Commercial-stage regenerative medicine company AVITA Medical (ASX:AVH) has entered an exclusive multi-year development and distribution agreement with Regenity Biosciences.
US-based Regenity is a leading regenerative medical product developer and manufacturer of bioresorbable technologies.
Under the agreement, following FDA clearance, AVITA Medical will hold exclusive marketing, sales, and distribution rights to a unique collagen-based dermal matrix manufactured by Regenity.
“This strategic collaboration significantly strengthens our portfolio and advances our long-term growth objectives,” said Jim Corbett, the CEO 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.”
Regenity expects to secure FDA clearance for a collagen-based dermal matrix developed in collaboration with AVITA Medical in the fourth quarter of 2024. Once clearance is obtained, Regenity will manufacture and supply this product to AVITA Medical.
AVITA said that following FDA clearance and commercialisation, it plans to initiate multiple clinical studies to establish the unique synergies between the new dermal matrix and its 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, 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 said it 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 specific criteria. Under the terms of the agreement, AVITA will make a $2 million payment to Regenity upon receipt of FDA clearance.
AVITA will make up to an additional $3 million payment on or before January 4, 2026, to support manufacturing capacity, contingent on the positive results of the clinical studies related to the new dermal matrix. The first two years of revenue sharing from product sales is expected to equal 50 per cent of its average sales price. In subsequent years, AVITA Medical’s revenue share will increase to 60 per cent of the product’s average sales price.