About Us: Overview

FULFILLING THE POTENTIAL OF REGENERATIVE MEDICINE

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration. AVITA Medical is advancing the standard of care for burn patients with its novel technology platform, the RECELL^® System.

Our proprietary technology provides innovative treatment solutions derived from the skin’s own regenerative properties. The medical device works by preparing Spray-On Skin™ Cells, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medical introduced the RECELL^® System to the U.S. in September 2018. As the first new PMA-approved treatment for burn care in more than 20 years, the RECELL^® System represents a major advancement over the current standard of care for burn patients, offering benefits in both clinical outcomes and cost savings.

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.