AVITA Medical Announces FDA 510(k) Clearance for Cohealyx, Expanding its Addressable Market
AVITA Medical (NASDAQ: RCEL) has received FDA 510(k) clearance for Cohealyx, a collagen-based dermal matrix co-developed with Regenity Biosciences. The product is designed for tissue integration and revascularization in full-thickness wound treatment. Preclinical studies showed Cohealyx generated robust tissue supporting skin grafts faster than leading competitors.
This strategic addition complements AVITA's existing RECELL and PermeaDerm portfolio, expected to triple the company's addressable market in burns. The company plans to initiate clinical studies in early 2025 and launch full commercialization efforts in Q2 2025.
AVITA Medical (NASDAQ: RCEL) ha ricevuto l'approvazione FDA 510(k) per Cohealyx, una matrice dermica a base di collagene co-sviluppata con Regenity Biosciences. Il prodotto è progettato per l'integrazione dei tessuti e la revascularizzazione nel trattamento delle ferite a pieno spessore. Gli studi preclinici hanno dimostrato che Cohealyx genera un robusto supporto per innesti cutanei più rapidamente rispetto ai principali concorrenti.
Questa aggiunta strategica completa il portfolio RECELL e PermeaDerm esistente di AVITA, che si prevede che triplicherà il mercato indirizzabile dell'azienda per le ustioni. L'azienda prevede di avviare studi clinici all'inizio del 2025 e lanciare sforzi di commercializzazione completa nel secondo trimestre del 2025.
AVITA Medical (NASDAQ: RCEL) ha recibido la aprobación FDA 510(k) para Cohealyx, una matriz dérmica a base de colágeno co-desarrollada con Regenity Biosciences. El producto está diseñado para la integración de tejidos y la revascularización en el tratamiento de heridas de grosor completo. Los estudios preclínicos mostraron que Cohealyx genera un soporte robusto para injertos de piel más rápido que los principales competidores.
Esta adición estratégica complementa el portafolio existente de RECELL y PermeaDerm de AVITA, se espera que triplique el mercado direccionable de la compañía en quemaduras. La compañía planea iniciar estudios clínicos a principios de 2025 y lanzar esfuerzos de comercialización total en el segundo trimestre de 2025.
AVITA Medical (NASDAQ: RCEL)는 Cohealyx에 대해 FDA 510(k) 승인을 받았습니다. Cohealyx는 Regenity Biosciences와 공동 개발한 콜라겐 기반의 피부 이식용 진피 매트릭스입니다. 이 제품은 전층 상처 치료에서 조직 통합 및 재혈관화를 위해 설계되었습니다. 사전 임상 연구에 따르면 Cohealyx는 주요 경쟁자들보다 더 빠르게 피부 이식을 지원하는 robust한 조직을 생성하는 것으로 나타났습니다.
이 전략적 추가는 AVITA의 기존 RECELL 및 PermeaDerm 포트폴리오를 보완하여, 회사에서 진단할 수 있는 화상 시장을 세 배로 확대할 것으로 예상됩니다. 회사는 2025년 초에 임상 연구를 시작하고 2025년 2분기에 전체 상용화를 위한 노력을 시작할 계획입니다.
AVITA Medical (NASDAQ: RCEL) a reçu l'approbation FDA 510(k) pour Cohealyx, une matrice dermique à base de collagène co-développée avec Regenity Biosciences. Le produit est conçu pour l'intégration des tissus et la revascularisation dans le traitement des blessures à épaississement complet. Les études précliniques ont montré que Cohealyx générait un tissu robuste soutenant des greffes cutanées plus rapidement que les principaux concurrents.
Cette addition stratégique complète le portefeuille existant de RECELL et PermeaDerm d'AVITA, et devrait tripler le marché adressable de l'entreprise dans le secteur des brûlures. L'entreprise prévoit de commencer des études cliniques début 2025 et de lancer des efforts de commercialisation à grande échelle au deuxième trimestre de 2025.
AVITA Medical (NASDAQ: RCEL) hat die FDA 510(k)-Zulassung für Cohealyx erhalten, eine kollagenbasierte dermale Matrix, die gemeinsam mit Regenity Biosciences entwickelt wurde. Das Produkt ist für die Gewebeintegration und Revaskularisierung bei der Behandlung von Wunden in vollem Dicke konzipiert. Vorklinische Studien zeigten, dass Cohealyx robustes Gewebe erzeugt, das Hauttransplantate schneller unterstützt als führende Wettbewerber.
Diese strategische Ergänzung ergänzt das bestehende RECELL- und PermeaDerm-Portfolio von AVITA und wird voraussichtlich den adressierbaren Markt des Unternehmens für Verbrennungen verdreifachen. Das Unternehmen plant, Anfang 2025 klinische Studien zu initiieren und im 2. Quartal 2025 umfassende Commercialisierungsmaßnahmen zu starten.
- FDA 510(k) clearance received for Cohealyx
- Expected to triple addressable market in burns
- Preclinical studies showed faster tissue generation compared to competitors
- Complements existing product portfolio (RECELL and PermeaDerm)
- Commercial launch planned for Q2 2025
- Clinical efficacy in humans yet to be demonstrated
- Revenue impact dependent on successful market penetration
- Additional clinical studies required before full commercialization
Insights
The FDA 510(k) clearance for Cohealyx represents a pivotal expansion in AVITA Medical's wound care portfolio. The collagen-based dermal matrix addresses a critical gap in full-thickness wound treatment, where structural support for tissue regeneration is essential. The preclinical data showing faster tissue generation compared to existing matrices suggests potential for reduced hospital stays and treatment costs - key metrics that influence hospital purchasing decisions.
The strategic significance lies in the tripling of AVITA's addressable market in burns, as dermal matrices are mandatory in two-stage procedures. The synergistic integration with RECELL and PermeaDerm creates a comprehensive solution that could significantly strengthen AVITA's competitive position against established players like Integra LifeSciences and Smith+Nephew.
The planned Q2 2025 commercial launch, preceded by clinical studies, follows a prudent approach to build real-world evidence. This timing allows for proper market preparation and clinical validation, important for adoption in the conservative wound care market.
This clearance opens significant market opportunities in the $1.5 billion global dermal matrix market. The timing is particularly advantageous as healthcare systems increasingly focus on cost-effective solutions that can reduce length of stay and improve patient outcomes. The dual-benefit positioning of Cohealyx - potentially faster healing and cost savings - aligns perfectly with current healthcare economic trends.
The product's integration into AVITA's existing sales channels should enable efficient market penetration, leveraging established relationships with burn centers. The Q2 2025 launch timeline provides adequate runway for market preparation and payer engagement, critical for successful commercialization in the medical device space. For a company with a market cap of
- New collagen-based dermal matrix designed for tissue generation, complementary to RECELL and PermeaDerm
- Cohealyx expected to triple AVITA Medical’s addressable market in burns
VALENCIA, Calif., Dec. 19, 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 granted 510(k) clearance for Cohealyx™, a new collagen-based dermal matrix branded by AVITA Medical and co-developed with Regenity Biosciences. Cohealyx is designed for tissue integration and revascularization to facilitate wound healing, reduce treatment timelines, and improve patient outcomes in the treatment of full-thickness wounds.
Burns and full-thickness wounds penetrate all layers of the skin, resulting in significant tissue loss and structural damage. Unlike superficial wounds, full-thickness wounds lack the cellular components and structural support necessary to regenerate missing tissue. Without timely surgical intervention, there is heightened risk of delayed closure, infection, and severe scarring. Dermal matrices are essential in two-stage procedures for treating these wounds, as they support tissue generation for successful skin graft take and improve healing outcomes.
Cohealyx addresses this critical need in the treatment of full-thickness wounds with an advanced bovine collagen-based design engineered to facilitate cellular migration and blood vessel formation. Preclinical studies in porcine models demonstrated that Cohealyx generated robust tissue capable of consistently supporting a split-thickness skin graft in a two-stage procedure earlier than leading dermal matrices in the study. While animal model results do not necessarily translate to clinical results, this expedited timeline is anticipated to lead to quicker wound closure and streamlined clinician workflows, resulting in shorter hospital stays, reduced treatment costs, and better patient outcomes. These parameters will be evaluated in a clinical study.
“Cohealyx is a strategic addition to our RECELL-centric portfolio, unlocking the powerful synergies of RECELL and Cohealyx to address full-thickness wounds,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “This expansion to our product portfolio strengthens our ability to deliver superior patient outcomes and significantly expands our commercial potential in burns. By equipping clinicians with more comprehensive treatment options, we strengthen our competitive position, drive new growth opportunities, and further our commitment to advancing regenerative medicine.”
Cohealyx strengthens AVITA Medical’s portfolio by expanding its capabilities in the treatment of full-thickness wounds. Offered alongside RECELL and PermeaDerm®, Cohealyx enhances our comprehensive portfolio for addressing full-thickness wound care. This expanded portfolio is expected to triple AVITA Medical’s addressable market in burns, as dermal matrices are a critical component of the standard two-stage surgical procedure for definitive closure of these wounds. We also anticipate Cohealyx will generate significant revenue as we penetrate the full-thickness skin defect market.
AVITA Medical plans to develop clinical data for Cohealyx in early 2025 to build on the preclinical success and support the product’s commercial launch. The post-market clinical study will assess Cohealyx’s performance in real-world settings, focusing on clinical efficacy and cost savings in the treatment of full-thickness wounds and burns. In the U.S., we expect to launch full commercialization efforts in the beginning of the second quarter of 2025.
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.
About Regenity Biosciences
Regenity Biosciences, a Linden Capital Partners portfolio company, is a leading global developer and manufacturer of bioresorbable technologies to repair and regenerate natural tissue and bone for a variety of markets including dental, spine, orthopaedic, sports medicine, advanced wound, neurosurgery, ENT, and nerve repair. Founded in 1997, Regenity (formerly Collagen Matrix, Inc.) is headquartered in Paramus, New Jersey, with manufacturing locations in Oakland and Allendale, New Jersey and Groningen, the Netherlands. Regenity's product portfolio includes a variety of collagen-based and synthetic polymer solutions that support the company's platform for tissue and bone regeneration. Regenity develops proprietary products that are sold to OEM customers on either a contract or private label basis and offers partnership opportunities including contract product development and manufacturing services. For more information, please visit www.regenity.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.
FAQ
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