Annuncio • Jul 03
CapsoVision, Inc. Announces Board and Committee Changes, Effective July 1, 2026 CapsoVision, Inc. announced that on July 1, 2026, the Board of Directors appointed Dr. David Stanley Shields to serve as a Class I director of the Board and as a member of the Compensation Committee of the Board, in each case effective July 1, 2026, to fill the vacancy upon the resignation of Dr. Joanne Imperial. Dr. David S. Shields, age 75, is a board-certified gastroenterologist with more than four decades of experience in academic medicine, clinical gastroenterology, advanced endoscopy, and digestive disease management. Since 1986, he has maintained a private gastroenterology consulting practice in Palo Alto, California, providing comprehensive care to patients with gastrointestinal and liver disorders. Dr. Shields previously served as Assistant Professor of Medicine in the Division of Gastroenterology at Stanford University School of Medicine and served as Director of Endoscopy at Stanford Hospital. Throughout his career, he has remained actively involved in clinical education and physician training. He currently serves as a gastroenterology consultant and clinician at both San Mateo County Medical Center and the Palo Alto Veterans Affairs Health Care System, where he continues to teach medical residents and gastroenterology fellows. Dr. Shields established one of the earliest gastroenterology endoscopy programs associated with Stanford University and has been an early adopter and clinical investigator in capsule endoscopy technology. He has accumulated nearly two decades of experience utilizing capsule endoscopy for the diagnosis and management of small bowel disorders and gastrointestinal bleeding. Dr. Shields earned a Bachelor of Arts degree in Biochemistry with highest honors from the University of California, Santa Barbara, and received his Doctor of Medicine degree from the University of California, San Francisco School of Medicine. He completed his residency training in Internal Medicine at Stanford University School of Medicine and the University of Virginia, followed by a fellowship in Gastroenterology at the University of Virginia. The Board determined that Dr. Shields is an independent director of the Board, and that he satisfies all applicable requirements to serve on the Compensation Committee, including without limitation the applicable requirements of The Nasdaq Stock Market LLC and the Securities Exchange Act of 1934, as amended. On July 1, 2026, Dr. Joanne Imperial stepped down from the Board as a Class I director and as a member of the Compensation Committee of the Board, effective July 1, 2026. Dr. Imperial's decision to resign was not the result of any disagreement with the management or the Board on any matter relating to the Company's operations, policies or practices. Dr. Imperial will continue to serve the Company as an independent consultant. New Risk • May 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$24m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$24m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$24m net loss next year). Share price has been volatile over the past 3 months (14% average weekly change). New Risk • May 11
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$25m Forecast net loss in 1 year: US$23m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable next year (US$23m net loss next year). Share price has been volatile over the past 3 months (14% average weekly change). Annuncio • May 02
CapsoVision, Inc. to Report Q1, 2026 Results on May 14, 2026 CapsoVision, Inc. announced that they will report Q1, 2026 results After-Market on May 14, 2026 Annuncio • May 01
CapsoVision, Inc., Annual General Meeting, Jun 11, 2026 CapsoVision, Inc., Annual General Meeting, Jun 11, 2026. Major Estimate Revision • Apr 02
Consensus revenue estimates decrease by 18%, EPS upgraded The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast fell from US$19.2m to US$15.8m. EPS estimate increased from -US$0.49 to -US$0.48 per share. Medical Equipment industry in the US expected to see average net income growth of 12% next year. Consensus price target reaffirmed at US$10.50. Share price was steady at US$7.44 over the past week. Reported Earnings • Mar 27
Full year 2025 earnings: EPS in line with expectations, revenues disappoint Full year 2025 results: US$1.03 loss per share. Revenue: US$13.6m (up 15% from FY 2024). Net loss: US$25.3m (loss widened 27% from FY 2024). Revenue missed analyst estimates by 2.6%. Earnings per share (EPS) were mostly in line with analyst estimates. Revenue is forecast to grow 46% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Medical Equipment industry in the US. Annuncio • Mar 13
CapsoVision, Inc. to Report Q4, 2025 Results on Mar 26, 2026 CapsoVision, Inc. announced that they will report Q4, 2025 results After-Market on Mar 26, 2026 Annuncio • Jan 01
CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus®? CapsoVision, Inc. announced submission of its 510(k) application to the Food and Drug Administration (FDA) for its proprietary AI-assisted module for CapsoCam Plus®?. The addition of this reading tool will improve the detection of clinically significant pathology, as well as reduce clinician review time. The Company intends for U.S. commercialization activities to commence after the FDA clearance. CapsoVision's CapsoCam Plus capsule endoscopy system is intended for visualization of the small bowel mucosa to detect abnormalities of the small bowel in adults and children aged two years and older. The Company believes that it is a more advanced capsule endoscopy solution compared to competitor systems, both in how it captures and presents images of the GI tract and the clinical workflow and patient experience that it enables. Board Change • Dec 31
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Julia Gouw was the last director to join the board, commencing their role in 2025. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. New Risk • Dec 11
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Minor Risks Less than 3 years of financial data is available. Share price has been volatile over the past 3 months (14% average weekly change). Reported Earnings • Nov 14
Third quarter 2025 earnings: EPS and revenues miss analyst expectations Third quarter 2025 results: US$0.17 loss per share. Net loss: US$7.92m (flat on 3Q 2024). Revenue missed analyst estimates by 4.0%. Earnings per share (EPS) also missed analyst estimates by 36%. Revenue is forecast to grow 47% p.a. on average during the next 3 years, compared to a 8.4% growth forecast for the Medical Equipment industry in the US. Annuncio • Nov 11
CapsoVision, Inc. Submits Breakthrough Device Designation Application to FDA for Pancreatic Cancer Screening Capsule CapsoVision, Inc. announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) on November 6, 2025 requesting Breakthrough Device Designation (BDD) to accelerate development of the Company's CapsoCam UGI capsule endoscopy system for use in early-stage pancreatic cancer detection. This submission represents an important milestone in CapsoVision's mission to expand its capsule-based diagnostics platform beyond the small bowel and address some of the most challenging diseases in gastroenterology. Pancreatic ductal adenocarcinoma the most common form of pancreatic cancer is among the fatal cancers worldwide, with a five-year survival rate of only 8%, largely because it is diagnosed at advanced stages that cannot be treated. Currently, no early screening tools are recommended to identify the disease at a treatable stage in the general population. Unlike traditional endoscopic or imaging procedures, CapsoCam UGI is completely non-invasive. Patients simply allow a pill-sized camera, eliminating the need for sedation, intubation, or recovery time, while enabling physicians to review detailed images through a secure, cloud-based system. The FDA's Breakthrough Devices Program is designed to expedite the development and review of technologies that may offer more effective diagnosis or treatment for life-threatening conditions where no adequate alternatives exist. If granted, the designation would allow CapsoVision to work closely with the FDA to accelerate development and shape upcoming clinical studies, leading the regulatory review process. Pancreatic cancer remains one of the most lethal malignancies, with a five- year survival rate of only 10%, a figure that has seen little improvement in decades. It is now the third leading cause of cancer-related death in the United States, despite accounting for just over 3% of all cancer cases. Early detection can improve survival more than fourteen-fold5, yet no non-invasive screening method for the general population is currently recommended. This underscores an urgent global need for innovative, patient-friendly diagnostic technologies that can visualize pancreatic abnormalities earlier, before symptoms emerging and while curative treatment is still possible. Annuncio • Oct 31
CapsoVision, Inc. to Report Q3, 2025 Results on Nov 13, 2025 CapsoVision, Inc. announced that they will report Q3, 2025 results After-Market on Nov 13, 2025 Annuncio • Sep 27
CapsoVision, Inc. Announces Board Changes On September 22, 2025, Rebecca Petersen notified CapsoVision, Inc. (the Company") of her planned retirement as the Company's Senior Director of Clinical Affairs, effective October 15, 2025. Concurrently, the Company promoted Ms. Keri Jorgenson to Director of Clinical Operations and Ms. Jorgenson, together with the other members of the clinical operations team, will assume responsibility of the Company's clinical development operations and activities. The Company does not anticipate any disruption to its clinical development operations and activities during this transition. Ms. Jorgenson joined CapsoVision in March 2022 and most
recently served as the Company's Senior Clinical Project Manager, working closely with Ms. Petersen and the Company's broad, experienced clinical operations team. Annuncio • Sep 04
CapsoVision, Inc. Announces Step Down of Kevin Lundquist as Chief Financial Officer, Effective August 27, 2025 Effective August 27, 2025, Kevin Lundquist has stepped down as Chief Financial Officer of CapsoVision, Inc. (the “Company”). The Company has begun the search to identify a successor. The Company and Mr. Lundquist have mutually agreed that Mr. Lundquist will be available to provide consulting assistance and transition support to the Company for up to six months, until February 28, 2026. In connection therewith, the Company and Mr. Lundquist will enter into a Consulting Agreement to take effect immediately (the “ Consulting Agreement ”). Reported Earnings • Aug 19
Second quarter 2025 earnings: EPS and revenues exceed analyst expectations Second quarter 2025 results: US$2.02 loss per share. Net loss: US$4.63m (flat on 2Q 2024). Revenue exceeded analyst estimates by 2.1%. Earnings per share (EPS) also surpassed analyst estimates by 10%. Revenue is forecast to grow 43% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Medical Equipment industry in the US. Annuncio • Aug 01
CapsoVision, Inc. to Report Q2, 2025 Results on Aug 14, 2025 CapsoVision, Inc. announced that they will report Q2, 2025 results After-Market on Aug 14, 2025 Annuncio • Jul 02
CapsoVision, Inc. has completed an IPO in the amount of $27.5 million. CapsoVision, Inc. has completed an IPO in the amount of $27.5 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,500,000
Price\Range: $5
Discount Per Security: $0.35
Transaction Features: Sponsor Backed Offering Board Change • Jun 30
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 2 non-independent directors. Independent Chairman Chen Tsai was the last independent director to join the board, commencing their role in 2014. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. 
