Government Contract Highlights Importance of Cytori Technology to Support National Preparedness
Cytori Therapeutics (NASDAQ: CYTX) has been awarded a contract that may be valued up to $106 million by the U.S. Department of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA), if all Contract Options are executed. The Contract is for preclinical and clinical development of the Company’s cell therapy for the treatment of thermal burns combined with radiation injury. The aim is to evaluate and create a new countermeasure for thermal burns which would be useful following a mass-casualty event. Cytori’s cell therapy is based on a patient’s own adipose-derived stem and regenerative cells (ADRCs) processed by the Company’s proprietary Celution® System technology.
“We are honored that BARDA selected Cytori as the first company to be awarded a cell therapy development contract for thermal burns,” said Christopher J. Calhoun, chief executive officer of Cytori. “This relationship with the U.S. government will facilitate development of our cell therapy for thermal burns, which could then serve as an important new path to market for soft tissue indications in the U.S. Additionally, the findings under this contract will complement our existing efforts to develop cell therapies for a range of wound healing applications outside the scope of this contract. Our expectation of success is based on our extensive clinical experience treating a variety of conditions, including radiation-related wounds, thermal burns, fistulae and diabetic ulcers in Europe and Asia.”
The base contract covers a two year period and is extendable up to five years with Options. The total award will support all clinical, preclinical, regulatory, and technology development activities needed to complete the FDA approval process for use in thermal burn injury. The guaranteed base period is valued at approximately $4.7 million and includes preclinical research and the acceleration of Cytori’s ongoing development of the Celution® System to further improve cell processing. Under the terms of the contract, successful achievement of specified milestones will allow BARDA to review and, at its discretion, consider the execution of Options and qualify Cytori to receive up to approximately $101 million in additional funding, if completely executed, to bring the technology through the FDA approval process for thermal burns under a device-based PMA regulatory pathway.
Cytori’s cell therapy is developed using a patient’s own adipose-derived stem and regenerative cells (ADRCs) that are processed by the Company’s proprietary Celution® System and then delivered back to the patient. Cytori is developing cell therapies for cardiovascular and soft tissue indications, which if established, would create an infrastructure that the government could rely on to deliver cell therapy following a mass casualty event. Cytori expects that successful development of the Company’s cell therapy for thermal burns under this contract may result in government procurement.
The Government Accountability Office reports that in a mass casualty event, 10,000 patients could require thermal burn care. The limited number of specialist surgeons and burn centers in the U.S. creates a public health need for a burn wound therapy that can be quickly and broadly applied by non-specialist medical personnel following such an event. According to the American Burn Association, there are approximately 50,000 to 70,000 burn cases each year in the United States.
Management Conference Call and Webcast
Cytori’s management will host a conference call and webcast at 8:30 AM Eastern Time today to further discuss and answer investor questions related to the contract. The dial-in number for the webcast is +1.877.402.3914, Conference ID #36330078 and the webcast may be accessed under “Webcasts” in the Investor Relations section of Cytori’s website (http://ir.cytori.com). If you are unable to participate in the live conference call, you may access the archived webcast approximately 90 minutes after the end of the call.
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 immune 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, but not limited to, those regarding our expectation regarding our ability to successfully develop a thermal burn therapy, the potential benefits of a regulatory approval for thermal burn to advance approvals for other related indications, the sufficiency of the government funding to complete the device based PMA approval process, the potential decision of the government to procure Cytori products in the future, and the potential benefits of thermal burn development work to translate to other related therapies 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 preclinical, clinical and regulatory uncertainties, including risks in the collection and results of clinical data, and final clinical outcomes as well as our history of operating losses, regulatory uncertainties, future Government funding and procurement priorities, 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.