Neovasc Inc. (NASDAQ: NVCN) disclosed that the FDA has rejected the Pre-Market Approval regarding its Neovasc Reducer™. FDA has assessed the Reducer for the treatment of patients with refractory angina pectoris. The firm has revealed that the letter of FDA is very disappointed, but the firm has already sensed the outcome of PMA submission.
Neovasc disclosed that millions of patients are suffering from refractory angina, and the Reducer of the firm is the only ray of hope for the patients. But the hope is disappeared because of the rejection of the FDA. Neovasc is continuously endeavoring to assess its strategic options for bringing the Reducer to patients throughout the globe.
Shares of Neovasc (NASDAQ: NVCN) went up 0.84% during the trading session of Friday. In the past 52-weeks of trading, this firm's share went from a low point around $0.68 to briefly over $3.88. Its shares moved up 76.47% from its 52-weeks low and moved down to -69.07% from its 52-weeks high. Neovasc's (NASDAQ: NVCN) market cap has remained high, hitting $34.65 million at the time of writing.
In October, despite having a CE mark for the treatment of refractory angina in the European Union, Reducer failed to gain support from the FDA Advisory Committee. Despite guideline-directed medical therapy, the FDA checked Reducer for treating patients with refractory angina pectoris who are incompatible for revascularization by coronary artery bypass grafting or percutaneous coronary intervention.