- The U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) and Cytori Therapeutics (CYTX) amend their contract to fund the continued investigation and development of Cytori Cell Therapy for use in thermal burn injuries.
- The amended option is valued at $14.1M, which is an increase of $2M from the original value. The incremental money will support verification, testing and validation for the delivery and processing of adipose-derived regenerative cells (ADRCs). Upon the FDA clearance of the Investigational Device Exemption (IDE), BARDA expects to provide an additional ~$8.3M to fund an early stage clinical trial.
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The original contract retains two options to fund a pivotal clinical trial ($45M) and additional work in thermal burn complicated by radiation exposure ($23M).
- According to the American Burn Association, there were ~450K burn injuries in the U.S. in 2013 that required treatment with ~40K requiring hospitalization.