The market may be experiencing a downturn today, but AVITA Medical Inc (ASX: AVH) is defying the trend with a remarkable surge. In morning trade, the company’s shares have jumped 11% to $1.49 following a significant announcement.
AVITA Medical, a leader in regenerative medicine, has received the CE Mark under the European Union’s Medical Device Regulation for its innovative RECELL GO device. This approval allows the company to commence commercialization of the product across Europe and in other markets that recognize the certification.
Milestone Achievement for AVITA Medical
Investors are driving AVITA Medical’s shares higher today, buoyed by the company’s breakthrough in obtaining the CE Mark for RECELL GO. This development is seen as a pivotal moment for the company, as it opens doors to new markets and opportunities.
Jim Corbett, AVITA Medical’s Chief Executive, expressed his satisfaction with the approval, stating that it marks a turning point for the business. He commented:
CE Mark for RECELL GO is an important milestone for AVITA Medical and for patients. It enables us to bring this option to burn centers and clinicians in Europe to support their treatment of patients with acute wound injuries.
Understanding AVITA Medical’s Innovative Approach
AVITA Medical specializes in therapeutic acute wound care, with its flagship product, the RECELL System, designed to accelerate the healing of burns and traumatic wounds using a patient’s own skin. The technology involves creating a suspension of skin cells, known as Spray-On Skin Cells, which are applied to damaged areas to enhance recovery.
The newly approved RECELL GO product builds on this platform, simplifying and streamlining the process at the point of care. For healthcare providers, this means faster preparation of the cell suspension, while patients benefit from shorter hospital stays and improved healing outcomes.
In addition to RECELL, AVITA Medical holds exclusive rights in the U.S. to distribute complementary wound care technologies such as PermeaDerm, a biosynthetic wound matrix, and Cohealyx, a collagen-based dermal matrix. Together, these products form a comprehensive portfolio aimed at improving recovery and outcomes for patients with serious wounds.
Clinical Evidence and Future Prospects
The announcement of the CE Mark approval was bolstered by clinical evidence presented at the 2025 European Burns Association Congress. The data demonstrated that patients treated with RECELL experienced a 36% reduction in hospital stays compared to traditional grafting methods.
For health systems, that translates into lower costs. For patients, it means less time in hospital and a quicker recovery.
With the CE Mark approval in hand, AVITA Medical is poised to roll out RECELL GO in key European countries, including Germany, Italy, and the UK, in collaboration with burn centers and clinical partners. This expansion is expected to significantly enhance the company’s market presence and drive future growth.
The move represents a strategic step forward for AVITA Medical, positioning it as a leader in the field of regenerative medicine. As the company continues to innovate and expand its reach, it remains committed to improving patient outcomes and advancing the standard of care for acute wound injuries.
