China's Best One-Stop Medical Equipment Provider
About

SafeHeal is a clinical-stage medical device company based in Paris, France, with a U.S. subsidiary, SafeHeal Inc. Founded in 2015, the company specializes in developing innovative devices for colorectal surgery. Its flagship product, Colovac, is designed to enhance recovery for patients undergoing colectomy by eliminating the need for temporary diverting ostomies. Colovac is a flexible, endoluminal bypass sheath that protects the digestive anastomosis during the critical healing period after surgery. It reduces contact with fecal content and is designed to remain in place for 7 to 10 days, after which it can be removed endoscopically. This device aims to minimize complications and the physical and psychological burden associated with ostomy pouches. SafeHeal has received the CE mark in Europe and has been granted Breakthrough Device Designation by the U.S. FDA. The company is currently conducting clinical investigations in Europe and the U.S., with positive results reported in ongoing trials. SafeHeal's primary customers include colorectal surgeons, clinicians, and colorectal cancer patients, with endorsements from leading medical institutions.

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Keywords
medical device patient outcomes patient quality of life medical device development anastomosis healing fda breakthrough device medical equipment and supplies manufacturing clinical trials healthcare technology regulatory approval european market investigational colorectal device colovac endoscopic removal surgeon collaboration surgical procedure european mdr approval surgical protection device investigational device colorectal cancer clinical investigation device anastomosis protection surgical devices post-surgical complication reduction medical devices postoperative recovery anastomotic leak prevention postoperative care ostomy-free recovery clinical stage medical device
Company Information
  • Employees 23
  • Founded 2015
  • Annual Revenue $8500000
  • Total Funding $103601847
Location

9 Rue du 4 Septembre, Paris, Ile-de-France, France, 75002

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