AVITA Medical, a company specializing in regenerative medicine and advanced wound care devices, has entered a multi-year exclusive agreement with Regenity Biosciences.

This partnership grants AVITA Medical exclusive rights to market, sell, and distribute a unique collagen-based dermal matrix developed and manufactured by Regenity, pending FDA 510(k) clearance.

This strategic collaboration aims to strengthen AVITA Medical’s portfolio and advance its long-term growth objectives by integrating Regenity’s expertise in bioresorbable materials with AVITA's existing RECELL technology.

The goal is to establish a new standard of care with a one-stage closure, improving patient outcomes.

Regenity expects to obtain FDA 510(k) clearance for the collagen-based dermal matrix by the fourth quarter of 2024.

Upon approval, Regenity will produce the matrix, and AVITA Medical will handle its marketing, sales, and distribution in the U.S., European Union, Australia, and Japan.

The new product is designed to generate dermal-like tissue in full-thickness wounds by promoting rapid cell repopulation and revascularization. This will complement AVITA's RECELL technology used for thermal burns and full-thickness skin defects.

Following clearance, AVITA Medical plans to conduct clinical studies to examine the synergy between the new dermal matrix and RECELL. These studies will compare the new matrix with existing commercial products in full-thickness wounds, followed by delayed treatment with a split-thickness skin graft plus RECELL.

Additional studies will explore immediate grafting with RECELL in a single procedure, with the goal of establishing a new standard of care. Completion of these studies is anticipated by 2025.

The initial term of the agreement is five years, with an automatic extension of another five years upon meeting certain criteria. AVITA Medical will make a $2.0 million payment to Regenity upon receiving 510(k) clearance and may pay up to an additional $3.0 million by January 4, 2026, contingent on positive clinical study results.

Revenue sharing from sales of the product will start at 50% of its average sales price for the first two years, increasing to 60% in subsequent years.




Source: avitamedical.com

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