CapsoVision Reports Third Quarter 2026 Financial Results

Rhea-AI Summary

CapsoVision (NASDAQ: CV) reported third-quarter 2026 revenue of $3.568 million, up from $3.538 million a year earlier, alongside a narrower net loss. Net loss was $7.339 million, or $0.15 per share, versus $7.921 million, or $0.17 per share. Gross margin fell to 49% from 54%, while operating expenses declined to $9.148 million from $9.933 million.

AI Highlights received FDA clearance September 25 and launched in the U.S. November 2; the company expects its full commercial impact in 2027. CapsoCam Colon enrollment and clinical data collection are complete, with FDA submission targeted for year-end 2026. September's $18 million registered direct offering generated approximately $17.8 million net. Cash totaled $21.757 million September 30. Nine-month operating cash use increased to $21.511 million from $15.178 million, and net loss widened to $21.853 million from $17.921 million.

13 points · 1 major

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0 major · 8 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointSeptember's $18 million registered direct offering generated approximately $17.8 million in net proceeds. 5.4% of market cap
• Moderate pointAI Highlights received FDA clearance September 25, 2026; U.S. commercial launch followed November 2.
• Moderate point. Forward-looking: it has not happened yet and may not happen.CapsoVision expects AI Highlights to accelerate CapsoCam Plus sales growth, with full commercial impact anticipated in 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.CapsoCam Colon completed enrollment and clinical data collection; FDA 510(k) submission remains targeted for year-end 2026.
• Moderate point. Forward-looking: it has not happened yet and may not happen.CapsoCam UGI expansion discussions cover more than a dozen larger medical centers; CapsoVision expects faster enrollment.

8 minor points

• Minor pointThird-quarter revenue increased to $3.568 million from $3.538 million in 2025.
• Minor pointThird-quarter net loss narrowed to $7.339 million, or $0.15 per share, from $7.921 million, or $0.17.
• Minor pointThird-quarter operating expenses declined to $9.148 million from $9.933 million in 2025.
• Minor point. Forward-looking: it has not happened yet and may not happen.CapsoVision expects related clinical expenses to decline following completion of the colon study.
• Minor pointCapsoCam UGI added a third-site clinical trial agreement, alongside two active community-based sites.
• Minor pointThird-quarter at-the-market sales generated approximately $1.7 million in net proceeds.
• Minor pointCash increased to $21.757 million at September 30, 2026, from $10.112 million at December 31, 2025.
• Minor pointNine-month revenue increased to $10.003 million from $9.636 million in 2025.

Negative

• Moderate pointThird-quarter gross margin fell to 49% from 54%, reflecting higher material costs, inventory obsolescence and stock-based compensation.
• Moderate pointNine-month net loss widened to $21.853 million from $17.921 million; per-share loss narrowed to $0.44 from $1.05.
• Moderate pointNine-month operating cash use increased to $21.511 million from $15.178 million in 2025.
• Moderate pointNine-month operating expenses increased to $27.021 million from $23.271 million in 2025.
• Moderate pointCommon shares outstanding increased to 53,569,896 at September 30, 2026, from 46,865,051 at December 31, 2025.

3 minor points

• Minor pointThird-quarter gross profit declined to $1.764 million from $1.914 million in 2025.
• Minor pointNine-month gross profit declined to $4.964 million from $5.219 million in 2025.
• Minor pointThird-quarter at-the-market issuance of 276,446 shares diluted existing holders.

News Explained

In the third quarter, CapsoVision sold 276,446 shares through its ATM for approximately $1.7 million net; common shares outstanding were 53,569,896 at September 30, 2026, versus 46,865,051 at December 31, 2025, and issuing additional shares reduces existing holders’ percentage ownership.

Key Figures

Revenue: $3.568 million vs. $3.538 million Gross margin: 49% vs. 54% Net loss: $7.339 million vs. $7.921 million +5 more

Revenue

$3.568 million vs. $3.538 million

Q3 2026 vs. Q3 2025

Gross margin

49% vs. 54%

Q3 2026 vs. Q3 2025

Net loss

$7.339 million vs. $7.921 million

Q3 2026 vs. Q3 2025

Cash and cash equivalents

$21.8 million

As of September 30, 2026

Registered direct offering

$18 million

Completed in September 2026

Offering net proceeds

Approximately $17.8 million

September 2026 registered direct offering

CapsoCam Plus patients

More than 184,000

Worldwide as of September 30, 2026

510(k) submission

Year-end 2026

Company says submission remains on track

Previous Earnings Reports

2 past events · Latest: Aug 13

Same Type 2 events

1. Aug 13

   Q2 earnings

   24h Move

   -4.9%

   Revenue grew, but gross margin declined and operating expenses and net loss remained elevated.

2. Nov 13

   Q3 earnings

   24h Move

   -9.7%

   Revenue rose 19% and gross profit increased, while operating expenses also rose.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

capsule endoscopy, 510(k), pancreatic ductal adenocarcinoma, registered direct offering, +1 more

5 terms

capsule endoscopy medical

"developing advanced imaging and AI-enabled capsule endoscopy solutions"

A capsule endoscopy is a diagnostic procedure in which a person swallows a pill-sized device that contains a tiny camera, light and transmitter; it wirelessly records images as it travels through the digestive tract. Investors care because the technology can replace or complement traditional, more invasive tests — affecting demand, device sales, recurring consumable revenue, regulatory approval paths and insurance coverage, all of which influence a medical company’s growth and profitability.

510(k) regulatory

"FDA 510(k) submission remains on track for year-end 2026."

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

pancreatic ductal adenocarcinoma medical

"medical centers with expertise in pancreatic ductal adenocarcinoma (PDAC)"

A fast-growing cancer that starts in the cells lining the pancreas’ small ducts; it is the most common and aggressive form of pancreatic cancer. It matters to investors because its severity and limited treatment options drive high unmet medical need, large potential markets for effective drugs or diagnostics, and strong sensitivity of company valuations to clinical trial results, regulatory approvals, or changes in treatment guidelines—similar to how fixing a main leak can prevent major damage in a building.

registered direct offering financial

"Completed an $18 million registered direct offering with existing shareholders"

A registered direct offering is a way for a company to sell new shares of its stock directly to select investors with regulatory approval. This method allows the company to raise funds quickly and efficiently without needing a public auction, similar to offering exclusive access to a limited number of buyers. For investors, it often provides an opportunity to purchase shares at a favorable price, while giving the company immediate access to capital.

at-the-market offering financial

"through the at-the-market offering program during the third quarter of 2026"

An at-the-market offering is a method companies use to sell new shares of stock directly into the open market over time, rather than all at once. This allows them to raise money gradually, similar to selling small pieces of a product instead of a large batch. For investors, it means the company can access funding more flexibly, but it may also increase the supply of shares and influence the stock’s price.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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SARATOGA, Calif., Nov. 12, 2026 (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 and provided a business update for its third quarter ended September 30, 2026.

Recent Highlights

• Reported third quarter 2026 revenue of $3.6 million, compared with $3.5 million in the third quarter 2025.
• CapsoCam Plus® used by more than 184,000 patients worldwide as of September 30, 2026, compared with 151,000 a year earlier.
• Received FDA clearance for AI Highlights™, the Company’s AI-assisted reading tool for CapsoCam Plus®, on September 25, 2026, followed by its U.S. commercial launch on November 2, 2026. Available for both adults and pediatric patients aged two and older, AI Highlights supports physician review through both local computer and cloud-based platforms. The Company expects the addition of AI Highlights to accelerate CapsoCam Plus sales growth, with the full commercial impact anticipated in 2027.
• Completed enrollment and clinical data collection for the second-generation CapsoCam Colon™ study, including physician review of capsule videos both with and without AI assistance. FDA 510(k) submission remains on track for year-end 2026.
• Continued expanding the clinical footprint of the CapsoCam UGI study for pancreatic cancer detection. Building on two active community-based clinical sites, the Company has executed a clinical trial agreement with a third site and is in various stages of contracting and feasibility discussions with more than a dozen larger medical centers with expertise in pancreatic ductal adenocarcinoma (PDAC), which the Company expects will help accelerate patient enrollment.
• Completed an $18 million registered direct offering with existing shareholders in September 2026, generating approximately $17.8 million in net proceeds.
• Raised approximately $1.7 million in net proceeds through the at-the-market offering program during the third quarter of 2026.
• Appointed David S. Shields, M.D., to the Board of Directors effective July 1, 2026.

Management Commentary

"The FDA clearance and subsequent U.S. launch of AI Highlights marks an important step forward for CapsoVision,” said Johnny Wang, President and Chief Executive Officer. “Our four-camera, 360-degree panoramic capsule already provides physicians with a differentiated view of the small bowel. By combining that imaging capability with AI-assisted review, we believe we can reduce reading time, improve detection accuracy compared with manual review, and give physicians an additional level of diagnostic confidence. We believe the combination of panoramic imaging and FDA-cleared AI-assisted review, approved for use in patients two years and older is a meaningful differentiator for CapsoCam Plus.

At the same time, completing enrollment in our colon clinical study brings us closer to our planned FDA submission by year end, which we believe represents a substantially larger market opportunity. With the support of our existing shareholders through our recent financing, we are focused on translating these milestones into broader adoption and long-term growth,” concluded Wang.

Third Quarter 2026 Financial Results

Total revenue was $3.6 million compared to $3.5 million in the third quarter of 2025. Average selling price was stable year over year. The Company expects the addition of AI Highlights, launched on November 2, 2026, following FDA clearance, to accelerate CapsoCam Plus sales growth, with the full commercial impact anticipated in 2027.

Gross profit was $1.8 million, compared with $1.9 million in the third quarter of 2025. Gross margin was 49%, compared to 54% in the third quarter of 2025. The decline primarily reflected higher material costs associated with increased flash memory prices, a one-time inventory obsolescence charge, and higher stock-based compensation expense.

Operating expenses decreased to $9.1 million, from $9.9 million in the third quarter of 2025, reflecting continued expense management while supporting clinical and development programs, including the CapsoCam Colon pivotal study. With the study now complete, the Company expects related clinical expenses to decline while it continues advancing its development pipeline.

Net loss was $7.3 million, or $0.15 per share, compared with a net loss of $7.9 million, or $0.17 per share, in the third quarter of 2025.

Cash and cash equivalents totaled $21.8 million as of September 30, 2026. During September, the Company completed an $18 million registered direct offering with existing shareholders, generating approximately $17.8 million in net proceeds. The Company also sold 276,446 shares through its at-the-market offering program during the quarter for approximately $1.7 million in net proceeds.

Conference Call and Webcast

CapsoVision will host a conference call today, November 12, 2026, at 4:30 p.m. ET 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 2841803, 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 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 review. 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”, “positioned”, “on track”, “anticipate(s)”, “intend(s)”, “plan(s)”, “believe(s)”, “potential”, “will”, “should”, “could”, “would”, “may”, “continue”, “remain”, “advancing”, “approach(ing)”, “planned”, “look forward”, or “target(ed)” 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 sales growth of CapsoCam Plus® and the timing thereof, the Company’s expectations regarding clinical and other operating expenses, 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 the commercialization, physician adoption and anticipated benefits of AI Highlights™, the continued development and anticipated 510(k) submission for CapsoCam Colon™, and the market opportunity for CapsoCam Colon™, the clinical study for CapsoCam® UGI in pancreatic cancer detection) 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 (including competition in the capsule endoscopy market, including from competitors with FDA-cleared AI products), the Company’s financial condition and the availability of cash and financing (including through the Company’s at-the-market equity offering program), the success of the Company’s product and clinical development efforts, the failure to receive regulatory clearance or approval, changes in U.S. trade policies, tariffs or other government regulations that could increase the Company’s costs or affect the Company’s supply chain, 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 most recent Form 10-K and 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, 2026			December 31, 2025
ASSETS
Current Assets
Cash and cash equivalents	$	21,757		$	10,112
Accounts receivable, net		2,456			2,498
Inventory		4,747			2,987
Prepaid expenses and other current assets		2,086			1,072
Total current assets		31,046			16,669
Property and equipment, net		508			611
Operating lease right-of-use assets		747			843
Other long-term assets		451			41
TOTAL ASSETS	$	32,752		$	18,164
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable	$	1,102		$	1,143
Accrued expenses and other current liabilities		4,355			2,697
Deferred revenue		146			177
Operating lease liabilities – current		521			410
Total current liabilities		6,124			4,427
Operating lease liabilities – long-term		259			477
Total liabilities		6,383			4,904
Commitments and contingencies - Note 8

Stockholders’ Equity
Preferred stock, $0.001 par value: 10,000,000 shares authorized and none issued and outstanding as of September 30, 2026; 10,000,000 shares authorized and none issued and outstanding as of December 31, 2025		—				—
Common stock, $0.001 par value: 300,000,000 shares authorized as of September 30, 2026; 53,569,896 and 46,865,051 issued and outstanding as of September 30, 2026 and December 31, 2025, respectively		54				47
Additional paid-in capital		203,833				168,878
Accumulated deficit		(177,518	)			(155,665	)
Total stockholders’ equity		26,369				13,260
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	32,752			$	18,164

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,
		2026				2025				2026				2025
Net revenue	$	3,568			$	3,538			$	10,003			$	9,636
Costs of revenue		1,804				1,624				5,039				4,417
Gross profit		1,764				1,914				4,964				5,219
OPERATING EXPENSES
Selling and marketing		2,060				1,773				6,087				5,581
Research and development		4,803				6,090				14,547				12,589
General and administrative		2,285				2,070				6,387				5,101
Total operating expenses		9,148				9,933				27,021				23,271
Operating loss		(7,384	)			(8,019	)			(22,057	)			(18,052	)
NON-OPERATING INCOME
Interest income, net		46				132				187				175
Other non-operating income (expense), net		(1	)			(34	)			17				(44	)
Total non-operating income, net		45				98				204				131
Loss before income taxes		(7,339	)			(7,921	)			(21,853	)			(17,921	)
Provision for income taxes		—				—				—				—
Net loss and comprehensive loss	$	(7,339	)		$	(7,921	)		$	(21,853	)		$	(17,921	)
Net loss per share – basic and diluted	$	(0.15	)		$	(0.17	)		$	(0.44	)		$	(1.05	)
Weighted average common shares outstanding – basic and diluted		50,568,141				46,217,127				49,332,254				17,049,671

CAPSOVISION, INC. CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) (in thousands)
	Nine Months Ended September 30,
		2026				2025
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(21,853	)		$	(17,921	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		173				161
Loss on disposal of property and equipment		—				1
Amortization of operating lease right-of-use assets		307				260
Unrealized foreign exchange losses (gains)		57				(170	)
Stock in lieu of debt repayment		—				31
Stock-based compensation		1,863				629
Bad debt expense		10				11
Changes in operating assets and liabilities:
Accounts receivable		10				151
Inventory		(1,760	)			(558	)
Prepaid expenses and other current assets		(1,014	)			(303	)
Other long-term assets		(410	)			—
Accounts payable		(203	)			596
Accrued expenses and other current liabilities		1,658				2,220
Deferred revenue		(31	)			(26	)
Operating lease liabilities		(318	)			(260	)
Net cash used in operating activities	$	(21,511	)		$	(15,178	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment		(70	)			(82	)
Net cash used in investing activities	$	(70	)		$	(82	)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from IPO, net of commissions		—				26,557
Payment of IPO offering costs		—				(3,184	)
Repayment of promissory note		—				(1,000	)
Proceeds from Private Placement		14,000				—
Payment of Private Placement issuance costs		(601	)			—
Proceeds from ATM Program, net of issuance costs		1,710				—
Proceeds from Securities Purchase Agreement		18,000				—
Payment of constructive dividend		(12	)			—
Proceeds from promissory note issuance		—				1,000
Proceeds from exercises of options on common stock and warrants		164				216
Net cash provided by financing activities	$	33,261			$	23,589
Net increase in cash and cash equivalents		11,680				8,329
Effect of exchange rate changes on cash and cash equivalents		(35	)			139
Cash and cash equivalents at beginning of period		10,112				9,319
Cash and cash equivalents at end of period	$	21,757			$	17,787
SUPPLEMENTAL CASH FLOW DISCLOSURES
Cash paid for income taxes	$	10			$	7
Cash paid for interest		—				15
NON-CASH FINANCING AND INVESTING ACTIVITIES
Obtaining a right-of-use asset in exchange for a lease liability		211				—
Underwriters warrants issued in connection with the IPO		—				519
Conversion of convertible preferred stock into common stock upon initial public offering		—				143,625
Securities Purchase Agreement issuance costs in accounts payable		162				—

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were CapsoVision's third-quarter 2026 earnings results?

CapsoVision reported revenue of $3.568 million and a net loss of $7.339 million, or $0.15 per share. A year earlier, revenue was $3.538 million and net loss was $7.921 million, or $0.17 per share.

When does CapsoVision plan to submit CapsoCam Colon to the FDA?

CapsoVision's FDA 510(k) submission for second-generation CapsoCam Colon remains targeted for year-end 2026. Enrollment and clinical data collection are complete, including physician review of capsule videos with and without AI assistance.

Which patients can use CapsoVision's FDA-cleared AI Highlights?

AI Highlights is available for adults and pediatric patients aged two and older. The AI-assisted reading tool supports physician review of CapsoCam Plus through local computer and cloud-based platforms.