October 10, 2018 / 12:23 PM / 2 months ago

BUZZ-Neovasc: Jumps after FDA grants 'breakthrough' status to its device

** U.S.-listed shares of Canadian medical device maker soar 53.7 pct to $3.75 premarket after FDA grants Neovasc Reducer, used to treat refractory angina, breakthrough device status

** NVCN is top pct gainer among U.S. stocks and if gains hold, stock is on pace for its best day in nearly 2 years

** Refractory angina is a chronic condition characterized by debilitating chest pain, estimated to affect 600,000-1.8 mln Americans

** On Oct. 3, data showed the first U.S. patient implanted with the Reducer was able to walk several miles, reduce usage of nitroglycerine for chest pains, experience lesser chest discomfort

** Breakthrough device status is usually granted to speed up review of a device that can potentially treat life-threatening conditions

** The device is not currently approved for commercial sale in the U.S.

** Up to Tuesday’s close, stock has lost ~96 pct of its value this year (Reporting by Amy Caren Daniel in Bengaluru)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below