AVITA Medical Announces FDA Approval of RECELL GO mini

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Stock Avita Medical Inc (AVH.ASX)
Release Time 24 Dec 2024, 8:21 a.m.
Price Sensitive Yes
 AVITA Medical Announces FDA Approval of RECELL GO mini
Key Points
  • RECELL GO mini approved for treating smaller wounds up to 480 sq cm
  • Designed to reduce resource use and minimize waste for smaller skin samples
  • Enables broader accessibility and use in trauma and burn centers
Full Summary

AVITA Medical, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for RECELL GO mini. As a line extension of the RECELL GO system, the RECELL GO mini disposable cartridge is designed specifically to treat smaller wounds up to 480 square centimeters, compared to the standard RECELL GO disposable cartridge, which treats an area of 1,920 square centimeters. RECELL GO mini addresses a critical need in the full-thickness skin defect market, which includes a high volume of smaller wounds. As part of the RECELL GO platform, RECELL GO mini uses the same multi-use processing device as the standard disposable cartridge but features a modified cartridge optimized for smaller skin samples that reduces resource use and minimizes waste. This design provides an entry point for clinicians who may not have previously used the RECELL GO platform for smaller wounds, enabling broader accessibility and use in trauma and burn centers. The company expects RECELL GO mini to serve as a growth driver within the broader RECELL GO platform, further advancing AVITA Medical's strategy to expand its impact on patient care. Rollout will begin with trauma and burn centers that currently treat smaller wounds during the first quarter of 2025.

Outlook

The company expects RECELL GO mini to serve as a growth driver within the broader RECELL GO platform, further advancing AVITA Medical's strategy to expand its impact on patient care.