SafeHeal Raises €35M for Colovac IDE Study

SafeHeal has completed an oversubscribed €35 million Series C equity financing that will help the firm validate the clinical use of its temporary endoluminal fecal bypass system, Colovac. The product is designed to be an alternative to temporary diverting ostomy for colorectal cancer resection patients.

The proceeds leave SafeHeal well-funded to complete its IDE Pivotal study and prepare to commercially launch Colovac, according to company bigwigs. The financing led by Solar Eclipse with new investors Gideon Strategic Partners and M&L Healthcare, part of M&L Group, and returning investors Sofinnova Partners and one of the largest multinational life sciences corporations from a strategic standpoint.

“This is a very exciting time at SafeHeal as we continue to achieve a number of critical value-creating milestones in the coming months,” SafeHeal President/CEO Chris Richardson stated. “We are grateful for the continuing support from Sofinnova Partners and delighted to welcome Solar Eclipse, Gideon and M&L Healthcare, part of M&L Group as new investors. This capital raise places SafeHeal in an excellent position to continue our momentum toward FDA approval and commercialization of Colovac.”

In conjunction with the financing, Martin 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 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 two to six months. The eventual ostomy reversal requires another operation, with a second hospital stay, recovery period, and associated (potential) 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.

“The current standard of care for treatment of colon resection is associated with significant morbidity, risk of permanent stoma and reduced quality of life, driving both the clinical community and regulators to search for better treatment options. SafeHeal is addressing this significant unmet medical need with a highly novel approach,” Martin Sands said. “I believe SafeHeal’s therapeutic platform will dramatically improve quality of life and outcomes for patients with colon resections. I look forward to supporting the team to achieve multiple key milestones over the next 18 months.”

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 United States, Europe, and Asia, and has received U.S. Food and Drug Administration Breakthrough Designation status.

“We’ve been with SafeHeal since day one, when it was born out of our medtech accelerator MDStart. Our continued support in this Series C reflects a deep growing belief in their potential to revolutionize care for patients facing ostomy,” Sofinnova Partners Chairman/Managing Partner Antoine Papiernik said.

Headquartered in Paris, SafeHeal SAS and its wholly owned U.S. subsidiary SafeHeal Inc., is a clinical-stage medical device company developing Colovac, a device intended as an alternative to diverting ostomy in colorectal surgery patients. Colovac is a flexible endoluminal bypass sheath designed to reduce the contact of fecal content at the anastomotic site following colorectal surgery. The device is placed endoluminally and is fully reversible. The device remains in place for seven to 10 days, until the body’s natural healing and tissue repair processes are complete, after which it is removed during an endoscopic procedure without the need for a second surgical intervention. This enables patients to resume their normal life without the stigma and complications associated with an ostomy procedure. Colovac is an investigational device, not currently available for sale.