Direct Flow Medical® Announces Fifth Patent Issuance of Their Unique Percutaneous Aortic Valve Technology

Santa Rosa, California, May 19, 2009 – Direct Flow Medical®, Inc. a privately held, emerging medical device Company developing a next generation, minimally invasive implant to treat patients with heart valve disease announced today the issuance of its 5th patent on their Percutaneous Aortic Valve (PAV) Technology. The patent (USP# 7,534,259) entitled: “Nonstented Heart Valves with Formed in situ Support” provides further protection for this second generation PAV device.

The Direct Flow Medical PAV System is a non-metallic, expandable cuff, bovine pericardial tissue valve that allows the physician to assess the hemodynamic outcomes prior to final deployment of the device. The unique and easily 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 delighted that we continue to receive significant protection for our second generation PAV technology,” stated Bernard Lyons, President & CEO. “The unique design features of our device have now been awarded key claims regarding controlled deployment, positioning and retrieval. In addition to a major clinical advantage of the Direct Flow Medical PAV system that allows placement without hemodynamic compromise, our device is immediately competent upon the inflation of the initial ring in the left ventricle.” Added Lyons: “We are most pleased with the progress we have made in the last 12 months with three new patents issued and another allowed which is a testament to the counsel and guidance of our patent attorneys at Knobbe, Martens, Olsen & Bear, LLP, led by Gerard von Hoffman.”

The Company‟s comprehensive intellectual property strategy has been built on the seminal patent issued to inventor and world renowned pioneer in interventional cardiology and treatment of valvular disease, Dr. Peter Block, Emory University. This patent (USP# 5,554,185) entitled: “Inflatable Prosthetic Cardiovascular Valve for Percutaneous Translumenal Implantation of Same” was issued in 1996 and was assigned exclusively to Direct Flow Medical upon its founding in 2004. The ’185 Block patent represents one of the earliest innovations in the fast emerging space of transcatheter aortic valve implantation ( TAVI). “I am excited that the Company‟s Founders, Randy Lashinski and Gordon Bishop, have continued to advance my original invention and moreover, that the Company has rapidly progressed in its clinical assessment of this unique second generation technology in humans,” stated Dr. Block. “The Company‟s recent announcement of the first human use of the first ever repositionable and retrievable 18F system is a major advancement to the field.”

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 approximately 65 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 as its placement and security in an annulus is not dependent on calcium. Direct Flow Medical has raised a total of $35M to date and is funded by EDF Ventures, New Leaf Venture Partners, Spray Venture Partners, Foundation Medical Partners, Johnson & Johnson Development Corporation, VantagePoint Venture Partners and ePlanet Ventures.

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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