Direct Flow Medical is an emerging medical device company focused on the Direct Flow Medical Transcatheter Aortic Valve System, a metal-free valve that uses a polymer frame. The system is expanded with saline/contrast for assessment and repositioning, then locked in place with a quick-curing polymer; its double-ring design creates a tight seal and the valve is fully repositionable and retrievable up until polymer exchange. The low-profile, fully sheathed delivery system avoids rapid pacing and minimizes vascular complications and is commercially available in Europe for extreme-risk surgical patients. The company is progressing toward U.S. regulatory approval and is currently enrolling patients in the SALUS pivotal trial while pursuing expansion outside the U.S. Financially, Direct Flow Medical closed a $32 million financing to support the SALUS trial and international growth. The company has strengthened its commercial leadership with the appointment of Chris Richardson as Chief Commercial Officer and named Dan Rose Vice President and General Manager of EMEA to support global commercialization. Direct Flow Medical develops a transcatheter aortic valve implantation (TAVI) system designed with a metal-free frame and a low-profile, flexible delivery system intended to reduce aortic regurgitation. The company won CE Mark approval in the European Union for its flagship TAVI device and has closed a U.S. feasibility study. It has begun initial enrollment in its SALUS U.S. feasibility trial and hopes to proceed to a pivotal trial later this year. Direct Flow is positioning its relative newness as an advantage by addressing surgeon complaints about rival devices. The company faces competition from large medtech firms but is using recent regulatory and clinical milestones to support commercialization efforts. The new financing is intended to support those commercialization activities. Direct Flow Medical develops a catheter-based, percutaneous-delivered prosthetic aortic valve for transcatheter aortic valve replacement. The company is pursuing a Series C financing to fund business build-out in a large, fast-growing market sector. It has raised $40.0M to date toward a projected $42.5M Series C round. Wolverine Venture Fund announced its participation in the Series C; this marks WVF's second investment in the company, the first having occurred in 2005. Past and participating investors named in the articles include Johnson & Johnson Development Corp., Foundation Medical Partners, VantagePoint Venture Partners, ePlanet Ventures, EDF Ventures, New Leaf Venture Partners and Spray Venture Partners. The financing is intended to provide the critical funds the company needs to advance its business, according to WVF commentary. Direct Flow Medical is a Santa Rosa, Calif.-based startup developing heart implants. The company makes minimally invasive aortic-valve replacements for the heart. It raised $27 million in a second funding round. Investors in the round included Johnson & Johnson Development, Foundation Medical Partners, VantagePoint Venture Partners, ePlanet, EDF Ventures, New Leaf Venture Partners and Spray Venture Partners. The article notes the aortic-valve replacement field is booming. Competitors mentioned include JenaValve, AorTx and Sadra.

Total raised

$113M

Funding rounds

5

Latest round

Debt Financing

Latest activity

Dec 2014