Neovasc Inc (NASDAQ: NVCN) rose Wednesday after the company disclosed that the U.S. Food and Drug Administration granted Breakthrough Device designation to the Neovasc Reducer.
The Vancouver-based Neovasc prides itself on being a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina
The FDA grants Breakthrough Device designation in order to expedite the development and review of a device that demonstrates compelling potential to provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.
To qualify as a Breakthrough Device, there must either be no FDA-approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives.
CEO Fred Colen said, "We are pleased that the FDA has approved our request for Breakthrough Device designation for the Reducer. We will now start a process of further discussions and filings with the FDA, to obtain further guidance as to the regulatory pathway for entrance into the U.S. market. This designation supports our belief that this technology offers a significant benefit to patients suffering from refractory angina.
"We look forward to working closely with FDA through this regulatory process."
Refractory angina, resulting in continued symptoms despite maximal available medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year
Shares began trading Wednesday morning static at $3.17
