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Neovasc’s Tiara(TM) transcatheter mitral valve selected as a “best” new device concept at TCT 2012 Scientific Symposium

October 23, 2012

–Researchers Presented Positive Preclinical Data That Set the Stage for
Longer-Term Tiara Studies Now Underway and Human Trials Planned for
2013–

–Researchers Also Presented Preliminary Registry Study Results Showing
Improved Clinical  Status in Refractory Angina Patients Implanted with
Neovasc Reducer(TM)–

TSX Venture Exchange: NVC

VANCOUVER, Oct. 23, 2012 /PRNewswire/ - Neovasc Inc. (TSXV: NVC) today announced that its Tiara(TM) transcatheter
mitral valve in preclinical development for the treatment of mitral
valve disease was selected for an oral presentation as a “Best” New
Device Concept for 2012 during an opening session at the 24(th) Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific
symposium, sponsored by the Cardiovascular Research Foundation.  Ten
abstracts were selected for this honor from among 1750 abstracts
submitted.  A second oral presentation of Tiara data is scheduled for
tomorrow.  Researchers are also presenting Registry data showing that
refractory angina patients implanted with the Neovasc Reducer(TM) have
demonstrated improved clinical status and had no adverse events six
months after implantation.

“This has been a very positive meeting for Neovasc as we continue to
generate positive data that support the advancement of both the Tiara
transcatheter mitral valve program and the Reducer, our device-based
therapy for patients with refractory angina,” noted Alexei Marko, CEO
of Neovasc.  “Early Registry data for the Reducer confirm that patients
exhibit significant, measurable clinical benefits post-implantation,
and the Tiara program is generating a great deal of interest as the
successful completion of our acute preclinical testing has enabled us
to begin long-term animal safety studies.  If all goes well, we
anticipate Tiara human trials will commence in 2013.”

The Tiara program is a novel solution to treat mitral valve
regurgitation, a serious and poorly served condition affecting millions
of cardiac patients.  Current treatment options are limited since
conventional surgical treatments are only appropriate for a small
percentage of these patients. Tiara is intended to provide a minimally
invasive transcatheter replacement for the mitral valve.

In the Tiara presentation, researchers concluded that initial
preclinical experience with the Tiara mitral valve was encouraging and
that implantation was feasible, relatively straightforward and has
resulted in a securely-implanted, well-functioning device that
maintained good hemodynamics in the test animals.

They reported that during these acute animal studies, the Tiara valves
were implanted successfully in 81% of the test animals, with total
procedure times ranging from 17 to 26 minutes.  In the successful
implantations, angiographic and echo imaging demonstrated excellent
function of the Tiara device, with no obstruction of the left
ventricular outflow tract, no pericardial effusion, no encroachment on
the aortic valve, no transvalvular gradients and most importantly, no
significant paravalvular leak.  Researchers also reported early results
from the first long-term animal implantations of the Tiara device,
including echocardiogram images of Tiara valves obtained  approximately
three months after implant, which demonstrated continuing good function
and integrity of the valve.  These chronic animal studies are ongoing.

At TCT 2012, researchers are also presenting new data on the Neovasc
Reducer, a novel device designed to treat the millions of patients
worldwide who suffer from refractory angina, a painful and debilitating
condition that occurs when the coronary arteries deliver an inadequate
supply of blood to the heart muscle.  The Reducer is intended to
provide relief of refractory angina symptoms by altering blood flow
through the myocardium, thereby increasing perfusion of oxygenated
blood to ischemic areas of the heart.  Placement of the Reducer is
performed using a percutaneous procedure that is similar to implanting
a coronary stent.

The Reducer has received a CE mark designation in Europe for the
treatment of refractory angina, and patients are presently being
enrolled in two open-label, multicenter, non-randomized, prospective
Registries (REDUCE-1 and REDUCE-2) to collect additional clinical data
on the product. Neovasc is also enrolling patients in the COSIRA trial,
a sham-controlled, randomized, double-blinded study designed to further
demonstrate the efficacy of the Reducer and to support additional
regulatory applications.

The Neovasc researchers reported on the experience of the first 11
patients who were implanted with the Reducer and followed for six
months or more as part of the REDUCE-1 and REDUCE-2 Registries. No
complications or cardiac adverse events were recorded in these
patients.  Clinical parameters including the patients’ angina scores
and their daily consumption of nitroglycerin were diminished
significantly six months after Reducer implantation. Additionally,
exercise stress test parameters improved, and functional imaging of
myocardial perfusion showed that blood flow in the heart improved
significantly.  Measures of left ventricular ejection fraction,
considered a key indicator of cardiac function, also improved after
Reducer implantation.

Dr. Shmuel Banai, lead author of the study and Medical Director of
Neovasc, commented, “These preliminary results from the REDUCE
Registries further confirm that implantation of the Reducer in patients
with refractory angina is safe and simple to perform.  We are
encouraged that these patients are demonstrating improvement on
multiple objective parameters of cardiac function six months after
implantation.  We look forward to analyzing additional data from the
Registries and from the COSIRA trial, which we expect to complete in
2013.”

The Neovasc TCT 2012 presentations include the following:

Interventional Innovation: Novel Therapies and the “Best” New Device
Concepts for 2012

Session IV. The Transcatheter Valve Therapy Explosion:  An Innovators
Dream Scenario
A Novel Catheter-based Mitral Valve Bio-Prosthesis: Short Term
Pre-Clinical Results
, Shmuel Banai, E. Marc Jolicoeur, Marc Schwartz, Patrick Garceau, Simon
Biner, Jean-Francois Tanguay, Raymond Cartier, Stefan Verheye,
Christopher J. White, Elazer Edelman
Oct. 22, 2012, 1:30pm

Poster Abstract Session
Heart Failure, LV Dysfunction and Shock
The Coronary Sinus Reducer – a Device Based Therapy for Refractory
Angina: Efficacy and Safety Results from the Ongoing Open Label
Registry,
Shmuel Banai, Maayan Konigstein, E. Marc Jolicoeur, Marc Schwartz, Yaron
Arbel, Stefan Verheye
Oct. 23, 2012, 8:00-10:00am

Next Generation Transcatheter Mitral Valve Therapies
Session IV. Transcatheter Mitral Valve Replacement Neovasc Tiara Program Update, Shmuel Banai, E. Marc Jolicoeur, Marc Schwartz, Patrick Garceau, Simon
Biner, Jean-Francois Tanguay, Raymond Cartier, Stefan Verheye,
Christopher J. White, Elazer Edelman                        
Oct. 24, 2012, 10:38am

About TCT
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific
symposium of the Cardiovascular Research Foundation. TCT gathers
leading medical researchers and clinicians from around the world to
present and discuss the latest developments in the field. TCT 2012 is
being held October 22-26, 2012 in Miami, FL. For more information,
visit www.tctconference.com.

About Neovasc
Neovasc Inc. is a specialty medical device company that develops,
manufactures and markets products for the rapidly growing
cardiovascular marketplace. Its products include the Neovasc Reducer(TM)
for the treatment of refractory angina, the Tiara(TM) technology in
development for the transcatheter treatment of mitral valve disease and
a line of advanced biological tissue products that are used as key
components in a variety of third-party medical products, such as
vascular surgical patches and transcatheter heart valves. For more
information, visit: www.neovasc.com.

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SOURCE Neovasc Inc.


Source: PR Newswire