With a new contract that could top almost $54 million and a just-announced patent, Avita Medical, Ltd. CEO Adam Kelliher said further development of the company's ReCell technology is in full swing.
The ReCell is a single-use device that allows medical professionals to generate a regenerative epithelial suspension that can be applied to a burn injury – in other words, ReCell “helps retrigger the regrowing of cells,” Kelliher told BioPrepWatch.
As a cell suspension preparation device, ReCell is a simple, rapid and cost-effective technique for harvesting and delivering disaggregated skin cells along with the associated cell signaling for regeneration of healthy skin, he said.
“The device truly is amazing and we’re only just beginning to see how important ReCell is and can be,” Kelliher said. “Not only have early tests shown that ReCell can help short-term healing, it also improves long-term outlooks for victims having such injuries.”
What’s key about ReCell, Kelliher told BioPrepWatch, is that using it also reduces a patient’s chances of infection; “and this is crucial when someone has had skin burned off or suffered a chronic wound,” he said.
To further develop ReCell, Avita Medical – which manufactures regenerative medicines and devices to treat skin defects and wounds – in October garnered a contract worth up to $53.9 million from the Biomedical Advanced Research and Development Authority (BARDA). The initial contract is worth $16.9 million to complete necessary clinical regulations for premarket application. An additional $37 million is possible to continue development and testing in the post-market period and for stockpiling operations.
With BARDA’s financial support, Kelliher said the company aims to apply for U.S. Food and Drug Administration (FDA) premarket approval.
"Securing this contract from a U.S. federal agency is a momentous milestone," Kelliher said.
Though restricted on releasing specific forward information on the company’s FDA plan, Kelliher did say that Avita Medical is currently completing a device trial with 30 patients. So far, 24 patients have been enrolled in the trial. Kelliher said enrollment will be completed by Christmas. “We’re currently on track,” he said.
The good news just keeps on coming for Avita Medical.
In October, the company announced that the Walter Reed National Military Medical Center in Bethesda, Maryland began conducting a study to determine how the ReCell device could be used to treat the traumatic wounds suffered by civilians and military personnel.
The U.S. military wound trial is funded by the U.S. Department of Defense research program. So far, one patient has been treated under the trial, which is receiving advisory support from Avita Medical.
Earlier this month, Avita Medical also received a new Australian patent that effectively extends the original ReCell patents to 2033 in Australia and provides greater claim coverage for its conditioned Regenerative Epithelial Suspension (RES), and the methods of preparing and using RES for skin treatment.
With the new patent, a broad range of exogenous agents may be added to RES, including items such as heat shock protein, hyaluronic acid and adipose-derived stem cells.
“This patent is an important step in securing the company's global footprint for our proprietary ReCell technology,” Kelliher said. "It provides further validation of the significant need for our skin repair technology.”
Having the extended coverage for several other uses of RES, he said, will create further value for the company and its regenerative therapy.