Cytori Therapeutics (NASDAQ: CYTX) has received notice from the Australian Therapeutic Goods Administration (TGA) that the Celution® System is approved for commercial use through inclusion on the Australian Registry of Therapeutic Goods for autologous re-implantation or re-infusion of a patient’s adipose-derived regenerative cells (ADRCs). The Celution® System produces autologous (a patient’s own) ADRCs at the point-of-care which may then be used for a range of injuries or conditions. “Following an intensive two year review by the TGA, hospitals and physicians in Australia will have full commercial access to the only closed-system, point-of-care device which produces clinical-grade ADRCs for re-implantation or re-infusion into the patient,” said David C. Oxley, Vice President Emerging Markets for Cytori Therapeutics. “This approval establishes the foundation for enabling treatment of critical unmet medical needs across a variety of indications for patients in Australia.” During the past two years, Dr. David Chin, MCh, PhD (Plast), FRCS, FRACS (Plast) of Queensland, Australia worked with Cytori under a TGA Authorized Prescriber Approval to treat a variety of conditions, particularly in the area of soft tissue injury and limited blood flow. “We have had very favourable outcomes in the 80 plus patients treated using the Celution® System. Cases include breast reconstruction and patients who no longer wish to have silicone breast implants. Additional medical conditions, such as rheumatoid arthritis and soft tissue sports medicine related injuries are included,” commented Dr. Chin. “I can attest to the healing power of these cells based on the positive outcomes in my own clinical practice. In total, my experience includes a variety of presenting conditions over two years. Being able to access the patient’s own adipose derived regenerative cells during a single procedure opens up a whole dimension of acute and chronic medical conditions that may be addressed, including some previously considered untreatable under conventional treatment modalities.”
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 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 the challenges inherent in convincing physicians and patients to adopt the new technology as well as our history of operating losses, regulatory uncertainties, 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.