Breakthrough Device Designations Granted for AVITA Medical’s RECELL System

AVITA Medical Inc.’s. RECELL System has received U.S. Food and Drug Administration (FDA) Breakthrough Device designation for its proposed soft tissue repair and vitiligo indications.

“We are pleased 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,” AVITA Medical CEO Jim Corbett said. “We are hopeful 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.”
 
The FDA Breakthrough Devices Program is designed to provide patients and healthcare 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.
 
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.
 
AVITA Medical is a regenerative medicine company developing and commercializing devices and autologous cellular therapies for skin restoration. The RECELL System technology platform, approved by the FDA to treat acute thermal burns in both adults and children, harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin cells. Delivered at the point-of-care, RECELL is the catalyst of a new treatment paradigm and AVITA Medical is leveraging its capabilities to develop cellular therapies for multiple indications, including soft tissue repair and repigmentation of stable vitiligo lesions.
 
The RECELL System was approved by the FDA in September 2018 for acute partial-thickness thermal burn wounds in adult patients or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. In February 2022, the FDA reviewed and approved the PMA supplement for RECELL Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow.
 
The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. Data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 15,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings.
 
In international markets, AVITA Medical’s products are approved under the RECELL System brand to promote skin healing in a wide range of applications including burns, soft tissue repair, vitiligo, and aesthetics. The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe, and has PMDA approval in Japan.