AVITA Medical wins EU green light for RECELL GO; shares surge as Europe launch begins

Key highlights

• CE Mark granted for RECELL® GO under EU MDR, enabling commercial roll-out across Europe and in other CE-recognising markets. 
• Initial launch countries: Germany, Italy, United Kingdom—working with burn centres and clinical partners. 
• Clinical signal: adults with deep partial-thickness burns treated with RECELL saw a 36% shorter hospital stay versus traditional grafting in recent European data. 
• Management view: CEO Jim Corbett calls the authorisation “an important milestone,” enabling access for European burn clinicians. 
• Market snapshot (2:18pm AEST, Mon 15 Sep 2025): AVH A$1.46 (+8.96%), vol. ~972k, mkt cap ~A$219m, 1-yr return −47.9%, 52-wk A$1.27–4.52; 150.0m shares on issue. (Session figures per user-supplied data.)
  
   

AVITA Medical (ASX: AVH; Nasdaq: RCEL) has received CE Mark approval for RECELL® GO, clearing the way for European commercialisation of its point-of-care device that prepares a patient’s own Spray-On Skin™ Cells from a small skin sample for application to acute wounds. The company will begin rolling out in Germany, Italy and the UK, with broader access in other CE-recognising markets to follow. 

“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,” said Jim Corbett, Chief Executive Officer. 

What was announced—and why it matters

RECELL GO is a next-generation, point-of-care device that allows clinicians to create an autologous cell suspension from a small split-thickness biopsy and apply it directly to the wound bed. The CE Mark indicates compliance with the European Union Medical Device Regulation (EU MDR)—the stricter post-2017 framework that has become the global standard for clinical evidence and manufacturing controls. For hospitals, MDR authorisation typically smooths procurement and reimbursement dialogues and signals that a product has cleared European quality and safety bars. 

AVITA notes that RECELL-treated patients with deep partial-thickness burns had a 36% reduction in length of stay versus traditional grafting in data presented at the 2025 European Burns Association Congress—a relevant metric for both patient recovery and hospital economics. Shorter stays can lower costs and free up beds in high-acuity burn units, where capacity is often constrained. 

Where RECELL GO fits in AVITA’s portfolio

RECELL GO builds on the existing RECELL System already used in Europe and complements the company’s U.S. portfolio, where RECELL is FDA-approved for thermal burns and trauma wounds. In the U.S., AVITA also has exclusive rights to the PermeaDerm® biosynthetic wound matrix and Cohealyx™ collagen-based dermal matrix, extending its toolkit beyond cell therapy into advanced wound dressings. The European launch adds a second major theatre for growth alongside the U.S. and Japan. 

Management’s message and commercial priorities

Corbett’s emphasis on patient access aligns with a pragmatic commercial plan: start with core burns centres in Germany, Italy and the UK, gather post-market evidence in routine use, and then expand. For investors, watch for:

• Site counts and utilisation trends across early adopters;
• Training throughput and time-to-first-use at new centres;
• Any reimbursement milestones or clinical-society endorsements that shorten hospital sales cycles. 
  
   

AVITA’s release retains the usual forward-looking caveats—from regulatory and market risks to uptake variability—appropriate given the company’s transition from a single-region to a multi-region commercial footprint. 

What to watch next

• Launch metrics: hospital onboarding in Germany/Italy/UK, initial utilisation, and clinician feedback on workflow and outcomes. 
• Evidence read-throughs: additional real-world data on healing time, graft requirements, and length of stay—key inputs for payers and hospital administrators. 
• Geographic expansion: timelines for entry into other CE-recognising markets and any distribution partnerships. 
• U.S. updates: progress across burn/trauma indications and any portfolio synergies with PermeaDerm® and Cohealyx™. 
  
   

Upsides and risks

Upside: MDR-level approval provides regulatory credibility; the 36% shorter stay metric offers a concise economic story; and a device-plus-biomaterials mix gives AVITA multiple touchpoints in wound care. Early country focus should keep the launch tight and measurable. 

Risks: European adoption can be country-by-country—with differences in coding, reimbursement and procurement—so timelines can vary. Training demand and supply-chain/logistics for a point-of-care device must scale smoothly. Macro-wise, rate and FX moves swing med-tech valuations; a less-dovish Fed would tighten financial conditions and risk appetite. 

At the time of writing this article, AVH traded at A$1.46, up by 9%.