Quantcast
Last updated on April 17, 2014 at 8:20 EDT

Neovasc’s COSIRA clinical trial protocol selected for publication in peer-reviewed journal

February 28, 2013

-Trial Further Assessing Efficacy of Neovasc Reducer(TM) 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-

TSX Venture Exchange: NVC

VANCOUVER, Feb. 28, 2013 /PRNewswire/ - 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 Reducer(TM), 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(TM)
for the treatment of refractory angina, the Tiara(TM) 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.

Statements contained herein that are not based on historical or current
fact, including without limitation statements containing the words
“anticipates,” “believes,” “may,” “continues,” “estimates,” “expects,”
and “will” and words of similar import, constitute “forward-looking
statements” within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995. Such forward looking statements involve
known and unknown risks, uncertainties and other factors that may cause
the actual results, events or developments to be materially different
from any future results, events or developments expressed or implied by
such forward-looking statements. Such factors include, among others,
the following: general economic and business conditions, both
nationally and in the regions in which the Company operates; history of
losses and lack of and uncertainty of revenues, ability to obtain
required financing, receipt of regulatory approval of product
candidates, ability to properly integrate newly acquired businesses,
technology changes; competition; changes in business strategy or
development plans; the ability to attract and retain qualified
personnel; existing governmental regulations and changes in, or the
failure to comply with, governmental regulations; liability and other
claims asserted against the Company; and other factors referenced in
the Company’s filings with Canadian securities regulators. Although the
Company believes that expectations conveyed by the forward-looking
statements are reasonable based on the information available to it on
the date such statements were made, no assurances can be given as to
the future results, approvals or achievements. Given these
uncertainties, readers are cautioned not to place undue reliance on
such forward-looking statements. The Company does not assume the
obligation to update any forward-looking statements except as otherwise
required by applicable law.

SOURCE Neovasc Inc.


Source: PR Newswire