CapsoVision (NASDAQ: CV) secures $14M and pivots colon capsule strategy

Rhea-AI Filing Summary

CapsoVision, Inc. entered into a securities purchase agreement with accredited investors for a $14 million private placement, issuing 2,867,089 common shares at $4.883 per share, a 5% discount to the March 16 closing price. The company plans to use the cash for sales and marketing, R&D, general corporate purposes and working capital.

CapsoVision reported preliminary, unaudited revenue of $3.9 million for the fourth quarter of 2025 and $13.6 million for full year 2025, with approximately $10.1 million in cash, cash equivalents, restricted cash and investments as of December 31, 2025.

The company decided not to pursue FDA clearance for its first-generation CapsoCam Colon capsule after 510(k) feedback, and is prioritizing a second-generation version supported by an expanded pivotal study targeting about 800 patients, with over 500 enrolled and a planned 510(k) submission in the third quarter of 2026. CapsoVision is also developing a pancreatic cancer screening application using its CapsoCam UGI system; an initial Breakthrough Device Designation request was not approved, and the company expects to resubmit after a planned study of about 90 patients starting in the second quarter of 2026.

Positive

• $14 million private placement completed, providing significant additional capital compared with the disclosed $10.1 million in cash and investments as of December 31, 2025, to fund sales, marketing, R&D and working capital.
• Clearer GI pipeline focus, with resources prioritized toward a second-generation CapsoCam Colon capsule supported by an expanded pivotal study and a targeted 510(k) submission in the third quarter of 2026.

Negative

• First-generation CapsoCam Colon 510(k) effort discontinued after FDA feedback on imaging methodology and study design, delaying potential U.S. regulatory clearance until a second-generation submission planned for the third quarter of 2026.
• Initial Breakthrough Device Designation request not approved for the CapsoCam UGI pancreatic cancer screening application, requiring additional clinical data from a new ~90-patient study before resubmission.

Insights

Medical technology and capital markets analyst

$14M equity raise funds GI pipeline pivot and new studies.

CapsoVision completed a $14 million private placement, issuing 2,867,089 shares at $4.883 each, a 5% discount to the March 16 closing price. This roughly matches the disclosed preliminary liquidity of $10.1 million at December 31, 2025, meaning the financing materially extends its cash runway.

The company is reallocating resources away from its first-generation CapsoCam Colon 510(k) after FDA feedback, concentrating instead on a second-generation capsule with improved imaging and AI. A pivotal study arm is being expanded to about 800 patients at up to 20 U.S. sites, with over 500 enrolled and a planned 510(k) submission in Q3 2026.

Separately, the initial Breakthrough Device Designation application for pancreatic cancer screening using CapsoCam UGI was not approved, but the FDA acknowledged the device’s ability to visualize relevant lesions. A planned ~90-patient study starting in Q2 2026 is intended to define diagnostic criteria before resubmission. Overall, the filing combines meaningful dilution with clearer funding for a more focused development path, so the net effect is best characterized as neutral.

FALSE000137832500013783252026-03-202026-03-20

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 20, 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

CV

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.

On March 16, 2026, CapsoVision, Inc. (the “Company”) entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with selected accredited investors (the “Investors”), for the purposes of raising approximately $14 million in aggregate gross proceeds for the Company (the “Private Placement”). Pursuant to the terms of the Securities Purchase Agreement, the Company agreed to issue and sell to the Investors in the Private Placement an aggregate of 2,867,089 shares (the “Shares”) of common stock of the Company, par value $0.001 per share (the “Common Stock”), at $4.883 per Share, which represents a 5% discount to the March 16th closing price, as per the terms of the agreement.

The Securities Purchase Agreement contains customary representations and warranties and agreements of the Company and the Investors and customary indemnification rights and obligations of the parties.

The closing of the Private Placement occurred on March 16, 2026. The Company intends to use the net proceeds from the Private Placement for general corporate purposes, including sales and marketing, research and development activities, general and administrative matters, working capital and capital expenditures.

The Shares have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), and were offered pursuant to an exemption from registration provided in Section 4(a)(2) under the Securities Act and Rule 506 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:

Exhibit No.						Description
10.1						Form of Securities Purchase Agreement.
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 20, 2026			By:			/s/ Kang-Huai (Johnny) Wang
			Name:			Kang-Huai (Johnny) Wang
			Title			President and Chief Executive Officer

Exhibit 99.1

CapsoVision Announces $14 Million Private Placement Financing

Reports Preliminary, Unaudited Fourth-Quarter and Full Year 2025 Financial Results

SARATOGA, Calif., March 20, 2026 - CapsoVision, Inc. (the “Company”) (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today announced the closing of a $14 million private placement in public equity financing (the “Private Placement”) pursuant to a securities purchase agreement entered into by the Company with selected accredited investors on March 16, 2026 for such investors to purchase shares (the “Shares”) of common stock of the Company.

Pursuant to the securities purchase agreement, the Company has agreed to sell 2,867,089 shares of common stock of the Company, with par value $0.001 per share, at $4.883 per share, which represents a 5% discount to the March 16th closing price, as per the terms of the agreement. The closing occurred on March 16, 2026, with approximately $14 million aggregate gross proceeds. The Company expects to use the net proceeds from the Private Placement for general corporate purposes, including sales and marketing, research and development activities, general and administrative matters, and working capital.

The offer and sale of the Shares in the Private Placement were made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws, and are being issued and sold in reliance on Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated under the Securities Act. Accordingly, the Shares may not be re-offered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Shares were offered only to accredited investors. Pursuant to a registration rights agreement with such investors, the Company has agreed to file a registration statement with the SEC covering the resale of the Shares within 90 days after the closing of the Private Placement. The Benchmark Company, LLC and Roth Capital Partners acted as financial advisors for the transaction.

“The participation of both new and existing investors in this financing underscores confidence in our platform and long-term opportunity,” said Johnny Wang, President and Chief Executive Officer. “We intend to deploy the proceeds toward continued product innovation and advancement of our pipeline, including CapsoCam Colon, CapsoCam UGI, and enhanced AI capabilities. We remain committed to disciplined execution and delivering sustainable, long-term value for our shareholders.”

Preliminary, Unaudited Fourth Quarter and Full Year Financial Results

CapsoVision also announced today preliminary, unaudited financial results for the fourth quarter and full year ended December 31, 2025:

•Fourth quarter 2025 revenue is $3.9 million

•Full year 2025 revenue is $13.6 million

•As of December, 31, 2025, the Company had preliminary cash, cash equivalents, restricted cash and investments of approximately $10.1 million.

As previously announced, the company will release fourth quarter and full year 2025 financial results on Thursday, March 26, 2026, after the close of market. CapsoVision will host a corresponding conference call and a live webcast at 1:30 pm PT / 4:30 pm ET on the same day to discuss the results and provide a corporate update.

About CapsoVision

CapsoVision is a commercial-stage medical technology company focused on developing advanced imaging and AI-enabled solutions to transform the detection and screening of gastrointestinal diseases. Its flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that enables high-resolution visualization of the small bowel and supports cloud-based or direct capsule video retrieval. The Company’s next pipeline product, CapsoCam Colon with enhanced AI, is designed to enable non-invasive colon imaging and polyp detection. With a proprietary platform targeted to expand across multiple GI indications, including esophageal and pancreatic disorders, CapsoVision is advancing a new era in capsule-based diagnostics. For more information on CapsoVision, please visit www.capsovision.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this context, forward-looking statements mean statements related to future events, which may impact our expected future business and financial performance, and often contain words such as “expected”, “anticipates”, “intends”, “plans”, “believes”, “potential”, “estimates”, “committed”, “will”, “should”, “could”, “would” or “may” and other words of similar meaning. Examples of these forward-looking statements include, but are not limited to, expectations regarding the Private Placement, including the Company’s use of proceeds from the Private Placement and registration of the Shares being issued and sold in the Private Placement, as well as statements concerning possible or assumed future results of operations and financial position, including the Company’s expectations regarding the Company’s product and clinical development efforts, the timing and receipt of regulatory submissions and approvals, the Company’s plans, strategies and timing for its pipeline development (including plans to address future indications in terms of new GI pathologies, patient enrollment in support of new generation colon capsule, and expanded patient populations and related timing of these efforts) and the success of the Company’s plans and strategies. These forward-looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties, including those beyond the Company’s control. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, market conditions, the Company’s financial condition and the availability of cash, the failure to receive regulatory clearance and the failure to adapt the Company’s products for new indications. These and other risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s prospectus filed on July 3, 2025 with the SEC, as part of the Company’s Registration Statement on Form S-1 (File No. 333-287148), and the Company’s most recent Form 10-Q. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these statements, except as required by law.

Investor Relations Contact

Leigh Salvo

New Street Investor Relations

Investors@CapsoVision.com

Media Contact

Leslie Strickler and Paul Spicer

Être Communications

leslies@etrecommunications.com | (804) 240-0807

pauls@etrecommunications.com | (804) 503-9231

FAQ

What capital did CapsoVision (CV) raise in the March 2026 private placement?

CapsoVision raised approximately $14 million in gross proceeds through a private placement, selling 2,867,089 common shares at $4.883 per share, a 5% discount to the March 16, 2026 closing price, to selected accredited investors.

How does the new financing compare to CapsoVision’s existing cash balance?

CapsoVision reported preliminary cash, cash equivalents, restricted cash and investments of about $10.1 million as of December 31, 2025. The additional $14 million from the private placement more than doubles that preliminary liquidity, supporting operations and product development.

What are CapsoVision’s preliminary revenue results for Q4 and full year 2025?

Preliminary, unaudited fourth quarter 2025 revenue is $3.9 million, and full year 2025 revenue is $13.6 million. These early figures will be supplemented by detailed financial statements when the company releases full results on March 26, 2026.

What change did CapsoVision make to its CapsoCam Colon regulatory strategy?

After FDA feedback on its first-generation CapsoCam Colon 510(k) submission, CapsoVision chose not to pursue that application further. Instead, it is prioritizing a second-generation capsule, supported by an expanded ~800-patient pivotal study and a planned 510(k) submission in the third quarter of 2026.

What happened with CapsoVision’s Breakthrough Device Designation request for pancreatic cancer screening?

An initial Breakthrough Device Designation application for the CapsoCam UGI system, submitted November 6, 2025, was not approved because it lacked specific diagnostic criteria. CapsoVision plans a ~90-patient study starting in the second quarter of 2026 and expects to resubmit after obtaining additional data.

How will CapsoVision use proceeds from the $14 million private placement?

CapsoVision intends to use net proceeds for general corporate purposes. These include sales and marketing efforts, research and development activities, general and administrative expenses, working capital and capital expenditures to support its GI imaging and AI-enabled capsule endoscopy pipeline.

Filing Exhibits & Attachments

6 documents

Press Releases

• EX-99.1 EX-99.1 13.0 KB

Agreements & Contracts

• EX-10.1 EX-10.1 270.0 KB
• EX-10.2 EX-10.2 166.4 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT 1.7 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT 24.0 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT 13.8 KB