CapsoVision Submits Breakthrough Device Designation Application to FDA for Pancreatic Cancer Screening Capsule

Rhea-AI Summary

CapsoVision (NASDAQ: CV) announced it submitted a Breakthrough Device Designation (BDD) application to the FDA on Nov 6, 2025 for its CapsoCam UGI capsule endoscopy system to support earlier detection of pancreatic ductal adenocarcinoma.

The non-invasive, swallowed capsule provides panoramic imaging to visualize the duodenal papilla, a potential early indicator of pancreatic abnormalities, and streams images to a secure cloud for physician review. The company said the BDD could accelerate development, help shape clinical studies, and speed regulatory review.

The release highlights pancreatic cancer's poor prognosis (five-year survival as low as 8–10%), that ~80% of diagnoses occur at advanced stages, and the absence of recommended non-invasive screening for the general population.

News Market Reaction

+4.44% 1.8x vol

3 alerts

+4.44% News Effect

+5.4% Peak Tracked

+$11M Valuation Impact

$254M Market Cap

1.8x Rel. Volume

On the day this news was published, CV gained 4.44%, reflecting a moderate positive market reaction. Argus tracked a peak move of +5.4% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $11M to the company's valuation, bringing the market cap to $254M at that time. Trading volume was above average at 1.8x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Non-invasive capsule endoscopy system aims to enable earlier detection of pancreatic ductal adenocarcinoma - among the most fatal cancers worldwide

SARATOGA, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today 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 deadliest 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.

CapsoVision is pursuing the potential use of its CapsoCam UGI endoscopy to identify pancreatic disease at an earlier stage. The device’s unique panoramic imaging capability enables clear visualization of the duodenal papilla, a small bowel landmark that controls release of digestive fluids. Changes in the papilla’s appearance can be associated with pancreatic abnormalities and may serve as an early indicator of disease.

Unlike traditional endoscopic or imaging procedures, CapsoCam UGI is completely non-invasive. Patients simply swallow 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 Screenings

Pancreatic cancer remains one of the most lethal malignancies, with a five-year survival rate of only 10%¹, a figure that has seen little improvement in decades. It is now the third leading cause of cancer-related death in the United States², despite accounting for just over 3% of all cancer cases. Approximately 80% of diagnoses occur at advanced stages³ when the disease is already unresectable or metastatic, leaving limited options for curative treatment. Existing diagnostic methods including CT, MRI, and endoscopic ultrasound are invasive, costly, and lack the sensitivity needed to detect small or early-stage lesions⁴.

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 emerge and while curative treatment is still possible.

About CapsoVision

CapsoVision is a commercial-stage medical technology company focused on developing advanced imaging and AI-enabled solutions to transform the detection and diagnosis of gastrointestinal diseases. Its flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that enables high-resolution visualization of the small bowel and supports cloud-based or direct capsule video retrieval. The Company’s next pipeline product, CapsoCam Colon™ with enhanced AI, is designed to enable non-invasive colon imaging and polyp detection. With a proprietary platform targeted to expand across multiple GI indications, including esophageal and pancreatic disorders, CapsoVision is advancing a new era in capsule-based diagnostics. For more information on CapsoVision, please visit www.capsovision.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this context, forward-looking statements mean statements related to future events, which may impact our expected future business and financial performance, and often contain words such as “expected”, “anticipates”, “intends”, “plans”, “believes”, “potential”, “will”, “should”, “could”, “would” or “may” and other words of similar meaning. Examples of these forward-looking statements include, but are not limited to, statements concerning possible or assumed future results of operations, including the timing and receipt of regulatory approvals, the Company’s plans, strategies and timing for its pipeline development, 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 and the failure to receive regulatory clearance. Specifically, the Company’s proposed capsule endoscopy solution may not meet the eligibility requirements for the Breakthrough Device Designation and, even if a Breakthrough Device Designation is received, it may not receive the FDA authorization required to market the proposed capsule endoscopy solution. These and other risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s prospectus filed on July 3, 2025 with the SEC, as part of the Company’s Registration Statement on Form S-1 (File No. 333-287148), and the Company’s most recent Form 10-Q. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these statements, except as required by law.

Investor Relations Contact

Leigh Salvo
New Street Investor Relations
Investors@CapsoVision.com

Media Contact

Leslie Strickler and Paul Spicer
Être Communications
leslies@etrecommunications.com | (804) 240-0807
pauls@etrecommunications.com | (804) 503-9231

Sources

1. SEER Cancer Statistics Review, 2025. National Cancer Institute. https://seer.cancer.gov/statfacts/html/pancreas.html
2. Rawla P, Sunkara T, Gaduputi V. Epidemiology of pancreatic cancer: global trends, etiology and risk factors. World Journal of Oncology. 2019;10(1):10.
3. MD Anderson Cancer Center. Pancreatic Cancer Overview. Accessed July 2025. https://www.mdanderson.org/cancer-types/pancreatic-cancer.html
4. Olakowski M, Bułdak Ł. Current status of inherited pancreatic cancer. Hereditary Cancer in Clinical Practice. 2022;20(1):26.
5. SEER Statistics Network Explorer. U.S. Cancer Statistics. https://seer.cancer.gov/statistics-network/explorer
   

FAQ

What did CapsoVision (CV) file with the FDA on November 6, 2025?

CapsoVision filed a request for Breakthrough Device Designation (BDD) for the CapsoCam UGI capsule to support earlier pancreatic cancer detection.

How does the CapsoCam UGI capsule work for pancreatic screening (CV)?

Patients swallow a pill-sized camera that captures panoramic images of the duodenal papilla, with images reviewed via a secure cloud portal.

What clinical need does CapsoVision (CV) aim to address with the CapsoCam UGI?

The company aims to enable earlier detection of pancreatic abnormalities where current methods lack sensitivity and no non-invasive general-population screening exists.

What would FDA Breakthrough Device Designation mean for CapsoVision (CV)?

If granted, BDD could allow closer FDA collaboration to accelerate development, shape clinical study design, and expedite regulatory review.

What survival and diagnosis statistics did CapsoVision cite in the announcement?

The announcement noted five-year survival as low as 8–10% and that about 80% of pancreatic cancer cases are diagnosed at advanced stages.

Will CapsoCam UGI replace standard imaging like CT or MRI for pancreatic cancer screening?

The company positions CapsoCam UGI as a non-invasive alternative to improve early visualization, but did not claim it replaces established imaging modalities.