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

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Tue May 19, 2009 7:51pm EDT

SANTA ROSA, Calif.--(Business Wire)--
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. 







Direct Flow Medical, Inc.
Bernard E. Lyons, Ph.D., President/CEO, 707-576-0420 

Copyright Business Wire 2009

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