Regenerative medicine company AVITA Medical has partnered with Regenity Biosciences for a collagen-based dermal matrix to advance wound care.
New Jersey-based Regenity Biosciences, previously known as Collagen Matrix, develops and manufactures bioresorbable technologies.
Under the multi-year development and distribution agreement, Regenity will produce the dermal matrix.
Once the US Food and Drug Administration (FDA) grants 510(k) clearance, expected by Q4 2024, AVITA Medical will have exclusive rights to market, sell, and distribute the product.
Following the clearance, the bioresorbable technologies maker will handle the manufacturing and supply of the product to AVITA Medical.
AVITA Medical will then distribute the product, including any future enhancements or modifications, under its brand name in the US, and potentially in the European Union, Australia, and Japan.
The new product will be used to generate dermal-like tissue in full-thickness wounds through rapid cell repopulation and revascularisation of the dermal collagen matrix.
AVITA Medical already has the RECELL System. It is an FDA-approved product for the treatment of thermal burn wounds and full-thickness skin defects.
Upon the regulatory nod, the regenerative medicine company plans to initiate several clinical studies to explore the synergies between the new dermal matrix and RECELL platform.
These studies will compare the new dermal matrix with other commercially available dermal matrices in full-thickness wounds.
Additional studies will assess the use of the new dermal matrix with immediate grafting and RECELL in a single procedure, aiming to establish a new standard of care.
AVITA Medical expects to complete these studies by 2025.
The initial term of the exclusive development and distribution agreement is five years, with an automatic five-year extension based on meeting specific criteria.
According to the agreement, AVITA Medical will make a $2m payment upon Regenity’s receipt of US clearance.
The regenerative medicine firm is also required to make up to an additional $3m payment on or before 4 January 2026 to support manufacturing capacity, contingent on favourable results from the clinical studies.
For the first two years, revenue sharing from product sales will be split 50/50. In the following years, AVITA Medical’s share of revenue will increase to 60% of the product’s average sales price.
AVITA Medical CEO Jim Corbett said: “This strategic collaboration significantly strengthens our portfolio and advances our long-term growth objectives.
“Regenity’s proven expertise in developing and manufacturing bioresorbable materials aligns with our vision.”
