SafeHeal is the first company created and incubated by MD Start II. It is based on the invention of a French surgeon, Dr. Khosrovani.
SafeHeal develops an innovative solution for colorectal surgery patients, which obviates the need for an artificial anus and related pouches. The SafeHeal Colovac device ensures the protection of the digestive anastomosis during healing. It is designed to reduce anastomotic complications and to eliminate the need for temporary ostomies for patients undergoing colectomy.
Many patients receiving lower GI surgery have to bear a temporary colostomy (also known as a loop or diverting ostomy) in order to let the anastomosis (the new junction in the digestive tract created by the surgery) heal. The ostomy typically remains for 2 to 6 months. Afterward, the patient returns for another surgical operation to reverse or takedown the ostomy. The whole process is debilitating for the patient, costly for healthcare systems, and prone to frequent complications, with about 20 to 30% of patients developing adverse events and not being able to go through the ostomy takedown procedure.
The SafeHeal device is meant to enable patients to resume their normal life after a colorectal surgery, without having to wear an ostomy pouch.
SafeHeal received CE mark in 2019 and is currently working on initiating its FDA clinical trial.