Neovasc commences enrollment in Reducer trial for refractory angina

Sep 20 2010

-- Controlled and Double-Blinded Clinical Study is Designed to Demonstrate the Efficacy of Reducer in Reducing Angina Symptoms --

Neovasc Inc. (TSXV: NVC), a developer of novel technologies used to treat vascular disease, today announced that the first patients have been enrolled in its COSIRA trial designed to assess the clinical efficacy of the Neovasc Reducer(TM) product for the treatment of refractory angina. The COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) trial is a multicenter, sham-controlled, randomized, double-blinded study of the Reducer that is expected to enroll up to 124 patients. The primary endpoint is efficacy in reducing angina symptoms after six months. The COSIRA study is being conducted under the supervision of Principal Investigator Dr. Stefan Verheye at the Antwerp Cardiovascular Institute/ZNA Middelheim in Antwerp, Belgium, who performed the first four cases for the study on the first day of patient enrollment last week.

The Neovasc Reducer is a novel implantable product designed to treat heart disease patients who suffer from refractory angina. 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. The incidence of refractory angina is growing, and current treatment options are limited.

The Neovasc Reducer is a unique device that is implanted in the coronary sinus vein using minimally invasive techniques. It 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 where it is needed most. Placement of the Reducer is performed using a minimally invasive percutaneous procedure that is similar to implanting a coronary stent and takes approximately 20 minutes.

In March, results from an initial clinical trial of the Reducer were presented at the American College of Cardiology 2010 annual meeting. The data from this trial showed that three years after implantation of the Reducer, the product was safe and the vast majority of the 15 patients tested continued to show measurable improvement in angina symptoms. These three-year results built on positive six-month data were previously reported in the Journal of the American College of Cardiology. The COSIRA trial has been designed to provide controlled, statistically significant data to further demonstrate the efficacy of the Reducer and to support regulatory applications to enable marketing of the product.

In addition to the Antwerp Cardiovascular Institute, the COSIRA trial is also initiating patient enrollment at Ziekenhuis Oost-Limburg Hospital in Genk, Belgium; Montreal Heart Institute and the University of Ottawa Heart Institute in Canada; and Maastricht University Medical Centre and Utrecht University Medical Center in the Netherlands. Enrollment is expected to be completed by mid-2011.

"We are optimistic that the clinical data from COSIRA will support the excellent results we have seen in our previous clinical studies and confirm that the Reducer offers a relatively straightforward and viable long-term treatment option for patients with refractory angina, who currently lack alternatives for relieving their symptoms and improving their quality of life," said Prof. Shmuel Banai, MD, Neovasc Medical Director. "We are very pleased to have attracted such a strong group of clinical investigators from high quality cardiovascular medical centers for this trial and look forward to sharing initial data from COSIRA in the coming year."