At Medlatest we’re avid followers of Direct Flow Medical with its unique “inflatable ring” transcatheter aortic valve, which obviates the need for a metallic scaffold and claims to achieve among the lowest levels of paravalvular leakage post-implantation. Now the company has received a significant cash injection that should help its progress towards FDA approval.
Direct Flow Medical’s receipt of $50 million investment comes from PDL Biopharma, a company with its roots in antibody patents, but a strategy to bring in alternative, new income generating assets from the healthcare sector. It’s doing this by providing non-dilutive growth capital and financing solutions to companies like Direct Flow Medical, on this occasion two tranches of $35 million and $15 million respectively.
Direct Flow Medical has been making steady progress, both with its European approvals, but also on the long road to U.S. approval. Now, with its newly flush bank balance the company is hoping to build on what it has achieved thus far, doubling its global workforce to more than 300, and expanding R&D efforts at its Santa Rosa facility.
Top of the list for the company now is its pivotal trial, which once complete will pave the way for U.S. FDA approval. That trial requires FDA’s nod to commence, but Direct Flow’s recently completed six site U.S. trial of 30 patients could mean the FDA will look favourably on the company’s new study.
CEO Bernard Lyons said; “It really puts us on great financial footing for an expansion that we need, both in Europe and for the U.S. trial, which we hope to commence in the second quarter of this year. We are well capitalized.”
Source: Direct Flow Medical, Inc., North Bay Business Journal