Neovasc stock (NASDAQ:NVCN) is skyrocketing more than 26% on Wednesday as the company received good news from the U.S. Food and Drug Administration (FDA) regarding one of its latest products.
The medical device company revealed that its Neovasc Reducer device that was designed to treat refractory angina was granted a Breakthrough Device designation by the FDA. The news caused Neovasc stock to skyrocket with volume soaring up to 21.2 million shares, which is considerably higher than the stock’s full-day average of just under 800,000 shares.
The Breakthrough Device designation paves the way for expedited development and review of a device that has proven to have “compelling potential” to offer more effective treatment for life-threatening illnesses.
“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,” said Neovasc CEO Fred Colen. The Breakthrough Therapy designation also opens the way for the FDA giving more attention to the development of the device.
This means that the company will garner more intensive guidance on development from the agency, as well as the involvement of more senior agency personnel. In addition to all this, the Neovasc Reducer will receive a case manager who will be assigned to the product, as well priority review of the marketing application.
NVCN stock is up about 26.2% on Wednesday following the news.