Neovasc Responds to FDA Not-Approvable Letter

  Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that it has received a “not-approvable” letter from U.S. Food & Drug Administration (FDA) regarding its PMA submission for the Neovasc Reducer™ (Reducer).  

Fred Colen, Neovasc CEO, said, “While we are disappointed in FDA’s decision, the letter was not unexpected, given the outcome of the Panel meeting.” He continued, “Millions of patients suffer from refractory angina, and for many, the Reducer offers hope for symptom relief. We will continue to evaluate our strategic options for bringing the Reducer to patients around the world.”

The FDA reviewed Reducer for treatment of patients with refractory angina pectoris despite guideline directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention. The Reducer is CE-marked in the European Union for the treatment of refractory angina.

https://www.globenewswire.com/news-release/2021/01/15/2159623/0/en/Neovasc-Responds-to-FDA-Not-Approvable-Letter-Regarding-Neovasc-Reducer.html