|ReCell burn treatment device--Courtesy of Avita|
Tiny OTC-traded micro-cap Avita Medical ($AVMXY) has won backing from the U.S. Biomedical Advanced Research and Development Authority (BARDA) of its PMA approval trial for its ReCell burn treatment device. It will get $16.9 million upfront for the study and for procurement of more than 5,000 of the devices. The ongoing pivotal trial is expected to complete enrollment by the end of the this year.
A future, additional amount of $37 million in contract options is available to BARDA over a 5-year period to support more clinical testing and to provide up to 20,000 of the ReCell devices. The intention is to use these as part of a U.S. mass casualty preparedness program.
The ReCell Autologous Cell Harvesting Device is a single-use device that enables healthcare providers to quickly and easily make a Regenerative Epithelial Suspension (RES) that can be applied to a burn. Thus far, clinical data have shown that this can improve short-term healing as well as provide superior long-term outcomes. The device can create the RES using small skin samples--reducing the need for donor skin.
The ReCell device first attracted attention when it was used for burn victims after a 2002 bombing in Bali, Indonesia. It was most recently deployed in another mass casualty event at a Taiwan water park.
The BARDA deal is a "transformational opportunity" for Avita, said its CEO Adam Kelliher in a statement.
"Securing this contract from a US 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," he said. "Further, this deal highlights the importance of preparedness for mass casualties. We look forward to meeting BARDA's criteria for large-scale product delivery."
Avita was up about 25% on the BARDA news--but it still has a tiny market valuation of less than $30 million.
- here is the announcement