SafeHeal, a clinical-stage medical device company focused on innovations in colorectal cancer surgery, has successfully completed an oversubscribed €35 million Series C equity financing round. The funding will support the final stages of development for Colovac, a groundbreaking temporary endoluminal fecal bypass system designed as an alternative to temporary diverting ostomy for patients undergoing colorectal cancer resection.
The financing round was led by Solar Eclipse, with participation from new investors Gideon Strategic Partners and M&L Healthcare (part of M&L Group), alongside returning investor Sofinnova Partners and a major multinational life sciences corporation. As part of the transaction, Martin Sands and Steven Sands of Solar Eclipse will join SafeHeal as board member and observer, respectively.
Addressing a Critical Unmet Need in Colorectal Surgery
Temporary diverting ostomy is currently the standard of care for patients undergoing low anterior resection (LAR) and anastomosis in colorectal surgery. This procedure diverts stool away from the healing anastomosis to an external ostomy bag, typically for 2-6 months until healing is complete. Patients then require a second surgery to reverse the ostomy, resulting in additional hospitalization, recovery time, and potential complications. In some cases, temporary ostomies become permanent.
"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," explained Martin Sands of Solar Eclipse. "SafeHeal is addressing this significant unmet medical need with a highly novel approach."
Beyond the surgical complications, patients with ostomies often experience reduced quality of life due to social isolation, limited physical activity, and intimacy challenges.
How Colovac Works
Colovac offers a less-invasive alternative to diverting ostomy. The flexible endoluminal bypass sheath reduces contact between fecal content and the anastomotic site following colorectal surgery. The device is placed endoluminally and remains in place for 7-10 days while the body's natural healing processes occur. It is then removed during an endoscopic procedure, eliminating the need for a second surgical intervention.
This innovative approach aims to improve patient recovery and quality of life by eliminating stoma-related complications and the physical and emotional burden associated with stoma management and care.
Clinical Progress and Regulatory Status
Colovac has already been studied in over 100 patients across the U.S., Europe, and Asia, demonstrating promising results. The technology has received FDA Breakthrough Designation status, highlighting its potential to address this significant medical need.
"This is a very exciting time at SafeHeal as we continue to achieve a number of critical value-creating milestones in the coming months," said Chris Richardson, President and Chief Executive Officer of SafeHeal. "This capital raise places SafeHeal in an excellent position to continue our momentum toward FDA approval and commercialization of Colovac."
Long-term Support and Vision
Sofinnova Partners, which has supported SafeHeal since its inception through the Medtech accelerator MDStart, continues to back the company in this latest funding round.
"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," said Antoine Papiernik, Chairman and Managing Partner at Sofinnova Partners.
Path to Commercialization
The proceeds from this financing round will support the completion of SafeHeal's IDE pivotal study, a critical step toward obtaining regulatory approval. Additionally, the funding will accelerate preparations for the commercial launch of Colovac.
Martin Sands of Solar Eclipse expressed optimism about the company's future: "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."
SafeHeal is headquartered in Paris, France, with a wholly owned U.S. subsidiary, SafeHeal Inc. The company is focused on bringing Colovac to market as an investigational device that could potentially transform the standard of care for patients undergoing colorectal surgery.
