Registry Data Presented at EuroPCR 2013 Confirms the Neovasc Reducer™ Improves Cardiovascular Parameters in Refractory Angina Patients
-Initial Data from Patient Registries Shows the Reducer Significantly Improves Angina Scores at Six Months Post-Implantation-
TSX Venture Exchange: NVC
PARIS and VANCOUVER, May 21, 2013 /CNW/ - Neovasc Inc. (TSXV: NVC), a developer of novel technologies to treat vascular disease, today reported initial data from open label patient Registries that are tracking the progress of refractory angina patients implanted with the Neovasc ReducerTM, a novel percutaneous device that is CE marked in the European Union for the treatment of refractory angina. The data were presented at EuroPCR 2013, the annual meeting of the European Association for Percutaneous Cardiovascular Interventions.
Neovasc Medical Director Professor Shmuel Banai, who is also Associate Professor of Medicine and Cardiology at Tel Aviv University's Sackler School of Medicine and Director of Interventional Cardiology at Tel Aviv Medical Center, presented six-month follow up data from 15 Registry patients showing that their angina and physical disability were significantly improved after Reducer implantation. Among other measures, patients were assessed on the Canadian Cardiovascular Society (CCS) grading scale, which is widely used to describe and classify the severity of effort-related angina. Despite the small size of this sample, the change in CCS scores was highly statistically significant compared to baseline (p=<.001). Patient subsets who received stress thallium and echo dobutamine testing also showed significant improvement with the Neovasc Reducer.
Professor Banai commented, "We consider these results very encouraging. In these initial Registry patients, quality of life improved as average angina scores were substantially reduced, signalling a significant improvement in their ability to engage in daily activities without limiting chest pain. We also are seeing significant improvements in stress-related objective imaging measures, as well as trends suggesting that improvements in treadmill stress testing results will reach significance as our Registry population continues to grow. Consistent with other experience to date, the Reducer appears very safe, with no reports of serious safety issues."
The Neovasc Reducer is a percutaneous device designed to treat patients who suffer from refractory angina, which occurs when there is an inadequate supply of blood to the heart muscle. Refractory angina affects millions of patients worldwide. These patients experience severe chest pain from even minor physical exertion, and therefore lead restricted lives. The Reducer provides relief from symptoms by altering blood flow in the coronary sinus vein and thereby increasing perfusion of oxygenated blood to certain areas of the heart muscle. The Reducer is inserted using a percutaneous procedure that is similar to implanting a stent and takes less than 20 minutes.
Neovasc CEO Alexei Marko noted, "These promising data from Reducer Registry patients are consistent with previous studies, which showed that refractory angina patients receiving the Reducer continued to show improvements in angina-related symptoms three years post-implantation. We expect definitive data from our COSIRA study in the coming months, which should enable us to plan for broader commercialization in Europe and to further assess options for regulatory review and commercialization in the U.S."
Professor Banai presented "The Coronary Sinus Reducer--a Device Based Therapy for Refractory Angina: Efficacy and Safety Results from the Ongoing Open Label Registry," at the Outcome in Contemporary Coronary Intervention session held today at EuroPCR from 12:30 - 2:00pm.
EuroPCR is the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions. EuroPCR 2013 is being held in Paris, France May 21-24, 2013. For information, visit www.europcr.com.
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 valve 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.
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.