Direct Flow Medical said today that it landed a $32 million funding round for its replacement heart valve technology and tapped a 25-year medical device veteran, Chris Richardson, to lead its commercialization program.
Santa Rosa, Calif.-based Direct Flow said the funding round includes a $17 million equity investment led by new backers SV Life Sciences and an unnamed strategic investor. The remaining $15 million comes from the 2nd tranche of a $50 million loan from PDL BioPharma, the company said.
Direct Flow won CE Mark approval in the European Union last October for its transcatheter aortic valve implant for patients at extreme risk for open heart surgery, after 1st winning a CE Mark in January 2013. The company won FDA approval for a U.S. pivotal trial in May.
Today the company said it plans to use the proceeds from its latest round to complete that trial, the Salus study, and "fuel growth of the Direct Flow Medical system outside of the U.S.”
“Direct Flow Medical has developed a true, 2nd-generation transcatheter aortic replacement system that solves many of the clinical issues associated with earlier devices. This platform technology is not only applicable to the treatment of aortic stenosis, but also holds tremendous promise for the treatment of aortic insufficiency and mitral disease," chairman Paul LaViolette, a managing director at SV LifeSciences, said in prepared remarks. "SV Life Sciences is pleased to join the existing group of investors at Direct Flow Medical and provide the capital necessary to build the company’s global business in 2015 and beyond."
Richardson’s pedigree includes a stint as general manager at Abbott Vascular’s structural heart business after Abbott (NYSE:ABT) in 2009 snapped up Evalve and its MitraClip device in a deal worth up to $410 million. He was also an area vice president for Boston Scientific‘s (NYSE:BSX) cardiac rhythm management unit and held positions at Guidant, Heartport and Devices for Vascular Intervention, according to a press release.
"We strive to strengthen our management team at key inflection points in the company’s lifespan, and Chris joins us at a time of rapid growth," Direct Flow president & CEO Bernard Lyons said in a statement. "We are excited to add his expertise and experience to our leadership team as we continue to expand our market share in Europe and focus on enrollment for the Salus pivotal trial in the U.S."
Direct Flow also said it promoted Dan Rose to EMEA vice president & general manager.