VALENCIA, Calif. - AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), specializing in regenerative medicine and skin restoration, has recently submitted a response to the U.S. Food and Drug Administration (FDA) regarding additional information for its RECELL GO™ device.
This step marks the continuation of the FDA's review process under the Breakthrough Devices Program, following an information request from October 2023.
The company's response includes data from in-house testing, which aims to support the premarket approval (PMA) supplement of RECELL GO™. With the FDA's review expected to resume for the remaining 90 days, AVITA Medical anticipates approval by May 30, 2024.
The Chief Executive Officer, Jim Corbett, expressed confidence in RECELL GO™, highlighting its potential to reduce training burdens and facilitate broader adoption in various medical applications.
RECELL GO™ is an extension of AVITA Medical's RECELL® System, which utilizes a patient's own skin cells to promote healing for burns and other skin defects. The technology has been approved by the FDA for specific treatments and has garnered international approvals for a wider range of applications.
The company's optimistic outlook for RECELL GO™ is based on its potential to streamline the training process for medical professionals, which may lead to increased usage and impact on patient care. AVITA Medical has a history of developing innovative devices for wound care management and sees RECELL GO™ as a strategic addition to its product lineup.
The information provided in this article is based on a press release statement from AVITA Medical, Inc. As the company awaits the FDA's decision, the healthcare community and investors are keeping a close watch on the potential expansion of AVITA's regenerative medicine offerings.
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