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CardiAQ Valve Technologies Reports Cardiovascular Medicine Milestone: First-in-Human Nonsurgical Percutaneous Implantation of a Bioprosthetic Mitral Heart Valve

June 15, 2012 By AxoGen, Inc.

IRVINE, Calif.–(BUSINESS
WIRE
)–CardiAQ Valve Technologies (CardiAQ), which has developed the
world’s first self-conforming and self-anchoring technology for nonsurgical
Transcatheter Mitral Valve Implantation (TMVI), today announced that the
Company has achieved a cardiovascular medicine milestone: a bioprosthetic
mitral heart valve was successfully implanted as a compassionate treatment into
an 86-year-old male suffering from severe mitral regurgitation (MR 4+). The
breakthrough TMVI procedure was performed on June 12, 2012, at The Heart
Centre, Rigshospitalet University Hospital,
Copenhagen, Denmark, by interventional
cardiologists Lars Søndergaard, M.D., and Olaf Franzen, M.D., cardiovascular
surgeon Susanne Holme, M.D., anesthesiologist Peter Bo Hansen, M.D., and
echocardiographer Nikolaj Ihlemann, M.D.

“Our TMVI system is designed to make nonsurgical mitral
heart valve replacement a future alternative to open-heart surgical replacement
and repair,” said Rob Michiels, CEO of CardiAQ Valve Technologies. “CardiAQ is
currently the only transcatheter-transvessel implantation approach to treating
MR. While several companies have been trying to perfect a percutaneous approach
to repair the mitral valve, we believe that such technologies will have a very
difficult time demonstrating sufficient efficacy in treating such a
heterogeneous disease,” added Michiels. “CardiAQ’s nonsurgical valve
implantation approach is designed to become a disruptive technology with a much
broader application.”

“CardiAQ has focused on replacement or implantation—not
repair—for three reasons: Replacement of the diseased mitral valve offers (1)
the best chance of eliminating regurgitation, (2) the widest applicability
across patient and disease variations, and (3) can be made into a simple, fast,
straightforward interventional—i.e., nonsurgical—procedure,” said Brent Ratz,
co-founder and COO.

“As cardiac surgeons, we are taught that residual mitral
regurgitation will only lead to more mitral regurgitation and progressive
symptoms. That is why we have focused our efforts on developing a replacement
technology with the potential to eliminate clinically significant MR, not just
reduce it,” said Arshad Quadri, M.D., chairman, founder/inventor and CMO of
CardiAQ. “Moreover, many of these inoperable patients suffer from functional MR,
which is actually a result of ventricular dilatation. CardiAQ’s chordal-sparing
approach, combined with its unique anchoring system, provides what can best be
described as a ‘face-lift for the heart’ that may also help promote positive
remodeling of the ventricle.”

About CardiAQ Valve Technologies

Privately held CardiAQ, headquartered in Irvine,
Calif., has developed a
proprietary system for Transcatheter Mitral Valve Implantation (TMVI). Through
the combination of a unique anchoring mechanism and a novel delivery catheter,
physicians will be able to accurately and securely implant a new mitral valve
within a beating heart, thus avoiding open-heart surgery. The CardiAQ procedure
is designed to be performed in a cardiac catheterization laboratory or hybrid
operating room. Ultimately the procedure will be similar to angioplasty or
stenting, resulting in less trauma to the patient and substantial potential
cost-savings to the healthcare system.

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