CV

This article first appeared on GuruFocus. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. CapsoVision Inc (NASDAQ:CV) reported a 10% year-over-year revenue growth in Q2 2026, driven by a 13% increase in capsule shipments. The company achieved a significant milestone with the commercial launch of AI Highlights in the European Union and other international markets, enhancing its AI-enabled platform. CapsoVision Inc (NASDAQ:CV) continues to expand its customer base, securing renewals with major medical centers like University of Minnesota and Henry Ford, and becoming the top capsule used in Washington state hospitals. The company's pipeline is advancing, with the CapsuleCam Colon program expected to submit for FDA review in Q4 2026, and the pancreatic cancer detection study progressing as planned. CapsoVision Inc (NASDAQ:CV) has established an at-the-market equity offering program of up to $100 million, providing financial flexibility for future investments. The company expects second-half 2026 revenue to be higher than the first half, supported by continued commercial momentum and the anticipated US launch of AI Highlights. CapsoVision Inc (NASDAQ:CV) experienced a 3% decrease in average selling price due to competitive pricing pressure, impacting revenue growth. Gross margin declined to 51% from 55% in the prior year, primarily due to pricing pressure and higher customs and tariff expenses from US trade policy changes. Operating expenses increased significantly to $9.5 million from $6.5 million, driven by investments in clinical trials, product development, and public company costs. The FDA clearance for AI Highlights in the US has been delayed, with the company expecting clearance by the end of Q3 2026, but acknowledging that approval is beyond their control. The submission for the second-generation CapsuleCam and AI module has been shifted by a quarter due to the need for more positive subjects with significant polyps, based on FDA discussions. The company's cash position is relatively low at $9.1 million, and it may need to rely on the ATM program to fund ongoing operations and development. Warning! GuruFocus has detected 1 Warning Sign with CV. Is CV fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide more detail on the source of the pricing pressure and whether the tariff pressure is from inbound raw material costs or outbound sales?A: Dave Garcia, Senior Vice President of Finance: The pricing pressure comes from one particular competitor we go up against, which impacted us a bit in the quarter. The tariff pressure is inbound, affecting raw material costs, and we saw that impact in Q2 as well. Q: Given the pricing and tariff conditions, should we expect the fourth quarter to be stronger than the third quarter in the second half?A: Dave Garcia, Senior Vice President of Finance: Yes, that's correct. There is seasonality in this business, and the fourth quarter tends to be the strongest. Overall, the second half of the year should be much stronger than the first half. Johnny Wong, CEO, added that to maintain price and margin, they need to increase the value of their system, and launching AI in the U.S. should help with that. Q: What initial feedback have you captured since launching AI Highlights in the EU and international markets?A: Doug Atkinson, Senior Vice President of Sales: We're excited about the international launch, primarily in the EU. AI is a primary driver of capsule endoscopy adoption because it makes physicians more efficient, decreasing reading time and allowing them to perform more studies. The international launch gives us the opportunity to build real-world experience with the platform added to Capsule Cloud and Capsule View. We believe AI will help drive broader platform adoption, opening doors where competitors lack AI, benefiting us into Q3, Q4, and 2027. The key will be positioning AI in the U.S. with marketing in Q4. Q: For the Q4 submission of the second-generation CapsuleCam and AI module, what outstanding items need to be addressed before submitting? And is the current sales force of 26 reps and seven regional managers sufficient for the foreseeable future?A: Johnny Wong, CEO: Regarding the AI FDA clearance, the demographic analysis is something we are aware of and is the key thing we need to address based on FDA interaction. However, no one can guarantee FDA approval or clearance; it's beyond our control. Doug Atkinson, Senior Vice President of Sales: We will continue to grow the sales force and add territories where it makes sense. We have the luxury of one sales force selling multiple products for colon and small bowel diagnostics, so we can utilize our current feet on the street and management team while expanding over time. Q: Can you elaborate on the competitive pressure impacting pricing and how the company plans to mitigate it?A: Dave Garcia, Senior Vice President of Finance: The competitive pressure comes from one specific competitor, which impacted pricing in the quarter. Johnny Wong, CEO, added that to keep price and margin, they need to increase the value of their offering, and launching AI in the U.S. should help achieve that. Q: What is the status of the FDA review for AI Highlights, and when do you expect clearance?A: Johnny Wong, CEO: We submitted the 510K application for AI Highlights in December of last year. The FDA requested additional information regarding demographic representation in the clinical data set. We are working closely with the agency and expect to obtain FDA clearance by the end of the third quarter, with commercial launch shortly thereafter. Q: Can you provide an update on the CapsuleCam development program and the timing for FDA submission?A: Johnny Wong, CEO: Development continues to advance well, and we now expect to submit the second-generation CapsuleCam and AI module for FDA review during the fourth quarter of this year. The submission timing shifted by a quarter due to the need for more positive subjects with significant polyps based on discussions with FDA. Our strategy remains unchanged, and we believe taking the time to deliver a highly differentiated platform positions us for greater long-term commercial success. Q: What is the progress on the CAPSOK-UGI clinical study for pancreatic cancer detection?A: Johnny Wong, CEO: Enrollment continues as planned, and we remain very encouraged by the progress of the study. While still in early stages of clinical development, we believe it represents one of the most exciting long-term opportunities for our technology platform. Pancreatic cancer is challenging to detect early, and capsule endoscopy has the potential to become a valuable non-invasive diagnostic tool in this area. Q: Can you discuss the customer renewals and commercial momentum during the quarter?A: Dave Garcia, Senior Vice President of Finance: We secured important customer renewals, including University of Minnesota Medical Center, Henry Ford Medical Center, University of Colorado Medical Center, and Providence Swedish Medical Center, making CapsuleCam the number one capsule used in hospitals in Washington state. This highlights the value of the platform and the strength of our long-term customer relationships. Q: What is the company's cash position and financial flexibility going forward?A: Dave Garcia, Senior Vice President of Finance: We ended the second quarter with $9.1 million in cash and cash equivalents. During the first quarter, we raised $14 million in gross proceeds through a private placement. More recently, we established an at-the-market equity offering program of up to $100 million with Cantor Fitzgerald, providing additional financial flexibility to invest in our commercial organization, product development, and clinical programs. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

SARATOGA, Calif., Aug. 13, 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 second quarter ended June 30, 2026. Recent Highlights Reported second quarter 2026 revenue was $3.6 million, up 10% year over year. CapsoCam Plus® used by over 176,000 patients as of June 30, 2026. Launched AI Highlights™, the AI-assisted reading feature for CapsoCam Plus®, commercially in the European Union and other international markets to support physician review of small bowel capsule endoscopy studies using the CapsoCam Plus® system. Anticipate FDA clearance of AI Highlights™ by the end of the third quarter of 2026, with U.S. commercial launch expected shortly thereafter. Continued commercial momentum with expanding adoption across large hospital systems and GI networks, including key customer renewals and growing traction with new customers. Pipeline continues to advance with CapsoCam Colon™ on track for 510(k) submission in the fourth quarter of 2026, with ongoing enrollment in the CapsoCam UGI clinical study for pancreatic cancer detection. Appointed David S. Shields, M.D., to the Board of Directors, effective July 1, 2026. Entered into a sales agreement of up to $100 million providing for an at-the-market equity offering program with Cantor. Management Commentary "The second quarter marked another important step in the evolution of CapsoVision as we advanced both our commercial execution and product innovation. We were pleased to launch AI Highlights™ internationally, providing physicians in Europe with an AI-assisted workflow solution that complements our CapsoCam Plus® platform and reinforces our long-term vision of integrated, AI-enabled capsule endoscopy," said Johnny Wang, President and Chief Executive Officer of CapsoVision. "Commercially, we continue to see encouraging momentum across our business. Revenue growth was in line with our expectations, hospital network adoption continues to expand, and we are adding new customers who recognize the value of our panoramic capsule platform. We also continue to hear strong interest from customers awaiting the U.S. launch of AI Highlights™, which we now anticipate following FDA clearance expected this fall. As we look toward the second half of the year, we remain focused on executing against our commercial strategy while advancing our broader product pipeline." Second Quarter 2026 Financial Results Total revenue was $3.6 million compared to $3.3 million in the second quarter of 2025. The primary driver for the revenue growth was a 13% increase in the number of CapsoCam Plus capsules sold offset by a period-over-period decrease of approximately 3% in the average selling price. Gross profit was 1.9 million, an increase of $0.1 million, or 3% compared to the second quarter of 2025. Gross margin was 51%, compared to 55% in the second quarter of 2025. The decrease was due to a pressure on selling prices we have when operating in a highly competitive market and changes the U.S. government made to the trade policies and tariffs at the beginning of the year resulting in an increase in expenses for customs and tariffs. Operating expenses were $9.5 million, a $3.0 million increase from the second quarter of 2025, driven primarily by expenses associated with the colon pivotal study and other clinical trials, non-recurring engineering services for the Canon development project, expenses for operating as a public company, and stock-based compensation. Cash and cash equivalents totaled $9.1 million as of June 30, 2026. Conference Call and Webcast CapsoVision will host a conference call today, August 13, 2026, at 4:30 p.m. ET to discuss its second 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 9178774, 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 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”, “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 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 anticipated timing of FDA clearance of AI Highlights™ and its subsequent U.S. commercial launch, the continued development and anticipated 510(k) submission for CapsoCam Colon™, and 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), 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 ContactLeigh SalvoNew Street Investor [email protected] Media ContactLeslie Strickler and Paul SpicerÊtre [email protected] | (804) [email protected] | (804) 503-9231

Interested in CapsoVision, Inc.? Here are five stocks we like better. Second-quarter revenue rose 10% to $3.6 million, driven by a 13% increase in CapsoCam Plus capsule sales and shipments of 8,845 units. More than 176,000 patients worldwide have now used the system. CapsoVision launched its AI Highlights software internationally, while awaiting potential FDA clearance for a U.S. launch by the end of the third quarter. The company also plans to submit its second-generation CapsoCam Colon capsule and AI module for FDA review in the fourth quarter. Financial pressure increased as gross margin fell to 51% due to competitive pricing and higher customs and tariff costs, while operating expenses climbed to $9.5 million. The company ended the quarter with $9.1 million in cash and has access to a new at-the-market equity program of up to $100 million. 3 Under-the-Radar Cybersecurity Stocks With Major Upside Potential CapsoVision (NASDAQ:CV) reported second-quarter revenue growth as sales of its CapsoCam Plus capsule endoscopy system increased, while the company advanced its artificial intelligence software rollout and development programs for colon and upper gastrointestinal applications. Revenue for the second quarter of 2026 was $3.6 million, up approximately 10% from $3.3 million in the same period a year earlier. Senior Vice President of Finance David Garcia said the increase reflected a 13% year-over-year rise in CapsoCam Plus capsule sales, partly offset by an approximately 3% decline in average selling prices. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be 3 Under-the-Radar Software Stocks Ready to Bounce The company shipped 8,845 CapsoCam Plus capsules during the quarter, compared with 7,856 in the prior-year period. More than 176,000 patients worldwide had been imaged using CapsoCam Plus as of June 30, up 23% from more than 143,000 patients at the end of the second quarter of 2025, according to management. President and Chief Executive Officer Johnny Wang said CapsoVision continued to expand adoption among larger hospital systems and gastroenterology networks, renew customer relationships and add new accounts during the quarter. He also cited utilization growth across the company’s installed base. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Hidden Gems: 3 Value Stocks to Watch for Strong 2025 Returns Garcia said the quarter’s growth came from both continued use by existing customers and new account traction. The company renewed relationships with M Health Fairview University of Minnesota Medical Center, Henry Ford Hospital, the University of Colorado Anschutz Medical Campus and Providence Swedish. Garcia said Providence Swedish made CapsoCam the most-used capsule in hospitals in Washington state. CapsoVision had 26 U.S. direct sales representatives at quarter-end, supported by seven regional sales managers and trainers. Internationally, it sells through a combination of direct operations and distributors, including a dedicated commercial organization in Germany. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Senior Vice President of Global Sales Doug Atkinson said the company expects to expand its sales force and add territories where appropriate, while using the existing organization to support both its small-bowel diagnostic business and potential future colon products. A key second-quarter development was the commercial launch of AI Highlights in the European Union and other international markets. The software is intended to identify frames containing suspected pathology and present them in a structured physician workflow. The capability is integrated with CapsoVision’s CapsoView software and CapsoCloud platform. Wang said the company views the combination of panoramic capsule imaging, AI-assisted analysis and cloud-based workflow as a competitive differentiator rather than offering AI as a standalone feature. CapsoView software with AI analysis tools and CapsoCloud are included in the scope of CapsoVision’s European Union quality management system certificate under the Medical Device Regulation. Both are classified as Class IIa medical devices in Europe, management said. Atkinson said AI could help physicians reduce the time required to review capsule endoscopy studies and potentially allow them to perform more procedures. He said the international rollout will give the company real-world experience with the platform ahead of its planned U.S. introduction. CapsoVision submitted a 510(k) application for AI Highlights to the Food and Drug Administration in December 2025. Wang said the FDA requested additional information regarding demographic representation in the clinical data supporting the filing. The company expects FDA clearance by the end of the third quarter, followed by a commercial launch shortly thereafter, though Wang noted that FDA clearance cannot be guaranteed. CapsoVision said it now expects to submit its second-generation CapsoCam Colon capsule and AI module for FDA review during the fourth quarter. The timing shifted by one quarter because the company needs more positive subjects with significant polyps, based on discussions with the FDA. The company also said enrollment is continuing as planned in its CapsoCam UGI clinical study evaluating pancreatic cancer detection. Wang described the program as an early-stage clinical development effort and a potential long-term opportunity for the company’s capsule platform. Second-quarter gross profit was $1.9 million, compared with $1.8 million in the year-earlier quarter. Gross margin declined to 51% from 55%. Garcia attributed the margin pressure primarily to competitive pricing and higher customs and tariff expenses tied to changes in U.S. trade policies. During the question-and-answer session, he said the tariff impact was related to inbound costs, while competitive pressure came in part from a particular competitor. Operating expenses rose to $9.5 million from $6.5 million a year earlier. The increase included investments in product and clinical development, expenses related to the colon pivotal study and other clinical trials, non-recurring engineering work for the colon program, public-company costs and stock-based compensation. CapsoVision ended the quarter with $9.1 million in cash and cash equivalents. Garcia noted that the company raised $14 million in gross proceeds through a private placement in the first quarter and recently established an at-the-market equity offering program of up to $100 million with Cantor Fitzgerald. Looking ahead, management said it expects second-half revenue to exceed first-half revenue, with the fourth quarter typically representing the strongest period of the year due to seasonality. The company expects commercial momentum to be supported by wider CapsoCam Plus adoption, engagement with larger hospital and GI networks, international availability of AI Highlights and the anticipated U.S. AI software launch following FDA clearance. CapsoVision, Inc (NASDAQ: CV) is a medical device company specializing in advanced capsule endoscopy systems for gastrointestinal diagnostics. The company’s flagship product, the CapsoCam® Plus System, features a swallowable, tether-free capsule equipped with four side-viewing cameras that capture high-resolution, 360-degree images of the small intestine. By storing images internally rather than transmitting data wirelessly, CapsoCam Plus enables patients to maintain normal daily activities during the procedure and reduces the risk of signal loss or image drop-out. In addition to its capsule hardware, CapsoVision offers CapsoCloud®, a secure, cloud-based platform that streamlines image retrieval, storage and reporting. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "CapsoVision Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Interested in CapsoVision, Inc.? Here are five stocks we like better. CapsoVision reported Q1 revenue of $2.8 million, flat year over year, while capsule shipments slipped 3% due to order timing; management said the lower volume was partly offset by a better product mix and ongoing reimbursement support. The company expects mid-year FDA clearance for its AI-assisted reading tool, AI Highlights, and plans a commercial launch soon after. Management said physicians have responded positively because the feature could reduce review time while maintaining clinical rigor. CapsoVision continued investing in its pipeline, including its CapsoCam Colon Gen Two program and a pancreatic cancer study, and ended the quarter with $17.9 million in cash after a $14 million private placement. 3 Under-the-Radar Cybersecurity Stocks With Major Upside Potential CapsoVision (NASDAQ:CV) reported steady first-quarter revenue and said it continues to advance artificial intelligence and capsule endoscopy programs aimed at expanding the use of its gastrointestinal imaging platform. On the company’s first-quarter 2026 earnings call, President and Chief Executive Officer Johnny Wang said CapsoVision remains focused on developing “a unified ingestible capsule platform” intended to screen for multiple cancers through a single non-invasive procedure supported by advanced imaging and AI. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? 3 Under-the-Radar Software Stocks Ready to Bounce “We continued to see consistent solid underlying performance in the first quarter,” Wang said. “While revenue and the new account additions remained stable year-over-year, we saw further expansion of CapsoCam used to detect a widening range of small bowel diseases.” Senior Vice President of Finance David Garcia said first-quarter revenue was $2.8 million, consistent with the prior-year period. CapsoVision shipped 6,229 CapsoCam Plus capsules during the quarter, down 3% from 6,447 capsules in the prior-year period. → Micron Investors Face a High-Stakes Moment After the Latest Rally Hidden Gems: 3 Value Stocks to Watch for Strong 2025 Returns Garcia attributed the decline in capsule shipments to timing, saying some larger orders moved into April and were therefore placed in the second quarter. He said the lower unit volume was offset by a slight increase in average selling price, which reflected a mix shift toward higher-priced regions rather than a price increase. As of March 31, Garcia said more than 167,000 patients had been imaged with CapsoCam Plus for small bowel screening across U.S. and international markets. He also said reimbursement under CPT Code 91110 continues to support adoption across private practices and hospital systems. → How Bad Could Tesla’s Cybertruck Recall Be for Shares? Gross profit for the quarter was $1.3 million, with gross margin of 48%, compared with 54% in the first quarter of 2025. Garcia said the margin decline was primarily due to tariffs affecting cost of goods sold. Operating expenses were $8.4 million, up $1.5 million from the prior-year period. The increase was primarily driven by continued investment in the company’s pipeline, including development work tied to a next-generation imaging sensor under its agreement with Canon and clinical trial activity for the CapsoCam Colon Gen Two program. CapsoVision ended the quarter with $17.9 million in cash and cash equivalents. Garcia noted that the company closed a $14 million private placement in March with participation from new and existing investors, which he said provides added flexibility to support product innovation, clinical development and commercial expansion. Wang said CapsoVision continues to expect regulatory clearance around mid-year for its AI-assisted reading capability for CapsoCam Plus, which the company has branded AI Highlights. The company previously submitted a 510(k) application for the feature and is preparing for a commercial launch shortly after clearance. AI Highlights is designed to identify frames with suspected pathology and present them in a structured review workflow integrated into CapsoVision’s cloud-native CapsoCloud platform. Wang said physicians have responded positively to demonstrations of the technology at recent industry meetings, particularly its potential to reduce review time while maintaining clinical rigor. During the question-and-answer portion of the call, Titan Partners analyst Kyle Bauser asked about the status of the FDA application. Wang said the company and the FDA had several interactions in recent months, and that CapsoVision had responded to the agency’s requests. “We are waiting for a meeting in the next few weeks,” Wang said. “We have no showstoppers to my knowledge.” CapsoVision said its CapsoCam Colon development program remains on track, with submission of its second-generation capsule and AI module expected in the third quarter of 2026. Wang said the company believes prioritizing the second-generation product positions it to enter the market with a more competitive and clinically differentiated offering. The company also reported progress in its CapsoCam UGI program and pancreatic cancer initiative. Wang said enrollment began this week in a clinical study intended to establish diagnostic criteria and build a clinical foundation for a potential non-invasive screening approach for pancreatic disease. In response to a question from Bauser, Wang said the study is planned to enroll 120 patients with confirmed high-grade dysplasia or pancreatic cancer, with a target enrollment of 140 to account for possible dropouts. The study will also include 120 healthy reference subjects, with those images pulled from the company’s cloud storage repository, for a total of 240 subjects. Wang declined to provide a specific enrollment timeline but said he viewed the pancreatic study as “a much shorter study than colon.” CapsoVision said it secured renewals during the quarter with several large gastrointestinal networks, including Indiana University Health, Providence Health & Services and Gastro Health. Wang said those renewals reinforce the value of the company’s platform and its long-term customer relationships. Garcia said CapsoVision continues to see engagement from larger gastroenterology networks, hospital systems and group purchasing organizations, particularly as contracts come up for renewal and providers evaluate alternatives. As of quarter end, the company’s U.S. direct sales organization included 26 representatives, supported by seven regional sales managers and trainers. Internationally, CapsoVision has a dedicated team of four representatives in Germany and continues to expand through distributor partnerships. Garcia said the company expects second-quarter revenue to be higher than first-quarter revenue and expects revenue in the second half of the year to exceed first-half revenue. He cited pipeline momentum, customer engagement and the anticipated launch of the AI module for CapsoCam Plus. Asked about operating expenses, Garcia said investment in the colon study is expected to continue through the third quarter and begin trailing off in the fourth quarter, when the company expects the colon study to be completed. He said remaining expenses should be fairly stable, with nominal growth to support the business. Garcia also said full-year research and development spending is expected to be similar to 2025. Wang emphasized that the company’s cloud-based workflow gives CapsoVision visibility into end-user consumption and utilization. “We can tell you the end user consumption growth is healthy,” he said. Wang said CapsoVision remains focused on advancing an AI-enabled platform built around panoramic imaging, cloud-native workflow and AI-assisted diagnostics. He said the platform allows physicians to securely review cases “anytime and anywhere” without on-site servers or dedicated IT infrastructure, while also creating a cloud-based data repository that could support continued AI development and training over time. CapsoVision, Inc (NASDAQ: CV) is a medical device company specializing in advanced capsule endoscopy systems for gastrointestinal diagnostics. The company’s flagship product, the CapsoCam® Plus System, features a swallowable, tether-free capsule equipped with four side-viewing cameras that capture high-resolution, 360-degree images of the small intestine. By storing images internally rather than transmitting data wirelessly, CapsoCam Plus enables patients to maintain normal daily activities during the procedure and reduces the risk of signal loss or image drop-out. In addition to its capsule hardware, CapsoVision offers CapsoCloud®, a secure, cloud-based platform that streamlines image retrieval, storage and reporting. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "CapsoVision Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

SARATOGA, Calif., May 14, 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 for its first quarter ended March 31, 2026. Recent Highlights Delivered first quarter revenue of $2.8 million, stable compared to the first quarter of 2025. Existing customers continued to expand clinical use of CapsoCam Plus® for small bowel disease detection, while procedure volume demonstrated growing adoption and end-user consumption. Secured key customer renewals with large GI networks, including Indiana University Health Systems, Providence Health Systems, and Gastro Health, reinforcing platform value and long-term relationships. CapsoCam Plus® used by over 167,000 patients as of March 31, 2026. CapsoVision’s AI-assisted reading feature for CapsoCam Plus, on track for anticipated FDA clearance mid-year, with commercial launch expected shortly thereafter, subject to FDA review timelines. Pipeline programs progressing as planned, including our second-generation of CapsoCam Colon with 510(k) submission expected in the third quarter of 2026, and initiation of a clinical study for CapsoCam UGI in pancreatic cancer detection with the first patient enrolled in May 2026. Completed a $14 million private placement of public equity financing on March 16, 2026. Management Commentary “We saw continued strength in underlying utilization during the first quarter, reflecting deeper engagement across our installed base and the increasing role CapsoCam Plus® is playing in clinical practice,” said Johnny Wang, President and Chief Executive Officer of CapsoVision. “Importantly, we also secured key renewals with large GI networks, reinforcing the durability of our customer relationships and the value of our platform. "At the same time, we are approaching an important inflection point with the anticipated FDA clearance of our AI-assisted reading feature for CapsoCam Plus®, which we believe will further enhance workflow efficiency for physicians and we received positive feedback at recent industry meetings. Across the pipeline, we remain on track, including progress on the second-generation of our CapsoCam Colon capsule and the recent initiation of our pancreatic cancer study with initial patient enrollment. Taken together, we believe we are well positioned to continue advancing our platform and executing on our long-term strategy.” First Quarter 2026 Financial Results Total revenue was $2.8 million, stable compared to $2.8 million in the first quarter of 2025, due to a 3% decrease in capsule volume, offset by a slight increase in average selling price. Gross profit was $1.3 million, a decrease of $0.2 million, or 11%, compared to $1.5 million in the first quarter of 2025. Gross margin was 48%, compared to 54% in the first quarter of 2025. The decrease was due to the impact of changes in U.S. trade policies and tariffs. Operating expenses were $8.4 million, a $1.5 million increase from the first quarter of 2025, driven primarily by the development of the new CMOS image sensors under the development agreement with Canon Inc., as well as clinical trial activities supporting the second-generation of CapsoCam Colon. Cash and cash equivalents totaled $17.9 million as of March 31, 2026. On March 16, 2026, the Company closed a $14 million private placement in public equity financing. Conference Call and Webcast CapsoVision will host a conference call today, May 14, 2026, at 4:30 p.m. ET to discuss its first 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 5439091, 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 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”, “positioned”, “on track”, “anticipate(s)”, “intend(s)”, “plan(s)”, “believe(s)”, “potential”, “will”, “should”, “could”, “would”, “may”, “continue”, “remain”, “advancing”, “approach(ing)”, 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 the Company’s product and clinical development efforts, the timing and receipt of regulatory submissions and approvals (including anticipated FDA clearance of our AI-assisted reading feature for CapsoCam Plus® and commercial launch expected shortly thereafter), the Company’s plans, strategies and timing for its pipeline development (including the study for second-generation of CapsoCam Colon and related 510(k) submission, and 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, the Company’s financial condition and the availability of cash and financing, the success of the Company’s product and clinical development efforts, 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 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 [email protected] Media Contact Leslie Strickler and Paul Spicer Être Communications [email protected] | (804) 240-0807 [email protected] | (804) 503-9231

SARATOGA, Calif., March 26, 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 for the fourth quarter and full year ended December 31, 2025. Recent Highlights Fourth quarter 2025 revenue was $3.9 million, a 13% increase over the fourth quarter of 2024. Full year 2025 revenue was $13.6 million, a 15% increase compared to full year 2024. New accounts grew 16% in the fourth quarter of 2025 over the comparable quarter in 2024. Full year 2025 new accounts grew 21% compared to full year 2024. CapsoCam Plus® used by over 161,000 patients as of December 31, 2025. Submitted 510(k) application to the Food and Drug Administration (FDA) for its in-house developed AI-assisted module for CapsoCam Plus®. Completed a $14 million private placement of public equity financing on March 16, 2026. Management Commentary “2025 was a year of important operational and strategic progress for CapsoVision,” said Johnny Wang, President and Chief Executive Officer. “We continued to expand adoption of CapsoCam Plus®, advanced our AI-enabled analytics capabilities, and submitted our AI module for CapsoCam Plus to the FDA, marking an important milestone as we work to enhance the efficiency and clinical value of capsule endoscopy. During the year, we also continued development of our next-generation colon capsule in ongoing dialogue with the FDA, as we refine the regulatory pathway for that program, as well as for our CapsoCam UGI pancreas initiative. We recently completed a $14 million private placement with participation from new and existing investors, reinforcing confidence in our long-term strategy and supporting continued investment in product innovation and pipeline advancement. As we enter 2026, we remain focused on disciplined execution, as we continue to advance our capsule platform and expand the role of AI-driven insights in gastrointestinal disease screening and diagnostics.” Fourth Quarter and Full Year 2025 Financial Results Fourth quarter 2025 revenue was $3.9 million, a 13% increase over the fourth quarter of 2024. Full year 2025 revenue was $13.6 million, a 15% increase compared to full year 2024. The primary growth driver was an increase in the number of CapsoCam Plus capsules sold. Fourth quarter 2025 gross profit was $2.0 million, an increase of $0.2 million, or 13%, compared to the fourth quarter of 2024. Full year 2025 gross profit was $7.2 million, an increase of $0.8 million, or 12%, compared to full year 2024. Fourth quarter gross margin was 50%, compared to 50% in the fourth quarter of 2024. Full year 2025 gross margin was 53%, compared to 54% for full year 2024. Fourth quarter 2025 operating expenses were $9.4 million, a $3.0 million increase from the fourth quarter of 2024, driven primarily by the development of the new CMOS image sensors under the development agreement with Canon Inc. and expenses for clinical trial activities associated with AI technology in small-bowel capsule and second generation of CapsoCam Colon. Operating expenses for the year ended December 31, 2025 were $32.7 million, a $6.4 million increase compared to the year ended December 31, 2024, driven primarily by an increase in expenses associated with the development of the new CMOS image sensors under the development agreement with Canon Inc. and an increase in general and administrative expenses, as we were operating as a public company for half of the year. Cash and cash equivalents totaled $10.1 million as of December 31, 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. On March 16, 2026, the Company closed a $14 million private placement in public equity financing. Conference Call and Webcast CapsoVision will host a conference call today, March 26, 2026, at 4:30 p.m. ET to discuss the fourth quarter and full year 2025 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 2525025, 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 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, development of CapsoCam UGI pancreas initiative, 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-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 [email protected] Media Contact Leslie Strickler and Paul Spicer Être Communications [email protected] | (804) 240-0807 [email protected] | (804) 503-9231

CapsoCam Plus is gaining commercial momentum, with management citing roughly 15% full‑year revenue growth, about 9,400 Q4 patients (12% YoY) and over 161,000 patients imaged to date, driven by its wire‑free 360° capsule and cloud workflow. Pipeline progress includes a submitted 510(k) for an AI‑assisted reading module (end of 2025) and the CapsoCam Colon Gen2 pivotal study with over 500–600 enrollees; management plans a Gen2 and AI 510(k) filing in Q3 2026 with potential FDA clearance ~Q1 2027 and a H2 2027 launch, while a CapsoCam UGI pancreatic diagnostic study is expected to start in Q2 2026 to define scoring criteria. Financially, Q4 revenue was $3.9 million (up 13% YoY) with operating expenses of $9.4 million and year‑end cash of $10.1 million, and the company completed a $14 million private placement to support commercial expansion, R&D and pipeline advancement. Interested in CapsoVision, Inc.? Here are five stocks we like better. 3 Under-the-Radar Software Stocks Ready to Bounce CapsoVision (NASDAQ:CV) executives highlighted continued commercial growth for its CapsoCam Plus small-bowel capsule endoscopy product and provided updates on regulatory and clinical milestones for the company’s pipeline during its fourth-quarter and full-year 2025 earnings call. Chief Executive Officer Johnny Wang said the company ended 2025 with “increased commercial momentum” for CapsoCam Plus and reiterated CapsoVision’s broader mission to improve early, accurate, and accessible gastrointestinal (GI) disease detection. Wang described the company’s long-term vision as an ingestible capsule capable of screening for multiple cancers “in a single non-invasive procedure” supported by advanced imaging and artificial intelligence. → Quiet BNY and Northern Trust Reward Patient Investors Hidden Gems: 3 Value Stocks to Watch for Strong 2025 Returns For full-year 2025, Wang reported approximately 15% year-over-year revenue growth and a 21% increase in new account generation, which management attributed to continued adoption among both new and existing customers. Senior Vice President of Finance David Garcia said that as of December 31, 2025, more than 161,000 patients had been imaged with CapsoCam Plus. In the fourth quarter alone, Garcia said approximately 9,400 patients utilized CapsoCam Plus, up from about 8,374 in the prior-year period, representing 12% year-over-year growth. Garcia cited increasing physician awareness, clinical utility, and ease of workflow integration as drivers. He also pointed to reimbursement support across private practices and hospital systems. → The Silicon Squeeze: AI Pricing Power Lifts Chip Stocks 2 Small-Cap Stocks Set to Shine in a Bull Market Management emphasized the product’s differentiation as a “wire-free capsule” featuring 360-degree panoramic imaging, onboard storage, and a cloud-based workflow that does not require external hardware worn on the patient’s body or on-site computing infrastructure. Wang added that the cloud architecture supports the company’s AI strategy by enabling a growing image repository for model development aimed at improving diagnostic accuracy and reducing physician reading time. Garcia said CapsoVision’s commercial strategy includes leveraging its existing sales infrastructure as it expands into new indications, including a cross-selling opportunity for CapsoCam Colon if and when it receives FDA approval. As of year-end, the company’s U.S. direct sales organization consisted of 26 representatives supported by seven regional sales managers and trainers. Internationally, CapsoVision has a dedicated team of four representatives in Germany and is expanding through distributor partnerships in other markets. → Meta Reportedly Plans 20% Layoff: A Sign of Weakness or Strength? New account growth increased 16% year over year in the fourth quarter, according to Garcia. He also noted recent approvals that expand access, including use in pediatric patients over age two and the ability for remote capsule ingestion, which management said aligns with telemedicine adoption. Garcia said CapsoVision is seeing greater penetration in larger gastroenterology networks, including increased traction in hospital systems and group purchasing organizations, where the company is being evaluated against incumbent solutions. He stated that the number of hospital system customers increased 87% in the fourth quarter compared with the same period last year. Wang said CapsoVision submitted a 510(k) application at the end of 2025 for an AI-assisted reading module for CapsoCam Plus intended to enhance lesion detection and streamline physician review. For CapsoCam Colon, Wang said the company refined its development approach following interactions with the FDA, choosing to prioritize a second-generation system rather than continuing with a first-generation submission. He said Gen 2 is intended to incorporate improved imaging performance, an expanded field of view, and enhanced AI functionality. CapsoVision had enrolled over 400 patients in its pivotal study at the time of prepared remarks and was starting enrollment across U.S. sites. Wang said the company expects to submit a 510(k) for CapsoCam Colon Gen 2 and its AI module in the third quarter of 2026. In the question-and-answer session, Wang provided additional details on the colon program: He said Gen 2 has higher resolution, higher image quality, and a larger field of view, along with improved software and integration with the AI module. He said enrollment was “over 500, but close to 600,” with 11 sites across the U.S., and that the company remained on track to file by the end of the third quarter, with no delays reported. Wang noted that physician vacation schedules during summer can be an “X factor” affecting enrollment pace, though he said the study was tracking to plan. Asked about timing after submission, Wang said the company expects an FDA review period of about six months. Based on that assumption, he said CapsoVision expects clearance in the first quarter of 2027 and anticipated launching the product “the beginning of second half, 2027.” Wang also discussed CapsoVision’s CapsoCam UGI program and its pancreatic cancer initiative, describing a proposed non-invasive screening approach focused on visual assessment of the duodenal wall and anatomical landmarks such as the papilla of Vater. He said the company received constructive FDA feedback following an initial breakthrough device designation submission, including confirmation of the system’s ability to visualize the papilla and associated abnormalities, alongside guidance to further define diagnostic criteria. To address that, Wang said CapsoVision plans to initiate a clinical study expected to begin in the second quarter of 2026 enrolling approximately 60 to 90 patients to establish diagnostic criteria for malignancy using the CapsoCam UGI system. He said the work will be conducted with clinical experts and key opinion leaders, including leadership of professional societies in the pancreatobiliary field, and that the data is intended to support regulatory advancement and a future breakthrough designation resubmission. Wang added that the regulatory pathway for CapsoCam UGI is independent of the breakthrough program and “will remain on track.” In response to an analyst question, Wang outlined a contemplated diagnostic scoring system that would grade multiple features associated with pancreatic cancer, including papilla abnormalities and duodenal wall changes caused by tumor compression or invasion. He said the scoring system would include graded features (yes/no and severity) and could incorporate multivariate factors such as gender and age, with the model built from study results. He said the study would be an important step for a breakthrough designation application, while noting that additional validation in a separate population may be needed because the same cohort used to build the model cannot be used to validate it. For the fourth quarter of 2025, Garcia reported total revenue of $3.9 million, up 13% from the fourth quarter of 2024, driven by increased CapsoCam Plus capsule sales. Gross profit was $2.0 million, up $200,000, with gross margin of 50%, which he said was consistent with expectations as the business scales. Operating expenses were $9.4 million, an increase of $3.1 million year over year. Garcia attributed the increase primarily to development expenses tied to new CMOS image sensors under an agreement with Canon, continued investment in the colon clinical study, and higher public company expenses. CapsoVision ended 2025 with $10.1 million in cash and equivalents. Both Wang and Garcia discussed a subsequent $14 million private placement that management said strengthened the balance sheet. Garcia said the equity financing was completed at $4.88 per share, representing a 5% discount to the March 16 closing price under the agreement’s terms. He said net proceeds are intended to support commercial expansion, continued R&D investment, and advancement of pipeline programs, particularly CapsoCam Colon and the AI-enabled platform. In closing remarks, Wang said the company is entering “a highly competitive phase of execution” while building from a position of commercial strength in CapsoCam Plus. He emphasized continued traction in larger GI networks and hospital systems, ongoing investment in AI capabilities, and a “disciplined pipeline strategy” across colon and pancreatic initiatives, supported by the recent capital raise. CapsoVision, Inc (NASDAQ: CV) is a medical device company specializing in advanced capsule endoscopy systems for gastrointestinal diagnostics. The company’s flagship product, the CapsoCam® Plus System, features a swallowable, tether-free capsule equipped with four side-viewing cameras that capture high-resolution, 360-degree images of the small intestine. By storing images internally rather than transmitting data wirelessly, CapsoCam Plus enables patients to maintain normal daily activities during the procedure and reduces the risk of signal loss or image drop-out. In addition to its capsule hardware, CapsoVision offers CapsoCloud®, a secure, cloud-based platform that streamlines image retrieval, storage and reporting. The article "CapsoVision Q4 Earnings Call Highlights" was originally published by MarketBeat.