AVITA Medical Announces FDA Approval of RECELL GO mini, Optimizing Treatment for Smaller Wounds
AVITA Medical (NASDAQ: RCEL) has received FDA approval for RECELL GO mini, a new disposable cartridge designed for treating smaller wounds up to 480 square centimeters, compared to the standard RECELL GO's 1,920 square centimeters capacity. The device, part of the RECELL GO platform, uses the same multi-use processing device but features a modified cartridge optimized for smaller skin samples, reducing resource use and minimizing waste.
This approval addresses a critical need in the full-thickness skin defect market, particularly targeting high-volume smaller wounds. The company plans to begin rollout in trauma and burn centers during Q1 2025, aiming to provide an entry point for clinicians who may not have previously used the RECELL GO platform for smaller wounds.
AVITA Medical (NASDAQ: RCEL) ha ricevuto l'approvazione della FDA per RECELL GO mini, una nuova cartuccia monouso progettata per il trattamento di ferite più piccole fino a 480 centimetri quadrati, rispetto alla capacità standard di 1.920 centimetri quadrati di RECELL GO. Il dispositivo, parte della piattaforma RECELL GO, utilizza lo stesso dispositivo di elaborazione riutilizzabile ma presenta una cartuccia modificata ottimizzata per campioni di pelle più piccoli, riducendo l'uso delle risorse e minimizzando gli sprechi.
Quest'approvazione risponde a un'esigenza critica nel mercato dei difetti cutanei a spessore totale, rivolgendosi in particolare a ferite più piccole a elevato volume. L'azienda prevede di avviare il lancio nei centri di trauma e ustioni durante il primo trimestre del 2025, con l'obiettivo di fornire un punto d'ingresso per i medici che potrebbero non aver utilizzato in precedenza la piattaforma RECELL GO per ferite più piccole.
AVITA Medical (NASDAQ: RCEL) ha recibido la aprobación de la FDA para RECELL GO mini, un nuevo cartucho desechable diseñado para tratar heridas más pequeñas de hasta 480 centímetros cuadrados, en comparación con la capacidad estándar de 1,920 centímetros cuadrados de RECELL GO. El dispositivo, parte de la plataforma RECELL GO, utiliza el mismo dispositivo de procesamiento reutilizable pero presenta un cartucho modificado optimizado para muestras de piel más pequeñas, reduciendo el uso de recursos y minimizando los desechos.
Esta aprobación aborda una necesidad crítica en el mercado de defectos cutáneos de grosor total, enfocándose particularmente en heridas más pequeñas de alto volumen. La compañía planea comenzar el lanzamiento en los centros de trauma y quemaduras durante el primer trimestre de 2025, con el objetivo de proporcionar un punto de entrada para los clínicos que pueden no haber utilizado anteriormente la plataforma RECELL GO para heridas más pequeñas.
AVITA Medical (NASDAQ: RCEL)는 RECELL GO mini에 대한 FDA 승인을 받았습니다. 이는 480제곱센티미터까지의 작은 상처를 치료하도록 설계된 새로운 일회용 카트리지를 의미하며, 표준 RECELL GO의 1,920제곱센티미터 용량과 비교됩니다. 이 장치는 RECELL GO 플랫폼의 일부로, 동일한 다회용 처리 장치를 사용하지만 작은 피부 샘플에 최적화된 수정된 카트리지를 특징으로 하여 자원 사용을 줄이고 폐기물을 최소화합니다.
이 승인은 전층 피부 결함 시장의 중요한 요구를 해결하며, 특히 고용량의 작은 상처를 목표로 합니다. 회사는 2025년 1분기 동안 외상 및 화상 센터에서 출시를 시작할 계획이며, 이는 작은 상처에 대해 RECELL GO 플랫폼을 이전에 사용하지 않았던 임상의에게 진입점을 제공하는 것을 목표로 하고 있습니다.
AVITA Medical (NASDAQ: RCEL) a reçu l'approbation de la FDA pour RECELL GO mini, une nouvelle cartouche jetable conçue pour traiter des plaies plus petites, jusqu'à 480 centimètres carrés, par rapport à la capacité standard de 1 920 centimètres carrés de la RECELL GO. L'appareil, qui fait partie de la plateforme RECELL GO, utilise le même dispositif de traitement réutilisable mais possède une cartouche modifiée optimisée pour des échantillons de peau plus petits, réduisant ainsi l'utilisation des ressources et minimisant les déchets.
Cette approbation répond à un besoin critique sur le marché des défauts cutanés de pleine épaisseur, ciblant particulièrement les plaies plus petites à volume élevé. L'entreprise prévoit de commencer le déploiement dans les centres de traumatologie et de brûlures au cours du premier trimestre 2025, avec pour objectif de fournir un point d'entrée pour les cliniciens qui n'auraient peut-être pas utilisé auparavant la plateforme RECELL GO pour des plaies plus petites.
AVITA Medical (NASDAQ: RCEL) hat die FDA-Zulassung für RECELL GO mini erhalten, eine neue Einwegkartusche, die für die Behandlung kleinerer Wunden von bis zu 480 Quadratcentimetern entwickelt wurde, im Vergleich zur Standardkapazität von 1.920 Quadratcentimetern von RECELL GO. Das Gerät, Teil der RECELL GO-Plattform, verwendet dasselbe Mehrzweckverarbeitungsgerät, bietet jedoch eine modifizierte Kartusche, die für kleinere Hautproben optimiert ist, wodurch der Ressourcenverbrauch verringert und Abfall minimiert wird.
Diese Genehmigung adressiert einen kritischen Bedarf im Markt für vollständige Hautdefekte, der insbesondere auf kleinere Wunden mit hohem Volumen abzielt. Das Unternehmen plant, im ersten Quartal 2025 mit der Einführung in Trauma- und Brandzentren zu beginnen, um einen Einstiegspunkt für Kliniker zu schaffen, die die RECELL GO-Plattform möglicherweise zuvor nicht für kleinere Wunden genutzt haben.
- FDA approval received for RECELL GO mini, expanding product portfolio
- Addresses high-volume market segment for smaller wounds
- Optimized design reduces resource use and waste
- Expands potential customer base to include clinicians treating smaller wounds
- Commercial rollout planned for Q1 2025
- None.
Insights
The FDA approval of RECELL GO mini represents a strategic market expansion that addresses a significant unmet need in wound care. The smaller cartridge, optimized for wounds up to 480 square centimeters, opens up a substantial market opportunity in trauma centers where smaller wounds are prevalent.
The modified cartridge's design reduces resource utilization and waste, potentially improving the cost-effectiveness for healthcare providers. This is particularly important in the current healthcare environment where cost containment is crucial. The ability to use the same multi-use processing device with both cartridge sizes creates operational efficiency and reduces barriers to adoption.
In simple terms: Think of this like having both a large and small pizza cutter - while the handle (processing device) stays the same, the smaller blade (mini cartridge) is more practical and economical for smaller pizzas (wounds). This makes the product more attractive to centers that primarily deal with smaller injuries.
The Q1 2025 rollout timing aligns well with hospital budgeting cycles, potentially facilitating faster adoption. This approval strengthens AVITA's competitive position in the $2.4 billion U.S. burn care market by offering a more complete product portfolio that caters to various wound sizes.
The approval positions AVITA Medical to capture a larger share of the full-thickness skin defect market by addressing the high-volume segment of smaller wounds. This market expansion strategy is particularly shrewd as trauma centers typically see a higher volume of smaller wounds compared to major burns.
The timing is strategically significant, as the wound care market is experiencing rapid growth due to increasing prevalence of chronic wounds and rising geriatric population. By providing a more targeted solution for smaller wounds, AVITA could potentially increase its penetration in both existing and new accounts.
For investors: This development could accelerate revenue growth through: 1) Increased adoption in existing accounts due to better size-specific options, 2) New account acquisition, particularly in trauma centers that previously found the standard size less practical and 3) Improved margins through reduced waste and more efficient resource utilization.
In layman's terms: This is like a company that previously only sold bulk-size products now offering smaller portions - it opens up new customer segments and makes the product more practical for everyday use.
VALENCIA, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for RECELL GO® mini. As a line extension of the RECELL GO system, the RECELL GO mini disposable cartridge is designed specifically to treat smaller wounds up to 480 square centimeters, compared to the standard RECELL GO disposable cartridge, which treats an area of 1,920 square centimeters.
RECELL GO mini addresses a critical need in the full-thickness skin defect market, which includes a high volume of smaller wounds. As part of the RECELL GO platform, RECELL GO mini uses the same multi-use processing device as the standard disposable cartridge but features a modified cartridge optimized for smaller skin samples that reduces resource use and minimizes waste. This design provides an entry point for clinicians who may not have previously used the RECELL GO platform for smaller wounds, enabling broader accessibility and use in trauma and burn centers.
“The FDA approval of RECELL GO mini strengthens our ability to provide clinicians with fit-for-purpose solutions that meet the diverse needs of patients with full-thickness wounds,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “By introducing a treatment option specifically for smaller wounds, we are expanding the accessibility of RECELL to a wider range of patients. We believe this addition will drive greater adoption across trauma centers, where smaller wounds are common, and support our broader growth strategy.”
The company expects RECELL GO mini to serve as a growth driver within the broader RECELL GO platform, further advancing AVITA Medical’s strategy to expand its impact on patient care. Rollout will begin with trauma and burn centers that currently treat smaller wounds during the first quarter of 2025.
The PMA supplement follows the original PMA of RECELL Autologous Cell Harvesting Device and subsequent PMA supplements.
About AVITA Medical, Inc.
AVITA Medical is a commercial-stage regenerative medicine company transforming the standard of care in wound care management and skin restoration with innovative devices. At the forefront of our platform is the RECELL System, approved by the FDA for the treatment of thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions. RECELL harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin™ Cells, delivering a transformative solution at the point-of-care. This breakthrough technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. In the United States, AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix, and 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 burns, full-thickness skin defects, and vitiligo. The RECELL System, excluding RECELL GO™, is TGA-registered in Australia, has received CE mark approval in Europe, and has PMDA approval in Japan.
To learn more, visit www.avitamedical.com.
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 “anticipate,” “expect,” “intend,” “could,” “would,” “may,” “will,” “believe,” “continue,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “outlook,” “guidance,” “future,” and similar words or expressions, and the use of future dates. Forward-looking statements include, but are not limited to, statements relating to the timing and realization of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; anticipated market share growth and revenue generation from certain products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, as well as other economic or political conditions outside of the Company’s control. These statements 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.
Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b6b7df71-e67c-4a6e-847c-bdcca54fad27
FAQ
What is the treatment area capacity of RECELL GO mini compared to standard RECELL GO?
When will AVITA Medical (RCEL) begin rolling out RECELL GO mini?
What are the main advantages of RECELL GO mini for healthcare providers?
How does RECELL GO mini expand AVITA Medical's (RCEL) market reach?
