AVITA Medical Expands Wound Care Portfolio

AVITA Medical Inc. has negotiated an exclusive multi-year development and distribution agreement with Regenity Biosciences for wound care technology. 

The agreement gives AVITA Medical exclusive marketing, sales, and distribution rights to a collagen-based dermal matrix manufactured by Regenity. “This strategic collaboration significantly strengthens our portfolio and advances our long-term growth objectives,” AVITA Medical CEO Jim Corbett said. “Regenity’s expertise in developing and manufacturing bioresorbable materials aligns with our vision. By integrating their 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 U.S. Food and Drug Administration (FDA) 510(k) clearance in Q4 (2024) for a collagen-based dermal matrix it developed with AVITA Medical. Once it wins 510(k) clearance, Regenity will manufacture and supply this product to AVITA Medical, which will then market, sell, and distribute the product—including any future enhancements or modifications—under the AVITA Medical brand name within the United States, and potentially in the European Union, Australia, and Japan.
 
Alongside with the use of RECELL for treating thermal burn wounds and full-thickness skin defects, ther new product will generate a dermal-like tissue in full-thickness wounds through rapid cell repopulation and revascularization of the dermal collagen matrix. After FDA 510(k) clearance and commercialization, AVITA Medical will initiate multiple clinical studies to establish the synergies between the new dermal matrix and RECELL. These studies will evaluate 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 (current 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. AVITA Medical expects to complete these studies next year.

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READ MORE: Co-Primary Endpoints Met in AVITA Medical’s RECELL Trial

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The development and distribution agreement will last 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 pay Regenity $2 million upon receipt of each 510(k) clearance. AVITA Medical can also provide up to an additional $3 million in manufacturing support on or before Jan. 4, 2026, contingent on positive study results for the new dermal matrix. The first two years of revenue sharing from product sales is expected to be equal to 50% of its average sales price. In subsequent years, AVITA Medical’s share of revenue will increase to 60% of the product’s average sales price.
 
AVITA Medical is a commercial-stage regenerative medicine company developing wound care management and skin restoration solutions. The RECELL System is approved by the FDA for treating 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 solution at the point-of-care. This 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.
 
Regenity Biosciences, a Linden Capital Partners portfolio company, develops and manufactures bioresorbable technologies to repair and regenerate natural tissue and bone for various markets including dental, spine, orthopaedic, neurosurgery, ENT, advanced wound, and nerve repair. Founded in 1997, Regenity (formerly Collagen Matrix, Inc.) is headquartered in Paramus, N.J., with manufacturing locations in Oakland and Allendale, N.J. and Groningen, the Netherlands. Regenity’s product portfolio includes various 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.