AVITA Medical, Inc. has achieved a major milestone with the announcement that its RECELL GO device has received CE Mark certification under the European Union Medical Device Regulation (EU MDR). The approval, announced on September 14, 2025, allows the regenerative medicine company to commercialize its advanced wound-care technology across Europe, as well as in Switzerland, Turkey, and other markets that honor CE Mark standards.
Transforming Wound Care with RECELL GO
RECELL GO is a next-generation device that prepares a suspension of Spray-On Skin™ Cells using a small piece of a patient’s own healthy skin. This technology enables natural healing for acute wounds, including severe burns and surgical injuries. By automating critical steps such as enzyme incubation, cell separation, and filtration, the system significantly reduces preparation time and human error compared to the original RECELL System.
The innovation is particularly vital for thermal burns and full-thickness skin injuries, creating a sprayable cellular suspension that speeds up wound closure. A smaller version, RECELL GO mini, was cleared by the FDA in December 2024 for smaller injuries, expanding its clinical use cases.
Regulatory Approval Opens Market Access
The CE Mark certification was granted under the EU MDR framework, which demands high standards of safety and performance. This comes after RECELL GO’s earlier FDA approval in May 2024 for treating burn patients in the U.S. The original RECELL System has long been available in markets such as Australia, Japan, and the U.S., but the streamlined automation of RECELL GO positions it as a superior solution for high-volume burn centers.
For AVITA Medical, this approval means entry into key European markets, beginning with Germany, Italy, and the United Kingdom. Partnerships with burn centers and clinical specialists will be central to its rollout strategy.
Clinical Benefits Backed by Data
Recent studies have highlighted RECELL’s effectiveness in reducing patient hospital stays and improving recovery outcomes. At the 2025 European Burns Association Congress, data showed a 36% reduction in hospital time for burn patients treated with RECELL compared to traditional skin grafting. Other findings emphasize faster healing, reduced donor site needs, and improved cosmetic results, critical advantages in both trauma and surgical care.
Such results not only benefit patients but also reduce healthcare costs, making the device attractive to hospitals and insurers alike.
Company Outlook and Industry Impact
Headquartered in Valencia, California, AVITA Medical specializes in autologous cellular therapies aimed at accelerating recovery from acute wounds. With the CE Mark for RECELL GO, the company is positioned to strengthen its global footprint and enhance treatment options for patients across Europe.
“CE Mark for RECELL GO is an important milestone for AVITA Medical and for patients,” said CEO Jim Corbett. “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 announcement sparked wide discussion on financial and biotech news platforms, where industry watchers see it as a growth driver for AVITA. While no immediate stock data has surfaced, analysts expect the European rollout to boost revenue potential and adoption rates in trauma and burn care.
As commercialization begins, AVITA Medical faces opportunities as well as challenges. Market dynamics, regulatory changes, and broader economic conditions remain factors to watch, but with growing clinical evidence, RECELL GO could emerge as a transformative tool in global wound care.
