SafeHeal, an early-stage medtech company specialized in digestive surgery and focused on the development of the Colovac device, announces today that it has closed a €6 million Series A financing round led by Sofinnova Partners.

Based in Paris, SafeHeal develops an innovative digestive anastomosis protection device, called Colovac, designed to reduce complications and obviate the need for ostomies for colectomy patients. This technology consists of a minimally invasive and fully reversible implant that remains in place until the body’s natural healing and tissue repair processes are complete, for approximately two weeks, after which it is removed. SafeHeal’s device has the potential to radically transform the market while significantly improve patients’ quality of life by enabling them to resume their normal life without having to bear an artificial anus and wear ostomy pouches for several months. About 270,000 colectomy patients receive an ostomy every year in Europe and the USA, representing an initial market greater than 1 billion €.

Funds raised will allow to execute SafeHeal’s clinical and regulatory market access program, followed by a focused commercial launch. The company has already begun a CE mark study and has successfully tested the device on seven patients. Attesting of its disruptive potential, SafeHeal is laureate of the Worldwide Innovation Challenge 2015 edition.

SafeHeal was founded in 2015 by MD Start, a medtech accelerator founded by Sofinnova Partners in 2008 and specialized in building companies focusing on large, unaddressed clinical needs and significant market opportunities. Prior to leading this Series A financing round, Sofinnova Partners participated to SafeHeal’s seed funding, together with MD Start.

“This investment enables us to execute our aggressive clinical and regulatory strategy, launch commercial operations once CE mark will be received and also continue investing in our R&D. We are currently recruiting patients in our First-in-Human clinical trial in France and are planning to extend the enrollment to hospitals in Germany, the UK and the US”, said Karl Blohm, CEO of SafeHeal.

“SafeHeal is a great example of the high impact therapies we are focusing on” said Anne Osdoit, Partner at MD Start and co-founder of SafeHeal, “We are thrilled to see SafeHeal maturing into its next development phase. This financing round allows them to engage in the transformation from incubation status to commercial operations”.

“We are excited to invest in SafeHeal and believe that their endoluminal bypass sheath is the most innovative disruption in the protection of colorectal anastomosis”, said Antoine Papiernik, Managing Partner at Sofinnova Partners, “This investment also demonstrates the power of our strategy allowing us to be present from incubation, with MD Start building companies from the ground up, to much larger rounds of funding to create potential worldwide leaders in their space”.