SafeHeal completed a €35 million (approximately $40 million) Series C equity financing to validate the use of Colovac, a temporary endoluminal fecal bypass system intended as an alternative to temporary diverting ostomy for patients undergoing colorectal cancer resection.
The company said it will use the funds to complete its IDE Pivotal study and accelerate preparation for commercial launch of Colovac.
In conjunction with the financing, Martin Sands and Steven Sands of Solar Eclipse will join as board member and observer respectively.
The Colovac endoluminal bypass system is a less-invasive alternative to temporary diverting ostomy, the current standard of care for patients undergoing colorectal resection. Diverting ostomy is applied prophylactically to most patients today undergoing a low anterior resection (LAR) and anastomosis. The ostomy temporarily diverts the stool away from the healing anastomosis to the outside of the body and into an ostomy bag. In most cases, the ostomy is needed only until the anastomosis has healed, and then it can be reversed, typically after 2-6 months. The eventual reversal of the ostomy requires another operation, with a second hospital stay, recovery period and associated complications. In some cases, the ostomy may not be reversed and becomes permanent. In addition to the potential surgical complications associated with ostomy procedures, patients may experience an impact to their quality of life due to social isolation, reduced physical activity and/or intimacy.
Colovac is an alternative to diverting ostomy, designed to eliminate the need for a temporary stoma in most patients. It aims to improve patient recovery and quality of life by eliminating stoma related complications including permanent stoma and eliminating the physical and emotional burden associated with stoma management and care.
Colovac has been successfully studied in more than 100 patients in the U.S., Europe, and Asia and has received FDA Breakthrough Designation status.
