Neovasc Inc. announced enrollment of the first patient in the COSIRA-II clinical trial. COSIRA-II (COronary SInus Reducer for the Treatment of Refractory Angina) is a pivotal trial that will study the Neovasc Reducer™ (“Reducer”), designed to reduce angina symptoms in patients with refractory angina. The results of this study will complement existing international safety and effectiveness data and support a pre-market approval application (“PMA”) to the U.S. Food and Drug Administration (“FDA”) for approval of the Reducer device in the United States.

The first patient was enrolled at St. Francis Hospital & Heart Center, Roslyn, NY, under the care of Ziad Ali, M.D., DPhil., and Principal Investigator Evan Shlofmitz, D.O. The patient has a history of chronic refractory angina and previously endured multiple cardiac catheterization procedures at various hospitals to treat his recurrent symptoms. None of the previous procedures was successful at alleviating his chest pain. COSIRA-II is designed to evaluate the safety and effectiveness of the Reducer in treating patients suffering from refractory angina.

The randomized, double blinded, placebo-controlled trial will enroll approximately 380 patients in the United States and Canada at as many as 50 investigational sites. The primary endpoint of the trial is the change in exercise tolerance testing time measured at six months via a treadmill test. 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. The Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms. While the Reducer is not approved for commercial use in the United States, the FDA has granted Breakthrough Device designation to the Reducer. This designation is granted by the FDA to prioritize review of subsequent regulatory submissions for a device that demonstrates compelling potential to provide a more effective treatment of a life-threatening or irreversibly debilitating disease, represents breakthrough technology for which no approved alternatives exist or offers significant advantages over existing alternatives, and the availability of which is in the best interest of patients. Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.