Every 8-K that CapsoVision, Inc. (CV) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow CV and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full CV filings page.
CapsoVision, Inc. entered into a Controlled Equity Sales Agreement with Cantor Fitzgerald & Co. for an at-the-market offering program. Under this arrangement, CapsoVision may sell, at its sole discretion, shares of its common stock having an aggregate offering price of up to $100,000,000 through or to Cantor as sales agent or principal. The shares will be issued pursuant to a Registration Statement on Form S-3 (File No. 333-298315), which includes an at-the-market offering prospectus supplement filed on August 13, 2026. O’Melveny & Myers LLP provided a legal opinion on the validity of the shares, filed as Exhibit 5.1.
CapsoVision, Inc. entered into a Controlled Equity Sales Agreement with Cantor Fitzgerald & Co. for an at-the-market equity program under which it may sell up to $100,000,000 of common stock from time to time. Cantor will act as sales agent or principal for a commission of up to 3.0% of gross proceeds. The company plans to use a Form S-3 shelf registration and an at-the-market prospectus supplement for these potential issuances.
For the quarter ended June 30, 2026, CapsoVision reported revenue of $3.6 million, up about 10% year over year, driven by a 13% increase in CapsoCam Plus capsule volume, partly offset by lower average selling prices. Gross margin was 51%, down from 55% a year earlier due to pricing pressure and higher customs and tariff costs. Operating expenses rose to $9.5 million, mainly from clinical trials, development work and public company costs, leading to an operating loss of $7.6 million and a net loss of $7.5 million.
Cash and cash equivalents were $9.1 million as of June 30, 2026, with net cash used in operating activities of $14.5 million in the first half of 2026. Operationally, management highlighted international launch of its AI Highlights feature, broader hospital and GI network adoption, over 176,000 patients having used CapsoCam Plus, and pipeline progress including anticipated FDA clearance of AI Highlights by the end of the third quarter of 2026 and a planned 510(k) submission for CapsoCam Colon in the fourth quarter of 2026.
CapsoVision, Inc. appointed gastroenterologist Dr. David S. Shields to its Board of Directors as a Class I director and member of the Compensation Committee, effective July 1, 2026, filling the vacancy created by the resignation of Dr. Joanne Imperial.
The Board determined that Dr. Shields is an independent director and he will receive the company’s standard non-employee director compensation and a standard indemnification agreement. Separately, CapsoVision entered into a consulting agreement under which Dr. Shields will provide clinical consulting and industrial affiliation services at US$600 per hour for up to 3 hours per work week.
Dr. Imperial stepped down from the Board and the Compensation Committee, effective July 1, 2026, without any disagreement regarding the company’s operations, policies or practices. Under an amended and restated consulting agreement dated July 2, 2026, she will continue as an independent consultant at US$600 per hour for up to 5 hours per work week and received an option to purchase 10,000 shares of common stock, vesting over four years, as compensation for her services.
CapsoVision, Inc. reported the voting results from its 2026 annual meeting of stockholders held on June 11, 2026. Stockholders re-elected three Class I directors—Joanne Imperial, M.D., Wen-Herng (Henry) King, and Michele Harari—to serve until the 2029 annual meeting.
Support for each director was strong, with between 32,060,734 and 32,066,645 votes cast "for" and between 64,536 and 70,447 votes withheld, plus 2,244,596 broker non-votes for each nominee. Stockholders also ratified the appointment of Baker Tilly US, LLP as the company’s independent registered public accounting firm for the 2026 fiscal year, with 34,321,524 votes for, 154 against, and 54,099 abstentions.
CapsoVision, Inc. reported first quarter 2026 revenue of $2.8 million, essentially unchanged from the prior year period, as a small decline in capsule volume was offset by a slightly higher average selling price. Gross margin fell to 48% from 54%, reflecting the impact of changes in U.S. trade policies and tariffs.
Operating expenses increased to $8.4 million, mainly from development work under a Canon Inc. agreement and clinical trials for the second-generation CapsoCam Colon, leading to a wider net loss of $7.0 million. Cash and cash equivalents rose to $17.9 million as of March 31, 2026, helped by completion of a $14 million private placement of equity on March 16, 2026. The company highlighted progress toward anticipated FDA clearance of its AI-assisted reading feature for CapsoCam Plus and ongoing pipeline programs in colon and pancreatic cancer diagnostics.
CapsoVision reported fourth quarter and full-year 2025 results showing solid revenue growth but continued significant losses. Fourth quarter 2025 revenue was $3.9 million, up 13% year over year, and full-year 2025 revenue was $13.6 million, a 15% increase driven mainly by higher CapsoCam Plus capsule sales.
Full-year gross profit was $7.2 million with a 53% gross margin, slightly below 54% in 2024, while operating expenses rose to $32.7 million due to R&D, clinical activities, and public company costs. Net loss widened to $25.3 million, or $1.03 per share.
Cash and cash equivalents totaled $10.1 million as of December 31, 2025. The company completed an initial public offering with $23.4 million in net proceeds and subsequently closed a $14 million private placement in March 2026. Operationally, CapsoVision submitted a 510(k) application for its AI-assisted module for CapsoCam Plus and continued developing its colon and upper GI capsule pipeline.
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.
CapsoVision, Inc. amended its development agreement with Canon Inc. for CMOS image sensors, increasing the total fee by $1 million to reflect enhanced specifications. This raises the original approximately $4.1 million commitment, increasing the remaining development fee that will be paid through sensor purchase pricing. The amendment keeps the defined Additional Amount unchanged and confirms that all other terms, including the structure for future sensor purchases and clinical and FDA 510(k) objectives, remain in full force and effect.
CapsoVision, Inc. furnished a current report announcing it issued a press release with financial results for the fiscal quarter ended September 30, 2025. The press release is attached as Exhibit 99.1.
The information under Item 2.02 is being furnished and is not deemed filed for purposes of Section 18 of the Exchange Act. CapsoVision’s common stock trades on Nasdaq under the symbol CV.
CapsoVision, Inc. reported that it issued a press release announcing a 510(k) FDA application for Breakthrough Device Designation for its Pancreatic Cancer Screening Capsule. The disclosure was furnished under Item 8.01 and includes the press release as Exhibit 99.1 dated November 10, 2025.
This notice signals a regulatory step only; it does not reflect FDA clearance or authorization. The company did not disclose financial terms or operational changes in this update.
CapsoVision, Inc. appointed David Garcia as principal financial officer and principal accounting officer, effective November 3, 2025. Garcia brings more than 20 years of finance leadership experience, most recently serving as VP of Financial Planning and Analysis at Matterport from October 2020 to October 2025, with prior senior roles at View, Intelepeer, and Align Technology.
His compensation includes a $300,000 annual base salary, an option to purchase 165,000 shares granted on November 3, 2025 at the closing share price that day, and a $12,500 quarterly bonus. Vesting is structured with 25% on November 3, 2026, and the remainder in 36 equal monthly installments thereafter. The company entered into its standard indemnification agreement with Garcia. The company reported no arrangements leading to his appointment and no related-party relationships under Item 404(a). A press release announcing the appointment was furnished as Exhibit 99.1.
CapsoVision, Inc. reported that Rebecca Petersen plans to retire as Senior Director of Clinical Affairs effective October 15, 2025, and that Keri Jorgenson has been promoted to Director of Clinical Operations to take over responsibility for clinical development operations with the existing team. The company states it does not anticipate any disruption to its clinical development work during this transition. To support a smooth handover, Ms. Petersen will provide consulting services starting October 16, 2025 under an hourly arrangement of $150 per hour, with either party able to terminate the agreement on three days’ notice, and her unvested stock options will continue to vest according to their current schedule.
CapsoVision, Inc. reported that Chief Financial Officer Kevin Lundquist stepped down from his role effective August 27, 2025. The company has started a search for a new CFO.
Under a separation agreement, Mr. Lundquist will receive six months of base salary, a prorated annual bonus of $33,333.33, accelerated vesting of options to acquire 86,806 shares of common stock (exercisable until September 1, 2028), and continued healthcare coverage under COBRA. He has also agreed to provide consulting and transition support for up to six months, through February 28, 2026, under a separate consulting agreement.
CapsoVision, Inc. filed a current report to note that it issued a press release on August 14, 2025 announcing its financial results for the fiscal quarter ended June 30, 2025. The company is using this filing to formally furnish that earnings press release as Exhibit 99.1.
The earnings information in the press release is furnished rather than filed, which means it is not automatically incorporated into other securities law filings unless specifically referenced later. The report also identifies the company’s common stock as trading on The Nasdaq Stock Market LLC under the symbol CV.