Patients

WE’RE CREATING A NEW STANDARD OF CARE THROUGH REGENERATIVE MEDICINE.

About the RECELL^® System

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 to treat 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.

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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.

How the RECELL^® System Works

Medical Information – Adverse Events or Product Quality Complaints

In the U.S., to report an adverse event related to use of the RECELL^® System, or if you have a product quality complaint, please contact the Medical Information department.

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.