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Neovasc Sinks on FDA Bid

Neovasc Inc (NASDAQ:NVCN) shares fell sharply Thursday after the company announced it had submitted a pre-market approval application to the U.S. Food and Drug Administration for Neovasc Reducer, which is used for the treatment of refractory angina.

The Vancouver-based company has entered into definitive agreements with certain institutional investors for the sale of an aggregate of 2,418,322 series A units and series B units at a price of $4.1351 U.S. per Series A Unit and $4.135 U.S. per Series B Unit in a registered direct offering priced at-the-market under NASDAQ rules for aggregate gross proceeds to the Company of approximately $10 million U.S., before deducting placement agent's fees and estimated expenses of the Offering payable by the Company.

The Offering is expected to close next week, subject to customary closing conditions, with H.C. Wainwright & Co. the exclusive placement agent for the Offering.

Neovasc intends to use the net proceeds from the Offering for the development and commercialization of the Neovasc Reducer™, development of the Tiara™ and general corporate and working capital purposes.

Neovasc develops, manufactures and markets products for the rapidly growing cardiovascular marketplace.

Its products include the Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and the Tiara, for the transcatheter treatment of mitral valve disease

NVCN faltered $1.33, or 24.6%, to $4.08