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Cytori Granted Broad European Orphan Drug Designation

PSTV | May 10, 2016

Cytori Granted Broad European Orphan Drug Designation

Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that the European Commission has granted orphan drug status to a broad range of Cytori Cell Therapy® formulations when used for the treatment of hand dysfunction and Raynaud’s Phenomenon in patients with scleroderma.

Key benefits of this broad orphan drug designation include: (1) the ability to pursue multiple therapeutic formulations for systemic scleroderma that are not restricted to the processing of the adipose-derived cellular therapeutics at the bedside with the Celution® System or other current technology, (2) allows adipose-derived cellular therapeutics that are cryopreserved for later administration and (3) provides a pathway for Cytori to expeditiously seek conditional market approval in the EU.

“This broad orphan designation expands our strategic regulatory position and commercial options in Europe,” said Marc Hedrick, President and CEO of Cytori Therapeutics. “We intend to rely on this orphan designation, as well as long term safety and efficacy data from the SCLERADEC-I trial to seek conditional market authorization from the European Medicines Agency (EMA) on an accelerated timeline.”

“Orphan designation in Europe comes with significant benefits,” said Kenneth K. Kleinhenz, Vice President of Global Regulatory Affairs and Quality Assurance of Cytori Therapeutics. “These benefits include up to 10 years of market exclusivity if the medicine is authorized by the European Medicines Agency (EMA), access to the EMA’s conditional marketing authorization pathway (which is designed for orphan products that have initial clinical data and are actively in the process of completing their pivotal clinical studies), and an additional 10% reduction in regulatory fees beyond the reductions already afforded us because of our SME status. We believe the ECCS-50 therapy for scleroderma may benefit from these accelerated programs in Europe. This broad orphan designation will play a key role in our ability to fully access these programs.”

More information about the orphan drug designation process and the potential advantages of orphan designation within the European Union can be found at the EMA website.

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, benefits of our orphan drug designation (including access to the EMA’s conditional marketing authorization program, the ability to achieve a conditional and/or normal marketing authorization for Cytori ECCS-50, and the ability to secure ten years’ market exclusivity), benefits to Cytori of programs made accessible to it by reason of the orphan drug designation, and the role that the orphan drug designation will play in our regulatory and commercial strategies , are forward looking statements. Market exclusivity for orphan designated products is only granted to the first therapy that obtains a valid EMA marketing authorization. Should the first marketing authorization for adipose derived stem and regenerative cells in systemic scleroderma be awarded to another firm, the market exclusivity would be owned exclusively by such firm. Forward looking statements 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, the challenges inherent in convincing physicians and patients to adopt the new technology, dependence on third party performance, results of our clinical trials (including our STAR trial), 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.