Early stage medtech dev SafeHeal said today it has raised $7.4 million (EU €6 million) in a Series A round of financing, with funds slated to support the clinical and regulatory market access and a commercial launch.
The Paris-based company is developing the Colovac, a digestive anastomosis protection device designed to reduce complications and remove the need for ostomies in colectomy patients.
The system consists of a minimally invasive, full reversible implant that remains in place for approximately two weeks, or until tissue repair is complete, before removal.
“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”, SafeHeal CEO Karl Blohm said in a prepared statement.
Funding from the round, which was led by Sofinnova Partners, is slated to support the company’s clinical and regulatory market access program and a potential commercial launch.
“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. 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,” Sofinnova Partners managing partner Antoine Papiernik said in prepared remarks.
SafeHeal said it has already engaged in a CE Mark study for clearance in the European Union, with the device having already been tested on seven patients.
“SafeHeal is a great example of the high impact therapies we are focusing on. 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,” MD Start partner and SafeHeal co-founder Anne Osdoit said in a press release.
SafeHeal was founded in 2015 as part of the MD Start accelerator founded by Sofinnova, the company said.