Cytori Granted FDA Orphan Drug Designation For ECCS-50 In Scleroderma
SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that the US FDA Office of Orphan Products Development (OOPD) has granted Cytori an orphan drug designation for cryopreserved or centrally processed ECCS-50 for scleroderma.
“Our development plan for cryopreserved ECCS-50 will be described in greater detail over the next few quarters.”
“This orphan drug designation is part of our long-term strategy to facilitate the autologous retreatment of patients with scleroderma, if it is needed,” said Dr. Marc Hedrick, President and CEO of Cytori Therapeutics. “Our development plan for cryopreserved ECCS-50 will be described in greater detail over the next few quarters.”
Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and waivers from FDA user fees. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity for seven years.
About Cytori Therapeutics, Inc.
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 the role of Cytori’s U.S. orphan drug designation as part of Cytori’s strategy to facilitate the autologous retreatment of patients with scleroderma (if needed), and communication of Cytori’s development plan for cryopreserved ECCS-50 over the next few quarters are forward looking statements that are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include: clinical and regulatory uncertainties, such as failure to generate data supporting safety or efficacy of cryopreserved ECCS-50, and risks that regulation of cell therapies may impose significant hurdles and/or competitive challenges for our ECCS-50 product (including any development plans for cryopreserved ECCS-50); risks that a competitor may first obtain market exclusivity covering hand impairment resulting from systemic sclerosis or that we do not receive FDA approval of a cryopreserved ECCS-50 product and are therefore unable to avail ourselves of the commercial benefits of orphan drug designation; the challenges inherent in convincing physicians and patients to adopt Cytori’s technology; dependence on third party performance, including physicians conducting investigator-initiated trials and studies using our Celution platform; performance and acceptance of our ECCS-50 and other 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.