CapsoVision Reports Third Quarter 2025 Financial Results

Rhea-AI Summary

CapsoVision (NASDAQ: CV) reported third quarter 2025 results for the period ended September 30, 2025. Q3 revenue was $3.5 million, a 19% increase year‑over‑year, driven by higher CapsoCam Plus capsule sales and new accounts up 31%. Gross profit rose to $1.9 million (up $0.3 million; 54% gross margin). Operating expenses increased to $9.9 million, reflecting R&D with Canon, higher G&A costs and public‑company expenses. Cash and cash equivalents totaled $17.8 million; the company completed an IPO in July 2025 with $23.4 million net proceeds. The company filed for Breakthrough Device Designation for an early pancreatic cancer capsule and began enrollment for a new colon‑capsule study.

Positive

• Revenue +19% in Q3 2025 to $3.5 million
• New accounts +31% year‑over‑year in Q3 2025
• Gross profit +$0.3 million (16%) to $1.9 million
• IPO net proceeds of $23.4 million completed July 2025

Negative

• Operating expenses increased by $2.5 million to $9.9 million
• Cash and cash equivalents were $17.8 million as of Sept 30, 2025

Insights

Healthcare and Financial Analyst

Revenue growth, strategic partnerships, FDA breakthrough request, and IPO proceeds strengthen the company’s commercial and development runway.

CapsoVision shows clear commercial traction with third quarter revenue of $3.5 million, a 19% increase year‑over‑year and over 151,000 patients having used CapsoCam Plus® as of September 30, 2025. Gross profit rose to $1.9 million with a 54% gross margin, indicating continued product-level economics while sales volume appears to be the primary growth driver.

Development and regulatory activities now form the company’s near-term value drivers: the submission for Breakthrough Device Designation for early-stage pancreatic cancer detection and the agreement with Canon Inc. to develop higher-resolution CMOS sensors both target meaningful product improvements. Operating expenses increased to $9.9 million, driven by R&D for the Canon development, higher G&A costs and public company professional fees; cash and cash equivalents were $17.8 million at quarter-end supplemented by net IPO proceeds of $23.4 million, which together provide a clearer funding runway for the near term.

Key dependencies and risks include successful regulatory advances (the Breakthrough request and subsequent FDA interactions) and the technical outcomes from the Canon sensor program; both are cited as underway but not concluded. Monitor the status of the Breakthrough designation, FDA regulatory timelines now targeted for completion by the end of 2025 for the AI analytics submission, and clinical enrollment progress for the colon-capsule study as concrete milestones that will materially update the company’s development outlook within the next 6–12 months.

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® 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® 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®, 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
Être 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)
	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				—

FAQ

What were CapsoVision (CV) Q3 2025 revenue and growth rates?

CapsoVision reported Q3 2025 revenue of $3.5 million, a 19% increase versus Q3 2024.

How did CapsoVision's profitability change in Q3 2025 (CV)?

Gross profit rose to $1.9 million (up $0.3 million); gross margin was 54% in Q3 2025.

What drove the operating expense increase for CapsoVision (CV) in Q3 2025?

Operating expenses rose to $9.9 million, driven by CMOS development with Canon and higher G&A and public‑company costs.

How much cash did CapsoVision (CV) have after its July 2025 IPO?

CapsoVision held $17.8 million in cash and equivalents as of Sept 30, 2025 and received $23.4 million net IPO proceeds in July 2025.

What regulatory and clinical milestones did CapsoVision (CV) disclose on Nov 13, 2025?

The company submitted an application seeking Breakthrough Device Designation for an early pancreatic cancer capsule and began enrollment for a new colon‑capsule study.