(NASDAQ: CYTX) has received preliminary written notice of intent to exercise ‘Option 1’ of the Company’s contract with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.
Cytori was awarded a contract with BARDA in September 2012 for the development of Cytori Cell Therapy for thermal burns combined with radiation injury worth up to $106 million. On June 10
Cytori presented data generated during the Base Period of the contract at an In-Process Review (IPR) meeting to a panel of representatives from BARDA, the Department of Defense, the Center for Disease Control, the Food and Drug Administration, and the National Institute of Health. Receipt of this notice demonstrates that this panel has determined that Cytori has accomplished the goals of the Base Period to the government’s satisfaction. These goals involved preclinical studies, preliminary design and development of Cytori’s next generation Celution® System, and an assessment of Cytori’s technology in tissue samples from burn patients. Based on this notification, Cytori and BARDA are in negotiations on the specifics for the additions to the Statement of Work to be executed in the Option 1 period which will extend the contract to September 2016. It is anticipated that this process will take several weeks. Cytori will announce the contract details as soon as completed.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201200008C.
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 rescue tissue at risk of dying. 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.
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, but not limited to, those regarding finalizing key details regarding ‘Option 1’ and the modification and extension of the contract 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 future Government funding and procurement priorities, and the Government’s ability to reduce, modify or terminate the contract if it determines it is in the Government’s best interests to do so, as well as 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 communication.