Avita Medical (ASX:AVH), a regenerative medicine company specialising in the treatment of wounds and skin defects, has announced the execution of an expanded contract option valued at approximately US$24.3 million.
The newly executed contract option establishes funding for key clinical and health economics research in US paediatric burn care and extends Avita’s Project Bioshield contract through to September 2022.
The option execution relates to an original contract between Avita Medical and the Biomedical Advanced Research and Development Authority (BARDA), a division of the US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (ASPR).
Under the base contract BARDA made an initial investment of US$16.9 million to support Avita’s ongoing US clinical regulatory program towards FDA Premarket Approval (PMA) and to procure 5,000-plus ReCell devices.
The contract also allowed BARDA to exercise future options to support additional clinical trials and provide surge capacity for up to another 20,000 ReCell devices.
Supplemental funding worth up to US$7.96 million was also provided to Avita under the contract in June of 2016 to provide further operational support to Avita’s PMA preparation and Compassionate Use program.
Paediatric burn care is of particular concern to BARDA and Avita. Thirty percent of burns in the US occur in patients under 16 years of age. In the paediatric population, donor skin comes at a high premium due to limited availability and distinct increases in morbidity associated with harvesting skin for conventional autografts.
The company said two randomised control trials (RCTs), powered to demonstrate statistical significance, have been presented to the FDA via the pre-submission process.
One trial focuses on characterising benefit derived from use of Regenerative Epithelial Suspension prepared using the ReCell device to treat donor sites in patients aged 1 to 16 years. The other trial, planned to run in parallel, will aim to show decreases both in time to healing and in the frequency of conventional autografting in patients of the same age range who have suffered second-degree burn injuries.
“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,” said Andrew Quick, senior vice president of Clinical Development.