AVH·AVITA Medical·Repigmentation of stable vitiligo lesions·FDA PMA Approved·NCT05971381·Primary completion: 30 July 2024
Plain-language Brief
The trial in plain terms
The disease
Vitiligo is a chronic skin condition in which pigment-producing cells called melanocytes are lost, leaving patches of depigmented skin. Stable vitiligo refers to disease that has not progressed for a defined period, making it potentially amenable to repigmentation procedures. The condition affects appearance and can have significant quality-of-life impacts for patients. Treatment options range from topical therapies and light-based approaches to surgical techniques aimed at restoring pigmentation.
What the asset is trying to do
The RECELL System is an autologous cell harvesting device, meaning it uses cells taken from the patient's own skin. A small sample of the patient's skin is processed with the device to produce a suspension of cells including melanocytes and keratinocytes, which is then applied to the treated area to promote repigmentation. This approach differs from conventional skin grafting by requiring only a small donor area and delivering a cell suspension rather than a sheet graft. The device has received FDA premarket approval (PMA) for use in stable vitiligo repigmentation (per AVITA Medical ASX announcements).
What the trial is measuring, and why it matters
The completed pivotal trial (NCT05971381) enrolled up to 109 participants and used the RECELL Autologous Cell Harvesting Device in stable vitiligo lesions (per ClinicalTrials.gov NCT05971381). The primary completion date was July 2024 (per ClinicalTrials.gov NCT05971381). An earlier smaller study (NCT04547998, target 25 participants, completed 2022) compared ablative laser resurfacing plus RECELL plus ultraviolet B (UVB) light against UVB alone as a control (per ClinicalTrials.gov NCT04547998). Repigmentation endpoints in vitiligo trials typically assess the proportion of treated area that regains pigmentation, as this is the clinically meaningful outcome for patients.
Efficacy benchmarks in this setting
In the vitiligo surgical repigmentation setting, published data on comparator approaches provide context. Autologous non-cultured epidermal cell suspension techniques have been reported to achieve complete or near-complete repigmentation in a substantial proportion of stable vitiligo lesions in published case series and trials; for example, Mulekar et al. reported repigmentation outcomes with non-cultured melanocyte-keratinocyte transplantation, though study designs and patient populations vary across publications (). Narrowband UVB phototherapy, a standard non-surgical treatment, has been associated with meaningful but variable repigmentation rates depending on lesion location and disease subtype (). Early-stage or single-arm figures from RECELL vitiligo studies are not statistically comparable to results from these separately designed and powered trials.
Commercial context
AVITA Medical received FDA PMA approval for the RECELL System in stable vitiligo repigmentation (per AVITA Medical ASX announcements). The company also announced Australia and New Zealand clearance for the RECELL GO device in April 2026 (per AVITA Medical ASX announcement, 29 April 2026). AVITA Medical highlighted first UK clinical experience with RECELL GO in June 2026 (per AVITA Medical ASX announcement, 18 June 2026). The RECELL System is AVITA Medical's lead commercial asset, with vitiligo representing an approved indication alongside existing burn wound approvals (per AVITA Medical public disclosures). No specific deal values or manufacturing cost figures for the vitiligo indication were disclosed in the provided source material.
Completed; active not recruiting as of registry data (per ClinicalTrials.gov NCT05971381)
Sites
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Expected readout window
Primary completion was July 2024 per ClinicalTrials.gov NCT05971381; the trial status is listed as completed, indicating data collection is concluded. Full study results publication timing is [ TODO: fill in ].
Curated Commentary
Third-party coverage(none curated yet)
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External analyst notes, journalism, and industry commentary cited with attribution.
No third-party coverage curated for RECELL System yet. Broker coverage of AVITA Medical is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.
Asset Track Record
Did AVH deliver against its own guidance?
Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.
14 May 2026data readoutCohealyx I clinical study data readouthit · positivesrc
30 June 2026regulatory decision7th MAC reimbursement rate publicationoverdue
30 June 2026data readoutCohealyx I study data readoutoverdue
30 June 2026commercial milestoneFinal MAC reimbursement coverageoverdue
14 May 2026otherFinancial Results for Quarter Ending 31 March 2026hitsrcASX ↗
29 Apr 2026regulatory decisionRECELL GO TGA — AVITA Secures Australia & NZ Clearance for RECELL GOhit · positivesrcASX ↗
13 Apr 2026data readoutResults posted — Clinical Study to Investigate the Safety and Effectiveness of RECELL for RepigmehitsrcASX ↗
13 Apr 2026data readoutResults posted — Continued Access to the Recell® Device for Treatment of Acute Burn Injurieshitsrc
Class Catalyst Calendar
What's landed, what's next for RECELL System and peers
RECELL System's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for RECELL System.
"Sponsor guided" dates come from IR materials and earnings calls; hover for the cited source. "CT.gov proxy" dates fall back to the registry primary completion date — actual readouts typically follow by 3-6 months.
Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo
Hudson Biotech
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Phase 2
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RECELL Systemn = 109
AVITA Medical·Surgical Device·FDA PMA Approved·[ TODO: fill in ]
Design
Randomized controlled trial (NCT04547998: two-arm, active control). Single-arm observational study (NCT05971381). Both open-label.
Primary endpoint
[ TODO: fill in ] (specific primary endpoint not stated in ClinicalTrials.gov registry data provided)