Avita Medical (ASX:AVH) said yesterday it won $53.9 million in contracts from the Biomedical Advanced Research and Development Authority for development and procurement of Avita’s ReCell autologous cell harvesting device.
The 5-year contract will provide an initial $16.9 million to support the company’s pursuit of 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, Avita Medical said.
“Securing this contract from a U.S. federal agency is a momentous milestone. US authorities have conducted a detailed evaluation of our technology and this contract further validates the opportunity afforded by our unique regenerative medicine. Further, this deal highlights the importance of preparedness for mass casualties. We look forward to meeting BARDA’s criteria for large-scale product delivery,” CEO Adam Kelliher said in a press release.
Under the contract, Avita also has 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.
The contract also provides BARDA with “surge capacity”, according to Avita, which would allow the department to stockpile up to 25,000 of the devices.
The post Avita Medical reels in $53.9m from BARDA appeared first on MassDevice.
from MassDevice http://ift.tt/1JDhq8G
Cap comentari:
Publica un comentari a l'entrada