Avita Medical and BARDA execute a US$24.3m contract option

Regenerative medicine company Avita Medical has announced the execution of an expanded contract option valued at approximately US$24.3 million. This 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).

Avita Medical has had a relationship with BARDA since the execution of a five-year contract in September 2015. 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 5000-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. Both objectives support BARDA’s overarching goal of building burn care preparedness, by securing effective medical countermeasures for burn injuries for use in case of a mass casualty.

The base contract between BARDA and Avita Medical has provided substantial support to the shared primary goals of achieving US regulatory approval for the company’s ReCell Autologous Cell Harvesting Device, thus establishing preparedness for a potential US mass casualty event involving thermal burn injuries.

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. Second-degree burns often result from scald injuries, accounting for approximately 60% of burns in the US in the study population.

The two-cohort study design, planned to include collection of costing data in addition to clinical data, will further inform both clinical and health economic benefits of using ReCell. Both studies will compare treatment using the ReCell device versus current standard approaches. Up to 20 US burn centres may be involved in recruiting patients into these studies.