AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) announced today the U.S. commercial launch of Cohealyx™, a collagen-based dermal matrix designed to accelerate wound healing through enhanced cellular migration and revascularization. The product, co-developed with Regenity Biosciences, has demonstrated the ability to create an integrated wound bed in as little as seven days during pre-clinical and initial clinical use.
The launch represents a significant expansion of AVITA Medical's therapeutic wound care portfolio and addresses a critical stage in the treatment of full-thickness wounds.
Advancing the Standard of Care for Complex Wounds
Cohealyx integrates into AVITA Medical's existing product ecosystem, which includes the FDA-approved RECELL® System for treating thermal burns and full-thickness skin defects, and PermeaDerm®, a temporary biosynthetic dressing supporting healing before and after grafting. Together, these products provide a comprehensive solution for the two-stage standard of care in treating full-thickness wounds.
"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," explained 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."
The treatment regimen follows a logical sequence: Cohealyx is first applied as a dermal matrix to manage and prepare the wound bed, followed by RECELL Spray-On Skin™ Cells and PermeaDerm for definitive closure and protection. This integrated approach aims to improve clinical outcomes while potentially reducing hospitalization time.
Clinical Evidence and Ongoing Research
AVITA Medical is currently enrolling participants in the Cohealyx I trial, a post-market study evaluating clinical outcomes, wound bed preparation efficiency, and patient recovery timelines when Cohealyx is used to manage full-thickness wounds. This study underscores the company's commitment to generating robust clinical data supporting both the clinical benefits and cost-effectiveness of its wound care solutions.
The development of Cohealyx addresses significant unmet needs in wound care. Full-thickness wounds, which involve damage to all layers of the skin and potentially underlying tissues, present substantial clinical challenges and often require extended hospitalization. Current treatment approaches can be time-consuming and may result in suboptimal healing outcomes.
Market Opportunity and Strategic Positioning
The launch of Cohealyx strategically positions AVITA Medical to capture a larger share of the acute wound care market. By offering solutions for multiple stages of wound treatment, the company can now provide healthcare providers with a more comprehensive suite of complementary products.
AVITA Medical's RECELL System has already established a strong presence in burn care by harnessing the healing properties of a patient's own skin to create Spray-On Skin™ Cells. This technology offers improved clinical outcomes at the point-of-care, and the addition of Cohealyx extends these benefits to earlier stages of wound management.
In international markets, the RECELL System is approved for a wide range of applications beyond burns, including various full-thickness skin defects. The system has received regulatory approvals in multiple jurisdictions, including TGA registration in Australia, CE mark approval in Europe, and PMDA approval in Japan.
Collaborative Development
The development of Cohealyx represents a successful collaboration between AVITA Medical and Regenity Biosciences, a leading developer and manufacturer of bioresorbable technologies for tissue and bone regeneration. Regenity brings significant expertise in collagen-based and synthetic polymer solutions across multiple medical specialties.
Founded in 1997 and formerly known as Collagen Matrix, Inc., Regenity Biosciences is headquartered in Paramus, New Jersey, with manufacturing facilities in New Jersey and the Netherlands. The company's extensive experience in developing proprietary regenerative products has contributed to the technological foundation of Cohealyx.
Future Implications for Wound Care
The introduction of Cohealyx highlights ongoing innovation in the field of wound care, particularly for complex, full-thickness wounds that have traditionally been challenging to treat. By focusing on accelerating the preparation of the wound bed for definitive closure, AVITA Medical addresses a critical bottleneck in the treatment process.
If the clinical performance of Cohealyx matches the promising pre-clinical results, patients could benefit from faster healing times and shorter hospital stays. For healthcare systems, this could translate to improved resource utilization and potentially reduced costs associated with extended inpatient care for complex wounds.
As AVITA Medical continues to generate clinical evidence through the Cohealyx I trial, healthcare providers will gain additional insights into the optimal use of this new technology within comprehensive wound management protocols.
