Avita Medical has signed an exclusive development and distribution agreement with Regenity Biosciences for a collagen-based dermal matrix.

The multi-year agreement grants Avita exclusive marketing, sales, and distribution rights for the dermal matrix in the US, with potential expansion to the EU, Australia, and Japan.

This is subject to 510(k) clearance by the US Food and Drug Administration (FDA) for the dermal matrix.

Regenity is expected to secure 510(k) clearance for the dermal matrix by the fourth quarter of 2024.

Post-clearance, the company will manufacture the product, which Avita will market and distribute under its brand.

The product is designed to generate dermal-like tissue in full-thickness wounds, complementing Avita's Recell system for thermal burn wounds and skin defects.

Following commercialisation, AVITA plans to conduct clinical studies to explore the synergies between the dermal matrix and Recell.

The studies aim to establish improved standards for wound care and skin restoration, with completion anticipated next year.

The agreement spans five years with an automatic five-year extension based on performance.

AVITA will pay $2m upon 510(k) clearance and up to an additional $3m by 4 January 2026, to support manufacturing, subject to positive clinical study outcomes.

Revenue sharing from product sales will start at 50% of the average sales price, increasing to 60% in later years.

Avita Medical CEO Jim Corbett said: “This strategic collaboration significantly strengthens our portfolio and advances our long-term growth objectives.

“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.”

In May 2024, Avita secured FDA approval for a premarket approval supplement for its autologous cell harvesting device, the Recell GO System.