Cytori Comments On New Legislation For Regenerative Medicine In Japan

Cytori Therapeutics (NASDAQ: CYTX) reports that on November 20, 2013, the Japanese legislature (Diet) approved new legislation targeted at regenerative medicine therapies. The Regenerative Medicine Law directs the Ministry of Health, Labour and Welfare (MHLW) to adopt new procedures and rules that would accelerate the clinical development of regenerative medicine and cell therapies. The Japanese Pharmaceutical Affairs Law (J-PAL) will now become the Pharmaceuticals and Medical Devices Act that will include a new branch for Regenerative Medicine Products. Regenerative Medicine Products will be regulated on a Fast Track process that focuses primarily on product safety.

“Cytori has been investing in Japan for more than a decade and has an established, licensed and operational medical subsidiary, Cytori Therapeutics K.K., based in Tokyo,” said Christopher Calhoun, CEO of Cytori. “While we are still assessing the implications of this new legislation on our operations in Japan, we believe this legislation to be an important development since more than half of Cytori’s global revenue has been generated in Japan.”

“The legislation has been designed to benefit patients and developers alike to bring innovative, cost-effective therapies to market in a risk-adjusted manner, and enable Japan to capitalize on the economic opportunity represented by regenerative medicine,” said Seijiro N. Shirahama, President, for Cytori Therapeutics, Asia Pacific. “Multiple investigator-initiated and funded studies using Cytori Cell Therapy have been completed at leading hospitals in Japan, and more are underway or are in the planning stages. We look forward to providing more details on the impact of the legislation as they become available.”

About Adipose Tissue & ADRCs

Adipose tissue is considered the richest source of regenerative cells in the body. These cells are comprised of a heterogeneous population of cells which are collectively referred to as ADRCs. The heterogeneous nature of ADRCs are believed to contribute to the healing process via multiple mechanisms, which include cell-to-cell signaling, supporting improved blood flow and regulation of the inflammatory response.

About Cytori

Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical conditions. Our scientific data suggest ADRCs improve blood flow, moderate the inflammatory response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® System product family.

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, those regarding our understanding of the potential significance of the new legislation, are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include regulatory uncertainties in the application of the new law, the challenges inherent in convincing physicians and patients to adopt the new technology, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" section in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. 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 press release.

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