Product: Overview

CUTTING-EDGE TECHNOLOGY FOR SKIN RESTORATION

AVITA Medical’s first product, the RECELL® System, is a device that enables healthcare professionals to produce a suspension of Spray-On Skin™ Cells using a small sample of the patient’s own skin for the treatment of acute thermal burns. This suspension contains the cells necessary to regenerate the outer layer of natural, healthy skin and is prepared and applied at the point of care in as little as 30 minutes.

RECELL Logo

RECELL® System Product Videos

How the RECELL® System Works: Animated Video

This animated video illustrates how the RECELL® System helps treat adult burn injuries.

RECELL® System: Scraping Video

The cellular suspension created through the proprietary enzymatic and mechanical processes of the RECELL® System overcomes the limitations of conventional grafting techniques.

RECELL® System: Spray Video

The RECELL® System provides spray delivery of single living cells primed for epidermal regeneration.

RECELL® System: Full-Thickness Burn Mechanism of Action Video

The RECELL® System isolates skin cells from a small skin sample that is immersed in an enzyme solution to produce Spray-On Skin™ Cells. The regenerative epidermal suspension includes keratinocytes, fibroblasts, and melanocytes, which play a critical role in healing.

RECELL® System: Deep Partial-Thickness Burn Mechanism of Action Video

The RECELL® System isolates skin cells from a small skin sample that is immersed in an enzyme solution to produce Spray-On Skin™ Cells. The regenerative epidermal suspension includes keratinocytes, fibroblasts, and melanocytes, which play a critical role in healing

RECELL® System Patients Share Their Stories

Inside the RECELL® System: Patient Voices, Tiara

Tiara shares her story of being treated with the RECELL® System following a severe burn injury.

Inside the RECELL® System: Patient Voices, Sergeant Shepherd

Sergeant Shepherd shares his story of being treated with the RECELL® System following a severe motorcycle accident.

Burn Specialists Share Their Experience with the RECELL® System

Inside the RECELL® System:
Revolutionizing Burn Treatment

The RECELL® System is quickly being adopted in burn units across the country. Hear what burn specialists Drs. Sood, Foster and Carter have to say about this innovative treatment advancing burn care.

Pediatric Case Study

Pediatric Full-Thickness Case with >50% TBSA Using RECELL®

Pediatric Case Study

Treatment of Full-Thickness Burns in a 62% TBSA Pediatric Patient

A Mother’s Story

Using RECELL® to Treat Pediatric Scalds

Medical Information – Adverse Events or Product Quality Complaints

In the U.S., please contact Medical Affairs with questions or to report an adverse event related to use of 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®.

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.
©Copyright 2022 AVITA Medical. All Rights Reserved.
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.
©Copyright 2022 AVITA Medical. All Rights Reserved.