NetworkNewsBreaks – FDA Grants Small Business Status to Cytori (NASDAQ: CYTX)

Company: Cytori Therapeutics, Inc. (CYTX)
Category: Stock Spotlights

Cytori (NASDAQ: CYTX) has been granted Small Business status for fiscal year 2017 by the U.S. Food and Drug Administration Division of Industry and Consumer Education. The designation allows Cytori to receive substantial financial incentives, fee reductions, and fee waivers for selective FDA medical device regulatory filings. The company is also eligible for a substantial reduction in many medical device user fees and a one-time waiver of the user fee for its first premarket approval (PMA) application, potentially occurring later in 2017. “Cytori Cell Therapy benefits from being regulated as a device through the PMA process. The small business designation will substantially reduce filing fees in 2017 for our planned PMA application for HABEOTM Cell Therapy, our lead development candidate currently under investigation for use in scleroderma, should our STAR Phase III data support filing of this application,” stated Tiago Girao, VP of Finance and CFO of Cytori Therapeutics.

To view the full press release, visit: http://nnw.fm/J6UiH

About Cytori

Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information: visit www.cytori.com.

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