The Biomedical Advanced Research and Development Authority (BARDA) has amended a contract option originally signed in August 2014 to further fund development of Cytori Therapeutics’ countermeasure for thermal burn injuries.
In a mass casualty event, the Government Accountability Office (GAO) reports that as many as 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.
Beyond a mass casualty scenario, there were an estimated civilian 450,000 burn injuries in 2013 that required medical treatment in the United States, with approximately 40,000 requiring hospitalization. Countermeasures to treat burn injuries would also provide benefits in combat medicine environments.
The amended option is valued at $14.1 million, an increase of approximately $2 million from its original value of $12.1 million.
Upon Investigational Device Exemption (IDE) approval by the FDA, BARDA anticipates providing additional funding to cover costs associated with the completion of a clinical trial, currently estimated at $8.3 million, bringing the combined contract option value up to $22.4 million.
The original contract retains two additional options to fund a pivotal clinical trial and additional work in thermal burn complicated by radiation exposure valued at up to $45 million and $23 million, respectively.
“We are pleased to see that once again, BARDA continues to show strong support and interest in Cytori Cell Therapy for this indication,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori Therapeutics. “With these incremental funds, we can expedite the product development and clinical timelines by several months.”
