ABOUT RECELL® SYSTEM OUTSIDE THE UNITED STATES

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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. 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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SCIENTIFIC AND CLINICAL EVIDENCE

New

SCIENTIFIC AND CLINICAL EVIDENCE

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.

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Chest

Point-of-Care Regenerative Medicine

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Point-of-Care Regenerative Medicine

Skin Regeneration Transformed
RECELL® is a revolutionary approach to overcome limitations associated with traditional techniques with proven clinical results.

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Recell® Case Reports

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AVITA MEDICAL: INNOVATORS IN REGENERATIVE MEDICINE AROUND THE WORLD

EUROPE USA AUSTRALIA CHINA

RECELL® is FDA approved in the USA for the treatment of acute thermal burn wounds in patients 18 years of age and over, TGA-registered in Australia, CE-marked in Europe and CFDA-cleared in China.

RECELL® is FDA approved in the USA for the treatment of acute thermal burn wounds in patients 18 years of age and over, TGA-registered in Australia, CE-marked in Europe and CFDA-cleared in China.

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RECELL® SYSTEM OUS IMPORTANT SAFETY INFORMATION

INDICATIONS FOR USE: RECELL® is indicated for harvesting of skin cells from a patient’s split-thickness skin samples, for reintroduction to the patient. Please see the Instructions for Use for each country for the specific indication of RECELL.

CONTRAINDICATIONS: RECELL® are contraindicated for treatment of infected wounds or with necrotic tissue present in the wound bed or with necrotic tissue present in the wound bed, and for patients having unstable vitiligo or a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidine-iodine, or chlorhexidine solutions.

WARNINGS AND PRECAUTIONS: Regenerative Epidermal Suspension (RESTM ) prepared using the RECELL® Device should only be applied to patients from whom the original skin sample was taken. RECELL® is provided sterile and is intended for single-use. Do not use if packaging is damaged or expired. A skin sample should require between 15 and 30 minutes contact with the Enzyme. Contact in excess of 60 minutes is not recommended. RECELL® Enzyme is animal derived and freedom from infectious agents cannot be guaranteed. RESTM should be applied to a clean, dry, haemostatic vascularized wound bed.

For complete Important Safety Information refer to Instructions For Use for specific countries.

ADVERSE REACTIONS Any adverse reaction or suspected adverse reaction related to RECELL® should immediately be reported to Avita Medical.

Our portfolio is marketed under the RECELL® brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics.

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