Avita Medical (ASX:AVH) said today it is executing a $24.3 million expanded contract option with the US Department of Health and Human Services to support development and procurement of its ReCell devices.
The option is related to an original contract between Avita Medical and the Biomedical Advanced Research and Development Authority division of the HHS, and will extend Avita’s Project Bioshield contract through Sept. 2022, the Cambridge, U.K.-based company said.
The company originally won the BARDA contract in Sept. 2015, providing an initial $16.9 million to support eventual FDA premarket approval for its ReCell device and to procure more than 5,000 of the devices to establish an inventory to handle mass casualty scenarios that involve burn injuries.
Under the contract, Avita also gained the opportunity to receive up to $37 million upon execution of specific contract options to further support clinical studies and post-market surveillance that could be potentially required by the FDA to expand the device to the pediatric population, the company said.
“Continued development of the foundation of evidence supporting the use of ReCell is essential for elevating the standard of care in pediatric burns. These studies will contribute substantially toward rounding out the story and enabling changes to burn care in everyday clinical practice,” clinical development senior VP Andrew Quick said in a press release.
Avita Medical said it has presented 2 randomized controlled trials to the FDA through its pre-submission process as it seeks eventual clearance of its ReCell device. Both studies will compare treatment with the ReCell versus standard approaches, with up to 20 centers possibly involved in patient recruiting.
In June, Avita released data from a trial of its ReCell device used to treat skin graft patients, touting hastened healing and improved final outcomes.