California-based medtech company Direct Flow Medical landed $50 million in debt financing, planning on using the new funds to support commercialization of a new transcatheter aortic valve implantation system.
Direct Flow received $35 million up front with another $15 million payable upon meeting an unspecified milestone. The company earlier this year won CE Mark approval in the European Union for its flagship TAVI device and closed a U.S. feasibility study.
Funding was provided by PDL BioPharma, a portfolio company specializing in antibody humanization patents and license agreements with life sciences companies. PDL began in 2011 to fund late-stage and private healthcare groups in order to "bring in new income generating assets from the healthcare sector," according to a press release.
Direct Flow hopes to proceed to a pivotal trial some time this year.
Direct Flow has some serious competition in the TAVI arena and is approaching the market as a relative new-comer, but the company says it can use its greenness to its advantage. Building on experiences with older TAVI systems, Direct Flow designed its device to address complaints surgeons have had with rival device makers’ products. Direct Flow’s implant features a metal-free frame and a low-profile, flexible delivery system designed to eliminate aortic regurgitation, or valve leakage, that has been associated with long-term mortality.
Direct Flow and its TAVI technology will have to face down some of the medical device industry’s largest players, including Medtronic (NYSE:MDT), Boston Scientific (NYSE:BSX), Edwards Lifesciences (NYSE:EW) and St. Jude Medical (NYSE:STJ), in order to gain share in the TAVI arena.