UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________________

FORM 8-K

_________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 1320, 2026

_________________________

CapsoVision, Inc.

(Exact name of registrant as specified in its charter)

_________________________

Delaware

001-42705

20-3369494

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(IRS Employer
Identification Number)


18805 Cox Avenue, Suite 250 Saratoga, California						95070
(Address of Principal Executive Offices)						(Zip Code)

Registrant’s telephone number, including area code: (408)-624-1488

n/a

(Former Name or Former Address, if Changed Since Last Report)

_________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


o			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

Title of each class

Trading
Symbol

Name of each exchange
on which registered

common stock, $0.001 par value per share

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

Item 1.01. Entry into a Material Definitive Agreement.

AsOn ~~previously~~March ~~reported~~16, on2026, ~~Form 8-K filed by~~ CapsoVision, Inc. (the “Company”) onentered ~~July~~into ~~15,~~a ~~2026~~Securities Purchase Agreement (the “~~July~~Securities ~~15th~~Purchase ~~2025~~Agreement”) ~~8-K~~with selected accredited investors (the “Investors”), for the ~~Company~~purposes ~~entered~~of ~~into~~raising aapproximately ~~development~~$14 ~~agreement~~million in aggregate gross proceeds for the Company (the “~~Agreement~~Private Placement”). ~~with~~Pursuant ~~Canon~~to ~~Inc.,~~the aterms ~~Japanese~~of ~~corporation~~the ~~(“Canon”)~~Securities Purchase Agreement, ~~for~~the Company agreed to issue and sell to the ~~development~~Investors in the Private Placement an aggregate of ~~complementary~~2,867,089 ~~metal-oxide-semiconductor~~shares (the “~~CMOS~~Shares”) ~~image~~of ~~sensor~~common ~~samples~~stock toof ~~allow~~ the Company, topar ~~evaluate~~value ~~functionality~~$0.001 ~~and~~per ~~performance~~share (the “Common Stock”), ~~conduct~~at ~~clinical~~$4.883 ~~evaluation~~per ofShare, ~~capsule~~which ~~endoscopies~~represents ~~that~~a ~~incorporate~~5% ~~Canon~~discount ~~image~~to ~~sensors~~the ~~and~~March ~~obtain~~16th ~~FDA~~closing ~~510(k)~~price, ~~clearance~~as ~~thereof~~per the terms of the agreement.

~~Under~~The ~~the~~Securities Purchase Agreement, ~~the~~contains ~~Company~~customary ~~agreed~~representations toand ~~pay~~warranties ~~Canon~~and aagreements ~~fee~~ of ~~approximately $4.1 million for Canon’s development efforts, which is comprised of (a) an initial fee of $1 million to be paid in cash upon~~ the ~~Agreement’s~~Company ~~effectiveness~~ and ~~(b) following delivery of a specified number of CMOS image sensors meeting agreed specifications within~~ the ~~required~~Investors ~~timeframe,~~and acustomary ~~remaining~~indemnification ~~development~~rights ~~fee of approximately $3.1 million. In addition,~~ and ~~subject~~obligations toof ~~such delivery,~~ the parties ~~have undertaken to enter into a related master purchase agreement providing for the Company to purchase a specified minimum number of CMOS image sensors from Canon~~. ~~The remaining development fee will be paid over time by adding an additional agreed amount to the unit price of CMOS image sensors supplied by Canon under the master purchase agreement.~~

OnThe ~~March~~closing 9,of ~~2026,~~ the ~~Company~~Private ~~entered~~Placement ~~into~~occurred ~~the~~on ~~amendment~~March ~~to the original development agreement (the “Amendment”) with Canon~~16, ~~Inc,~~2026. aThe ~~Japanese corporation pursuant to which the~~ Company ~~agreed~~intends ~~that the total fee shall be increased by the amount of $1 million due~~ to ~~the~~use ~~increased features in~~ the ~~specification.~~net Asproceeds afrom ~~result of this increase,~~ the ~~remaining~~Private ~~development~~Placement ~~fee~~for ofgeneral ~~the~~corporate ~~Agreement shall also be increased accordingly. The parties also agreed that~~purposes, ~~taking~~including ~~into~~sales ~~account the foregoing (~~and ~~that there has been no other increase or decrease from the effective date of the original Agreement)~~marketing, ~~the~~research ~~remaining~~and development ~~fee as of the Amendment effective date shall be paid by CapsoVision pursuant to Article 12.4 through 12.6 of the original Agreement. For the avoidance of doubt~~activities, ~~notwithstanding~~general ~~the~~and ~~increase~~administrative ~~of the total fee~~matters, ~~the~~working ~~Additional~~capital ~~Amount (as defined in section 12.5 of the Agreement) shall remain unchanged~~ and ~~all~~capital ~~the other terms under the Agreement shall remain in full force and effect~~expenditures.

The ~~foregoing~~Shares ~~summary~~have ofnot ~~the~~been ~~terms~~registered ofunder the ~~original~~Securities ~~Agreement~~Act ~~and~~of ~~its Amendment subject to~~1933, ~~and~~as ~~qualified~~amended in(the ~~its~~“Securities ~~entirety by~~Act”), ~~the~~and ~~Amendment~~were ~~that~~offered ispursuant ~~filed~~to asan ~~Exhibit~~exemption ~~10.1~~from toregistration ~~this~~provided ~~Current~~in ~~Report~~Section on4(a)(2) ~~Form~~under ~~8-K~~the ~~and~~Securities isAct ~~incorporated~~and ~~herein~~Rule by506 ~~reference~~promulgated thereunder.

In connection with the Private Placement, the Company entered into a registration rights agreement, dated March 16, 2026 (the “Registration Rights Agreement”), with the Investors, pursuant to which, among other things, the Company will (i) prepare and file with the Securities and Exchange Commission (the “SEC”) a registration statement to register for resale the Shares within 90 days after the closing of the Private Placement, and (ii) use commercially reasonable efforts to have such registration statement declared effective as soon as reasonably practicable following the filing thereof with the SEC. The Registration Rights Agreement contains customary terms and conditions for a transaction of this type.

The foregoing description of the material terms of the Securities Purchase Agreement and the Registration Rights Agreement is not complete and is qualified in its entirety by reference to the full text of the Securities Purchase Agreement and the Registration Rights Agreement, which are filed as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

Item 2.02. Results of Operations and Financial Condition.

On March 20, 2026, the Company issued a press release announcing certain of its preliminary, unaudited financial results for the fourth quarter and full year ended December 31, 2025. The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item 2.02 by reference.

The information in Item 2.02 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 3.02. Unregistered Sales of Equity Securities.

The information contained in Item 1.01 of this Current Report on Form 8-K related to the Shares is incorporated herein by reference.

Item 7.01. Regulation FD Disclosure.

On March 20, 2026, the Company issued a press release announcing the Private Placement. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference.

The information in Item 7.01 of this Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

Update on CapsoCam Colon

The Company is a global commercial-stage medical technology company focused on creating diagnostic and screening products to identify abnormalities of the GI tract. Currently, the Company’s GI-tract capsule endoscopy solution comprises the single-use CapsoCam capsule and the associated software, CapsoCloud and CapsoView. In addition, the Company is developing its next pipeline capsule endoscope, CapsoCam Colon. The CapsoCam Colon capsule (i) leverages CapsoCam Plus’s existing capsule design with its panoramic view and (ii) incorporates both the self-developed AI to automatically detect polyps in the video and the polyp-size measurement tool enabled by a 3D sensor in the capsule.

The Company submitted the 510(k) application for its first generation CapsoCam Colon capsule to the U.S. Food and Drug Administration (the “FDA”) in June 2025 and received responses from the FDA in September 2025. During the Company’s meeting with the FDA in December 2025, the FDA raised inquiries on topics including panoramic image processing methodology, and the proposed study design, sample size and primary endpoint for an extended study. Based on the Company’s communications with the FDA, the Company has decided not to further pursue the first generation CapsoCam Colon capsule submission and approval, and to prioritize its resources for the development of its second generation CapsoCam Colon capsule, featuring improved imaging quality and increased field of review with use of AI and better lens. The Company also expanded a second arm pivotal study to enroll approximately 800 patients at up to 20 sites in the U.S. in preparation for submitting a new 510(k) application for the second generation CapsoCam Colon capsule. As of the date of this Current Report on Form 8-K, over 500 patients have been enrolled for the second arm pivotal study. The Company currently expects to submit the 510(k) application for the second generation CapsoCam Colon capsule to the FDA in the third quarter of 2026.

Update on Breakthrough Device Designation

The Company is pioneering a novel, visual assessment for the screening and detection of pancreatic cancer. This builds on the technology and clinical results the Company has previously demonstrated in evaluating abnormalities of the duodenal wall and identification of duodenal landmarks (e.g., papilla of Vater). The Company will execute on necessary clinical studies to support this non-invasive, paradigm-changing, screening method.

Starting with a planned study, the Company will build on established scientific literature and work with leading opinion leaders (including leadership in leading Societies in pancreatobiliary field) to define malignancy diagnosis with the device.

It is expected that the study will start in the second quarter of 2026, and enroll approximately 90 patients using the CapsoCam UGI system to define diagnosis criteria.

The Company is also exploring a Breakthrough Device Designation with the FDA. Regulatory clearance for the CapsoCam UGI system in the USA is independent of this designation, as Breakthrough Designation is intended as a mechanism to facilitate development and enhance communications with the agency. An initial application was submitted for the CapsoCam UGI system for early-stage pancreatic cancer detection on November 6, 2025. A response from FDA in January 2026 determined that the CapsoCam UGI does allow for visualization of the papilla and its abnormalities, for both pre-cancerous and cancerous lesions. Due to the fact that the device does not specifically define diagnostic criteria, the application was not approved. The Company expects to resubmit the Breakthrough Device Designation application following the study, when additional data is available. The breakthrough designation is a part of the on-going project, potentially supplementing the regulatory pathway and approval for early pancreas cancer detection.

Item 9.01 Financial Statements and Exhibits.

(d)The following exhibits are being filed herewith:

ExhibitNo.						Description
10.1						~~Amendment~~Form toof ~~Sample~~Securities Purchase Agreement~~, dated March 9, 2026, by and between the Company and Canon Inc~~.
10.2						Form of Registration Rights Agreement.
99.1						Press Release issued on March 20, 2026.
104						Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	CAPSOVISION, INC.
Date: March 13, 2026	By:	/s/ Kang-Huai (Johnny) Wang
Date: March 20, 2026	By:	/s/ Kang-Huai (Johnny) Wang
	Name:	Kang-Huai (Johnny) Wang
	Title	President and Chief Executive Officer

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