AVITA Medical Achieves CE Mark for RECELL GO, Expanding in Europe

AVITA Medical Earns CE Mark for RECELL GO Device

AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) has made a significant stride in its commitment to advancing wound care technology by securing the CE Mark for its innovative RECELL GO device. This certification empowers the company to market RECELL GO across Europe, which is an exciting opportunity for both healthcare providers and patients

Transforming Wound Care

Jim Corbett, CEO of AVITA Medical, emphasized the importance of this milestone, stating that the CE Mark for RECELL GO is not just a victory for the company, but for patients who require effective care for acute wound injuries. This device is aimed directly at enhancing treatment options available in burn centers throughout Europe.

RECELL GO represents a shift in how healthcare professionals can assist their patients. The device is designed to create a suspension of a patient's skin cells, known as Spray-On Skin™ Cells, sourced from a small section of healthy skin, which can then be applied directly to aid in the healing of burns and other serious wounds.

Significant Clinical Evidence

Recent clinical data reinforces the efficacy of the RECELL technology. During the 2025 European Burns Association Congress, findings indicated that patients with deep partial-thickness burns experienced a 36% reduction in hospital stay durations when treated with RECELL compared to traditional grafting methods. Such results highlight the clinical value that RECELL technology provides in enhancing patient outcomes.

AVITA Medical’s commitment to delivering advanced wound care is further reflected in their plans for commercialization. The company will partner with various burn centers and clinical entities to introduce RECELL GO in countries such as Germany, Italy, and the United Kingdom.

About AVITA Medical

AVITA Medical is dedicated to developing transformative solutions in the realm of therapeutic acute wound care. The company's innovative approaches are geared toward optimizing healing times and improving overall recovery for patients. Central to their operations is the RECELL System, which has received FDA approval for treatment of thermal burns and traumatic wounds.

RECELL harnesses the natural healing properties of the patient’s own skin, creating Spray-On Skin™ Cells that can be swiftly applied at the point of care. In addition to RECELL, AVITA also has rights in the U.S. for PermeaDerm®, a biosynthetic wound matrix, and Cohealyx™, a collagen-based dermal matrix.

Worldwide Reach

Globally, the RECELL System has gained approval for various skin healing applications, particularly for thermal and trauma wounds. It has marked regulatory clearances in multiple regions, including Europe, Australia, and Japan, showcasing AVITA Medical's dedication to making its technology accessible where it's most needed.

With these advancements, AVITA Medical is poised to revolutionize the standard of care in wound treatment as they expand their reach throughout Europe.

Frequently Asked Questions

What is RECELL GO?

RECELL GO is a point-of-care medical device designed to prepare a suspension of a patient’s own skin cells for treating acute wounds.

Why is the CE Mark important?

The CE Mark indicates that the product meets European health and safety standards, enabling AVITA Medical to market RECELL GO in Europe.

How does RECELL GO improve patient outcomes?

Clinical data shows that RECELL GO can significantly reduce hospital stays for patients with certain types of burns compared to traditional methods.

Where is RECELL GO being commercialized?

AVITA Medical plans to distribute RECELL GO in select European countries such as Germany, Italy, and the UK.

What other products does AVITA Medical offer?

In addition to RECELL, AVITA Medical offers PermeaDerm® and Cohealyx™, which are advanced solutions for wound care and healing.

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