Vivasure Medical, a company developing a novel bioabsorbable technology for percutaneous vessel closure, has completed a Series C financing of €16.2m ($18.3m).
The round was led by LSP (Life Sciences Partners) of The Netherlands, investing from its LSP Health Economics Fund, and co-led by Evonik Venture Capital (Germany), alongside Panakès Partners (Italy) with returning Series A and B investors led by Fountain Healthcare Partners, Ireland.
The funding will support European commercialization of the company’s PerQseal™ technology to meet the growing demand for absorbable, percutaneous vessel closure products, as well as execution of a U.S. Food and Drug Administration (FDA) regulatory study.
The Vivasure Closure Device is the first product from the company’s PerQseal™ technology platform, and is the only approved fully bioabsorbable, sutureless and entirely synthetic option to close large-bore arteriotomies that result from percutaneous transcatheter procedures, including transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR).
The device has been successfully evaluated in clinical studies, with patients treated in four European countries, achieving 97 percent device technical success with no major device related complications.
Long-term follow-up data has been collected to 12 months post-procedure, and CE Mark was received in January 2016. The global market for large arteriotomy closure devices is growing rapidly and is expected to be more than $500 million by 2021.
“Patients with aortic valve stenosis, abdominal aortic aneurysms and other serious conditions are increasingly treated with minimally invasive percutaneous procedures,” said Gerard Brett, co-founder and CEO of Vivasure Medical.
“The Vivasure closure device is designed to be easy to use, allowing the surgeon and interventional physician to provide a complete repair at the access site, without leaving metal implants, sutures, or exogenous tissue behind. Our goal is to facilitate improved therapeutic results for patients over the open-surgery alternative, faster recovery times, and cost savings for the healthcare system.”
“We are excited to support this innovative company and its vision of improving outcomes for patients as it moves into commercialization in the European Union and enters the United States,” said Anne Portwich, partner, LSP.
“We look forward to working closely with Vivasure as the company continues to work toward gathering more data through clinical studies that will facilitate expansion of adoption in European markets and drive U.S. approval and commercialization of its first product.”
An arteriotomy is a puncture hole in a vessel in the groin that provides access to arteries for catheter-based procedures. The proprietary Vivasure closure device offers physicians an easy-to-use and fully percutaneous (through the skin) alternative to surgical cut-down and sutured repair via a 3- to 5- centimeter incision for large-bore arteriotomies.
Based in Galway, Ireland, Vivasure Medical has developed a patented bioabsorbable implant platform technology for applications in vessel closure.