SafeHeal, a leading innovator in the field of digestive surgery and developer of the Colovac device, announced today a successful 40M€ financing, co-led by Sofinnova Partners and Genesis MedTech Group. Sofinnova Partners is a leading venture capital firm based in Paris, London, and Milan and a historic shareholder in the company. Genesis MedTech is a medical device company headquartered in Singapore.
SafeHeal’s Colovac device is a temporary flexible endoluminal bypass sheath used for patients undergoing colectomies. It is designed to eliminate the need for diverting ostomies, the current standard of care. The Colovac solution addresses the most serious complication of colorectal surgery – anastomotic leakage, the leaking of fecal content in the abdominal cavity, which can lead to sepsis or even death. Leakage is typically managed by placing a diverting ostomy to protect the surgical anastomosis during healing and is surgically closed 3 to 6 months after the initial surgery. Colovac is a temporary endoluminal anastomosis protection device, placed in lieu of the ostomy, and removed endoscopically after 10 days. If the patient is leak-free at that time, he or she can resume a normal life, without the need for a diverting ostomy, representing a significant improvement to the recovery process and quality of life.
Following the positive outcomes of its first clinical studies, SafeHeal will use the proceeds from this financing to accelerate the company’s investigational device exemption (IDE) pivotal clinical trial, SAFE-2, for which initiation has already been approved by the United States Food and Drug Administration (FDA). SAFE-2 is a prospective, randomized pivotal study, that will be conducted at leading medical centers in the U.S. and Europe and aims to evaluate the safety and efficacy of Colovac to support future regulatory approval in the U.S.