AVITA Medical recently achieved a major milestone with the CE Mark approval of its RECELL GO™ System under the European Union Medical Device Regulation (MDR). This next-generation device, which builds on the proven RECELL System, represents a leap forward in the treatment of burns, trauma, and surgical wounds by streamlining usability, reducing training requirements, and improving delivery consistency.
To explore the strategic significance of this approval and what it means for patients, clinicians, and AVITA’s global expansion plans, MedTech Spectrum spoke with Ben Atkins, Vice President of Investor Relations and Corporate Communications at AVITA Medical. In this conversation, Atkins discusses how RECELL GO is poised to enhance patient outcomes, reduce healthcare costs, and shape the company’s roadmap for innovation and market growth.
What does receiving the CE Mark under EU MDR mean for AVITA Medical strategically, and how does it impact your ability to scale adoption of RECELL GO in Europe?
The CE Mark for RECELL GO complements our existing RECELL System and enables its rollout both across Europe and in other markets that recognize the CE Mark. Strategically, it positions us to expand access to our more advanced RECELL GO technology.
How does RECELL GO improve upon the existing RECELL System in terms of usability, efficiency, or clinical outcomes for burn centres and surgeons?
RECELL GO builds on the legacy RECELL System by eliminating the need for manual management. This advancement reduces the training burden on medical staff and enables more timely, consistent delivery of therapy, helping burn centres treat patients with greater efficiency and reliability.
Data presented at the European Burns Association Congress showed a 36 per cent reduction in hospital stays. How do these outcomes translate into improved patient quality of life and reduced healthcare costs?
These data, which come via the US National Burn Repository, show that RECELL can reduce hospital lengths of stay for second-degree burn patients by 36 per cent (about six days) compared to traditional split-thickness skin grafts. This is a very meaningful difference (p <0.0001) and translates to per-patient savings in the U.S. of more than $40,000 since the national daily cost of an inpatient bed averages over $7,500. Also, a greater proportion of RECELL-treated patients were discharged directly home, indicating improved recovery trajectories. For the patient, that means getting home to family and back to their life sooner.
Which European markets will you prioritise first for commercialisation, and what role will collaborations with burn centres and clinical partners play in your go-to-market strategy?
We will be deliberate in our rollout, focusing initially on Germany, Italy, and the United Kingdom, in collaboration with burn centres and clinical partners.
RECELL technology has been applied in burns, trauma, and surgical wounds. Do you see broader opportunities for RECELL GO in other wound care or reconstructive indications?
Our focus remains on transforming acute wound care through the treatment of burns, trauma, and surgical wounds. These areas present significant unmet needs where RECELL GO can deliver meaningful clinical and economic impact.
Looking ahead, what are AVITA Medical’s next steps in global expansion and clinical innovation, and how does this CE Mark approval shape your R&D and market development priorities?
We have identified three priority markets outside the U.S., Australia, the European Union and United Kingdom, and Japan. Given the capital requirements to establish direct operations in these diverse regions, we have pursued a partnership model with third-party distributors who bring established networks and deep local market knowledge. The CE Mark strengthens our position in Europe, aligns with our global growth strategy, and informs our continued investment in both clinical innovation and market development.
Shraddha Warde
Shraddha.warde@mmactiv.com
