Transcatheter heart valve innovator Direct Flow Medical®, Inc., has announced the closing of a new round of financing for the company totaling $32 million.
The unique Direct Flow Medical Transcatheter Aortic Valve System is commercially available in Europe, while in the U.S., the company is progressing towards regulatory approval and is currently enrolling patients in its SALUS pivotal trial. Proceeds of the new investment round will be used to complete the U.S. SALUS pivotal trial and fuel growth of the Direct Flow Medical system outside of the U.S.
The new financing of $32 million includes $17 million in private equity, led by new investor SV Life Sciences and a new strategic investor, and the second tranche of a $50 million debt facility from PDL BioPharma worth $15 million.
The company has also announced the appointment of Chris Richardson as its first Chief Commercial Officer to support global growth. Chris Richardson has spent his 25‐year career taking cardiac startup companies from the clinical trial phase through worldwide commercialization and into acquisition.
Prior to joining Direct Flow Medical, Mr Richardson was General Manager at Abbott Vascular Structural Heart, a global company focused on percutaneous mitral valve repair, having joined Abbott through its acquisition of Evalve. Before Evalve, he was Area Vice President for the U.S. at Boston Scientific in its Cardiac Rhythm Management business.
“Direct Flow Medical has developed a true, second‐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,” said Paul LaViolette, Direct Flow Medical Chairman and Managing Director of SV LifeSciences. “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.”
About the appointment of Chris Richardson, Bernard E. Lyons, PhD, Direct Flow President and Chief Executive Officer said; “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. 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.”
Source: Direct Flow Medical, Inc.