Patients who require a colon resection often receive a diverting colostomy, where the colon is brought through the abdominal wall so that waste can exit the body through an ostomy. By doing so, the anastomotic site, where the colon has been re-attached, is protected from fecal contents and allowed to heal. However, the procedure carries social stigma and impact the patient emotionally. And it carries major complications, with about 10% of patients experiencing leakage, which is associated with significant mortality and morbidity.
The France-based startup SafeHeal is developing a device, called ColoVac, which obviates the need for bowel diversion surgery. The device is a covered stent that is placed inside the colon at the anastomosis, protecting the area from excessive pressure and from exposure to fecal contents. ColoVac can be delivered during both open and laparoscopic procedures, and is anchored above the anastomosis using a vacuum-based mechanism. Once in place, it remains there until the body’s natural healing is completed, after which it can be removed without the need for a second surgical intervention.
Anastomotic leaks are one of the most serious complications after colorectal surgery, and could have devastating implications. Patients with leaks have significantly greater chances of wound infection and mortality rates of up to 32%, placing a considerable additional burden on both patients and healthcare providers. Not to mention the lack of confidence in socializing, anxiety, embarrassment and difficulties with intimacy that many patients experience. SafeHeal has developed a device that avoid the need for a diverting colostomy, enabling patients to resume their normal life without having to wear an ostomy pouch. ColoVac could significantly improve quality of life for these patients, giving them their life back. In addition, the device could minimize post-operative complication, improve patient recovery, while reducing associated costs.
ColoVac is based on the invention of a French surgeon Dr. Khosrovani, and has so far been successfully tested in over 80 pigs. SafeHeal is incubated by MD Start II, a medtech accelerator developing innovative medical devices based on inventions from physicians, and is a laureate of the Worldwide Innovation Challenge 2015 (Concours Mondial De l’Innovation). The startup was also voted as the most promising and innovative medtech startup at the investor conference at Biovision 2016, and was a finalist at the 2016 Medtech Innovator Competition.