This section highlights FDA-related milestones and regulatory updates for drugs developed by Avita Medical (RCEL).
Over the past two years, Avita Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
RECELL, Cohealyx™, and RECELL. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
RECELL System FDA Regulatory Events
RECELL System is a drug developed by Avita Medical for the following indication: Extensive Burns and Pediatric Patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RECELL System
- Announced Date:
- September 4, 2025
- Indication:
- Extensive Burns and Pediatric Patients
Announcement
AVITA Medical, Inc. today reaffirmed real-world data from the U.S. national burn registry demonstrating that the use of the RECELL® System significantly reduces hospital length of stay (LOS) by an average of 36% compared to traditional split thickness skin grafts (STSG) in adult patients with deep partial thickness (second degree) burns affecting up to 30% total body surface area.
AI Summary
AVITA Medical reaffirmed data showing its RECELL® System reduces hospital stays by 36% versus traditional split-thickness skin grafts in adults with second-degree burns covering up to 30% of body surface. More RECELL patients went home directly, suggesting faster recovery.
In a matched analysis of 741 adults from a national burn registry, 247 RECELL patients experienced an average 5.6-day shorter stay compared to 494 STSG patients (p < 0.0001). This 36% reduction highlights RECELL’s effectiveness in modern burn care.
With daily bed costs about $7,554, RECELL may save over $42,000 per patient by shortening stays. Hospitals could treat up to 13 more burn patients per bed yearly, boosting efficiency.
AVITA’s CEO noted RECELL uses 97.5% less donor skin and leads to better donor‐site healing, less pain, and reduced scarring than traditional grafts. These findings underscore RECELL’s clinical and economic value in acute burn treatment.
Read Announcement- Drug:
- RECELL System
- Announced Date:
- December 19, 2024
- Indication:
- Extensive Burns and Pediatric Patients
Announcement
AVITA Medical, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Cohealyx™, a new collagen-based dermal matrix branded by AVITA Medical and co-developed with Regenity Biosciences.
AI Summary
AVITA Medical, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its new product, Cohealyx™, a collagen-based dermal matrix developed in partnership with Regenity Biosciences. Cohealyx is designed to promote tissue integration and revascularization, which can speed up wound healing and improve overall patient outcomes in full-thickness wounds, including those resulting from burns. Preclinical studies in animal models showed that Cohealyx can support a split-thickness skin graft more quickly than other dermal matrices. The clearance supports AVITA’s commitment to expanding their treatment options for severe skin injuries by complementing existing products like the RECELL System and PermeaDerm. This approval paves the way for further clinical studies in early 2025 and is expected to significantly boost the company’s market potential in the burns arena.
Read Announcement
Cohealyx™ FDA Regulatory Events
Cohealyx™ is a drug developed by Avita Medical for the following indication: collagen-based dermal matrix.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cohealyx™
- Announced Date:
- June 5, 2025
- Indication:
- collagen-based dermal matrix
Announcement
AVITA Medical, Inc. announced the first clinical publication evaluating Cohealyx™, an AVITA Medical-branded collagen-based dermal matrix, published in the Journal of Surgery (Akpunonu et al., 2025).
AI Summary
AVITA Medical, Inc. announced the first clinical publication evaluating Cohealyx™, an AVITA Medical-branded collagen-based dermal matrix, in the Journal of Surgery (Akpunonu et al., 2025). The study showed that Cohealyx™ enables significantly faster wound bed vascularization and readiness for autografting compared to conventional dermal matrices. In a case series at The Ohio State University Wexner Medical Center, two patients with complex full-thickness hand wounds were treated with Cohealyx™. One patient achieved a well-vascularized wound bed by day 5 and proceeded to autografting on day 7, while the other reached vascularization by day 10 and underwent autografting on day 13. Both patients experienced excellent skin graft take and improved functional recovery. The results suggest that Cohealyx™ may lead to earlier, definitive wound closure, reducing patient recovery time and overall complication risks.
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RECELL System (RSV) FDA Regulatory Events
RECELL System (RSV) is a drug developed by Avita Medical for the following indication: Repigmentation of Stable Vitiligo.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RECELL System (RSV)
- Announced Date:
- December 23, 2024
- Indication:
- Repigmentation of Stable Vitiligo
Announcement
AVITA Medical, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for RECELL GO® mini.
AI Summary
AVITA Medical, Inc. announced that the FDA has approved its premarket approval (PMA) supplement for the RECELL GO® mini. This new disposable cartridge is a line extension of the RECELL GO system and is designed for treating smaller wounds up to 480 square centimeters, compared to the standard cartridge which handles up to 1,920 square centimeters. The RECELL GO mini uses the same multi-use processing device but features a modified cartridge that is optimized for smaller skin samples, reducing resource use and minimizing waste. This expanded option targets clinicians treating full-thickness skin defects, particularly in trauma and burn centers, offering a more accessible and efficient solution. The FDA approval supports AVITA’s strategy to increase the accessibility of innovative wound care solutions and drive broader adoption of the RECELL platform.
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