SAN DIEGO & TOKYO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that the use of Cytori Cell Therapy™ was approved for clinical use on June 24th, 2016 to treat knee osteoarthritis at the Tokyo Osteoarthritis Clinic under the Japanese ‘Act on the Safety of Regenerative Medicine’ that was enacted on November 25, 2014.
Tokyo Osteoarthritis Clinic will begin to treat knee osteoarthritis patients with Cytori Cell Therapy immediately. This approval is limited to facilities under the clinic’s umbrella but does not restrict the number of patients that can be treated. Such approvals are not reimbursed by the social healthcare system and patients will be responsible for the costs of treatment.
“Osteoarthritis is very common in Japan and the new legislation gives us an approved pathway to make novel regenerative therapies available to patients today,” said Dr. Masayuki Yamakawa, CEO of the Tokyo Osteoarthritis Clinic.
In Japan, Cytori’s Celution system was granted a Class I notification originally in 2012. The recent legislation passed by the Japanese Diet originally in 2013 and later enacted and enforced, provides a mechanism allowing leading healthcare facilities in Japan to use certain regenerative medicine technologies deemed innovative and safe by the Japanese government for particular indications if approved by a certified and accredited regenerative medicine committee.
“The innovative regenerative medicine law recently approved in Japan creates expanded opportunities for therapeutic innovation for Cytori,” said John Harris, Cytori’s Vice President & General Manager, Cell Therapy. “This registration and those anticipated in the future should be important elements in helping us expand access for our Cytori Cell Therapy to a large population of patients in Japan suffering with osteoarthritis. For the Tokyo Osteoarthritis Clinic, this is a significant milestone and I believe they are well positioned for leadership in arthritis therapy in Japan.”
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.
About Tokyo OA Clinic
Tokyo OA Clinic is a dedicated knee osteoarthritis clinic under "THE CLINIC Group." The affiliated doctors use breakthrough technology to treat osteoarthritis. Their team collaborates closely with academia, hospital and industry to bring high level treatments to patients in Japan. For more information, please visit https://www.knee-joint.net/. For media requests, please contact Ms. Yanagino, 03-6455-5307; patients can call 0120-013-706.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, statements regarding anticipated immediate treatment of knee osteoarthritis patients by Tokyo Osteoarthritis Clinic, responsibility for cost of treatment, opportunities for therapeutic and commercial innovation afforded to Cytori, the benefits to Cytori of Tokyo Osteoarthritis Clinic’s registration to treat knee osteoarthritis at its clinics, anticipated future registrations that could benefit Cytori and Cytori Cell Therapy, and Tokyo Osteoarthritis Clinic’s anticipated leadership in arthritis therapy in Japan, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, regulatory risks and uncertainties (including repeal or material amendment of Japan’s regenerative medicine laws, or amendment, suspension or termination of currently available registration pathways under such laws), perceived benefits of Cytori Cell Therapy by customers and patients, inherent risk and uncertainty in the protection and disposition of intellectual property rights, regulatory uncertainties in the conduct of clinical trials, risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace and introduction of competitive therapies, as well as other risks and uncertainties described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.