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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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

Explore RECELL® System's approved uses and applications in your area.

EUROPE The RECELL® brands are indicated to treat burns, chronic wounds, scars, & vitiligo.* USA The RECELL® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds in patients 18 years of age and older. AUSTRALIA RECELL® treats burns, acute wounds, scars, and vitiligo. CHINA RECELL® treats burns, acute wounds, scars, and vitiligo.

* In Europe, our portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. RECELL® is designed for the treatment of burns and plastic reconstructive procedures; ReGenerCell has been formulated for chronic wounds including leg and foot ulcers; and ReNovaCell is tailored for aesthetic applications including the restoration of pigmentation.

RECELL® is TGA-registered is Australia, and CFDA-cleared in China.

The RECELL® brands are indicated to treat burns, chronic wounds, scars, & vitiligo.*

RECELL® is an investigational device, limited by US Federal law to investigational use only

RECELL® treats burns, acute wounds, scars, and vitiligo

RECELL® treats burns, acute wounds, scars, and vitiligo.

* In Europe, our portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. RECELL® is designed for the treatment of burns and plastic reconstructive procedures; ReGenerCell has been formulated for chronic wounds including leg and foot ulcers; and ReNovaCell is tailored for aesthetic applications including the restoration of pigmentation.

RECELL® is TGA-registered is Australia, 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 specific indication use of RECELL.

CONTRAINDICATIONS: RECELL® are contraindicated for treatment of infected wounds

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® ReCell should immediately be reported to Avita Medical.

*In all countries outside of Europe, our portfolio is marketed under the RECELL® brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. RECELL® is TGA-registered in Australia, CFDA-cleared in China and CE-mark in Europe. In the United States, RECELL® is not approved for sale and is limited by federal law to investigational use.

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