Neovasc (NSDQ:NVCN) announced that an FDA advisory panel voted against reasonable assurance of effectiveness for its Reducer system.
The FDA’s Circulatory System Devices Advisory Panel voted 1 to 17 “against” on the issue of “a reasonable assurance of effectiveness,” according to a news release.
“We would like to thank the FDA, the panel and members of the public that offered their insights during yesterday’s Circulatory System Devices Advisory Panel meeting,” Neovasc president & CEO Fred Colen said in the release. “Clearly, we are disappointed with the meeting’s outcome, and we will provide further updates in the coming weeks.”
About a day after the panel came to its decision, shares of Neovasc are trading down -42.1% at $1.06 per share in late-afternoon trading.
Neovasc’s Reducer is designed to relieve angina symptoms by altering blood flow within the myocardium of the heart while increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. It can be placed in a minimally invasive transvenous procedure that is similar to implanting coronary stents and is intended for patients who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention.
The company announced in November 2019 that it would seek a PMA for the Reducer, having received CE Mark approval in 2011.
Last month, the FDA set the advisory panel meeting to review the Reducer, at which point Neovasc said it was “enthusiastic” about the meeting.
In addition to the “against” decision, the panel voted 14 to 4 in favor of the notion that the Reducer is “safe when used as intended.” The panel aso voted 13 to 3 (with two abstentions) against whether the relative benefits of the system outweighed the relative risks.
