AVITA Medical (ASX: AVH) has announced encouraging interim results from its Cohealyx-I study, demonstrating a significant acceleration in the time to skin grafting.
The interim analysis of the multi-centre post-market single-arm study involving 40 patients revealed a mean time to grafting of just 13.6 days.
This represents a substantial improvement when compared to a literature-derived benchmark of 33.2 days, with statistical superiority reported.
Notably, the study showcased early grafting success, with a median time to grafting of 11 days.
Grafting was achieved as early as 5 days, with 25% of patients grafted within 7 days and 72% within 14 days.
Full Dataset Expected in 2026
Investigator satisfaction with the grafting process was high, with 90% of clinicians, including predominantly first-time users, reporting positive experiences at the time of grafting.
This suggests strong potential for adoption in clinical practice.
The Cohealyx-I study is currently ongoing, with the full dataset anticipated in 2026.
The interim analysis data will be presented during an AVITA symposium on April 15 and further discussed in a key opinion leader webinar on April 16.
Annual Report Highlights Financials
Beyond the clinical update, AVITA's latest annual report for FY2025 highlighted an 11% increase in revenue, reaching USD 71.6 million.
However, the overall gross margin experienced a decline to 82.1% from 85.8% in the prior year, primarily attributed to product mix and higher inventory reserves.
Despite this, the company managed to narrow its net loss attributable to owners by 21% to USD 48.6 million, driven by a reduction in operating expenses.
Cash and marketable securities decreased to USD 18.1 million in total at December 31, 2025.
A senior secured credit facility of up to USD 60 million was subsequently executed in January 2026, providing a significant liquidity boost.
Financial Flexibility via Shelf Registration
Adding to its financial flexibility, AVITA Medical filed a new SEC Form S-3 shelf registration statement on March 31, 2026.
This registration allows for potential future offerings of up to USD 200 million in common stock, preferred stock, warrants, or units.
The company has stated it currently has no plans to issue securities under this shelf, preserving it as an option for future capital raising should market conditions be favourable or specific financing needs arise.
This complements the aforementioned credit facility, enhancing the company's capital access.
Outlook and Investor Concerns
The positive interim results for Cohealyx-I offer encouraging clinical data, potentially supporting the product's value proposition and commercial adoption.
However, investors will continue to monitor AVITA's progress in translating these clinical successes into sustained commercial growth, particularly given the company's ongoing financial challenges, including recurring losses and the need for careful liquidity management.
Key concerns include managing debt obligations and covenants, potential future dilution from capital raising, and navigating reimbursement uncertainty for new indications.
