|Direct Flow Medical secured up to $50 million to support its TAVI system.--Courtesy of Direct Flow Medical|
Transcatheter aortic valve developer Direct Flow Medical has nailed down up to $50 million in financing, cash that'll help it stand out in a space dominated by giants like Edwards Lifesciences ($EW) and Medtronic ($MDT).
PDL BioPharma is providing the debt financing, forking over $35 million upfront with another $15 million tied to an undisclosed milestone. With the money, Direct Flow plans to refinance its existing credit facility and amp up the marketing of its CE-marked TAVI system, a next-generation product the company said can virtually eliminate the dangerous valvular leakage that plagues other devices.
In 6-month data from its 100-patient European trial presented last week, Direct Flow's system posted not one instance of moderate or severe aortic regurgitation, a 78.6% rate of heart function improvement and 96% freedom from all-cause mortality, results the company said are unprecedented for a TAVI device.
Now, the Santa Rosa, CA, outfit is in the midst of enrollment for an FDA-approved U.S. trial, planning to study the system on 30 patients across the country with the eventual goal of securing the agency's marketing go-ahead.
In the meantime, in Europe, Direct Flow is competing with Edwards' market-leading Sapien and offerings from Medtronic, Boston Scientific ($BSX), St. Jude Medical ($STJ) and 2013 Fierce 15 winner JenaValve. But, despite a crowded market and a disparity in size of sales force, Direct Flow believes its technology outpaces the competition with its ability to pass through smaller-diameter blood vessels, giving it a chance to treat patients who otherwise couldn't tolerate a TAVI procedure.
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