Updated on 30 September 2015
Avita Medical partners with an US federal agency
Singapore: Australia based Avita Medical, a medical device company specializing in the treatment of wounds and skin defects, has been awarded a contract with the Biomedical Advanced Research and Development Authority (BARDA) worth up to $53.9 million for late-stage clinical development and procurement of its ReCell Autologous Cell Harvesting Device under a US mass casualty preparedness program.
ReCell enables clinician to rapidly create, at point of care in approximately 30 minutes, Regenerative Epithelial Suspension (RES) using a small sample of the patient's skin. RES is an autologous suspension comprising the cells and wound healing factors necessary to regenerate natural, healthy skin
BARDA is a US federal agency assigned to ensure the United States is well prepared for public health emergencies. The agency is within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services, and one of its core aims is to develop medical countermeasures to mitigate the medical consequences from potential chemical, biological, radiation and nuclear threats.
The contract, which will run for five years, commits funding of $16.9 million to support Avita's ongoing US clinical regulatory programme towards FDA Premarket Approval (PMA) and to procure more than 5,000 ReCell devices to establish an inventory so that ReCell can be deployed to help deal with a mass casualty scenario involving burn injuries.
Under the contract, Avita also has the potential to receive up to $37 million when contract options are executed which provide support for further clinical studies potentially required by the FDA as part of post-market surveillance, or as needed to expand the use of ReCell to the paediatric population.