FDA Clears AVITA Medical’s Cohealyx Dermal Matrix

AVITA Medical Inc. has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for Cohealyx, a new collagen-based dermal matrix designed for tissue integration and revascularization to facilitate wound healing, reduce treatment timelines, and improve patient outcomes in full-thickness wound treatment.

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—which AVITA Medical co-developed with Regenity Biosciences—addresses this critical need in treating 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,” AVITA Medical CEO Jim Corbett stated. “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 treating full-thickness wounds. Offered with RECELL and PermeaDerm, Cohealyx enhances the company’s portfolio; such a bulked-up lineup 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 wound closure. AVITA Medical also expects Cohealyx to generate significant revenue.

AVITA Medical plans to develop clinical data for Cohealyx early this year to build on its 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 treating full-thickness wounds and burns. The company expects to launch the product in the United States at the start of Q2.

AVITA Medical is a commercial-stage regenerative medicine company transforming the standard of care in wound care management and skin restoration with devices. At the forefront of its platform is the RECELL System, approved by the U.S. Food and Drug Administration for treating thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions. RECELL harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin Cells, delivering a transformative solution at the point-of-care. This technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. In the United States, AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm, a biosynthetic wound matrix, and Cohealyx, an AVITA Medical-branded collagen-based dermal matrix.

In international markets, the RECELL System is approved to promote skin healing in various applications including burns, full-thickness skin defects, and vitiligo. The RECELL System, excluding RECELL GO, is TGA-registered in Australia, has received CE mark approval in Europe, and has PMDA approval in Japan.

Regenity Biosciences, a Linden Capital Partners portfolio company, is a global developer and manufacturer of bioresorbable technologies to repair and regenerate natural tissue and bone for a variety of markets including dental, spine, orthopedic, sports medicine, advanced wound, neurosurgery, ENT, and nerve repair. Founded in 1997, Regenity (formerly Collagen Matrix, Inc.) is headquartered in Paramus, N.J., with manufacturing locations in Oakland and Allendale, N.J., and Groningen, the Netherlands. Regenity’s product portfolio includes various collagen-based and synthetic polymer solutions that support the company’s platform for tissue and bone regeneration. Regenity develops proprietary products that are sold to OEM customers on either a contract or private label basis and offers partnership opportunities including contract product development and manufacturing services.