(NASDAQ:CV),
SARATOGA, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) — CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today reported financial results for its third quarter ended September 30, 2025.
Recent Highlights
- Third quarter 2025 revenue was $3.5 million, a 19% increase over the third quarter of 2024.
- New accounts grew 31% in the third quarter of 2025 over the comparable quarter in 2024.
- CapsoCam Plus(R) used by over 151,000 patients as of September 30, 2025.
- Submitted an application to the FDA requesting Breakthrough Device Designation to accelerate development of the Company's endoscopy capsule for use in early-stage pancreatic cancer detection.
- Entered into an agreement with Canon Inc. to develop higher-resolution CMOS image sensors with enhanced dynamic range for future capsule endoscopes.
- Appointed David Garcia as Senior Vice President of Finance, effective November 3, 2025.
Management Commentary
“We delivered a strong third quarter, driven by robust uptake of our CapsoCam Plus(R) endoscopy capsule for small-bowel and growing physician-and-clinic engagement. At the same time, our recent submission for Breakthrough Device Designation to pursue use of our endoscopy capsule for early-stage pancreatic cancer detection underscores our commitment to delivering a solution for this highly unmet need. We are equally energized by our progress on the artificial-intelligence front — developing our next-generation analytics engine for capsule endoscopy and preparing for regulatory submission by the end of 2025 once the FDA resumes normal operations following the government shutdown. In addition, while our colon-capsule program continues to advance in close collaboration with the FDA, positioning us to expand into another important new indication, we have commenced enrollment of a clinical study in support of our new generation colon-capsule” said Johnny Wang, President and Chief Executive Officer. “We are also delighted to welcome David Garcia to the CapsoVision team as our new SVP of Finance. I am confident that his broad experience in financial oversight and capital markets engagement will provide us with the added leadership needed to pursue our vision of delivering the next generation of gastrointestinal screening and diagnostics.”
Third Quarter 2025 Financial Results
Total revenue was $3.5 million, a 19% increase over the third quarter of 2024. The primary growth driver was an increase in the number of CapsoCam Plus capsules sold.
Gross profit was $1.9 million, an increase of $0.3 million, or 16%, compared to the third quarter of 2024. Gross margin was 54%, compared to 56% in the third quarter of 2024.
Operating expenses were $9.9 million, a $2.5 million increase from the third quarter of 2024, driven primarily by an increase in expenses associated with the development of the new CMOS under the development agreement with Canon Inc. and an increase in general and administrative expenses due to higher payroll and benefits expenses and stock-based compensation expenses associated with the executive officer departure and higher professional services expenses, including audit, legal and consulting fees, as we were operating as public company.
Cash and cash equivalents totaled $17.8 million as of September 30, 2025.
The Company completed an initial public offering in July 2025. Net proceeds totaled $23.4 million, after deducting underwriting discounts, commissions and offering expenses.
Conference Call and Webcast
CapsoVision will host a conference call today, November 13, 2025 at 4:30 p.m. Eastern Time to discuss its third quarter financial results. Individuals interested in listening to the conference call may do so by dialing (800) 715-9871 for domestic callers or (646) 307-1963 for international callers and referencing conference ID 2181260, or from the webcast link on the Events page in the investor relations section of the company's website at www.capsovision.com.
To access the replay, please register via the webcast link on the Events page. The webcast will be available for one year following the completion of the call.
About CapsoVision
CapsoVision is a commercial-stage medical technology company focused on developing advanced imaging and AI-enabled solutions to transform the detection and diagnosis of gastrointestinal diseases. Its flagship product, CapsoCam Plus(R), 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”, “will”, “should”, “could”, “would” or “may” and other words of similar meaning. Examples of these forward-looking statements include, but are not limited to, 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
Etre Communications
leslies@etrecommunications.com | (804) 240-0807
pauls@etrecommunications.com | (804) 503-9231
| CAPSOVISION, INC. CONDENSED BALANCE SHEETS (UNAUDITED) (in thousands, except par value and share amounts) |
|||||||
| September 30, 2025 | December 31, 2024 | ||||||
| ASSETS | |||||||
| Current Assets | |||||||
| Cash and cash equivalents | $ | 17,787 | $ | 9,319 | |||
| Accounts receivable, net | 1,870 | 2,001 | |||||
| Inventory | 3,187 | 2,629 | |||||
| Prepaid expenses and other current assets | 1,201 | 898 | |||||
| Total current assets | 24,045 | 14,847 | |||||
| Property and equipment, net | 640 | 720 | |||||
| Operating lease right-of-use assets | 935 | 1,195 | |||||
| Other long-term assets | 41 | 41 | |||||
| TOTAL ASSETS | $ | 25,661 | $ | 16,803 | |||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT) | |||||||
| Current Liabilities | |||||||
| Accounts payable | $ | 1,345 | $ | 749 | |||
| Accrued expenses and other current liabilities | 2,790 | 569 | |||||
| Deferred revenue | 106 | 132 | |||||
| Note payable, current | — | — | |||||
| Operating lease liabilities – current | 394 | 351 | |||||
| Total current liabilities | 4,635 | 1,801 | |||||
| Operating lease liabilities – long-term | 584 | 887 | |||||
| Total liabilities | 5,219 | 2,688 | |||||
| Commitments and contingencies – Note 9 | |||||||
| Convertible Preferred Stock (each Series: $0.001 par value) | |||||||
| Series A, B, C, C-1, D, D-1, D-2, E, F-1, F-2, G, G-1, H: none and 153,682,280 shares authorized, none and 38,665,583 issued and outstanding, and liquidation preference of none and $152,378 as of September 30, 2025 and December 31, 2024, respectively | — | 143,625 | |||||
| Total convertible preferred stock | — | 143,625 | |||||
| Stockholders' Equity | |||||||
| Common stock, $0.001 par value: 300,000,000 and 190,000,000 shares authorized; 46,798,901 and 2,090,945 issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | 47 | 2 | |||||
| Additional paid-in capital | 168,710 | 838 | |||||
| Accumulated deficit | (148,271 | ) | (130,350 | ) | |||
| Total stockholders' equity (deficit) | 20,486 | (129,510 | ) | ||||
| TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT) | $ | 25,661 | $ | 16,803 | |||
| CAPSOVISION, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (in thousands, except share and per-share amounts) |
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| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Net revenue | $ | 3,538 | $ | 2,966 | $ | 9,636 | $ | 8,304 | |||||||
| Costs of revenue | 1,624 | 1,309 | 4,417 | $ | 3,661 | ||||||||||
| Gross profit | 1,914 | 1,657 | 5,219 | 4,643 | |||||||||||
| OPERATING EXPENSES | |||||||||||||||
| Selling and marketing | 1,773 | 1,745 | 5,581 | 5,168 | |||||||||||
| Research and development | 6,090 | 4,522 | 12,589 | 12,004 | |||||||||||
| General and administrative | 2,070 | 1,193 | 5,101 | 2,754 | |||||||||||
| Total operating expenses | 9,933 | 7,460 | 23,271 | 19,926 | |||||||||||
| Operating loss | (8,019 | ) | (5,803 | ) | (18,052 | ) | (15,283 | ) | |||||||
| NON-OPERATING INCOME | |||||||||||||||
| Interest income, net | 132 | 8 | 175 | 22 | |||||||||||
| Other non-operating income/(expense), net | (34 | ) | 1 | (44 | ) | 2 | |||||||||
| Total non-operating income, net | 98 | 9 | 131 | 24 | |||||||||||
| Loss before income taxes | (7,921 | ) | (5,794 | ) | (17,921 | ) | (15,259 | ) | |||||||
| Provision for income taxes | — | — | — | — | |||||||||||
| Net loss and comprehensive loss | $ | (7,921 | ) | $ | (5,794 | ) | $ | (17,921 | ) | $ | (15,259 | ) | |||
| Net loss per share – basic and diluted | $ | (0.17 | ) | $ | (2.79 | ) | $ | (1.05 | ) | $ | (7.65 | ) | |||
| Weighted average common shares outstanding – basic and diluted | 46,217,127 | 2,076,979 | 17,049,671 | 1,993,934 | |||||||||||
| CAPSOVISION, INC. CONDENSED STATEMENTS OF CASH FLOWS(UNAUDITED) (in thousands) |
|||||||
| Nine months ended September 30, | |||||||
| 2025 | 2024 | ||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | |||||||
| Net loss | $ | (17,921 | ) | $ | (15,259 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Depreciation and amortization | 161 | 155 | |||||
| Loss on disposal of property and equipment | 1 | — | |||||
| Amortization of operating lease right-of-use assets | 260 | 234 | |||||
| Unrealized foreign exchange gains | (170 | ) | (18 | ) | |||
| Stock in lieu of debt repayment | 31 | — | |||||
| Stock-based compensation | 629 | 43 | |||||
| Bad debt expense | 11 | 1 | |||||
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable | 151 | 238 | |||||
| Inventory | (558 | ) | (596 | ) | |||
| Prepaid expenses and other current assets | (303 | ) | 7 | ||||
| Other long-term assets | — | (2 | ) | ||||
| Accounts payable | 596 | 226 | |||||
| Accrued expenses and other current liabilities | 2,220 | 481 | |||||
| Deferred revenue | (26 | ) | (3 | ) | |||
| Operating lease liabilities | (260 | ) | (199 | ) | |||
| Net cash used in operating activities | $ | (15,178 | ) | $ | (14,692 | ) | |
| CASH FLOWS FROM INVESTING ACTIVITIES | |||||||
| Purchases of property and equipment | (82 | ) | (153 | ) | |||
| Net cash used in investing activities | $ | (82 | ) | $ | (153 | ) | |
| CASH FLOWS FROM FINANCING ACTIVITIES | |||||||
| Proceeds from issuance of Series H convertible preferred stock | — | 10,000 | |||||
| Proceeds from IPO, net of commissions | 26,557 | — | |||||
| Payment of deferred IPO offering costs | (3,184 | ) | — | ||||
| Proceeds from promissory note issuance | 1,000 | — | |||||
| Repayment of promissory note | (1,000 | ) | — | ||||
| Proceeds from exercises of options on common stock and warrants | 216 | 73 | |||||
| Net cash provided by financing activities | $ | 23,589 | $ | 10,073 | |||
| Net increase (decrease) in cash and cash equivalents | 8,329 | (4,772 | ) | ||||
| Effect of exchange rate changes on cash and cash equivalents | 139 | 12 | |||||
| Cash and cash equivalents at beginning of period | 9,319 | 14,559 | |||||
| Cash and cash equivalents at end of period | $ | 17,787 | $ | 9,799 | |||
| SUPPLEMENTAL CASH FLOW DISCLOSURES | |||||||
| Cash paid for income taxes | $ | 7 | $ | 6 | |||
| Cash paid for interest | 15 | — | |||||
| NON-CASH FINANCING AND INVESTING ACTIVITIES | |||||||
| Underwriters warrants issued in connection with the IPO | $ | 519 | — | ||||
| Conversion of convertible preferred stock into common stock upon initial public offering | $ | 143,625 | — | ||||
