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. 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, 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.
Copyright Business Wire 2013