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Neovasc Shares Climb 80% Upon FDA Premarket Approval Filing for Refractory Angina Device

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Shares of specialty cardiovascular medical device company Neovasc Inc. opened more than 100% higher after the firm reported that it submitted a Premarket Approval application to the FDA for its Neovasc Reducer device for use in the treatment of refractory angina.

This morning Vancouver, Canada-based specialty medical device company Neovasc Inc. (NVCN:NASDAQ), which develops, manufactures and markets products for the cardiovascular marketplace, announced that "it has submitted a Premarket Approval application (PMA) to the U.S. Food and Drug Administration (FDA) for its Neovasc Reducer™ ("Reducer") medical device for the treatment of refractory angina." The firm noted that that the submission also included a request for an Advisory Panel meeting.

The company's President and CEO Fred Colen commented, "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...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."

The company advised that "the PMA for Reducer includes clinical data from the COSIRA 104 patient randomized, double-blind, sham-controlled trial, the ongoing REDUCER-I European Post-Market study, with over 200 patients currently enrolled with up to 5 years of follow-up, and supportive clinical evidence from multiple peer reviewed publications on Reducer."

The firm explained that refractory angina is a painful and debilitating condition that affects millions of patients worldwide. The condition occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle despite treatment with standard revascularization or cardiac drug therapies. The company claims that "the Reducer provides 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 and that placement of the Reducer is performed using a minimally invasive transvenous procedure."

Neovasc is headquartered in Vancouver, British Columbia, and describes itself as "a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina." The firm's products include the Tiara technology in development for the transcatheter treatment of mitral valve disease and the Neovasc Reducer for the treatment of refractory angina, and tissue products. The Tiara transcatheter device is designed to treat mitral regurgitation as a result of mitral heart valve disease, an often severe condition that can lead to heart failure and death. The Neovasc Reducer is a percutaneous treatment for refractory angina, a condition which affects millions worldwide. Though not yet commercially approved in the U.S., the company received Breakthrough Device designation for the Neovasc Reducer in October 2018 from the FDA.

Neovasc has a market capitalization of about $30 million with approximately 7.65 million shares outstanding. NVCN shares opened greater than 100% higher today at $7.99 (+$4.06, +103.31%) over yesterday's closing price of $3.93. The stock has traded today between $6.11 and $8.65 per share and is currently trading at $7.09 (+$3.16, +80.41%).

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