Neovasc (NASDAQ:NVCN) news for Tuesday about the company submitting a Premarket Approval application (PMA) to the U.S. Food and Drug Administration (FDA) has NVCN stock soaring.
The PMA submitted to the FDA is for Neovasc Reducer. This is a medical device from the company with the purpose of treating refractory angina. That’s a disease where coronary arteries deliver an inadequate supply of blood to the heart muscle.
A Neovasc news release notes that the submission to the FDA includes results from its COSIRA 104 clinical trial. It also includes information from an ongoing trial with more than 200 patients that will have a five-year follow-up period.
Fred Colen, President and CEO of Neovasc, has this to say about the NVCN stock news.
“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. 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.”
It’s worth noting that Neovasc Reducer was granted Breakthrough Device designation in October 2018. This designation for its treatments that cover unmet needs and allows them to move through the approval process quicker.
NVCN stock was up 64.76% as of Tuesday afternoon.
As of this writing, William White did not hold a position in any of the aforementioned securities.