We are a commercial-stage medical technology company that develops advanced imaging and artificial intelligence (“AI”) technologies that are deployed in our capsule endoscopy solutions to identify abnormalities of the gastrointestinal (“GI”) tract for diagnostic and screening purposes. We developed our first capsule endoscope system, currently comprising the CapsoCam Plus single-usecapsule and the CapsoCloud and CapsoView software, to panoramically visualize the small-bowel mucosa to investigate abnormalities such as obscure GI bleeding and Crohn’s disease. The capsule acquires and stores video images in onboard memory while moving through the GI tract, and the software component allows healthcare providers to view the video retrieved from the capsule—either by streaming it from the cloud, where it is securely stored, to anywhere, at their convenience, using our CapsoCloud software, or downloading it from the capsule themselves and reviewing it in our CapsoView software. The CapsoCam is a wire-free capsule endoscopy solution, eliminating patient-worn data recorders and providing clinicians a zero-capex, maintenance-free, flexible, and scalable workflow. The CapsoCam Plus is classified as a Class II device and has received FDA marketing authorization through the 510(k)-clearance process. We are (i) in the process of updating CapsoCam Plus to add our self-developed AI assisted reading technology and (ii) targeting related FDA 510(k) and EU submissions in the second half of 2025 and clearance of the updated capsule by the end of 2025, with commercialization shortly thereafter. Our AI assisted reading tools detect and highlight suspected abnormalities for a clinician, reducing their time to review the video and making capsule endoscopy more financially attractive to their practice. Our 510(k) submission and FDA review thereof may be delayed and we may not receive 510(k) clearance from the FDA on a timely basis or at all. We began sales of our small-bowel capsule system to our provider customers (i.e., primarily gastroenterologists practicing in clinics and/or hospitals) both internationally (in 2012) and in the U.S. (in 2017) through our global sales and marketing team. In the U.S., we sell to customers directly. Internationally, we sell both directly and through qualified exclusive distributors in specified regions. Our largest international markets (based on shipping destination) are France, Germany, and Canada. In 2023, we established a direct sales team in Germany to better serve our customers and strengthen our market presence in this key market. We plan to (i) further grow our existing sales and marketing team to increase small-bowel-related sales and (ii) leverage our existing sales and marketing team to sell future product additions to our GI-tract capsule endoscopy solution. Our revenue has increased in each year since we began U.S. direct sales in 2020. Our revenues for the years ended December 31, 2023 and 2024 totaled approximately $9.8 million and $11.8 million, respectively, representing a year-over-year growth of approximately 21%. Our revenues for the three months ended March 31, 2024 and 2025 totaled approximately $2.5 million and $2.8 million, respectively, representing a year-over-year growth of approximately 12%. The primary driver for our revenue growth was an increase in the number of CapsoCam Plus capsules sold: an increase of 19% from 2023 to 2024 and 11% from the three month period ended March 31, 2024 to the three month period ended March 31, 2025, with an increase in unit sales of 26% in the U.S. and 4% internationally from 2023 to 2024 and 10% in the U.S. and 13% internationally from the three month period ended March 31, 2024 to the three month period ended March 31, 2025. In 2023 and 2024, international sales accounted for 26% and 23% of total revenue. In the three-month periods ended March 31, 2024 and 2025, international sales accounted for 23% of total revenue. As of March 31, 2025, our small bowel capsule has been used in more than 135,000 patients worldwide and for 2024 our customer retention rate was approximately 90%. All of our revenues to date have been, and in the near-term will continue to be, generated from CapsoCam Plus related sales for the small bowel; and our ability to grow our small-bowel-related revenue is subject to our ability to successfully and timely execute related elements of our revenue growth strategy, including being able to compete effectively against our competitors (including those with an existing FDA-cleared product and that have established a market presence). To expand beyond small-bowel-related sales, we are developing our next pipeline capsule endoscope product, CapsoCam Colon. Our CapsoCam Colon capsule (i) leverages CapsoCam Plus’s existing capsule design with its panoramic view and (ii) incorporates both our self-developed AI to automatically detect polyps in the video and our polyp-size measurement tool enabled by a 3D sensor in the capsule (polyp size being highly correlated with a polyp’s risk of becoming cancer). Based on our current regulatory development plan, we are targeting CapsoCam Colon revenues beginning, in the U.S., in the second half of 2026 after receiving FDA 510(k) clearance, and in the EU, in early 2027 after receiving a CE Mark, of our second generation of CapsoCam Colon system, designed with a larger field of view and better image quality to improve accuracy, and which would be classified as a Class II device. We recently submitted our 510(k) for the first generation of our CapsoCam Colon. FDA review of our 510(k) submissions may be delayed and we may not receive 510(k) clearances from the FDA on a timely basis or at all. Longer term, we believe our CapsoCam family of products, incorporating our panoramic imaging solution, can be adapted to address new GI medical indications. Potential new medical indications include esophageal medical conditions (such as esophageal varices and Barrett’s esophagus) and pancreatic cancer. We plan to commence feasibility studies of CapsoCam’s accuracy in (i) screening esophageal varices (i.e. enlarged blood veins in the esophagus) in cirrhotic patients with portal hypertension in the second half of 2025 and (ii) detecting abnormalities indicative of cancerous and precancerous pancreatic neoplasia (abnormal cell growth) in the first half of 2026, in each case, subject to timely availability of sufficient funding and liquidity and/or potential adjustment of our clinical development priorities. Our ability to pursue our growth strategies is subject to our ability to timely and successfully meet our cash and liquidity needs (through this offering, cash generated from operations and the issuance of additional equity securities or borrowings). These efforts may be adversely impacted by our history of operating losses, accumulated deficit, and substantial doubt about our ability to continue as a going concern qualification as stated in the footnotes to our financial statements. We were incorporated under the laws of the State of Delaware on August 1, 2005, under the name “Capso Vision, Inc.” and changed our name to CapsoVision, Inc. on May 31, 2016. Our principal executive office is located in Saratoga, CA.
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- CapsoVision is the camera pill version of Medtronic's digestive diagnostics.
- CapsoVision is like a doctor-prescribed GoPro for your intestines, designed for medical diagnosis.
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- CapsoCam Plus: A capsule endoscope system used for visualizing the small bowel.
- CapsoView: Proprietary software designed to review and analyze the images captured by the CapsoCam Plus capsule.
- CapsoRetrieve: A magnetic retriever used to non-invasively retrieve the CapsoCam Plus capsule from the colon.
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CapsoVision (symbol: CV) primarily sells its capsule endoscopy systems, such as the CapsoCam SV3, to healthcare providers and medical institutions. Therefore, its business model is primarily business-to-business (B2B).
While CapsoVision does not publicly disclose specific names of individual major customer companies that account for a disproportionate share of its revenue, its customer base generally consists of various entities within the healthcare sector that purchase and utilize medical diagnostic equipment for patient care. These typically include:
- Hospitals and Hospital Systems: Large medical facilities, often part of broader networks, that incorporate advanced diagnostic tools into their gastroenterology departments. Examples of large public hospital systems in the U.S. that could potentially be customers (though not explicitly named by CapsoVision as such) include HCA Healthcare (HCA), Universal Health Services (UHS), and Tenet Healthcare (THC). However, CapsoVision does not name these specific systems as direct major customers.
- Gastroenterology Clinics and Private Practices: Specialized medical practices focused on diagnosing and treating digestive system disorders are key purchasers and users of capsule endoscopy technology. These are often smaller, privately owned entities.
- Ambulatory Surgery Centers (ASCs) and Diagnostic Centers: Outpatient facilities that perform a range of diagnostic and minor surgical procedures, where capsule endoscopy can be utilized.
In summary, CapsoVision's major customers are a broad array of healthcare institutions and providers rather than a few specific, publicly named corporate entities.
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Kang-Huai (Johnny) Wang, President and Chief Executive Officer
Mr. Wang is a co-founder of CapsoVision and has served as President and Chief Executive Officer since November 2024. He previously held the roles of President and Chief Technology Officer from October 2006 to October 2024. Prior to co-founding CapsoVision, Mr. Wang was the Vice President of Engineering for ESS Technology, and co-founder and Chief Executive Officer of Divio, Inc., a video processing chip design company. He also served as Design Manager for C-Cube Microsystem and held various other engineering roles in the semiconductor industry.
David Michael Garcia, Senior Vice President of Finance and Principal Accounting Officer
Mr. Garcia was appointed Senior Vice President of Finance and Principal Accounting Officer, effective November 3, 2025. He brings over 20 years of financial leadership experience in corporate finance, capital markets, and strategic transactions. Before joining CapsoVision, Mr. Garcia served as Vice President of Financial Planning and Analysis at Matterport, Inc., where he played a key role in leading its initial public offering and supported a recent acquisition. His career also includes senior finance positions at View, Inc., Intelepeer Cloud Communications, and Align Technology, as well as earlier experience with Oracle and Deloitte.
Douglas Atkinson, Head of Global Sales
Mr. Atkinson joined CapsoVision as Head of Global Sales in October 2016. Prior to this, he was the Director of Sales for MedTech Micro-Fixation, a distributor of Zimmer-Biomet, from May 2015 to October 2016. From January 2005 to April 2015, he served as Regional Sales Director at Medtronic PLC. Mr. Atkinson also held positions as Regional Director of Sales and National Accounts at Stryker Corporation from May 1995 to December 2004, where he received multiple sales leadership and revenue growth awards.
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CapsoVision's main products and services are centered around capsule endoscopy solutions, primarily featuring the CapsoCam Plus single-use capsule and associated software like CapsoCloud and CapsoView. These technologies are designed for visualizing the small-bowel mucosa to detect abnormalities such as obscure gastrointestinal bleeding and Crohn's disease. The company also offers CapsoCam Colon for colon polyp detection and is developing CapsoColon 3D.
The addressable markets for CapsoVision's products and services are within the broader capsule endoscopy market and the larger gastrointestinal (GI) diagnostics market. The market sizes are as follows:
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Global Capsule Endoscopy Market:
- In 2024, the global capsule endoscopy market was estimated at approximately USD 443.8 million or USD 557.1 million or USD 569.41 million or USD 553.8 million.
- This market is projected to reach between USD 695.4 million by 2030 and USD 1.6 billion in 2032, with some projections suggesting it could reach USD 1217 million by 2030 or USD 1409.29 million by 2034.
- The Compound Annual Growth Rate (CAGR) for the global capsule endoscopy market is expected to range from 7.9% (2025-2030) to 18.6% (2025-2030).
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U.S. Capsule Endoscopy Market:
- The U.S. capsule endoscopy market was valued at USD 124.28 million in 2024 and is projected to reach approximately USD 272.33 million by 2034, with an expected CAGR of 8.16% from 2025 to 2034.
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Global Gastrointestinal (GI) Diagnostics Market:
- This broader market is projected to surpass USD 8.5 billion by 2030, growing at a CAGR of 4.58%.
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CapsoVision (CV) is anticipated to experience significant revenue growth over the next 2-3 years, driven by several key factors:
- Continued Growth and Expanded Indications for CapsoCam Plus: The company's flagship product, CapsoCam Plus, a wire-free capsule endoscopy platform for small bowel visualization, continues to demonstrate strong performance. Revenue for CapsoCam Plus increased by 17% year-over-year in Q2 2025, with new accounts growing by 75% in the same period. Analysts project small bowel revenue growth to be 19% in 2025, accelerating to 25% in 2026. Furthermore, label expansions in December 2024 to include pediatric patients as young as two and permit remote ingestions are expected to further accelerate its adoption.
- Launch and Commercialization of CapsoCam Colon: A major future revenue driver is the planned introduction of CapsoCam Colon, a non-invasive capsule for colon imaging and polyp detection. CapsoVision submitted a 510(k) notification to the FDA for this product in June 2025. Analysts anticipate FDA approval by the end of 2025, paving the way for a commercial launch in the second half of 2026. This product is poised to enter the substantial $10 billion colon screening market, with Roth Capital estimating significant revenue contributions starting from 2026.
- Integration and Advancement of AI Technology: CapsoVision is leveraging artificial intelligence (AI) to enhance its diagnostic solutions. The company expects a substantial boost from FDA 510(k) clearance for the integration of AI technology into CapsoCam Plus by the end of 2025. AI is projected to improve clinical outcomes, streamline workflow efficiency, and increase cost-effectiveness, thereby overcoming barriers to broader adoption of capsule endoscopy.
- Expansion into New Gastrointestinal Indications: The company's proprietary technology platform is designed for broader application across various gastrointestinal (GI) indications. CapsoVision plans to expand into new areas such as esophageal disorders and pancreatic cancer. Breakthrough designation for pancreatic imaging is anticipated later in 2025, with trials for both pancreatic and esophageal indications expected to commence by early 2026.
- International Market Expansion: CapsoVision is also focusing on growing its international presence. International sales for the small bowel market are forecast to grow by 28% year-over-year in 2025. Additionally, international sales for CapsoCam Colon are projected to begin in 2027, with significant growth expected in subsequent years.
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Share Issuance
- CapsoVision, Inc. completed its Initial Public Offering (IPO) on July 3, 2025, with shares beginning to trade on the Nasdaq Capital Market on July 2, 2025, under the ticker symbol "CV".
- The company offered 5,500,000 shares of common stock at a public offering price of $5.00 per share, resulting in gross proceeds of approximately $27.5 million.
- Net proceeds from the IPO totaled approximately $23.4 million, after deducting underwriting discounts, commissions, and offering expenses.
Inbound Investments
- Prior to its IPO, CapsoVision had raised a total of $118 million in funding over 14 rounds since October 2006.
- The company's Initial Public Offering in July 2025 raised gross proceeds of $27.5 million from public investors.
Capital Expenditures
- For the last 12 months ending November 4, 2025, CapsoVision reported capital expenditures of approximately -$74,000.
- The company's focus for development is on advanced imaging and AI technologies for its capsule endoscopy solutions, including updating CapsoCam Plus with AI-assisted reading technology and developing CapsoCam Colon for non-invasive colon imaging.
