SafeHeal Launches Pivotal SAFE-3CV IDE Study to Advance Colovac Toward U.S. Approval

New updates have been reported about SafeHeal.

SafeHeal has initiated patient enrollment in SAFE-3CV, its pivotal IDE study for Colovac, positioning the company for U.S. market entry and expanded commercialization in Europe for its colorectal anastomosis protection technology. The two-phase study, which will enroll up to 252 patients across as many as 20 sites in the U.S. and Europe, is designed to compare the safety and efficacy of Colovac—a temporary endoluminal bypass sheath intended to replace diverting ostomy—against historical control data from standard-of-care ostomy procedures. Led by Principal Investigator Dr. Patricia Sylla in the U.S. and EU Principal Investigator Prof. Jérémie Lefevre, the trial is expected to complete enrollment by late 2026 and serves as the final clinical step toward U.S. FDA marketing approval while also contributing to EU post-market surveillance requirements. The first patient was enrolled at Hôpital Saint-Antoine in Paris under Prof. Lefevre, who has previously co-led multinational studies where Colovac demonstrated favorable safety and efficacy, supporting its EU marketing approval in August 2025 under the Medical Device Regulation (EU MDR 2017/745).

Strategically, SAFE-3CV is critical for SafeHeal’s path to commercial scale, particularly in the U.S., where Colovac already holds Breakthrough Device designation, enabling expedited regulatory review for technologies addressing serious conditions. Colovac is designed to obviate the need for temporary stoma in most patients by shielding the anastomosis from fecal content for roughly 10 days post-surgery, after which it is removed endoscopically without a second operation, potentially reducing complications, hospital stays, and the risk of permanent ostomy. This value proposition targets both clinical outcomes and health-economic benefits for providers and payers by addressing complications and quality-of-life burdens associated with ostomy, including additional surgeries and extended recovery. SafeHeal President and CEO Chris Richardson emphasized that building this final body of evidence with leading colorectal surgeons is central to the company’s U.S. commercialization strategy and to unlocking broader adoption of Colovac in markets where regulatory clearance is in place. Colovac remains investigational and not for sale in the U.S., but successful completion of SAFE-3CV would give SafeHeal the data package needed to convert regulatory milestones into commercial opportunities across major colorectal surgery centers.