Regenerative medicine company AVITA Medical (ASX: AVH) has submitted its response to the US Food and Drug Administration (FDA) for additional information requested in connection to its premarket approval (PMA) supplement for RECELL GO.
This submission resumes the substantive interactive review process under the Breakthrough Devices Programme.
The response addresses various questions and incorporates data from in-house testing to support the PMA supplement and fulfil the additional information request, which we received in October of 2023.
Upon receipt by the FDA, the application of the PMA supplement resumes its 180-day real time review, with 90 days remaining in the review period. Therefore, we expect FDA approval on May 30, 2024, positioning us for a product launch on May 31, 2024.
“RECELL GO will enhance our capabilities and reach to continue our already impressive growth,” said Jim Corbett, CEO of AVITA Medical. “RECELL GO reduces the training burden on medical professionals and our field sales organization. In doing so, we anticipate broader adoption of RECELL across various applications, ultimately amplifying our impact and transforming patient care."
The supplement follows the original PMA of its RECELL Autologous Cell Harvesting Device and subsequent PMA supplements.
AVITA Medical is a commercial-stage regenerative medicine company transforming the standard of care in wound care management and skin restoration with innovative devices. At the forefront of its platform is the RECELL System, approved by the FDA for the treatment of thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions.
RECELL harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin Cells, delivering a transformative solution at the point-of-care. This breakthrough technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm, a biosynthetic wound matrix, in the United States.
