Regulatory OverviewThe FDA regulates medical devices as class 1, 2, or 3. Typically, class 2 devices require a demonstration of substantial equivalence to a pre-existing device with limited or no clinical data. Class 3 devices are considered novel and more complex, thus require clinical data and/or clinical testing under the PMA pathway. Cytori and the FDA agree that marketing approval for the Company’s Celution® System for use in cardiovascular disease and other therapeutic indications requires a PMA. The appeals rulings announced today relate to the Company’s separate actions to seek approval for tissue processing systems for use in banking and research as class 2 medical devices. About Cytori Therapeutics Cytori Therapeutics, Inc. is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. 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 those regarding our expected enrollment completion date of our Athena trial, are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include clinical and regulatory uncertainties, risks in the collection and results of clinical data, clinical outcomes, dependence on third party performance, and other risks and uncertainties described under the “Risk Factors” in Cytori’s Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
The Celution® System is available in the United States for investigational use only.