Neovasc Inc. (NASDAQ: NVCN) shares nearly doubled on Tuesday after the firm announced the submission of a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for its Neovasc Reducer medical device for the treatment of refractory angina. The submission also includes a request for an Advisory Panel meeting.

Refractory angina is 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, and its incidence is growing.

The PMA for Reducer includes clinical data from the Cosira 104 trial, the ongoing Reducer-I European Post-Market study, with over 200 patients currently enrolled with up to five years of follow-up, and supportive clinical evidence from multiple peer-reviewed publications on Reducer.

Although the Reducer is not approved for commercial use in the United States, the FDA granted Breakthrough Device designation to it in October 2018.

Fred Colen, president and chief executive officer of Neovasc.

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.

Shares of Neovasc were last seen up about 81%, at $7.15 in a 52-week range of $2.34 to $11.00. The consensus price target is $1.88.

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