Shares of Neovasc Inc (NVCN), a developer, manufacturer, and seller of specialty medical devices and products for the rapidly growing cardio market, have been losing ground this morning. The stock price is down 6.67% to $1.12.
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The major reason for Neovasc’s decline is a “not approvable” letter from the U.S. Food & Drug Administration (FDA). Neovasc received the FDA’s reply last Friday regarding its Neovasc Reducer’s PMA submission.
Neonasc manufactures several medical devices and among those Reducer is the company’s key product. The product used for the treatment of angina has been commercially available in Europe since 2015, but not presently available in the United States. Tiara is another product developed by the company that is under clinical trials in the United States, Canada, Israel, and Europe.
So how is NVCN affected by this news?
The company expressed its dismay at the FDA’s decision, as it was not expecting it given the outcome of the Panel meeting, as Fred Colen, Neovasc CEO put it.
He went on to explain that millions of patients suffer from refractory angina and that for many, the Reducer could provide hope of relief.
The reducer will continue to be evaluated by the company in order to bring it to patients worldwide.
The first three Neovasc Reducer implants in France have recently been performed by the firm. As the Business aims to improve access to Reducer care for patients suffering from refractory angina, the implants are a significant development for Neovasc.