AVITA Medical Receives CE Mark for RECELL® GO, Enabling Commercialization Across Europe
AVITA Medical (NASDAQ: RCEL) has received CE Mark approval under the EU Medical Device Regulation for RECELL GO, enabling commercialization across Europe and other markets that recognize the CE Mark. RECELL GO is a point-of-care device that prepares Spray-On Skin™ Cells from a patient's own skin sample to promote healing in burns and traumatic or surgical wounds.
Recent data presented at the 2025 European Burns Association Congress showed that adults with deep partial-thickness burns treated with RECELL experienced a 36% reduction in hospital stays compared to traditional grafting. The company plans to begin commercialization in select European countries, including Germany, Italy, and the United Kingdom.
AVITA Medical (NASDAQ: RCEL) ha ottenuto la marcatura CE secondo il Regolamento sui dispositivi medici dell’UE per RECELL GO, permettendone la commercializzazione in Europa e in altri mercati che riconoscono la marcatura CE. RECELL GO è un dispositivo da utilizzare sul posto che prepara le Spray-On Skin™ Cells a partire da un campione di pelle del paziente per favorire la guarigione di ustioni e ferite traumatiche o chirurgiche.
Recenti dati presentati al Congresso 2025 dell’European Burns Association hanno mostrato che gli adulti con ustioni di profondità parziale profonda trattati con RECELL hanno registrato una riduzione del 36% della durata del soggiorno ospedaliero rispetto al grafting tradizionale. L’azienda intende avviare la commercializzazione in alcuni paesi europei selezionati, tra cui Germania, Italia e Regno Unito.
AVITA Medical (NASDAQ: RCEL) ha obtenido la marca CE conforme al Reglamento de Dispositivos Médicos de la UE para RECELL GO, lo que permite la comercialización en Europa y en otros mercados que reconocen la marca CE. RECELL GO es un dispositivo de uso en el punto de atención que prepara las Spray-On Skin™ Cells a partir de una muestra de piel del propio paciente para promover la curación de quemaduras y de heridas traumáticas o quirúrgicas.
Datos presentados recientemente en el Congreso de la European Burns Association 2025 mostraron que los adultos con quemaduras profundas de espesor parcial tratados con RECELL experimentaron una reducción del 36% en las estancias hospitalarias frente al injerto tradicional. La compañía planea iniciar la comercialización en algunos países europeos seleccionados, entre ellos Alemania, Italia y el Reino Unido.
AVITA Medical (NASDAQ: RCEL)은 EU 의료기기 규정에 따른 CE 마크 승인을 받아 RECELL GO를 유럽 및 CE 마크를 인정하는 다른 시장에서 상업화할 수 있게 되었습니다. RECELL GO는 환자의 피부 샘플로부터 Spray-On Skin™ Cells를 조제하여 화상 및 외상 또는 수술 상처의 치유를 촉진하는 현장 사용 지향 디바이스입니다.
최근 2025년 European Burns Association Congress에서 발표된 데이터에 따르면 RECELL로 치료된 깊은 부분층 화상 환자들은 전통적 이식에 비해 병원 체류 기간이 36% 감소했습니다. 회사는 독일, 이탈리아, 영국 등 일부 유럽 국가에서 상업화를 시작할 계획입니다.
AVITA Medical (NASDAQ: RCEL) a obtenu l’homologation CE conformément au Règlement européen relatif aux dispositifs médicaux pour RECELL GO, ce qui permet sa commercialisation en Europe et sur d’autres marchés reconnaissant le label CE. RECELL GO est un dispositif prêt à l’emploi qui prépare des Spray-On Skin™ Cells à partir d’un échantillon de peau du patient afin de favoriser la guérison des brûlures et des plaies traumatiques ou chirurgicales.
Des données présentées récemment au Congrès 2025 de l’European Burns Association ont montré que les adultes souffrant de brûlures profondes de profondeur partielle traités avec RECELL ont connu une réduction de 36 % de la durée d’hospitalisation par rapport à la greffe traditionnelle. L’entreprise prévoit de commencer la commercialisation dans certains pays européens sélectionnés, dont l’Allemagne, l’Italie et le Royaume-Uni.
AVITA Medical (NASDAQ: RCEL) hat die CE-Kennzeichnung gemäß der EU-Verordnung über Medizinprodukte für RECELL GO erhalten, wodurch die Vermarktung in Europa und in otros Märkten, die das CE-Zeichen anerkennen, ermöglicht wird. RECELL GO ist ein Healthcare-Device für die Anwendung vor Ort, das aus einer Hautprobe des Patienten Spray-On Skin™-Zellen erzeugt, um die Heilung von Verbrennungen sowie traumatischen oder operativen Wunden zu fördern.
Jüngste im Congress 2025 der European Burns Association vorgestellte Daten zeigten, dass Erwachsene mit tiefen partiellen Verbrennungen, die mit RECELL behandelt wurden, eine 36%-Reduzierung der Krankenhausaufenthalte im Vergleich zur herkömmlichen Transplantation verzeichneten. Das Unternehmen plant die Markteinführung in ausgewählten europäischen Ländern, darunter Deutschland, Italien und das Vereinigte Königreich.
AVITA Medical (NASDAQ: RCEL) قد حصلت على علامة CE وفقًا للوائح الأجهزة الطبية في الاتحاد الأوروبي لـ RECELL GO، مما يتيح التسويق في أوروبا وأسواق أخرى تعترف بعلامة CE. RECELL GO هو جهاز للاستخدام في مكان العمل يعِد أنسجة Spray-On Skin™ Cells من عينة جلد المريض نفسه لتعزيز الشفاء من الحروق والجروح الناتجة عن إصابات أو جراحات.
البيانات الأخيرة المقدَّمة في مؤتمر 2025 لجمعية الحروق الأوروبية أظهرت أن البالغين الذين يعانون من حروق عميقة من طبقة جزئية عوملت باستخدام RECELL شهدوا خفضًا بنسبة 36% في فترات الإقامة في المستشفى مقارنة بالزرع التقليدي. تخطط الشركة لبدء التسويق في بعض الدول الأوروبية المختارة، بما في ذلك ألمانيا وإيطاليا والمملكة المتحدة.
AVITA Medical (NASDAQ: RCEL) 已获得符合欧盟医疗设备法规的CE标志用于RECELL GO，允许在欧洲及其他承认CE标志的市场开展商业化。RECELL GO是一种现场使用设备，可从患者自体皮肤样本中制备 Spray-On Skin™ 细胞，以促进烧伤及创伤或手术伤口的愈合。
最近在2025年欧洲烧伤协会大会上公布的数据表明，接受RECELL治疗的深度部分层烧伤的成年人，与传统移植相比，住院时间缩短了36%。公司计划在包括德国、意大利和英国在内的部分欧洲国家启动商业化。
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VALENCIA, Calif., Sept. 14, 2025 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (“AVITA Medical”, or the “Company”), a leading therapeutic acute wound care company, today announced it has received the CE Mark under the European Union Medical Device Regulation (EU MDR) for RECELL GO. This allows the Company to commercialize RECELL GO in Europe and in other markets that recognize the CE Mark.
“CE Mark for RECELL® GO is an important milestone for AVITA Medical and for patients,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “It enables us to bring this option to burn centers and clinicians in Europe to support their treatment of patients with acute wound injuries.”
RECELL GO is a point-of-care device used by healthcare professionals to prepare a suspension of a patient’s own skin cells (Spray-On Skin™ Cells) from a small sample of healthy skin. The cells are applied to promote healing in burns and traumatic or surgical wounds. RECELL GO builds on the RECELL System already in use across Europe.
Data recently presented at the 2025 European Burns Association Congress demonstrated that adults with deep partial-thickness (second-degree) burns treated with RECELL experienced a
With the CE Mark secured, AVITA Medical will begin commercialization of RECELL GO in select European countries, including Germany, Italy, and the United Kingdom, in collaboration with burn centers and clinical partners.
About AVITA Medical, Inc.
AVITA Medical® is a leading therapeutic acute wound care company delivering transformative solutions. Our technologies are designed to optimize wound healing, effectively accelerating the time to patient recovery. At the forefront of our platform is the RECELL® System, approved by the U.S. Food and Drug Administration for the treatment of thermal burn and trauma wounds. RECELL harnesses the healing properties of a patient’s own skin to create Spray-On Skin™ Cells, offering an innovative solution for improved clinical outcomes at the point-of-care. In the U.S., AVITA Medical also holds the exclusive rights to manufacture, market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix, and the exclusive rights to market, sell, and distribute Cohealyx™, an AVITA Medical-branded collagen-based dermal matrix.
In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including thermal burn and trauma wounds, with regulatory clearances in Europe, and excluding RECELL GO, in Australia and Japan.
To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements generally may be identified by the use of words such as “could,” “expect,” “may,” “will,” “would,” and similar words or expressions, and the use of future dates. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation: industry market conditions; failure to obtain and/or maintain regulatory approvals and comply with applicable regulations; market reaction to growth or product initiatives; market penetration of our products; changes in the legal or regulatory environments; and other business effects, including the effects of industry, as well as other economic or political conditions outside of the Company’s control. Any forward-looking statements made herein are made as of the date of this release, and the Company undertakes no obligation to publicly update or revise any of these statements, except as required by law. For additional information and other important factors that may cause actual results to differ materially from forward-looking statements, please see the “Risk Factors” section of the Company’s latest Annual Report on Form 10-K and other publicly available filings for a discussion of these and other risks and uncertainties.
Investor & Media Contact:
Ben Atkins
Phone +1-805 341 1571
investor@avitamedical.com | media@avitamedical.com
Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.
FAQ
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