The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Cohealyx, a new collagen-based dermal matrix designed for tissue integration and revascularization to facilitate wound healing.
Branded by AVITA Medical and co-developed with Regenity Biosciences, Cohealyx may reduce treatment timelines, and improve patient outcomes in the treatment of full-thickness wounds.
Cohealyx comprises a bovine collagen-based design that is 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.
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. The Company expects to launch full commercialization efforts in the beginning of the second quarter of 2025 in the U.S.
“Cohealyx is a strategic addition to our RECELL-centric portfolio, unlocking the powerful synergies of RECELL and Cohealyx to address full-thickness wounds,” says Jim Corbett, Chief Executive Officer of AVITA Medical, in a news release. “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.”
