-- Data Presented at the American College of Cardiology 2010 Annual Meeting Suggests Treatment with the Neovasc Reducer Is Safe and Improves Angina Symptoms for at Least Three Years --
TSX Venture Exchange: NVC
VANCOUVER and ATLANTA, March 16 /CNW/ - Neovasc Inc. (TSXV: NVC), a developer of novel technologies used to treat vascular disease, today presented results from the follow-up phase of the initial clinical trial of its Neovasc Reducer(TM) product at the American College of Cardiology 2010 annual meeting. The Neovasc Reducer is a novel implantable product designed to treat heart disease patients who suffer from refractory angina. The new data shows that three years after implantation of the Reducer, the majority of patients continued to show measurable improvement in angina symptoms. These three-year results build on the positive six-month data previously reported in the Journal of the American College of Cardiology.*
Refractory angina is a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle. It currently affects over two million patients worldwide, who typically lead severely restricted lives, and its incidence is growing. Current treatment options are limited.
The Neovasc Reducer is a unique device that is implanted in the coronary sinus vein. The Reducer is intended to provide relief of refractory angina symptoms by modulating blood flow in the coronary sinus and thereby increasing perfusion of oxygenated blood to areas of the heart muscle were it is most needed. Implantation of the Reducer is performed using a minimally invasive percutaneous procedure that is similar to implanting a coronary stent and takes approximately 20 minutes.
"The results from the Reducer three-year follow-up study confirm the positive data seen in the initial trial and are very promising," said Dr. Shmuel Banai, principal investigator of the study and medical director of Neovasc, who presented the data at the ACC meeting. "We are encouraged by the continuing excellent safety profile of the Reducer and its apparent ability to maintain improvement in angina symptoms over time. This data suggests that the Reducer may offer a viable long-term treatment option for patients with refractory angina who lack other alternatives for relieving their symptoms and improving their quality of life."
The results presented today show that implantation of the Neovasc Reducer in the hearts of refractory angina patients is feasible and safe, and that the objective and subjective improvements in angina scores and in ischemia parameters that were seen six months after implantation were maintained for the entire three-year follow-up period. Imaging studies revealed that the Reducer devices were in good functioning condition and were still located at the original site of deployment. There were no reported deaths, heart attacks (myocardial infarctions), strokes or other adverse events attributed to the Reducer.
Based on these positive long-term results, Neovasc is preparing to initiate the COSIRA clinical trial. COSIRA (Coronary Sinus Reduction for Treatment of Refractory Angina) is a randomized, controlled, multi-center trial of the Reducer in patients with refractory angina. It is designed to build on the successful results of the initial Reducer trial and advance the product through the regulatory review process.
"The positive data presented at the ACC meeting support our expectations that the Reducer has the potential to greatly benefit patients suffering from refractory angina, allowing them to resume a more active lifestyle," said Neovasc CEO Alexei Marko. "We look forward to commencing our Reducer COSIRA trial shortly."
* Banai S, Ben Muvhar S, Parikh KH, et. al. Coronary Sinus Reducer
Stent for the Treatment of Chronic Refractory Angina Pectoris.
J Am Coll Cardiol 2007;49: 1783-9
About Neovasc Inc.
Neovasc Inc. is a specialty vascular device company that develops, manufactures and markets medical devices for the rapidly growing vascular marketplace. The company's current products include the Neovasc Reducer(TM), a novel product in development to treat refractory angina, as well as a line of advanced biological tissue technologies that are used to enhance surgical outcomes and as key components in a variety of third party medical products such as percutaneous 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. Forward-looking statements contained in this news release include the Company's intention to complete the COSIRA clinical trial and the expectation of positive results from this trial. 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. There can be no assurance that the described clinical trials and data can be used to successfully commercialize the Neovasc Reducer. 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.
For further information: For further information: Corporate contact: Neovasc Inc., Chris Clark, (604) 248-4138; U.S. media & investor contact: GendeLLindheim BioCom Partners, Barbara Lindheim, (212) 918-4650