Regenerative medicine company AVITA Medical has received clearance from the US Food and Drug Administration (FDA) for Cohealyx, a bovine collagen-based dermal matrix.
Co-developed with New Jersey-based Regenity Biosciences, Cohealyx is designed to enhance tissue integration and promote revascularisation.
The dermal matrix is engineered to accelerate wound healing, shorten treatment durations, and improve patient outcomes in the management of full-thickness wounds.
Cohealyx’s advanced bovine collagen-based design is said to address full-thickness wound treatment. Engineered to support cellular migration and blood vessel formation, the product has shown promising results in preclinical porcine models.
In these studies, the dermal matrix formed tissue that consistently supported a split-thickness skin graft in a two-stage procedure, outperforming other commercially available dermal matrices in speed.
Nasdaq-listed AVITA Medical said that this faster healing timeline could lead to quicker wound closure, shorter hospital stays, reduced treatment costs, and improved patient outcomes.
AVITA Medical CEO Jim Corbett said: “Cohealyx is a strategic addition to our RECELL-centric portfolio, unlocking the powerful synergies of RECELL and Cohealyx to address full-thickness wounds.
“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 full-thickness wound treatment capabilities. Combined with RECELL and PermeaDerm, the latest offering also enhances AVITA’s comprehensive full-thickness wound care solutions.
RECELL, which has FDA approval for the treatment of thermal burn wounds and full-thickness skin defects, also aids in repigmentation of stable depigmented vitiligo lesions.
In May this year, AVITA Medical secured the FDA premarket approval (PMA) for its RECELL GO System.
According to the wound care solutions developer, this expanded portfolio is expected to triple its addressable market in burns, as dermal matrices play a key role in the two-stage surgical procedure for wound closure.
Furthermore, Cohealyx is anticipated to generate significant revenue as the company enters the full-thickness skin defect market.
AVITA Medical plans to develop clinical data for Cohealyx in early 2025, building on its preclinical success to support its commercial launch.
A post-market clinical study will evaluate Cohealyx’s performance in real-world settings, focusing on clinical efficacy and cost savings for treating full-thickness wounds and burns.
Full commercialisation efforts in the US are expected to begin in Q2 2025.
