AVITA RECELL Approved for Pediatric Patients banner image

Now Approved
for Pediatric Patients.

The RECELL^® System is now approved by the FDA for the treatment of all sizes of acute full-thickness thermal burn wounds, in combination with meshed autografting, for patients 1-month of age and older.

RECELL Vitiligo

One Platform. Endless Possibilities.

We're harnessing point-of-care regenerative medicine to unlock bold ways of restoring skin.

Recell Patient

One Platform. Endless Possibilities.

We're harnessing point-of-care regenerative medicine to unlock bold ways of restoring skin.

Chardaih, treated with RECELL^® System

AVITA Medical RECELL Research

One Platform. Endless Possibilities.

We're harnessing point-of-care regenerative medicine to unlock bold ways of restoring skin.

RECELL Patient Tiara

One Platform. Endless Possibilities.

We're harnessing point-of-care regenerative medicine to unlock bold ways of restoring skin.

Tiara, treated with RECELL^® System

News Highlights

PRESS RELEASE | JUNE 07, 2023
AVITA Medical Announces FDA Approval of RECELL for Treatment of Full-Thickness Skin Defects

PRESS RELEASE | MAY 15, 2023
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In the News

A recent National Geographic article highlights treatments that are helping people with severe skin injuries.

This article may contain information for uses of our product that are not approved in certain countries or regions.

In the United States, RECELL® is approved for use in patients suffering acute thermal burns. Use of RECELL in other patient populations is either prohibited by United States law or may be made available pursuant to a relevant investigational device exemption granted by the FDA (and likewise limited by United States law to investigational use only) or otherwise prohibited.

In the news video thumbnail

AVITA Medical is a regenerative medicine company focused on the development and commercialization of innovative therapies with the power to transform lives. Harnessing the regenerative properties of a patient’s own skin, AVITA Medical’s RECELL^® System was approved by the U.S. Food and Drug Administration (FDA) in September 2018.

RECELL^® System

Avita Medical Recell Product

The RECELL^® System is the first new PMA-approved treatment in more than 20 years for acute thermal burn wounds.

Clinical Outcomes

Avita Medical Clinical Outcome

We’re elevating the standard of care for the treatment of skin restoration.

Pipeline

We’re exploring the potential of this novel technology platform to harness the regenerative properties of a patient’s own skin across a number of dermatological indications.

At AVITA Medical, patients are at the center of what we do. They guide and inspire our tireless dedication to advance bold innovation in regenerative medicine to deliver medical outcomes that transform lives.

The RECELL^® System

IMPORTANT SAFETY INFORMATION (United States)

INDICATIONS FOR USE: The RECELL^® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds. The RECELL^® device is used by an appropriately-licensed healthcare professional at the patient’s point of care to prepare autologous RES^® Regenerative Epidermal Suspension for direct application to acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients.

CONTRAINDICATIONS: RECELL^® is contraindicated for: the treatment of wounds clinically diagnosed as infected or with necrotic tissue, the treatment of patients with a known hypersensitivity to trypsin or compound sodium lactate (Hartmann’s) solution, patients having a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidone-iodine, or chlorhexidine solutions.

WARNINGS AND PRECAUTIONS: Autologous use only. Wound beds treated with a cytotoxic agent (e.g., silver sulfadiazine) should be rinsed prior to application of the cell suspension. RECELL^® is provided sterile and is intended for single-use. Do not use if packaging is damaged or expired. Choose a donor site with no evidence of cellulitis or infection and process skin immediately. A skin sample should require between 15 and 30 minutes contact with Enzyme. Contact in excess of 60 minutes is not recommended. RECELL^® Enzyme is animal derived and freedom from infectious agents cannot be guaranteed.

PRECAUTIONS: RECELL^® is not intended for use without meshed autograft for treatment of full-thickness burn wounds. The safety and effectiveness of RECELL^® without meshed autograft have not been established for treatment of partial-thickness burn wounds: on the hands and articulating joints, >320 cm2, in patients with wounds totaling >20% total body surface area (TBSA). The safety and effectiveness of RECELL with autografting have not been established for treatment of full-thickness burn wounds: on the hands and articulated joints, and in patients younger than 28 days of age (neonates).

SPECIAL PATIENT POPULATIONS: The safety and effectiveness of RECELL^® have not been established for treatment of acute thermal partial-thickness burn wounds in pediatric patients younger than 18 years of age.

For complete Important Safety Information, refer to Instructions For Use. Please be aware that any indication for RECELL^® outside of the United States may differ from the US indication. Please see the Instructions for Use for each country for the specific indication of RECELL^®.

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Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to AVITA, its subsidiaries or affiliates. No use of any AVITA trademark, trade name, or trade dress in this site may be made without the prior written authorization of AVITA, except to identify the product or services of the company.