(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.
Adipose Derived Stem and Regenerative Cells (ADRCs)
“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.