VALENCIA, Calif., April 03, 2025 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a leading therapeutic acute wound care company delivering transformative solutions, today announced the U.S. commercial launch of Cohealyx™, a collagen-based dermal matrix branded by AVITA Medical and co-developed with Regenity Biosciences. Cohealyx is designed to facilitate cellular migration and revascularization, thereby providing an ideal wound bed for definitive closure. In pre-clinical and initial clinical utilization, an integrated wound bed was seen as early as 7 days.
Cohealyx expands AVITA Medical’s therapeutic wound care portfolio, complementing its flagship product, the RECELL® System, which is FDA-approved for the treatment of thermal burns and full-thickness skin defects, and PermeaDerm®, a temporary biosynthetic dressing used to support healing before and after grafting. These products support the two-stage standard of care for full-thickness wounds. Cohealyx is used as a dermal matrix to manage the wound bed. RECELL Spray-On Skin™ Cells and wound protection with PermeaDerm provide solutions for definitive closure. This integrated approach may improve clinical outcomes and expands AVITA Medical’s market opportunity.
“When treating full-thickness acute wounds in a two-stage procedure, a shorter time to graft readiness translates to a shorter hospital stay for the patient,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “During our pre-clinical validated porcine model study, wounds treated with Cohealyx were consistently graft-ready faster than the leading competitors used as controls. This treatment regimen has the potential to deliver faster healing and shorter hospital stays, consistent with the benefits of our flagship RECELL System and our overall mission.”
AVITA Medical is currently enrolling participants in the Cohealyx I trial, a post-market study designed to further evaluate clinical outcomes, wound bed preparation for definitive closure, and patient recovery timelines when Cohealyx is used in the management of full-thickness wounds. The Cohealyx I trial underscores AVITA Medical’s commitment to generating robust clinical data supporting the benefits and cost-effectiveness of its products.
About AVITA Medical, Inc.
AVITA Medical® is a leading therapeutic acute wound care company delivering transformative solutions. Our technologies are designed to optimize wound healing, effectively accelerating the time to patient recovery. At the forefront of our platform is the RECELL® System, approved by the FDA for the treatment of thermal burn wounds and full-thickness skin defects. RECELL harnesses the healing properties of a patient’s own skin to create Spray-On Skin™ Cells, offering an innovative solution for improved clinical outcomes at the point-of-care. In the U.S., AVITA Medical also holds the exclusive rights to market, sell, and distribute both Cohealyx™, an AVITA Medical-branded collagen-based dermal matrix, and PermeaDerm®, a biosynthetic wound matrix.
In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns and full-thickness skin defects. The RECELL System, excluding RECELL GO®, is TGA-registered in Australia, has received CE mark approval in Europe, and has PMDA approval in Japan.
To learn more, visit www.avitamedical.com.
About Regenity Biosciences
Regenity Biosciences, a Linden Capital Partners portfolio company, is a leading global developer and manufacturer of bioresorbable technologies to repair and regenerate natural tissue and bone for a variety of markets including dental, spine, orthopaedic, sports medicine, advanced wound, neurosurgery, ENT, and nerve repair. Founded in 1997, Regenity (formerly Collagen Matrix, Inc.) is headquartered in Paramus, New Jersey, with manufacturing locations in Oakland and Allendale, New Jersey and Groningen, the Netherlands. Regenity's product portfolio includes a variety of 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. For more information, please visit www.regenity.com.
Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements generally may be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “would,” “may,” “will,” “believe,” “continue,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “outlook,” “guidance,” “future,” and similar words or expressions, and the use of future dates. Forward-looking statements include, but are not limited to, statements relating to the timing and realization of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval or adoption of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and risks of other business effects, including the effects of industry, as well as other economic or political conditions outside of the Company’s control. These statements are made as of the date of this release, and the Company undertakes no obligation to publicly update or revise any of these statements, except as required by law. For additional information and other important factors that may cause actual results to differ materially from forward-looking statements, please see the “Risk Factors” section of the Company’s latest Annual Report on Form 10-K and other publicly available filings for a discussion of these and other risks and uncertainties.
Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.
Investor & Media Contact: Jessica Ekeberg Phone +1-661-904-9269 investor@avitamedical.com media@avitamedical.com
