SAN DIEGO, Feb. 06, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today that the US Food and Drug Administration (FDA) Division of Industry and Consumer Education (DICE) has granted Small Business status to Cytori Therapeutics for Fiscal Year 2017. The newly granted Small Business status allows Cytori to receive significant financial incentives, fee reductions, and fee waivers for selective FDA medical device regulatory filings. Such designation makes the company 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.
The STAR trial is a Phase 3, US-based, multi-center (19 sites), randomized, controlled trial of HABEO in 88 patients with hand dysfunction and Raynaud’s phenomenon associated with scleroderma. Enrollment was completed in mid-2016. Data unblinding and analysis will commence once the last enrolled subject has completed their 48-week follow-up visit, anticipated to be in mid-2017.
In the United States, the scleroderma affected population appears to be approximately 184 per million, which would account for a market size of 45,000 scleroderma patients.1 Additionally, in Europe, scleroderma is estimated to have a prevalence between 31 per million and 277 per million which equates to approximately 17,000 to 149,000 scleroderma affected people in the Europe.2
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.
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, statements regarding: timeframes for, and conditions under which, Cytori would submit a PMA application for Habeo; projected savings to Cytori as a result of obtaining SME status; and other potential benefits to Cytori of small business status in the U.S. and Europe. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include STAR clinical trial results (including the risk that STAR data are deemed insufficient to support a PMA application) and other clinical uncertainties; regulatory uncertainties and other uncertainties that could cause us to lose SME status in the U.S. or in Europe; unexpected costs and expenses related to PMA approval unrelated to SME status; unforeseen delays or hurdles in our anticipated Habeo PMA application process; the challenges inherent in convincing physicians and patients to adopt the new technology, dependence on third party performance, performance and acceptance of our products; and other risks and uncertainties described under the “Risk Factors” in Cytori's Securities and Exchange Commission Filings, including in its most recent annual and quarterly reports. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this communication.
1. Furst, Daniel et al. “Epidemiology of systemic sclerosis in a large US managed care population.” J Rheum 2012; 38:784-6.
2. Varga, John et al. “Scleroderma: From Pathogenesis to Comprehensive Management.” 2012