MedPath

AVITA Medical's RECELL GO mini Receives FDA Approval for Smaller Wound Treatment

• AVITA Medical's RECELL GO mini has been approved by the FDA for treating smaller full-thickness skin defects, up to 480 square centimeters. • The RECELL GO mini utilizes the same processing device as the standard RECELL GO but with a modified cartridge optimized for smaller skin samples, reducing waste. • This approval expands the accessibility of RECELL technology to a broader range of patients, particularly in trauma and burn centers where smaller wounds are common. • The rollout of RECELL GO mini is expected to commence in the first quarter of 2025, targeting trauma and burn centers.

AVITA Medical Inc (ASX: AVH) has secured FDA approval for its premarket approval (PMA) supplement for RECELL GO mini, a line extension of the existing RECELL GO system designed to treat smaller wounds. The announcement led to a surge in the company's shares on the ASX.
RECELL GO mini is tailored for full-thickness skin defects up to 480 square centimeters, addressing a critical need for treating smaller wounds, while the standard RECELL GO cartridge treats areas up to 1,920 square centimeters. This new offering is designed to minimize resource use and waste by using a modified cartridge optimized for smaller skin samples, while still utilizing the same multi-use processing device as the standard RECELL GO.

Addressing Unmet Needs in Wound Care

The RECELL GO mini aims to provide an entry point for clinicians who may not have previously used the RECELL GO platform for smaller wounds, thereby broadening accessibility and use in trauma and burn centers. The design is intended to meet the needs of a high volume of smaller wounds, which are frequently encountered in clinical practice.

Management Perspective

Jim Corbett, CEO of AVITA Medical, expressed enthusiasm about the FDA approval, stating, "The FDA approval of RECELL GO mini strengthens our ability to provide clinicians with fit-for-purpose solutions that meet the diverse needs of patients with full-thickness wounds. By introducing a treatment option specifically for smaller wounds, we are expanding the accessibility of RECELL to a wider range of patients. We believe this addition will drive greater adoption across trauma centers, where smaller wounds are common, and support our broader growth strategy."

Commercialization Strategy

AVITA Medical plans to roll out RECELL GO mini in the first quarter of 2025, focusing on trauma and burn centers that frequently treat smaller wounds. The company anticipates that RECELL GO mini will serve as a growth driver within the broader RECELL GO platform, furthering the company's strategy to expand its impact on patient care.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Alterity Therapeutics' ATH-434 Shows Promise in Slowing Multiple System Atrophy

Alterity Therapeutics' ATH-434 demonstrated statistically significant slowing of clinical progression in early-stage multiple system atrophy (MSA) patients.
The Phase II trial showed up to 48% of patients experienced a slowing of the disease with the 50mg dose at week 52, as measured by the UMSARS scale.

AVITA Medical's RECELL GO Mini Receives FDA Approval for Smaller Wound Treatment

AVITA Medical's RECELL GO mini has been approved by the FDA for treating smaller full-thickness skin defects, addressing a critical need in wound care.
The RECELL GO mini cartridge treats wounds up to 480 square centimeters, offering a resource-efficient option compared to the standard RECELL GO cartridge.

FDA Approves Ryoncil, First Mesenchymal Stromal Cell Therapy for Pediatric Steroid-Refractory Acute Graft-versus-Host Disease

The FDA has approved Ryoncil (remestemcel-L-rknd) as the first mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients.
Ryoncil's approval was based on a Phase III trial demonstrating a 70% overall response rate in children with SR-aGVHD after 28 days of treatment.

Invion Doses First Patient in Phase I/II Trial of INV043 for Non-Melanoma Skin Cancer

Invion Ltd has dosed the first patient in its Phase I/II clinical trial of INV043 for non-melanoma skin cancer (NMSC).
The trial, conducted in Brisbane, will assess the safety and efficacy of INV043 in treating NMSC, which accounts for over 98% of skin cancers globally.

FDA Lifts Partial Hold on Avidity Biosciences' Myotonic Dystrophy Drug, Stock Surges

The FDA has lifted a partial clinical hold on Avidity Biosciences' delpacibart etedesiran (AOC 1001), a drug targeting myotonic dystrophy type 1, allowing patient recruitment for the Phase 3 trial to resume.
Following the FDA's decision, Avidity Biosciences' stock (RNA) experienced a 0.53% increase, reaching $47.30, signaling positive investor response to the advancement of AOC 1001.

Zydus Life Receives US FDA Approval for Enzalutamide Capsules in Prostate Cancer Treatment

Zydus Lifesciences secures US FDA approval for Enzalutamide capsules, a key medication in treating metastatic castration-resistant prostate cancer.
The approved drug, with an estimated annual sales of $869.4 million in the US, will be manufactured at Zydus' facility in Moraiya, Ahmedabad.

FDA Grants Fast Track Designation to Immuneering's IMM-1-104 for Pancreatic Cancer

The FDA has granted Fast Track designation to Immuneering's IMM-1-104 for pancreatic ductal adenocarcinoma after one prior line of therapy.
This designation aims to expedite the development and review of IMM-1-104, addressing a critical unmet need in pancreatic cancer treatment.

4DMedical, TrivarX, and Artrya Advance with FDA Clearances and US Partnerships

4DMedical's CT LVAS receives FDA clearance, expanding functional lung imaging accessibility in the US after its Australian rollout.
TrivarX accelerates its Phase 2 study for Major Depressive Episode, aiming to validate its MEB-001 algorithm for screening and diagnosis.

FDA Approves Krystal Biotech's Vyjuvek, a Topical Gene Therapy for Dystrophic Epidermolysis Bullosa

The FDA has approved Vyjuvek, Krystal Biotech's topical gene therapy, marking the first treatment of its kind for dystrophic epidermolysis bullosa.
Vyjuvek is approved for patients aged six months and older with either recessive or dominant forms of dystrophic epidermolysis bullosa.

Acadia To Seek First-Ever FDA Approval in Rett Syndrome

Acadia Pharmaceuticals' shares increased following positive late-stage data from a Phase III study of trofinetide for Rett syndrome, indicating the drug's potential effectiveness and safety. The company plans to submit a New Drug Application by mid-2022.

Reference News

[1]
Guess which ASX healthcare stock is jumping 7% on US FDA approval news - Motley Fool
fool.com.au · Dec 24, 2024

AVITA Medical Inc's shares rose 7% to $4.10 after FDA approval of RECELL GO mini, a smaller version of its RECELL GO sys...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy