Direct Flow Medical® Announces Key Addition to Management Team and Ninth Patent Issuance

Santa Rosa, California, May 5, 2011 Direct Flow Medical®, Inc. (www.directflowmedical.com) a privately held, emerging medical device company developing a next generation, minimally invasive implant to treat patients with heart valve disease announced today the appointment of Mr. David R. Elizondo as the Company’s Chief Development Officer and the issuance of its 9th patent on their Transcatheter Aortic Valve Replacement (TAVR) Technology.

The Direct Flow Medical TAVR System is a non-metallic, expandable cuff, bovine pericardial tissue valve that allows the physician to position and/or reposition the device in order to assess the hemodynamic outcomes prior to final device deployment. The unique and repositionable “stentless” valve conforms to the native annulus resulting in tight sealing of the valve which minimizes any paravalvular leaks. The reduction of aortic insufficiency is believed to improve clinical status in these high risk patients with significant co-morbidities including coronary heart disease and congestive heart failure.

“We are extremely excited to have David join our team and lead the development organization through the next phase of growth. The Company is completing the development of its next generation (18F) device and will begin its CE Mark Trial in the second half of 2011. As we transition into our clinical and regulatory phase, this time is critical in a start up organization. Our ability to attract someone of David’s management talent and industry experience is very important to our ongoing success,” stated Gordon Bishop, Co-Founder and Chief Technology Officer. Mr. Elizondo was previously Vice President Research & Development and General Manager of Tissue Valve Operations at ATS Medical in Minneapolis after successful roles in R&D and Business Development at Boston Scientific Corporation. Mr. Elizondo has a B.S. and M.S. in Biomedical Engineering from the Milwaukee School of Engineering and the University of Iowa, respectively, and started his career as a research engineer at St. Jude Medical in their heart valve group.

Further, Direct Flow Medical, Inc. was recently awarded a 9th USA patent (USP# 7,935,144) entitled: “Profile Reduction of Valve Implant.” This patent provides significant additional coverage for this unique platform technology which has the potential to be the lowest profile device in the TAVR market. “The breadth and depth of our intellectual patent portfolio is unparalleled. Our second generation TAVR technology is clearly differentiated from any other device in this exciting new market,” said Mr. Bishop.

“I am very impressed with the Company’s unique product design, excellent clinical results out beyond 3 years and strong management team. I look forward to working with Gordon Bishop and the entire team at Direct Flow Medical to improve upon the impressive, initial clinical results with this technology and bring the latest commercial design of the 18F system to the market,” stated Mr. Elizondo./p>

About Direct Flow Medical, Inc.
Founded in 2004, the Company is headquartered in Santa Rosa, California, has a second manufacturing facility in Lake Forest, CA and employs 75 people. The Company’s unique implant design is not limited to aortic valve disease but is readily applicable to mitral and other heart valve anatomical sites. Direct Flow Medical has raised 3 rounds of funding to date with the following investors: EDF Ventures, New Leaf Venture Partners, Spray Venture Partners, Foundation Medical Partners, VantagePoint Venture Partners, ePlanet Venture Partners and strategic corporate investors.

Contact: Ashlee Hollen, Direct Flow Medical, Inc., (707) 576-0420 ext. 202 or ahollen@directflowmedical.com

The Direct Flow Medical Transcatheter Aortic Valve System is an investigation device, limited by applicable law to investigational use and not available for sale.

 

The information on this site is only intended for health care providers in certain markets outside the United States (US) where the Direct Flow Medical Trancatheter Aortic Valve Replacement System is approved for use as indicated by the instructions for use. The information on this page is not intended for health care providers in the US or US health care institutions as this site contains information about a product that is limited by US law to investigational use.

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