---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-309133"
form_type: "8-K"
ticker: "RCEL"
cik: "0001762303"
company_name: "AVITA Medical, Inc."
filed_at: "2022-12-20T23:59:59+00:00"
generated_at: "2026-06-21T01:50:37.249775+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# AVITA Medical submits FDA PMA application for RECELL System to treat stable vitiligo

## Summary
- PMA submitted to FDA to expand RECELL indication to stable vitiligo; received Breakthrough Device designation.
- Pivotal trial met primary endpoint of super-superiority (p<0.025) on repigmentation success rates.
- Standard FDA review timeline for PMA is 180 days; full launch anticipated January 2025 if approved.
- Vitiligo affects up to 6.5M Americans (~1.3M stable); limited treatment options exist.
- This PMA follows original RECELL approval for burns in September 2018.

## SEC filing metadata
- accession: 0001193125-22-309133
- form_type: 8-K
- ticker: RCEL
- cik: 0001762303
- company_name: AVITA Medical, Inc.
- filed_at: 2022-12-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1762303/000119312522309133/0001193125-22-309133-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1762303/000119312522309133/d434009d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-309133
- JSON: https://secwatch.observer/filing/0001193125-22-309133.json
- Plain text: https://secwatch.observer/filing/0001193125-22-309133.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.