The U.S. Department of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) has awarded a contract valued up to $106 million to Cytori Therapeutics of San Diego, CA.
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 and then delivered back to the patient.
The base contract covers a two year period worth approximately $4.7 million to conduct preclinical research and accelerate Cytori’s ongoing development of their proprietary technology. Successful achievement of specified milestones will allow BARDA to execute options which qualify Cytori to receive up to approximately $101 million in additional funding over the next five years. The total award would support all clinical, preclinical, regulatory, and technology development activities needed to complete the FDA approval process for use in thermal burn injury.
The GAO reports that in a mass casualty event, over 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.
