Neovasc Inc. (NASDAQ: NVCN) shares are trading sharply higher Tuesday after the company announced it had submitted a premarket approval application to the U.S. Food and Drug Administration for Neovasc Reducer, which is used for the treatment of refractory angina.
"This submission marks an important milestone in our effort to bring Reducer to the U.S. market, where it is estimated that there are up to 1.8 million patients with refractory angina," said Fred Colen, CEO of Neovasc.
"These patients have traditionally had no options – they are either unsuitable for revascularization or continue to suffer with angina following revascularization procedures. The Reducer provides potential relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle."
Neovasc's stock traded up 160.76% at $10.30 per share in Tuesday’s pre-market session. The stock has a 52-week high of $11 and a 52-week low of $2.34.