March 31, 2014 – Neovasc Inc.
—Successful Implantations of Neovasc’s TiaraTM Mitral Valve Also Discussed in a Session at ACC.14—
Vancouver, BC, Canada and Washington, DC, USA – March 31, 2014 – Neovasc Inc. (TSXV: NVC) today reported that final data from its COSIRA trial assessing the efficacy and safety of the Neovasc ReducerTM, a novel percutaneous device for the treatment of refractory angina, was presented on March 29, 2014 in a Featured Clinical Research Presentation at ACC.14, the American College of Cardiology 63rd Annual Scientific Session & Expo.
In November 2013, Neovasc announced topline data indicating that the COSIRA trial had met its primary endpoint, significantly improving the symptoms and functioning of patients disabled by previously untreatable refractory angina. The final study data presented at ACC.14 provides details of primary endpoint analysis and shows that patients receiving the Reducer also demonstrated potential improvement on important secondary endpoints.
The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow in the heart’s circulatory system, thereby increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure that is similar to implanting a coronary stent and is completed in approximately 20 minutes.
Dr. Stefan Verheye, Senior Interventional Cardiologist at the Antwerp Cardiovascular Center / ZNA Middelheim and Principal Investigator of the COSIRA trial, presented the COSIRA data at ACC.14. Dr. Verheye commented, “This detailed COSIRA data reinforces the topline results showing that the Reducer represents a potential breakthrough in refractory angina treatment. Many patients receiving the Neovasc Reducer were able to resume daily activities that can have a profound impact on their quality of life. The Reducer’s positive impact on multiple secondary endpoints was also encouraging. It is noteworthy that the implantation procedure is quick and uncomplicated, and to date the Reducer appears safe and well-tolerated in ongoing use.”
The presented COSIRA data showed that patients receiving the Reducer achieved a statistically significant improvement in Canadian Cardiovascular Society (CCS) angina grading scale scores (two classes or better) compared to patients receiving a sham control (p-value = 0.024). Patients treated with a Reducer were 2.3 times more likely so see an improvement of two classes or better in CCS score than the sham controls. The analysis also showed that patients treated with the Reducer showed a statistically significant improvement of one or more CCS classes compared to the sham control patients (p-value = 0.003). On the secondary endpoints, refractory angina patients implanted with the Reducer demonstrated strong signals of improvements in quality of life, total exercise duration, and anginal stability and anginal frequency scores, as well as in other measures of cardiovascular fitness, however these secondary results did not meet statistical significance. The study also demonstrated a 96.2% technical success rate and a 100% procedural success rate for Reducer implantation.
In addition, Neovasc reported that the first clinical experience with its Tiara™ product was discussed in a session at ACC.14. Dr. John Webb, Director of Interventional Cardiology at St. Paul’s Hospital in Vancouver, Canada, showed imaging and preliminary results from their first Tiara human implantations during his presentation, “Transcatheter Mitral Valve Replacement” (session 2601-18) on March 29, 2014. Neovasc has previously reported that two patients were successfully implanted with Tiara valves in cases performed under Health Canada Special Access approvals at St. Paul’s Hospital in Vancouver, Canada. The implantations were completed expediently and without complications and resulted in the complete replacement of the patients’ diseased native valves with trivial or no paravalvular leak. The patients continue to recover uneventfully at six and nine weeks post-implant. Full details of the first Tiara cases will be presented at EuroPCR in May, 2014 by Dr. Anson Cheung, St. Paul’s Hospital Professor of Surgery and Director of Cardiac Transplant.
Alexei Marko, CEO of Neovasc, commented, “We welcomed the opportunity to present comprehensive data from our COSIRA trial at ACC.14, enabling us to share our positive Reducer efficacy and safety data with leading cardiologists as we assess strategic options for commercial launch in Europe and prepare for further clinical and regulatory activities in the US. We were also pleased that the first clinical experience from the Tiara mitral valve program was discussed in this high profile setting.”
The COSIRA (Coronary Sinus Reducer for treatment of Refractory Angina) trial was a prospective, multicenter, sham-controlled, randomized, double-blinded study assessing the safety and efficacy of the Reducer in 104 patients in the European Union and Canada. Patients were randomized 1:1 between treatment and sham control arms. Its primary endpoint is a two-class improvement six months after implantation in patients’ ratings on the Canadian Cardiovascular Society (CCS) angina grading scale, a four-class functional classification that is widely used to characterize the severity of angina symptoms and disability. Only patients with severe angina, CCS Class 3 or 4, were enrolled in the COSIRA trial.
About Neovasc Inc.
Neovasc Inc. is a specialty medical device company that develops, manufactures and markets products for the rapidly growing global cardiovascular marketplace. Its products include the Neovasc Reducer™ for the treatment of refractory angina and the Tiara™ transcatheter mitral value replacement device in development for the treatment of mitral regurgitation. In addition, Neovasc’s advanced biological tissue products are widely 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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