PARIS & TAMPA, Fla. — SafeHeal, a medical technology company specializing in colorectal cancer surgery, has closed an oversubscribed €35 million Series C equity financing round to support the continued development and commercialization of its flagship device, Colovac. The funding will enable the company to complete its ongoing pivotal clinical trial under the FDA’s Investigational Device Exemption (IDE) pathway and prepare for a commercial launch.
The round was led by Solar Eclipse, with new participation from Gideon Strategic Partners and M&L Healthcare, a division of the M&L Group. Returning investors included Sofinnova Partners and a major multinational life sciences corporation. As part of the deal, Martin Sands of Solar Eclipse will join SafeHeal’s board, while Steven Sands will serve as a board observer.
Colovac is a temporary endoluminal bypass device designed to offer a less-invasive alternative to the current standard of care for patients undergoing colorectal resection: temporary diverting ostomy. While a diverting ostomy is commonly used to protect the healing surgical site by rerouting waste into an external ostomy bag, it requires a second surgery to reverse the procedure. In some cases, the ostomy becomes permanent, leading to complications and a significant impact on a patient’s quality of life.
SafeHeal’s Colovac system is intended to eliminate the need for a temporary stoma in most patients by internally diverting waste away from the surgical site during the critical healing phase. The technology has been tested in over 100 patients across the U.S., Europe, and Asia and has received Breakthrough Device Designation from the U.S. Food and Drug Administration.
“This is a very exciting time at SafeHeal as we continue to reach key milestones,” said Chris Richardson, President and CEO of SafeHeal. “The strong support from our new and existing investors puts us in a strong position to drive toward FDA approval and ultimately bring Colovac to market to improve outcomes for patients.”
Investors expressed strong confidence in the company’s potential to transform care for colorectal surgery patients. “The current standard of care poses significant risks and long-term burdens for patients,” said Martin Sands of Solar Eclipse. “SafeHeal’s technology addresses a critical need with a truly novel solution. We’re excited to support their journey toward regulatory and commercial success.”
Antoine Papiernik, Chairman and Managing Partner at Sofinnova Partners, added, “We’ve supported SafeHeal since its inception through our medtech accelerator MDStart. Our continued investment reflects our belief in the company’s potential to redefine care for patients facing ostomy.”
With this latest round of funding, SafeHeal is positioned to accelerate the final stages of clinical development and bring its innovative solution to market, offering patients a new path to recovery that avoids the physical and emotional burden of a stoma.
