Clinical Outcomes: Overview

REAL-WORLD EXPERIENCE BACKED BY EXTENSIVE RESEARCH

AVITA Medical is committed to pursuing the full potential of its innovative regenerative technology platform to advance patient care in skin restoration, which includes a number of areas with significant unmet medical need. Currently approved in the U.S. for the acute treatment of thermal burns, studies are underway assessing the RECELL^® System for the treatment of soft tissue reconstruction, pediatric scalds and vitiligo. The team is also conducting early-stage research into epidermolysis bullosa and rejuvenation, and exploring the use of the RECELL^® System for treatment of chronic wounds.

Globally, the RECELL^® System is approved for additional skin applications, such as chronic and traumatic wounds, scar revision, and vitiligo, which provides AVITA Medical with valuable experience and confidence in pursuing expanded labeling in the U.S. following the completion of additional clinical trials.

PATIENT OUTCOMES

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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.