AVITA Medical Launches Cohealyx, Supporting Healing and Unlocking New Market Opportunity
AVITA Medical (NASDAQ: RCEL) has launched Cohealyx™, a collagen-based dermal matrix co-developed with Regenity Biosciences, expanding its therapeutic wound care portfolio. The product is designed to facilitate cellular migration and revascularization for wound bed preparation, with integrated wound bed formation observed as early as 7 days in initial testing.
Cohealyx complements AVITA's existing products - the RECELL® System (FDA-approved for thermal burns and full-thickness skin defects) and PermeaDerm® (a temporary biosynthetic dressing). This integrated approach supports the two-stage standard of care for full-thickness wounds.
The company is currently conducting the Cohealyx I trial, a post-market study evaluating clinical outcomes and wound bed preparation effectiveness. Pre-clinical studies showed faster graft-ready results compared to leading competitors, potentially leading to shorter hospital stays.
AVITA Medical (NASDAQ: RCEL) ha lanciato Cohealyx™, una matrice dermica a base di collagene co-sviluppata con Regenity Biosciences, ampliando il suo portafoglio terapeutico per la cura delle ferite. Il prodotto è progettato per facilitare la migrazione cellulare e la revascularizzazione per la preparazione del letto della ferita, con la formazione integrata del letto della ferita osservata già dopo 7 giorni nei test iniziali.
Cohealyx completa i prodotti esistenti di AVITA - il RECELL® System (approvato dalla FDA per ustioni termiche e difetti cutanei a pieno spessore) e PermeaDerm® (una medicazione biosintetica temporanea). Questo approccio integrato supporta il protocollo di cura in due fasi per le ferite a pieno spessore.
L'azienda sta attualmente conducendo il trial Cohealyx I, uno studio post-marketing che valuta i risultati clinici e l'efficacia della preparazione del letto della ferita. Gli studi preclinici hanno mostrato risultati più rapidi per la prontezza del innesto rispetto ai principali concorrenti, con la possibilità di ridurre i tempi di ospedalizzazione.
AVITA Medical (NASDAQ: RCEL) ha lanzado Cohealyx™, una matriz dérmica a base de colágeno co-desarrollada con Regenity Biosciences, ampliando su cartera terapéutica para el cuidado de heridas. El producto está diseñado para facilitar la migración celular y la revascularización para la preparación del lecho de la herida, con formación integrada del lecho de la herida observada tan pronto como a los 7 días en las pruebas iniciales.
Cohealyx complementa los productos existentes de AVITA: el RECELL® System (aprobado por la FDA para quemaduras térmicas y defectos cutáneos de grosor completo) y PermeaDerm® (un apósito biosintético temporal). Este enfoque integrado apoya el estándar de atención en dos etapas para heridas de grosor completo.
La compañía está llevando a cabo actualmente el ensayo Cohealyx I, un estudio post-comercialización que evalúa los resultados clínicos y la efectividad de la preparación del lecho de la herida. Los estudios preclínicos mostraron resultados más rápidos listos para injertos en comparación con los principales competidores, lo que podría llevar a estancias hospitalarias más cortas.
AVITA Medical (NASDAQ: RCEL)가 Cohealyx™를 출시했습니다. 이는 Regenity Biosciences와 공동 개발한 콜라겐 기반의 피부 매트릭스이며, 치료적 상처 관리 포트폴리오를 확장합니다. 이 제품은 세포 이동과 재혈관화를 촉진하여 상처 침대 준비를 돕도록 설계되었으며, 초기 테스트에서 7일 이내에 통합된 상처 침대 형성이 관찰되었습니다.
Cohealyx는 AVITA의 기존 제품인 RECELL® System (FDA 승인, 열 화상 및 전층 피부 결함용) 및 PermeaDerm® (일시적인 생체 합성 드레싱)를 보완합니다. 이 통합 접근법은 전층 상처에 대한 2단계 표준 치료를 지원합니다.
회사는 현재 Cohealyx I 시험을 진행 중이며, 이는 임상 결과와 상처 침대 준비 효과성을 평가하는 시판 후 연구입니다. 전임상 연구에서는 주요 경쟁사에 비해 더 빠른 이식 준비 결과를 보여주었으며, 이는 병원에 머무는 시간을 단축시킬 가능성이 있습니다.
AVITA Medical (NASDAQ: RCEL) a lancé Cohealyx™, une matrice dermique à base de collagène co-développée avec Regenity Biosciences, élargissant ainsi son portefeuille thérapeutique de soins des plaies. Le produit est conçu pour faciliter la migration cellulaire et la revascularisation pour la préparation du lit de la plaie, avec une formation intégrée du lit de la plaie observée dès 7 jours lors des premiers tests.
Cohealyx complète les produits existants d'AVITA - le RECELL® System (approuvé par la FDA pour les brûlures thermiques et les défauts cutanés de pleine épaisseur) et PermeaDerm® (un pansement biosynthétique temporaire). Cette approche intégrée soutient le standard de soins en deux étapes pour les plaies de pleine épaisseur.
La société mène actuellement l'essai Cohealyx I, une étude post-commercialisation évaluant les résultats cliniques et l'efficacité de la préparation du lit de la plaie. Les études précliniques ont montré des résultats de préparation de greffe plus rapides par rapport aux principaux concurrents, ce qui pourrait conduire à des séjours hospitaliers plus courts.
AVITA Medical (NASDAQ: RCEL) hat Cohealyx™ eingeführt, eine kollagenbasierte dermale Matrix, die in Zusammenarbeit mit Regenity Biosciences entwickelt wurde, und damit sein therapeutisches Portfolio für Wundversorgung erweitert. Das Produkt ist darauf ausgelegt, die Zellmigration und Revascularisierung zur Vorbereitung des Wundbettes zu erleichtern, wobei eine integrierte Wundbettbildung bereits nach 7 Tagen in ersten Tests beobachtet wurde.
Cohealyx ergänzt die bestehenden Produkte von AVITA - das RECELL® System (von der FDA genehmigt für thermische Verbrennungen und Vollhautdefekte) und PermeaDerm® (ein temporärer biosynthetischer Verband). Dieser integrierte Ansatz unterstützt den zweistufigen Standard der Versorgung für Vollhautwunden.
Das Unternehmen führt derzeit die Cohealyx I Studie durch, eine Nachmarktforschung zur Bewertung klinischer Ergebnisse und der Wirksamkeit der Wundbettvorbereitung. Präklinische Studien zeigten schnellere ergebnisbereite Resultate im Vergleich zu führenden Wettbewerbern, was potenziell zu kürzeren Krankenhausaufenthalten führen könnte.
- Launch of new product Cohealyx expands market opportunity in wound care
- Pre-clinical studies showed superior performance vs competitors in graft-ready timing
- Product complements existing portfolio creating an integrated treatment approach
- Potential for reduced hospital stays, improving cost-effectiveness
- Post-market study still ongoing - full clinical benefits yet to be proven
Insights
AVITA Medical's launch of Cohealyx represents a significant expansion of their acute wound care portfolio with strategic implications for their clinical positioning. This collagen-based dermal matrix addresses a critical need in the standard two-stage treatment approach for full-thickness wounds, working synergistically with their existing RECELL System and PermeaDerm.
The technology's ability to facilitate cellular migration and revascularization addresses a crucial clinical challenge in wound management. Pre-clinical data showing faster graft-readiness compared to competitors suggests potential for meaningful clinical advantages, particularly in reducing hospital stays – a key metric for both patient satisfaction and healthcare economics.
What makes this launch particularly compelling is how it creates a complete ecosystem for wound treatment, with Cohealyx managing the wound bed preparation while RECELL and PermeaDerm handle definitive closure. This integrated approach differentiates AVITA from competitors offering isolated products and may drive increased adoption across their entire product line.
The initiation of the Cohealyx I post-market study demonstrates commitment to clinical validation, which is essential for driving physician adoption and securing favorable reimbursement. The company's focus on generating evidence for both clinical outcomes and cost-effectiveness aligns with healthcare's value-based purchasing trends.
This launch strategically positions AVITA to capture more comprehensive treatment protocols while potentially reducing healing time and hospitalization duration – a win for patients, providers, and payers alike.
AVITA's Cohealyx launch represents a well-executed market expansion strategy that addresses multiple business objectives. By adding this collagen-based dermal matrix to their portfolio, AVITA has transformed from a single-product company into a comprehensive wound care solution provider with products addressing the complete treatment pathway.
This strategic portfolio expansion unlocks significant cross-selling opportunities with their existing customer base while potentially attracting new customers seeking integrated solutions. Healthcare facilities already using RECELL now have incentives to adopt Cohealyx rather than competing products, potentially increasing AVITA's wallet share within accounts.
The full-thickness wound market represents a natural adjacent opportunity for AVITA, leveraging their existing commercial infrastructure, clinical relationships, and expertise in wound healing. This approach to expansion typically offers better return on investment than entering entirely new therapeutic areas.
While financial projections weren't disclosed, the value proposition centers on reducing hospital stays – a compelling economic argument that resonates with both providers and payers in today's cost-conscious healthcare environment. If the clinical data from their ongoing study confirms the pre-clinical findings of faster graft-readiness, AVITA could establish a differentiated position based on total economic value rather than competing solely on product cost.
This launch demonstrates management's focus on building long-term value through portfolio diversification, strengthening AVITA's competitive positioning and creating multiple growth avenues beyond their flagship RECELL System.
VALENCIA, Calif., April 03, 2025 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a leading therapeutic acute wound care company delivering transformative solutions, today announced the U.S. commercial launch of Cohealyx™, a collagen-based dermal matrix branded by AVITA Medical and co-developed with Regenity Biosciences. Cohealyx is designed to facilitate cellular migration and revascularization, thereby providing an ideal wound bed for definitive closure. In pre-clinical and initial clinical utilization, an integrated wound bed was seen as early as 7 days.
Cohealyx expands AVITA Medical’s therapeutic wound care portfolio, complementing its flagship product, the RECELL® System, which is FDA-approved for the treatment of thermal burns and full-thickness skin defects, and PermeaDerm®, a temporary biosynthetic dressing used to support healing before and after grafting. These products support the two-stage standard of care for full-thickness wounds. Cohealyx is used as a dermal matrix to manage the wound bed. RECELL Spray-On Skin™ Cells and wound protection with PermeaDerm provide solutions for definitive closure. This integrated approach may improve clinical outcomes and expands AVITA Medical’s market opportunity.
“When treating full-thickness acute wounds in a two-stage procedure, a shorter time to graft readiness translates to a shorter hospital stay for the patient,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “During our pre-clinical validated porcine model study, wounds treated with Cohealyx were consistently graft-ready faster than the leading competitors used as controls. This treatment regimen has the potential to deliver faster healing and shorter hospital stays, consistent with the benefits of our flagship RECELL System and our overall mission.”
AVITA Medical is currently enrolling participants in the Cohealyx I trial, a post-market study designed to further evaluate clinical outcomes, wound bed preparation for definitive closure, and patient recovery timelines when Cohealyx is used in the management of full-thickness wounds. The Cohealyx I trial underscores AVITA Medical’s commitment to generating robust clinical data supporting the benefits and cost-effectiveness of its products.
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 FDA for the treatment of thermal burn wounds and full-thickness skin defects. 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 market, sell, and distribute both Cohealyx™, an AVITA Medical-branded collagen-based dermal matrix, and PermeaDerm®, a biosynthetic wound matrix.
In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns and full-thickness skin defects. 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; failure to achieve the anticipated benefits from approval or adoption of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and risks of 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.
Investor & Media Contact: Jessica Ekeberg Phone +1-661-904-9269 investor@avitamedical.com media@avitamedical.com
FAQ
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