Direct Flow Medical Raises $27 Million and Initiates European Clinical Trial

SANTA ROSA, Calif.--(BUSINESS WIRE)--Direct Flow Medical, Inc., [www.directflowmedical.com] a privately held, medical device company developing a next generation, minimally invasive implant to treat patients with heart valve disease, announced today the completion of its Series B financing and the initiation of clinical trials in Europe. The Company has developed a catheter-based system to replace the aortic valve percutaneously in patients with valvular disease. The investigational device is an implantable pericardial tissue valve that allows simple delivery via a transfemoral approach. Its easy positioning (or repositioning) and retrieval features are intended to enable physicians to correctly size and place the device in its targeted location providing a new level of safety for patients. The design also is intended to allow the physician to obtain full hemodynamic data and imaging prior to final device placement.

“The trackability and ease of delivery of the Direct Flow Medical system due to its non-metallic construct will allow true percutaneous delivery in the future. We are very excited by the potential of this system and look forward to being involved in the rigorous initial clinical evaluation of the device”

Johnson & Johnson Development Corporation and Foundation Medical Partners co-led the $27 million second round of financing and were joined by new co-investors, VantagePoint Venture Partners and ePlanet as well as existing investors, EDF Ventures, New Leaf Venture Partners and Spray Venture Partners.

“The Company has a truly unique and proprietary design in what has become one of the most exciting new markets for cardiac device development. The capital raised will allow the team at Direct Flow Medical to expand upon the significant progress they have achieved to date and to complete the clinical feasibility phase of device evaluation,” stated Lee Wrubel, MD, General Partner, Foundation Medical. Both Dr. Wrubel and Dr. Brad Vale, Vice President, Johnson & Johnson Development Corporation have joined the Company’s Board of Directors.

The Company also announced that it commenced its European clinical trial with the first device implanted 3 weeks ago in an 81 - year old, non-operative patient at the University Heart Center Hamburg under the direction of Professor Joachim Schofer, a recognized expert in interventional cardiology and Professor Hermann Reichenspurner, Chief of Cardiac Surgery. The device was delivered in the cardiac catheter lab via the femoral artery by Prof. Schofer. Monitoring the initial clinical case were Dr. Reginald Low, an interventional cardiologist at University of California, Davis and Dr. Steven Bolling, a cardiac surgeon at the University of Michigan. All of the attending clinicians agreed that the most important features of the device were its ability to function immediately upon expansion, allowing the patient to be hemodynamically stable throughout the procedure and that there were no perivalvular leaks with this unique product.

“The trackability and ease of delivery of the Direct Flow Medical system due to its non-metallic construct will allow true percutaneous delivery in the future. We are very excited by the potential of this system and look forward to being involved in the rigorous initial clinical evaluation of the device,” stated Prof. Schofer. “The ability to offer our patients with aortic valve disease that are not candidates for surgical valve replacement this unique treatment option is of significant clinical benefit,” said Prof. Reichenspurner.

About Direct Flow Medical, Inc.

Direct Flow Medical was founded in 2004 by Gordon Bishop and Randy Lashinski. The Company is headquartered in Santa Rosa, California and currently employs 25 people. Direct Flow Medical was initially funded by EDF Ventures in 2004 and completed its Series A round of private equity financing in August 2005 which was co-led by Spray Venture Partners and New Leaf Venture Partners.