AVITA Medical receives EU regulatory approval for RECELL GO device

VALENCIA, California - AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH) has received the CE Mark under the European Union Medical Device Regulation for its RECELL GO device, according to a press release statement issued Sunday. The company, which generated revenue of $29.41 million in the last twelve months with a 2.98% growth rate, is looking to expand its market presence despite challenging financials.

The regulatory approval allows the company to commercialize RECELL GO in Europe and other markets that recognize the CE Mark. RECELL GO is a point-of-care device used by healthcare professionals to prepare a suspension of a patient’s own skin cells from a small sample of healthy skin, which are then applied to promote healing in burns and traumatic or surgical wounds. According to InvestingPro analysis, AVITA Medical currently shows a weak financial health score of 1.19, with an EBITDA of -$39.31 million, highlighting the importance of this expansion for the company’s growth strategy.

"CE Mark for RECELL GO is an important milestone for AVITA Medical and for patients," said Jim Corbett, Chief Executive Officer of AVITA Medical in the statement. "It enables us to bring this option to burn centers and clinicians in Europe to support their treatment of patients with acute wound injuries."

The company plans to begin commercialization of RECELL GO in select European countries, including Germany, Italy, and the United Kingdom, working with burn centers and clinical partners.

Data presented at the 2025 European Burns Association Congress showed that adults with deep partial-thickness burns treated with RECELL technology experienced a 36% reduction in hospital stays compared with traditional grafting, according to the company.

RECELL GO builds upon the RECELL System that is already in use across Europe. In the United States, AVITA Medical’s RECELL System is approved by the Food and Drug Administration for the treatment of thermal burn and trauma wounds. Investors anticipating more details about the expansion plans should note that AVITA Medical’s next earnings report is scheduled for September 15, 2025. For comprehensive financial analysis and additional insights, consider exploring InvestingPro, which offers exclusive metrics and professional-grade tools for informed investment decisions.

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