Neovasc Inc (NASDAQ: NVCN) was one of the top gainers in yesterday’s session. The stock rallied to close the day with gains of 37.66%. This came after the company announced that, it had submitted a pre-market approval application to the FD.A. The approval is for the company’s Neovasc Reducer, a medical device for treating refractory angina. It also announced that, the submission included a request for a meeting with an advisory panel.
Speaking on this development, the CEO, Fred Colen stated that, the submission marked a key milestone in the company’s efforts to take Reducer to the U.S market, where there are about 1.8 million people suffering from refractory angina. He further added that, at the moment these patients do not have options, as the options available are either not well suited for revascularization, or that the patient continually suffers angina even after the procedures.
The CEO added that, the Reducer offers potential relief for angina symptoms. It does this by changing blood flow in the myocardium of the heart, and also by pushing up the perfusion of oxygen-rich blood to the heart’s ischemic areas. Refractory Angina is a painful condition that comes when there isn’t enough blood supply to the heart muscles.
The company’s Premarket Approval Application for its reducer incorporates clinical data from the ongoing COSIRA 104 randomized, double-blind trial in the European Post-Market study. The study has more than 200 patient that are enrolled for a period of up to 5-years. It also includes clinical evidence from different peer-reviewed publications on it.
Looking at the stock’s price action in yesterday’s session, it traded between a low of $5.29 and a high of $8.65 before closing the day at $5.41. Volumes in the day stood at 20.59 million.
About Neovasc Inc
Neovasc Inc is a specialty medical devices company. It is based in Richmond, Canada.