Cytori expects new Japan laws to boost adoption of Cytori cell therapy Cytori Therapeutics confirmed that two Japanese regenerative medicine laws, which went into effect on November 25, remove regulatory uncertainties and provide a clear path for the company to commercialize and market Cytori Cell Therapy and its Celution System under the company’s existing and planned regulatory approvals. Under the two new laws, Cytori believes its Celution System and autologous adipose-derived regenerative cells can be provided by physicians under current Class I device regulations and used under the lowest risk category for many procedures with only the approval by accredited regenerative medicine committees and local agencies of the Ministry of Health, Labour and Welfare. This regulatory framework is expected to streamline the approval and regulatory process and increase clinical use of Cytori Cell Therapy and the Celution System over the former regulations. “Japan’s new regenerative medicine laws substantially clarify regulatory ambiguities of pre-existing guidelines and this news represents a significant event for Cytori. We have a decade of operating experience in Japan and Cytori is nicely positioned to see an impact both on existing commercial efforts and on our longer-term efforts to obtain therapeutic claims and reimbursement for our products,” said CEO Marc Hedrick.