Cytori Therapeutics Inc (NASDAQ: CYTX) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced that it has received a medical device approval in Japan, opening the door to revenue in the region. Of course, the news excited investors who are sending the stock on a run for the top. Today, we’ll talk about:
- The approval;
- what we’re seeing from CYTX as a result; and
- what we’ll be watching for with regard to the stock ahead.
CYTX Heads Up On Japanese Approval
As mentioned above, Cytori Therapeutics is having an incredibly strong start to the trading session this morning after announcing a regulatory approval. In a press release issued early this morning, the company announced that it has received approval for the Celution Cell Therapy System. The system was approved in Japan as a Class III medical device.
In the release, CYTX said that the Class III designation will allow it to expand its current commercial efforts in Japan and provides a clear framework for future expanded regulatory claims and reimbursement.
In other news, the company announced that it has successfully outsourced an important assembly portion of the production process for its Celution Cell Therapy product. The first consumable lots under this new process were shipped to customers in November of this year.
In a statement, Marc H. Hedrick, MD, President and CEO at CYTX, had the following to offer:
Obtaining Class III designation follows many months of constructive interaction with the Japanese Ministry of Health, Labour and Welfare following the approval of the 2014 PMD Act… This approval coupled with the outsourced production allows Cytori to meet forecasted product demand, particularly in Japan, and better prepares us for the data read out in our Japan ADRESU pivotal trial next year.
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 Cytori, the news proved to be overwhelmingly positive. After all, the Class III designation will likely lead to stronger sales in Japan. So, it’s not surprising to see that excited investors are sending the stock screaming for the top in the market this morning. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:21), CYTX is trading at $0.36 per share after a gain of $0.031 per share or 9.46% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on CYTX. In particular, we’re interested in following the sales of its Celution Cell Therapy System in Japan following the expanded regulatory approval announced today. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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