SafeHeal Medical is a company developing a breakthrough solution for patients undergoing colorectal surgery. Its product, the SafeHeal Colovac device, eliminates the traditional need for an artificial anus and related pouches through the protection of the digestive anastomosis during healing.
Traditionally, patients undergoing lower GI surgery must use a temporary colostomy for 2-6 months to allow for healing of the new junction in the digestive tract created by the surgery. Later, the patient must undergo another surgery to reverse the ostomy. The process not only causes burdens for the patient, but involves high costs for the healthcare system. Further, complications are frequent, as nearly 30% of patients develop adverse effects from the temporary colostomy and are often unable to undergo the second operation.
Invented by French surgeon, Dr. Charam Khosrovani, Colovac eliminates the need for a patient to wear an ostomy pouch, and also reduces anastomotic complications for patients undergoing a colectomy. It is anchored above the anastomosis using an innovative, seamless, minimally invasive and fully reversible vacuum-based mechanism. Within two weeks, the anastomosis is healed and the device is retrieved without surgery.
Colovac has been tested on over 80 pigs including a randomized pig study. SafeHeal is currently finalizing its prototype design in preparation for clinical trials. After clinical data is solidified, the product could be used as a prophylactic in any procedure during which a patient receives a lower GI anastomosis.
SafeHeal seeks to be a global leader in digestive anastomosis protection devices and projects revenue to hit €10 million by 2020 and €100 million in 2025.