Neovasc?s Cosira Clinical Trial Protocol Selected for Publication in Peer-Reviewed Journal
—Trial Further Assessing Efficacy of Neovasc
Reducer™ in Treatment of Refractory Angina Expected to
Complete Patient Enrollment in Coming Months—
—Company Also Announces Issuance of Incentive Options to
Directors, Management and Staff—
Vancouver, BC, Canada – February 28, 2013 – Neovasc
Inc. (TSXV: NVC) today announced that the clinical protocol for its
COSIRA (coronary sinus reducer for treatment of refractory angina)
trial has been published in the peer-reviewed journal Trials.
COSIRA is a double-blind, randomized, multicenter trial that is
further assessing the efficacy and safety of the Neovasc ReducerTM,
a novel percutaneous device for the treatment of refractory angina.
The COSIRA trial is currently enrolling patients in the UK, Europe
and Canada. Separately, Neovasc also announced that it has issued
new stock option grants to company directors, management and
staff.
“COSIRA was designed as a rigorous, sham-controlled study to
provide definitive evidence of the efficacy of the Reducer device,
and we are pleased that the protocol is being recognized as
noteworthy by the clinical research community,” said Shmuel
Banai, MD, Chief Medical Officer of Neovasc. “We are on
target for completion of patient enrollment in the second quarter
of 2013, with six-month follow-up data from all patients expected
to be available around year’s end.”
The Reducer has received a CE mark designation in Europe for the
treatment of refractory angina. The COSIRA trial is designed to
further demonstrate the efficacy of the Reducer and to support
additional regulatory applications. Neovasc is also following
Reducer patients in two open-label Registries being conducted in
Europe and Israel.
Neovasc CEO Alexei Marko noted, “Patient outcome data from
our pilot studies and Registry patients enrolled to date has been
very promising, and we look forward to reporting the results of the
COSIRA study in the coming months. If these results are consistent
with past experience, we will be able to move forward with the
commercialization of this exciting new product that has the
potential to help alleviate painful and debilitating symptoms in
millions of angina patients around the world who have no current
options for effective therapy.”
Separately, Neovasc announced today that its Board of Directors has
recently approved amendments to the company’s stock option
plan that, among other matters, increase the number of options
exercisable into common shares available for grant by 1,148,081.
These amendments remain subject to the approval of Neovasc
shareholders at the next annual general meeting, as well as to the
approval of the TSX Venture Exchange.
Neovasc also announced that its Board of Directors granted a total
of 855,250 stock options (the “Options”) to Neovasc
directors, management and staff. The Options have an exercise price
of $2.49, the equivalent to Neovasc’s closing market price of
$2.49 on the date of the grant. The Options will vest as follows:
(i) 350,000 immediately on the date of the grant; (ii) 152,000 on
December 31, 2013, contingent upon management achieving certain
performance milestones established by the Board of Directors; and
(iii) 353,250 of which 20% vest immediately and 20% vest on each of
the next four anniversaries of the date of grant. Of the 855,250
newly-granted Options, 502,000 have been drawn from the increased
option pool created as a result of the new stock option plan
amendments and as such, remain subject to Neovasc receiving
shareholder and TSX Venture Exchange approval prior to their
exercise.
The COSIRA article, “A phase II, sham-controlled,
double-blinded study testing the safety and efficacy of the
coronary sinus reducer in patients with refractory angina: study
protocol for a randomized controlled trial,” by Jolicoeur ME,
Banai S, Henry DT, Schwartz M, Doucet S, White JC, Edelman E, and
Verheye S, is being published in Trials 2013, 14:46,
http://www.trialsjournal.com/content/14/1/46.
About Neovasc Inc.
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™ for the treatment of refractory angina, the
Tiara™ device 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 transcatheter heart valves.
For more information, visit: www.neovasc.com.
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Posted: February 2013
