Avita Medical announces FDA 510 clearance for Cohealyx

AVITA Medical (RCEL) “announced that the FDA has granted 510(k) clearance for Cohealyx, a new collagen-based dermal matrix branded by AVITA Medical and co-developed with Regenity Biosciences. Cohealyx is designed for tissue integration and revascularization to facilitate wound healing, reduce treatment timelines, and improve patient outcomes in the treatment of full-thickness wounds. Burns and full-thickness wounds penetrate all layers of the skin, resulting in significant tissue loss and structural damage. Unlike superficial wounds, full-thickness wounds lack the cellular components and structural support necessary to regenerate missing tissue. Without timely surgical intervention, there is heightened risk of delayed closure, infection, and severe scarring. Dermal matrices are essential in two-stage procedures for treating these wounds, as they support tissue generation for successful skin graft take and improve healing outcomes. Cohealyx addresses this critical need in the treatment of full-thickness wounds with an advanced bovine collagen-based design engineered to facilitate cellular migration and blood vessel formation. Preclinical studies in porcine models demonstrated that Cohealyx generated robust tissue capable of consistently supporting a split-thickness skin graft in a two-stage procedure earlier than leading dermal matrices in the study. While animal model results do not necessarily translate to clinical results, this expedited timeline is anticipated to lead to quicker wound closure and streamlined clinician workflows, resulting in shorter hospital stays, reduced treatment costs, and better patient outcomes. These parameters will be evaluated in a clinical study.”