AVITA Medical (ASX:AVH) reports the Food and Drug Administration (FDA) has granted the RECELL System designations as a Breakthrough Device for its proposed soft tissue repair indication as well as its vitiligo indications.
The company says the goal of the FDA Breakthrough Devices Program is 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 prioritised review and interactive communications with the FDA throughout the premarket review phase.
“We are hopeful that the designations will help ensure timely patient access to RECELL as therapeutic treatments for both soft tissue repair and vitiligo”
AVITA Medical CEO Jim Corbett said the company is please that the FDA has recognised the therapeutic potential of the company’s RECELL System for proposed soft tissue repair and vitiligo indications with the Breakthrough Devices designations
“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.”
The company reports the clinical trial in soft tissue repair has been funded in part with the Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority.
AVITA Medical is a United States-based regenerative medicine company leading the development and commercialisation of devices and autologous cellular therapies for skill restoration and the RECELL System technology planform has been approved by the FDA for the treatment of acute thermal burns in adults and children.
The RECELL System uses the regenerative properties of a patient’s own skin to create Spray-on-Skin cells, and enables improved clinical outcomes and validated cost savings.
The company says RECELL is the ‘catalyst’ of a new treatment paradigm and AVITA is leveraging its capabilities to develop first-class cellular therapies for multiple indications, including soft tissue repair and repigmentation of stable vitiligo lesions.
RECELL was first approved by the FDA in September 2018 for acute partial thickness thermal burns in patients 18 and older, or an application in combination with meshed autografting for acute full thickness thermal burn wounds in paediatric and adult patients.
In February this year, AVITA reported the FDA reviewed and approved the PMA supplement for RECELL Autologous Cell Harvesting Device, an enhanced RECELL system capable of providing clinicians a more efficient user experience and simplified workflow.