BOSTON — Oct. 9, 2015 — International law firm Greenberg Traurig, LLP congratulates its client, Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY), on being awarded a contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) reported to be worth up to $53.9 million for late-stage clinical development and procurement of its ReCell® Autologous Cell Harvesting Device under a U.S. mass casualty preparedness program.
The five-year contract commits a minimum of $16.9 million to support Avita’s ongoing U.S. clinical regulatory program 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, according to the company. Additionally, they report that under the contract, Avita also has the potential to receive up to an additional $37 million if contract options are exercised 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 pediatric population. Lastly, contract options provide the U.S. government with surge capacity, supplementing a national stockpile of ReCell® devices. Total procurement under the contract would cover more than 25,000 units of the ReCell® devices, according to Avita.
Greenberg Traurig Boston Intellectual Property (IP) attorney and Of Counsel, Fang Xie, Ph.D., helps Avita design, build and secure IP protection around the company’s ReCell® technology. Michael J. Schaengold, Shareholder and co-chair of the firm’s Government Contracts & Projects Practice in Washington, D.C., advised Avita on the BARDA contract.