Cytori Therapeutics and the Biomedical Advanced Research and Development Authority (BARDA) are extending a contract they inked in September of 2012, executing an option to fund further development of Cytori Cell Therapy for use in thermal burn injuries. The current extension, Cytori says, is worth around $12.1 million, and BARDA noted the funds should cover the costs of the clinical trial (estimated to be around $8.3 million), giving the extension a combined value to up to $20.4 million.
The deal, which was said to be worth up to $106 million, was part of BARDA’s national preparedness initiative to prepare for a possible mass casualty event by developing technologies that may address unmet medical needs in the area of biodefense. The contract covered three milestones—preclinical studies demonstrating improved healing parameters using Cytori Cell Therapy in a thermal burn model; preliminary design and development of Cytori’s Celution® System; and demonstration of feasibility of obtaining functional regenerative cells from adipose tissue samples from burn patients—all of which, according to BARDA and Cytori, have been achieved.
BARDA and Cytori say that this latest investment will fund R&D activities aimed at determing whether adipose-derived regenerative cells (ADRCs™) could be used as a medical countermeasure for thermal burns when combined with radiation injury. The funds should cover the remaining activities needed to enable a pilot clinical trial of Cytori Cell Therapy for thermal burns and should also fund around two years of preclinical studies in other burn-related areas. They add that the immediate focus of activities under the contract is toward preclinical, clinical, and regulatory activities leading to FDA Investigational Device Exemption approval for the trial.
The contract is retaining two additional options that were part of the original contract to fund a pivotal clinical trial and additional work with thermal burns complicated by radiation exposure, valued at up to $45 million and $23 million respectively.
Cytori's president and CEO Marc Hedrick, M.D., said in a statement that this is the first technology in the area of thermal burn to have a contract option executed by BARDA. "The preclinical data from the initial phase of the project has been very positive and consistent with what we have observed in patients with chronic wounds treated with ADRCs and we anticipate submitting the data for publication later this year," he commented.