SafeHeal Named to LSI’s Q1 2026 “Hot 25” MedTech Startups List

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January 22, 2026 – SafeHeal® is proud to announce its inclusion in Life Science Intelligence’s (LSI) Q1 Hot 25 MedTech Startups list. This prestigious ranking recognizes the “hottest” medtech companies entering 2026 based on innovation, market potential, and clinical impact.

According to LSI, the Hot 25 is determined by aggregating investor interest through the Compass AI platform and leveraging proprietary insights from LSI’s global Emerging Medtech Summits. SafeHeal’s position at #22 reflects the company’s rising profile among investors and industry leaders as it works to redefine the standard of care in colorectal surgery.

Sustaining Clinical and Regulatory Momentum

SafeHeal’s inclusion on the LSI list follows a transformative year marked by several high-impact milestones for Colovac®, the company’s proprietary anastomosis protection technology:

  • Launch of the Pivotal SAFE-3CV IDE Study (January 2026): SafeHeal® recently achieved a critical milestone with the first patient enrollment in its SAFE-3CV study. This pivotal clinical trial is essential for supporting the continued evaluation of Colovac’s safety and efficacy across leading surgical centers in the U.S. and Europe.
  • EU MDR Marketing Approval (August 2025): The company successfully secured EU marketing approval under the rigorous Medical Device Regulation (EU MDR 2017/745). This certification validates SafeHeal’s quality standards and paves the way for commercial availability across European markets.
  • Oversubscribed €35 Million Series C Financing (Spring 2025): Last year, SafeHeal® closed an oversubscribed funding round, providing the strategic capital necessary to accelerate clinical execution and prepare for large-scale commercialization.

Advancing the Future of Colorectal Surgery

SafeHeal® remains dedicated to its core mission: improving patient outcomes and the surgical experience. By eliminating the need for a diverting stoma for many patients, Colovac® addresses a significant unmet need in colorectal procedures, thereby reducing complications and improving patients’ quality of life.

ABOUT SAFEHEAL®

SafeHeal SAS, headquartered in Paris, France, and its wholly owned U.S. subsidiary, SafeHeal Inc., is a medical device company developing Colovac®, a device intended as an alternative to diverting ostomy in patients undergoing colorectal surgery. Colovac® is a flexible endoluminal bypass sheath designed to reduce the contact of fecal content at the anastomotic site following colorectal surgery. The device is placed endoluminally and remains in place for approximately 10 days, until the body’s natural healing and tissue repair processes are complete, after which it is removed during an endoscopic procedure without the need for a second surgical intervention.

Colovac® is designed to protect colorectal anastomoses. In the United States, it is an investigational device and is not available for sale. In the European Union, Colovac® has received marketing approval under the Medical Device Regulation (EU MDR 2017/745) via Annex IX, Chapter I.