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.
Proceeds will support the completion of SafeHeal's IDE pivotal study and preparation for commercial launch of their lead technology, Colovac®.
SafeHeal®, a leading innovator in the field of colorectal cancer surgery, today announced a successful completion of an oversubscribed €35 million Series C equity financing to validate the use of Colovac, a groundbreaking temporary endoluminal fecal bypass system. Colovac is intended as an alternative to temporary diverting ostomy for patients undergoing colorectal cancer resection.
The proceeds leave SafeHeal well-funded to complete its IDE Pivotal study and accelerate preparation for commercial launch of their lead technology, 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 over 100 patients in the U.S., Europe, and Asia and has received FDA Breakthrough Designation status.
"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. "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."
"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," said Martin Sands of Solar Eclipse. "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."
"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.
About SafeHeal®
SafeHeal SAS, headquartered in Paris, France, 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 patients undergoing colorectal surgery. 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 7-10 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. For more information, please visit www.safeheal.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250430262559/en/
Contacts:
Media Contacts
USA
Scott DePierro, Vice President U.S. Operations and Global Business Development, SafeHeal
203-444-0279
sdepierro@safeheal.com
www.safeheal.com
Europe
Karl-Heinz Blohm, Vice President, International, SafeHeal
+33 (0) 6 5181 7895
kblohm@safeheal.com
www.safeheal.com
