(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.