AVITA Medical Inc., a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the U.S. Food and Drug Administration (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.
“Cohealyx is a strategic addition to our RECELL-centric portfolio, unlocking the powerful synergies of RECELL and Cohealyx to address full-thickness wounds,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “This expansion to our product portfolio strengthens our ability to deliver superior patient outcomes and significantly expands our commercial potential in burns. By equipping clinicians with more comprehensive treatment options, we strengthen our competitive position, drive new growth opportunities, and further our commitment to advancing regenerative medicine.”
Cohealyx strengthens AVITA Medical’s portfolio by expanding its capabilities in the treatment of full-thickness wounds. Offered alongside RECELL and PermeaDerm®, Cohealyx enhances our comprehensive portfolio for addressing full-thickness wound care. This expanded portfolio is expected to triple AVITA Medical’s addressable market in burns, as dermal matrices are a critical component of the standard two-stage surgical procedure for definitive closure of these wounds. We also anticipate Cohealyx will generate significant revenue as we penetrate the full-thickness skin defect market.
AVITA Medical plans to develop clinical data for Cohealyx in early 2025 to build on the preclinical success and support the product’s commercial launch. The post-market clinical study will assess Cohealyx’s performance in real-world settings, focusing on clinical efficacy and cost savings in the treatment of full-thickness wounds and burns. In the U.S., we expect to launch full commercialization efforts in the beginning of the second quarter of 2025.
