Neovasc Inc. is one step closer to a U.S. market launch for its chest pain device after the U.S. Food and Drug Administration granted breakthrough device designation for the Reducer.
Reducer has been approved in the EU since 2015 to treat refractory angina, a condition of recurring pain in the chest that occurs when the coronary arteries fail to deliver enough blood to the heart. The condition can occur despite treatment with standard cardiac drug therapies. Neovasc's device provides relief from angina symptoms by altering blood flow to the heart.
Neovasc will begin the process of further discussions and filings with the FDA to market the product in the U.S. following the designation, according to an Oct. 10 press release.
The FDA grants breakthrough device status to expedite the development and review of a device that has the potential to provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.
The Richmond, British Columbia-based medical device maker said refractory angina is estimated to impact 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases each year.
Neovasc recently regained compliance with the Nasdaq's $1 minimum bid price listing rule. Shares of the company were up just over 29% to $4.09 as of 11:30 a.m. ET on Oct. 10, according to S&P Global Market Intelligence.