AVITA Medical Expands Portfolio with Unique Dermal Matrix to Advance Wound Care
AVITA Medical (NASDAQ: RCEL, ASX: AVH) has entered an exclusive multi-year development and distribution agreement with Regenity Biosciences for a unique collagen-based dermal matrix. Following FDA 510(k) clearance, expected in Q4 2024, AVITA will have exclusive rights to market, sell, and distribute the product in the U.S. and potentially in EU countries, Australia, and Japan.
The collaboration aims to enhance AVITA's wound care portfolio by integrating Regenity's bioresorbable materials with AVITA's RECELL technology. AVITA plans to initiate clinical studies in 2025 to demonstrate improved outcomes and establish a new standard of care for full-thickness wounds.
The agreement includes a $2 million payment upon 510(k) clearance and up to $3 million by January 2026 for manufacturing support. Revenue sharing starts at 50% for the first two years, increasing to 60% thereafter.
AVITA Medical (NASDAQ: RCEL, ASX: AVH) ha stipulato un accordo esclusivo di sviluppo e distribuzione pluriennale con Regenity Biosciences per una matrice dermica unica a base di collagene. Dopo l'approvazione della FDA 510(k), prevista nel quarto trimestre del 2024, AVITA avrà diritti esclusivi per commercializzare, vendere e distribuire il prodotto negli Stati Uniti e potenzialmente in paesi dell'UE, Australia e Giappone.
La collaborazione mira a potenziare il portafoglio di cura delle ferite di AVITA integrando i materiali bioassorbibili di Regenity con la tecnologia RECELL di AVITA. AVITA prevede di avviare studi clinici nel 2025 per dimostrare risultati migliori e stabilire un nuovo standard di cura per ferite a spessore completo.
L'accordo include un pagamento di 2 milioni di dollari al momento dell'approvazione 510(k) e fino a 3 milioni di dollari entro gennaio 2026 per il supporto alla produzione. La condivisione dei ricavi inizia al 50% per i primi due anni, aumentando al 60% successivamente.
AVITA Medical (NASDAQ: RCEL, ASX: AVH) ha firmado un acuerdo exclusivo de desarrollo y distribución por varios años con Regenity Biosciences para una matriz dérmica única a base de colágeno. Tras la aprobación de la FDA 510(k), prevista para el cuarto trimestre de 2024, AVITA tendrá derechos exclusivos para comercializar, vender y distribuir el producto en EE.UU. y potencialmente en países de la UE, Australia y Japón.
La colaboración tiene como objetivo mejorar el portafolio de cuidado de heridas de AVITA integrando los materiales bioresorbibles de Regenity con la tecnología RECELL de AVITA. AVITA planea iniciar estudios clínicos en 2025 para demostrar resultados mejorados y establecer un nuevo estándar de atención para heridas de grosor completo.
El acuerdo incluye un pago de 2 millones de dólares tras la aprobación 510(k) y hasta 3 millones de dólares para enero de 2026 por apoyo a la manufactura. La distribución de ingresos comienza en el 50% durante los primeros dos años, aumentando al 60% después.
AVITA Medical (NASDAQ: RCEL, ASX: AVH)가 Regenity Biosciences와 독특한 콜라겐 기반 피부 매트릭스에 대한 독점적인 다년간 개발 및 배급 계약을 체결했습니다. 2024년 4분기에 예상되는 FDA 510(k) 승인이 완료되면 AVITA는 미국과 잠재적으로 유럽 연합 국가, 호주 및 일본에서 제품을 마케팅, 판매 및 배급할 수 있는 독점 권리를 갖게 됩니다.
이 협력은 AVITA의 상처 치료 포트폴리오를 강화하는 것을 목표로 하며, Regenity의 생체 흡수성 재료와 AVITA의 RECELL 기술을 통합합니다. AVITA는 2025년에 개선된 결과를 입증하고 전층 상처에 대한 새로운 치료 기준을 세우기 위해 임상 연구를 시작할 계획입니다.
계약에는 510(k) 승인 시 200만 달러 지급 및 제조 지원을 위한 2026년 1월까지 최대 300만 달러가 포함되어 있습니다. 수익 공유는 처음 2년 동안 50%에서 시작되며, 이후 60%로 증가합니다.
AVITA Medical (NASDAQ: RCEL, ASX: AVH) a conclu un accord exclusif de développement et de distribution sur plusieurs années avec Regenity Biosciences pour une matrice dermique unique à base de collagène. Après l'approbation de la FDA 510(k), prévue au quatrième trimestre 2024, AVITA aura des droits exclusifs pour commercialiser, vendre et distribuer le produit aux États-Unis et potentiellement dans des pays de l'UE, en Australie et au Japon.
Cette collaboration vise à améliorer le portefeuille de soins des plaies d'AVITA en intégrant les matériaux bioresorbables de Regenity avec la technologie RECELL d'AVITA. AVITA prévoit de lancer des études cliniques en 2025 pour démontrer des résultats améliorés et établir une nouvelle norme de soins pour les plaies complètes.
L'accord comprend un paiement de 2 millions de dollars à l'approbation 510(k) et jusqu'à 3 millions de dollars d'ici janvier 2026 pour un soutien à la fabrication. Le partage des revenus commence à 50% pendant les deux premières années, puis passe à 60% par la suite.
AVITA Medical (NASDAQ: RCEL, ASX: AVH) hat einen exklusiven mehrjährigen Entwicklungs- und Vertriebsvertrag mit Regenity Biosciences für eine einzigartige kollagenbasierte Dermalmatrix abgeschlossen. Nach der erwarteten FDA 510(k)-Genehmigung im 4. Quartal 2024 wird AVITA das exklusive Recht haben, das Produkt in den USA sowie möglicherweise in EU-Ländern, Australien und Japan zu vermarkten, zu verkaufen und zu vertreiben.
Die Zusammenarbeit zielt darauf ab, AVITAs Portfolio im Wundmanagement zu erweitern, indem Regenitys bioresorbierbare Materialien mit AVITAs RECELL-Technologie integriert werden. AVITA plant, 2025 klinische Studien zu starten, um verbesserte Ergebnisse zu demonstrieren und einen neuen Standard für die Versorgung von Vollwunden festzulegen.
Der Vertrag umfasst eine Zahlung von 2 Millionen Dollar bei Genehmigung 510(k) und bis zu 3 Millionen Dollar bis Januar 2026 für Unterstützung bei der Herstellung. Die Einnahmenaufteilung beginnt in den ersten zwei Jahren bei 50% und steigt danach auf 60%.
- Expansion of product portfolio with a unique collagen-based dermal matrix
- Exclusive marketing, sales, and distribution rights in key markets
- Potential to establish a new standard of care for full-thickness wounds
- Planned clinical studies to demonstrate improved outcomes
- Revenue sharing agreement with increasing share over time
- Initial $2 million payment required upon 510(k) clearance
- Additional $3 million payment contingent on positive clinical study results
- 510(k) clearance not yet obtained, introducing regulatory uncertainty
- Clinical studies and their positive outcomes are not guaranteed
AVITA Medical's exclusive agreement with Regenity Biosciences marks a significant strategic move in the wound care management sector. This collaboration brings several key advantages:
- Portfolio Expansion: The addition of a unique collagen-based dermal matrix complements AVITA's existing RECELL technology, potentially creating a more comprehensive wound care solution.
- Market Positioning: By securing exclusive rights, AVITA gains a competitive edge in the
$1.6 billion U.S. dermal matrix market. - Revenue Potential: The revenue-sharing model, starting at
50% and increasing to60% of the average sales price, presents a promising financial outlook.
However, investors should note that the success of this venture hinges on several factors:
- FDA Clearance: The
$2 million payment is contingent on 510(k) clearance, expected in Q4 2024. - Clinical Study Outcomes: An additional
$3 million payment depends on positive clinical results, adding an element of risk. - Market Adoption: The product's success will depend on its ability to establish a new standard of care in wound treatment.
Overall, this move aligns with AVITA's long-term growth strategy, potentially strengthening its market position in regenerative medicine. However, the full impact on the company's financials and market share will only become clear after successful clinical trials and market adoption.
AVITA Medical's partnership with Regenity Biosciences represents a strategic advancement in regenerative medicine. The collaboration's key scientific aspects include:
- Innovative Technology: The collagen-based dermal matrix aims to generate dermal-like tissue through rapid cell repopulation and revascularization, addressing a critical need in wound healing.
- Synergistic Potential: The planned clinical studies to evaluate the combined use of the new dermal matrix with RECELL technology could lead to a paradigm shift in wound treatment protocols.
- One-Stage Closure: The potential for a single-procedure treatment could significantly improve patient outcomes and reduce healthcare costs.
However, several scientific challenges and opportunities should be considered:
- Clinical Validation: The success of the product hinges on the outcomes of multiple clinical studies planned for 2025.
- Comparative Efficacy: Studies comparing the new matrix to existing commercial options will be important in establishing its market position.
- Long-term Performance: The durability and long-term efficacy of the combined treatment approach will be essential for widespread adoption.
This collaboration demonstrates AVITA's commitment to innovation in wound care. If successful, it could position the company as a leader in advanced wound treatment solutions. However, investors should closely monitor the progress of clinical trials and regulatory approvals, as these will be critical determinants of the product's ultimate success and market impact.
AVITA Medical's agreement with Regenity Biosciences presents a compelling financial opportunity with measured risks. Key financial aspects include:
- Investment Structure: The deal involves a
$2 million payment upon 510(k) clearance and a potential additional$3 million based on clinical results, representing a staged investment approach. - Revenue Sharing Model: Starting at
50% of the average sales price for the first two years, increasing to60% thereafter, this model balances risk and reward. - Market Expansion: The agreement covers the U.S. market with potential for expansion into the EU, Australia and Japan, offering significant growth opportunities.
Financial considerations for investors:
- Short-term Impact: The initial
$2 million payment may affect short-term cash flow but is relatively modest given the potential market opportunity. - Long-term Potential: Success could significantly boost AVITA's revenue stream, particularly if the product becomes a new standard of care.
- Risk Mitigation: The staged payment structure and revenue-sharing model help mitigate financial risk if the product underperforms.
While the agreement shows promise, investors should be aware of the execution risks, including regulatory approval, clinical trial outcomes and market adoption rates. The full financial impact will only be realized post-2025, following the completion of clinical studies. This deal represents a calculated investment in AVITA's future growth, with the potential to significantly enhance its market position and financial performance in the regenerative medicine sector.
Exclusive development and distribution agreement with Regenity Biosciences provides AVITA Medical with the commercialization rights to a unique collagen-based dermal matrix following 510(k) clearance
VALENCIA, Calif., July 31, 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 it has entered into an exclusive multi-year development and distribution agreement with Regenity Biosciences (“Regenity”), a leading regenerative medical product developer and manufacturer of bioresorbable technologies. Through this agreement, following 510(k) by the FDA, AVITA Medical will hold the exclusive marketing, sales and distribution rights to a unique collagen-based dermal matrix, which will be manufactured by Regenity.
“This strategic collaboration significantly strengthens our portfolio and advances our long-term growth objectives,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “Regenity’s proven expertise in developing and manufacturing bioresorbable materials aligns with our vision. By integrating their innovative collagen-based solutions with our existing RECELL technology, we believe we also have the potential to establish a new standard of care with a one-stage closure, thereby improving patient outcomes.”
As part of the exclusive development and distribution agreement, Regenity expects to secure 510(k) clearance for a collagen-based dermal matrix developed in collaboration with AVITA Medical in the fourth quarter of 2024. Once 510(k) clearance is obtained, Regenity will manufacture and supply this product to AVITA Medical. AVITA Medical will then hold its exclusive rights to market, sell, and distribute the product, including any future enhancements or modifications, under the AVITA Medical brand name within the U.S., and potentially in countries in the European Union, as well as in Australia and Japan.
Alongside the use of RECELL for the treatment of thermal burn wounds and full-thickness skin defects, our new product will generate a dermal-like tissue in full-thickness wounds through rapid cell repopulation and revascularization of the dermal collagen matrix. Immediately following 510(k) clearance and commercialization, AVITA Medical plans to initiate multiple clinical studies to establish the unique synergies between the new dermal matrix and RECELL. These studies will include the evaluation of the new dermal matrix and other commercially available dermal matrices in full-thickness wounds, followed by delayed treatment with a split-thickness skin graft plus RECELL in a two-stage procedure (the current standard of care), to demonstrate improved time to grafting and wound closure. Additional clinical studies will evaluate the use of the new dermal matrix in full-thickness wounds with immediate grafting together with RECELL in a single procedure, aiming to establish a new standard of care. AVITA Medical anticipates completing these studies in 2025.
The initial term of the exclusive development and distribution agreement is five years, with an automatic extension of an additional five years, contingent upon meeting certain criteria. Under the terms of the agreement, AVITA Medical will make a
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 U.S. Food and Drug Administration 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. AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix, in the United States.
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 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 (“Linden”) portfolio company, is the 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, neurosurgery, ENT, advanced wound 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,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “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 Company’s agreement with Regenity Biosciences, and the anticipated benefits and financial impact from such agreement. 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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