Avita Medical Ltd. is planning to launch its second generation ReCell burn treatment device in Europe, following CE Mark approval, the UK devicemaker announced recently.
The new model can treat up to a 1,920 square-centimeter surface area and features a six-fold greater coverage than the first generation device — the original ReCell could treat only 320 square centimeters -- roughly 1.5 percent of an adult's total body surface area. The new generation is designed for burn victims requiring heavier-duty grafts, the company said.
“This CE Mark approval represents an important step in realizing the full potential of Avita’s best-in-class regenerative product portfolio. ReCell is now better positioned to address the needs of the burn patients and we look forward to commencing commercial activities across Europe, and a corresponding uptick in revenue,” CEO Adam Kelliher said.
ReCell is TGA-registered in Australia and SFDA-cleared in China. It is limited to investigational use in the U.S. while an FDA Phase III trial is underway.
The company also has been awarded a new patent from the U.S. Patent and Trademark Office for the manufacture and use of an epithelial cell suspension, part of the firm's autologous skin regeneration therapy platform, ReCell.“This newly issued patent continues to strengthen and expand our overall patent coverage for ReCell. Moving forward, we are continuing to focus on the prosecution of additional patents that support our entire regenerative medicine franchise. This patent is a key milestone towards our commercialization effort in the United States,” Kelliher added.
The patent provides protection for methods for producing and using a transplantable cellular suspension of living tissue suitable for grafting to a patient. Avita has an intellectual property portfolio for its regenerative technology platform -- ReCell, ReGenerCell and ReNovaCell are protected by a family of patents and patent applications covering unique composition of final product, method of production, device and automation for methods and apparatus to generateepithelial suspension, according to the company.
Avita develops and distributes regenerative products for the treatment of various wounds, scars and skin defects. The company is based in Cambridge, United Kingdom, and operates a U.S. facility in Northridge, Calif.