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.
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.
Posted: February 2013