AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase
FDA Building 66. (Credit: The U.S. Food and Drug Administration from Wikimedia Commons)
AVITA Medical, a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, announced today that the Food and Drug Administration (FDA) granted the RECELL System designations as a Breakthrough Device for its proposed soft tissue repair indication as well as its vitiligo indication.
The goal of the FDA Breakthrough Devices Program is to provide patients and health care providers with timely access to new medical devices and technologies by expediting the development, assessment, and review of devices that provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. Under the program, AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase.
“We are pleased that the FDA has recognized the therapeutic potential of our RECELL System for our proposed soft tissue repair and vitiligo indications with the Breakthrough Device designations,” said Jim Corbett, AVITA Medical Chief Executive Officer. “We are hopeful that the designations will help ensure timely patient access to RECELL as therapeutic treatments for both soft tissue repair and vitiligo, and we look forward to interacting with the agency in its review of RECELL for these proposed indications.”
AVITA Medical’s clinical trial in soft tissue repair has been funded in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500028C.
Source: Company Press Release