The amended option is valued at $16.6 million, an increase of approximately $2.5 million from its previous value of $14.1 million.
Upon Investigational Device Exemption (IDE) approval by the FDA, if received, Cytori will request that BARDA provide additional funding to cover costs associated with the completion of a pilot clinical trial. This trial will employ IV administration of Cytori Cell Therapy.
The supplemental funds from this amended contract will be used to support the remaining activities necessary to seek approval of the IDE and support clinical readiness.
The original contract includes additional options, exercisable at BARDA’s discretion, valued at up to $68 million to fund both pilot and pivotal clinical trials and additional work in thermal burn complicated by radiation exposure.
“BARDA and Cytori continue to work closely to develop this technology in the interests of the nation,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. “Additional funding allows Cytori to complete activities necessary for conduct of a pilot trial with the objective of getting Cytori Cell Therapy into the clinic for thermal burn in 2017.”
The current healthcare system is ill-prepared for large numbers of patients requiring simultaneous treatment for thermal burns associated with radiation exposure. Current standard of care consists of dressings, skin grafts and skin substitutes.
Despite these treatments, patients with severe burns commonly suffer from prolonged pain, aggressive scarring, skin contracture and reduced range of motion. Cellular therapeutics such as those offered by Cytori may have the potential to improve the quality and rate of wound healing and reduce scarring and also can be deployed in a cost effective manner, even in mass casualty situations.
According to the American Burn Association, there were approximately 450,000 burn injuries in 2013 that required medical treatment in the United States, with approximately 40,000 requiring hospitalization. In a mass casualty event, the Government Accountability Office estimates 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.
