Tendersinfo keep you informed about the latest events in the national and international Procurement Industry. Procurement News provides in-depth coverage of the procurement industry, including contract awards, contract additions, new contract wins, mergers and acquisitions. Tendersinfo through its tender news section provides an update on all domestic and global tendering opportunities, invitation to bid & trade leads.
Australia : Avita Medical Awarded US Government Contract valued at up to $53.9m USD
Publish Date : 03-Oct-2015
Avita Medical Ltd., 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 USD$53.9 million for late-stage clinical development and procurement of its ReCell Autologous Cell Harvesting Device under a US mass casualty preparedness program.
The contract, which will run for five years, commits funding of USD$16.9m to support Avitas 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 USD$37m 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. Lastly, additional contract options provide the US government with surge capacity, supplementing a national stockpile of ReCell devices. Total procurement under the contract would cover more than 25,000 devices.
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.
