward~~are ~~periods and existing contracts that will result in future profits. The Company believes that it is more likely than~~ not ~~that~~required ~~it will not be able~~ to ~~utilize~~provide ~~its~~the ~~net~~information ~~operating~~otherwise ~~loss~~required ~~carryforwards and~~under ~~maintains~~this ~~a full valuation allowance~~item. ~~The Company maintains a full valuation allowance on research and development tax credits.~~

~~The~~ITEM ~~Guidance~~8. ~~also~~FINANCIAL ~~prescribes a~~STATEMENTS ~~comprehensive~~AND ~~model~~SUPPLEMENTARY for recognizing, measuring, presenting and disclosing in the consolidated financial statements tax positions taken or expected to be taken on a tax return, including a decision whether to file or not to file in a particular jurisdictionDATA.

~~ITEM~~This ~~7A.~~information ~~QUANTITATIVE~~appears ~~AND~~following ~~QUALITATIVE~~Item ~~DISCLOSURES~~15 of ~~ABOUT~~this ~~MARKET~~Annual ~~RISK~~Report on Form 10-K and is incorporated herein by reference.

WeITEM ~~are~~9. aCHANGES ~~smaller~~IN ~~reporting~~AND ~~company~~DISAGREEMENTS asWITH ~~defined by~~ACCOUNTANTS ~~Rule~~ON ~~12b-2~~ACCOUNTING ofAND ~~the~~FINANCIAL ~~Exchange Act and are not required to provide the information otherwise required under this item~~DISCLOSURE.

~~ITEM 8~~None. ~~FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.~~

~~This~~ITEM ~~information~~9A. ~~appears~~CONTROLS ~~following~~AND ~~Item 15 of this Annual Report on Form 10-K and is incorporated herein by reference~~PROCEDURES.

55Evaluation of Disclosure Controls and Procedures

~~ITEM~~We 9carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)). ~~CHANGES~~Based INupon ~~AND~~that ~~DISAGREEMENTS~~evaluation, ~~WITH~~our ~~ACCOUNTANTS~~principal ONexecutive ~~ACCOUNTING~~officer ~~AND~~and ~~FINANCIAL~~principal ~~DISCLOSURE~~financial officer concluded that, as of the end of the period covered in this report, our disclosure controls and procedures were ineffective to ensure that information required to be disclosed in reports filed under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the required time periods specified in the Commission’s rules and forms and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

~~None~~Our principal executive officer and principal financial officer, do not expect that our disclosure controls and procedures or our internal controls will prevent all error or fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs. Due to the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. During the fourth quarter ended December 31, 2022, we carried out an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures. Based on our evaluation and due to identified control deficiencies regarding the lack of segregation of duties and the need for a stronger internal control environment, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were ineffective as of the end of the period covered by this report.

~~ITEM 9A. CONTROLS AND PROCEDURES.~~47

~~Evaluation~~To ofaddress ~~Disclosure~~the ~~Controls~~material weaknesses, we performed additional analysis and ~~Procedures~~other post-closing procedures in an effort to ensure our financial statements included in this annual report have been prepared in accordance with generally accepted accounting principles. Accordingly, management believes that the financial statements included in this report fairly present in all material respects our financial condition, results of operations and cash flows for the periods presented.

We carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer , of the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)). Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered in this report, our disclosure controls and procedures were ineffective to ensure that information required to be disclosed in reports filed under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the required time periods specified in the CommissionManagement’s ~~rules~~ ~~and~~Report ~~forms~~on ~~and~~Internal ~~is accumulated and communicated to our management, including our principal executive officer and principal financial~~Control ~~officer,~~Over asFinancial ~~appropriate to allow timely decisions regarding required disclosure.~~Reporting

Our ~~principal~~management ~~executive~~is ~~officer~~responsible ~~and~~for ~~principal~~establishing ~~financial officer, do not expect that our disclosure controls~~ and ~~procedures~~maintaining oradequate ~~our~~ internal ~~controls will prevent all error or fraud. A~~ control ~~system,~~over nofinancial ~~matter~~reporting ~~how~~as ~~well~~defined ~~conceived~~in ~~and~~Rule ~~operated,~~13a-15(f) ~~can~~under ~~provide only reasonable, not absolute, assurance that~~ the ~~objectives of~~Securities ~~the~~Exchange ~~control~~Act ~~system are met. Further, the design~~ of ~~a control system must reflect the fact that there are resource constraints and the~~1934, ~~benefits~~as ~~of controls must be considered relative to their costs~~amended. ~~Due~~Our tomanagement assessed the ~~inherent~~effectiveness ~~limitations in all control systems, no evaluation~~ of ~~controls~~our ~~can~~internal ~~provide absolute assurance that all~~ control ~~issues~~over ~~and~~financial ~~instances~~reporting as of ~~fraud,~~December ~~if any~~31, ~~have been detected~~2022. ~~During~~In ~~the fourth~~making ~~quarter~~this ~~ended December 31~~assessment, ~~2021,~~our wemanagement ~~carried~~used ~~out an evaluation, under~~ the ~~supervision~~criteria ~~and~~set ~~with~~forth by the ~~participation~~Committee of ~~our~~Sponsoring ~~principal~~Organizations ~~executive officer and principal financial officer,~~ of the ~~effectiveness~~Treadway ofCommission ~~the~~(“COSO”) in ~~design~~Internal ~~and~~Control-Integrated ~~operation~~Framework of(2013). ~~our~~A ~~disclosure~~material ~~controls~~weakness ~~and~~is ~~procedures.~~a ~~Based on~~deficiency, ~~our~~or ~~evaluation~~a ~~and~~combination ~~due~~of ~~to identified control~~ deficiencies, ~~regarding~~in ~~the~~internal ~~lack~~control over offinancial ~~segregation~~reporting, ofsuch ~~duties~~that ~~and~~there ~~the~~is ~~need for~~ a ~~stronger~~reasonable ~~internal control~~possibility ~~environment,~~that ~~our~~a ~~principal~~material ~~executive~~misstatement ~~officer~~of ~~and principal financial officer concluded that~~ our ~~disclosure~~annual ~~controls~~or ~~and~~interim ~~procedures~~financial ~~were~~statements ~~ineffective~~will asnot ofbe ~~the~~prevented ~~end~~or ofdetected ~~the~~on ~~period~~a ~~covered~~timely ~~by this report~~basis.

ToAs ~~address~~disclosed ~~the~~in ~~material~~our ~~weaknesses~~previous filings, wethere ~~performed~~are ~~additional~~material ~~analysis~~weaknesses ~~and~~in ~~other~~the ~~post-closing~~Company’s ~~procedures~~internal incontrol anover ~~effort~~financial toreporting ~~ensure~~due ~~our~~to ~~financial~~the ~~statements~~fact ~~included~~that inthe ~~this~~Company ~~annual~~does ~~report~~not have an ~~been~~adequate ~~prepared~~process inestablished ~~accordance~~to ~~with~~ensure ~~generally~~appropriate ~~accepted~~levels of review of accounting ~~principles.~~and ~~Accordingly,~~financial ~~management~~reporting ~~believes~~matters, ~~that~~which ~~the~~resulted ~~financial~~in ~~statements~~our ~~included~~closing inprocess ~~this~~not ~~report~~identifying ~~fairly~~all ~~present~~required adjustments and disclosures in ~~all~~a ~~material~~timely ~~respects~~fashion. ~~our~~The ~~financial~~Company’s ~~condition,~~CEO/CFO ~~results~~has identified control deficiencies regarding the lack of ~~operations~~segregation of duties and ~~cash~~the ~~flows~~need for a stronger internal control environment. The small size of the Company’s accounting staff may prevent adequate controls in the future, such as segregation of duties, due to the cost/benefit ~~periods~~of ~~presented~~such remediation.

~~Management~~Although the Company has hired a financial controller to assist with SEC reporting and accounting matters, we expect that the Company will need to hire additional accounting personnel with the requisite knowledge to improve the levels of review of accounting and financial reporting matters. The Company may experience delays in doing so and any such additional employees would require time and training to learn the Company’s ~~Report~~business onand ~~Internal~~operating ~~Control~~processes ~~Over~~and ~~Financial~~procedures. ~~Reporting~~For the near-term future, until such personnel are in place, this will continue to constitute a material weakness in the Company’s internal control over financial reporting that could result in material misstatements in the Company’s financial statements not being prevented or detected.

~~Our~~The Company’s management, isincluding ~~responsible~~the Company’s ~~for~~CEO/CFO, ~~establishing and~~does ~~maintaining~~not ~~adequate~~expect that the Company’s internal control over financial reporting aswill ~~defined~~prevent inall ~~Rule~~errors ~~13a-15(f) under the Securities Exchange Act of 1934,~~and asall ~~amended~~fraud. ~~Our~~Because ~~management~~of ~~assessed~~its ~~the~~inherent ~~effectiveness~~limitations, ~~of our~~ internal control over financial reporting asmay ofnot ~~December~~prevent ~~31,~~or ~~2021~~detect misstatements. ~~In making~~Also, ~~this~~projections ~~assessment, our management used the criteria set forth by the Committee~~ of ~~Sponsoring~~any ~~Organizations~~evaluation of ~~the~~effectiveness ~~Treadway~~to ~~Commission~~future ~~(“COSO”) in~~periods ~~Internal~~are ~~Control-Integrated~~subject ~~Framework~~to ~~(2013).~~the Arisk ~~material~~that ~~weakness~~controls ismay abecome ~~deficiency,~~inadequate orbecause ~~a combination~~ of changes ~~deficiencies,~~ in ~~internal control over financial reporting~~conditions, ~~such~~or that ~~there~~the isdegree ~~a reasonable possibility that a material misstatement of our annual~~ or ~~interim~~compliance ~~financial statements~~with ~~will~~the ~~not~~policies ~~be prevented~~ or ~~detected~~procedures onmay ~~a timely basis~~deteriorate.

56Because of the above material weakness, management has concluded that we did not maintain effective internal control over financial reporting as of December 31, 2022, based on the criteria established in “Internal Control-Integrated Framework” issued by the COSO.

AsChanges ~~disclosed~~ in ~~our~~Internal ~~previous~~Control ~~filings,~~Over ~~there~~Financial are material weaknesses in the Company’s internal control over financial reporting due to the fact that the Company does not have an adequate process established to ensure appropriate levels of review of accounting and financial reporting matters, which resulted in our closing process not identifying all required adjustments and disclosures in a timely fashion. The Company’s CEO/CFO has identified control deficiencies regarding the lack of segregation of duties and the need for a stronger internal control environment. The small size of the Company’s accounting staff may prevent adequate controls in the future, such as segregation of duties, due to the cost/benefit of such remediation.Reporting

~~Although~~There ~~the~~was ~~Company~~no ~~has~~change ~~hired~~in aour ~~financial~~internal ~~controller to~~control ~~assist with SEC reporting and accounting matters, we expect that the Company will need to hire additional accounting personnel with~~over ~~the requisite knowledge to improve the levels of review of accounting and~~ financial reporting ~~matters.~~(as ~~The~~defined ~~Company may experience delays~~ in ~~doing~~Rules so13a-15(f) and ~~any~~15d-15(f) ~~such~~under ~~additional~~the ~~employees~~Exchange ~~would~~Act) ~~require~~during ~~time and training to learn~~ the ~~Company’s~~quarter ~~business~~ended ~~and~~December ~~operating~~31, ~~processes and procedures. For the near-term future~~2022, ~~until~~that has ~~such~~materially ~~personnel are in place~~affected, ~~this~~or ~~will~~is ~~continue~~reasonably likely to ~~constitute~~materially aaffect, ~~material~~our ~~weakness in the Company’s~~ internal control over financial reporting ~~that could result in material misstatements in the Company’s financial statements not being prevented or detected~~.

~~The~~No ~~Company’s~~Attestation ~~management,~~Report ~~including~~by ~~the Company’s~~Independent ~~CEO/CFO,~~Registered does not expect that the Company’s internal control over financial reporting will prevent all errors and all fraud. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree or compliance with the policies or procedures may deteriorate.Accountant

~~Because~~The effectiveness of ~~the~~our ~~above~~internal ~~material~~control ~~weakness, management~~over ~~has~~financial ~~concluded~~reporting ~~that~~as weof ~~did~~December ~~not~~31, ~~maintain~~2022 ~~effective~~has ~~internal~~not ~~control~~been ~~over~~audited ~~financial~~by ~~reporting~~our asindependent ofregistered ~~December~~public ~~31,~~accounting ~~2021,~~firm ~~based~~by onvirtue ~~the~~of ~~criteria~~our ~~established~~exemption infrom ~~“Internal~~such ~~Control-Integrated~~requirement ~~Framework”~~as ~~issued~~a bysmaller ~~the~~reporting ~~COSO~~company.

~~Changes~~ITEM in9B. ~~Internal~~OTHER ~~Control Over Financial Reporting~~INFORMATION.

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2021, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reportingNone.

No Attestation Report by Independent Registered Accountant

The effectiveness of our internal control over financial reporting as of December 31, 2021 has not been audited by our independent registered public accounting firm by virtue of our exemption from such requirement as a smaller reporting company.

ITEM 9B. OTHER INFORMATION.

None.

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.

Not Applicable.

5748

PART III

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.

Executive Officers and Directors

The following table sets forth the name, age and position of each of our executive officers, key employees and directors as of ~~the~~March ~~date~~6, ~~of this prospectus~~2023.

Name	Age		Position(s) with the Company
David Ludvigson		71	Chief Executive Officer, Chief Financial Officer, Secretary and Director
Thomas Schlumpberger		57	Chief Executive Officer and Director
Garrett Gruener		67	Director
Chris Hetterly		55	Chief Financial Officer
Jerry Fiddler		69	Director
Vidur Sahney		49	Chief Operating Officer
Gregory Schiffman		64	Director
John Hardesky		52	Chief Commercial Officer
Garrett Gruener		68	Director
Jerry Fiddler		70	Director
Gregory Schiffman		65	Director
David Ludvigson		72	Director
Tadd Lazarus, M.D.		66	Director

~~David~~Thomas ~~Ludvigson~~ Schlumpberger has served as ~~the~~chief ~~President~~executive officer and ~~Chief~~director ~~Executive Officer~~ of ~~Nanomix~~the ~~Corporation~~Company since ~~June~~July ~~2013~~2022. ~~From~~Dr. ~~October~~Schlumpberger ~~2009~~previously ~~through~~served ~~present~~as ~~day,~~the ~~Mr.~~Chief ~~Ludvigson~~Executive Officer ~~has~~of ~~served~~Pictor asLimited, ~~President~~a ofdiagnostic ~~Knight~~company, ~~Ludvigson~~from ~~Advisors providing~~August ~~advisory~~2020 ~~and~~to ~~business~~January ~~consulting services~~2022. toHe ~~Life~~also ~~Science~~previously ~~and~~served ~~Technology~~as ~~companies~~Executive ~~including~~Vice ~~M&A,~~President ~~financing,~~at ~~business strategy~~Anixa Biosciences, goa topharmaceutical ~~market planning~~ and ~~sales~~diagnostic ~~channel strategy~~biotech ~~and~~company ~~implementation.~~from ~~Mr.~~November ~~Ludvigson~~2019 ~~serves~~to onJuly ~~the~~2020, ~~board~~and ofas ~~directors~~Vice ofPresident ~~Imagion~~Business ~~Biosystems,~~Development at ~~Inc. (IBX)~~Inivata, ~~One~~a ~~BioMed~~liquid ~~PTE~~biopsy ~~LTD (privately held)~~company, ~~and~~from ~~China~~August ~~Stem~~2018 ~~Cells~~to ~~Ltd.~~August ~~(privately held)~~2019. MrDr. ~~Ludvigson~~Schlumpberger received his BSPh.D. ~~and~~in ~~MAS~~Molecular inand ~~Accounting~~Cell Biology from ~~Gies~~the ~~College of Business –~~ University of ~~Illinois~~California, ~~Urbana-Champaign. Mr.~~Berkeley ~~Ludvigson~~and ishis ~~not~~Masters ~~related~~in toElectrical ~~any~~Engineering ~~Officers~~and orInformation ~~Directors~~Technology offrom ~~the~~Technical ~~Company. There are~~University ~~no related party transactions reportable under Item 5~~Munich.~~02 of Form 8-K and Item 404(a) of Regulation S-K.~~

~~Garrett Gruener was~~Chris aHetterly ~~co-founder~~has ofserved ~~Alta~~as ~~Partners,~~chief financial ~~and~~officer ~~was~~of ~~also~~the aCompany ~~Partner~~since atJanuary ~~Burr,~~2023. ~~Egan, Deleage & Co~~Mr. HeHetterly previously served as the Chief ~~Executive~~ Financial Officer atof ~~Nanomix~~Octagos ~~from~~Health ~~2008~~LLC, a tohealthcare ~~2013~~Software-as-a-Service ~~and~~(“Saas”) ~~has~~company, ~~more~~from ~~than~~August ~~two~~2021 ~~decades~~to ofApril ~~experience~~2022. inHe ~~the~~also ~~fields~~previously ofserved ~~software~~as ~~development,~~the ~~systems~~Interim ~~engineering~~Chief ~~and~~Financial ~~corporate~~Officer ~~development.~~of ~~In 1982~~Weekdays, ~~he founded Virtual Microsystems~~Inc., a ~~successful~~Childcare-as-a-Platform ~~communications software~~ company, ~~that~~from ~~was later~~April

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