Neovasc Inc (NASDAQ: NVCN) is having an incredibly strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced that the FDA has granted its device the Breakthrough Device designation. Of course, the news excited investors, sending the stock on a run for the top. Today, we’ll talk about:
- The designation;
- what we’re seeing from NVCN as a result; and
- what we’ll be watching for with regard to the stock ahead.
NVCN Announces Breakthrough Device Designation
As mentioned above, Neovasc is having an incredibly strong start to the trading session this morning after the company announced regulatory news. In a press release issued early this morning, the company said that the United States Food and Drug Administration has granted Breakthrough Device designation to the Reducer.
The reducer is a medical device developed by NVCN for the treatment of refractory angina. At the moment, the Reducer is not approved for sale in the United States. Nonetheless, Breakthrough Device designation is great news as it will help the company achieve approval faster.
In a statement, Fred Colen, President and CEO at NVCN, had the following to offer:
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.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news leads to moves. In the case of Neovasc, the news proved to be overwhelmingly positive. After all, the Breakthrough Device designation means that the company will have a shorter path to approval for the Reducer in the United States. So, it comes as no surprise that excited investors are sending the stock screaming for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:00), NVCN is trading at $4.06 per share after a gain of $1.62 per share or 66.39% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on NVCN. In particular, we’re interested in following the story surrounding the Reducer and the company’s continued work to bring the product to market in the United States. Nonetheless, we’ll keep a close eye on the news and bring it to you as it breaks!
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