SafeHeal develops Colovac, an innovative solution for the protection of digestive anastomosis, designed to reduce anastomotic complications and to obviate the need for diverting ostomies for patients undergoing colectomy.
The Colovac device is meant to enable patients to resume their normal life after a colorectal surgery, without having to bear an artificial anus and wear an ostomy pouch.
SafeHeal, reshaping digestive surgery.
Anastomotic (point of surgical connection) leakage after a colorectal resection is associated with significant mortality and morbidity. Symptomatic anastomotic leakage occurs in 5 to 10% of all colorectal resections, and in more than 10% of anterior resections. Thus, there is a clear and unmet need for a way to improve the patient’s recovery and quality of life by reducing leakage, associated complications and the need for repeat operations.
Many patients receive a diverting ostomy receive a diverting ostomy in order to let the anastomosis heal. The colon is deviated towards a bag placed on the abdomen. Although the anastomosis typically heals in one or two weeks, the ostomy remains for two to six months, if not longer.
Afterwards, the patient returns for another surgical operation to reverse or takedown the ostomy.
The whole process is debilitating for the patient, costly, and prone to frequent complications.
Colovac is intended for delivery during both open and laparoscopic procedures. It is anchored above the anastomosis using an innovative vacuum-based mechanism, seamless, minimally invasive and fully reversible. Once in place, the implant covers the colon down to the anus. It remains in place until the body’s natural healing and tissue repair processes are complete (which takes approximately 2 weeks), after which it is removed manually without the need for a second surgical intervention.
The Colovac device has been tested on over 80 pigs including a randomized pig study. These extensive pre-clinical experiments successfully evaluated the safety and usability profile of Colovac.
SafeHeal is currently finalizing and validating the design of its Colovac prototypes in order get ready for clinical trials.