Products

RECELL® System

Products

RECELL® System

Providing point-of-care, multi-cell regenerative skin restoration with RECELL® System

The RECELL® System technology platform, approved by the FDA for the treatment of thermal burn wounds and full-thickness skin defects and for repigmentation of stable depigmented vitiligo lesions, harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin™ cells. Delivered at the point-of-care, RECELL enables improved clinical outcomes. RECELL is the catalyst of a new treatment paradigm and AVITA Medical is leveraging its proven and differentiated capabilities to develop first-in-class cellular therapies for multiple indications.

WOUND HEALING
thermal burn wounds | full-thickness skin defects

REPIGMENTATION
vitiligo patients

Providing point-of-care, multi-cell regenerative skin restoration with RECELL® System

The RECELL® System technology platform, approved by the FDA for the treatment of thermal burn wounds and full-thickness skin defects and for repigmentation of stable depigmented vitiligo lesions, harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin™ cells. Delivered at the point-of-care, RECELL enables improved clinical outcomes. RECELL is the catalyst of a new treatment paradigm and AVITA Medical is leveraging its proven and differentiated capabilities to develop first-in-class cellular therapies for multiple indications.

WOUND HEALING
thermal burn wounds | full-thickness skin defects

REPIGMENTATION
vitiligo patients

Instructions for Use
Instructions for Use

Revolutionizing Vitiligo Treatment

FDA APPROVES RECELL SYSTEM FOR SKIN REPIGMENTATION

Vitiligo is a chronic autoimmune disease that causes loss of skin color in patches. The disease causes the patient’s immune cells to attack and destroy melanocytes, which are pigment producing cells, resulting in depigmented patches of skin. Although vitiligo is not contagious nor is it fatal, people with vitiligo often suffer from depression and anxiety, poor body image, and low self-esteem, leading to an impaired quality of life.1,2

The U.S. Food and Drug Administration (FDA) approved the RECELL System for the repigmentation of stable vitiligo lesions in patients 18 years of age and older in June 2023. RECELL is the first and only FDA-approved device designed to isolate and transfer a patient’s own healthy skin cells to restore pigmentation of stable vitiligo lesions. Used at the point-of-care, RECELL enables rapid preparation of a regenerative cell suspension, Spray-On Skin™ Cells, using a small sample of a patient’s own skin.3

The power of multi-phenotype Spray-On Skin Cells.
Autologous therapy at point-of-care allows for delivery of the patient’s own living cells:

MELANOCYTES
produce melanin to allow restoration of natural pigmentation4
Dermal FIBROBLAST
depost new extraceullular matrix proteins5
KERATINOCYTES
regenerate the epidermis4,5

The suspension of Spray-On Skin Cells contain a combination of single living cells that stimulate healing and repigmentation throughout the wound bed. The preservation of melanocytes is important for restoring natural pigmentation to the recipient area. The suspension of Spray-On Skin Cells is suitable for application to skin resurfaced by an ablative laser. A portion of the suspension of Spray-On Skin Cells may also be applied to the donor site.3

When applied to laser-ablated depigmented stable lesions, the RECELL-prepared cell suspension has been shown to restore pigmentation, offering new hope to those living with vitiligo.

References

  1. Ezzedine K, Eleftheriadou V, Jones H, et al. Psychosocial effects of vitiligo: a systemic literature review. Am J Clin Dermatol. 2021;22:757-774. doi: 10.1007/ s40257-021-00631-6.
  2. Bergqvist C, Ezzedine K. Vitiligo: A focus on pathogenesis and its therapeutic implications. J Dermatol. 2021;48(3):252-270. doi:10.1111/1346-8138.15743.
  3. RECELL Autologous Cell Harvesting Device Instructions for Use. AVITA Medical; 2022.
  4. Hirobe T. Keratinocytes regulate the function of melanocytes. Dermatol Sin. 2014;32(4):200-204.
  5. Freedberg I, Tomic-Canic M, Komine M, et al. Keratins and the Keratinocyte Activation Cycle J Invest Dermatol 116:633-640, 2001.
Important Safety Information

Indications for use:

The RECELL Autologous Cell Harvesting Device is indicated for repigmentation of stable depigmented vitiligo lesions in patients 18 years of age and older. The RECELL Device is intended for use by an appropriately licensed and trained healthcare professional at the patient’s point-of-care for the safe and rapid preparation of Spray-On Skin Cells from a small sample of a patient’s own skin. The suspension of Spray-On Skin Cells is suitable for application to skin resurfaced by an ablative laser. A portion of the suspension of Spray-On Skin Cells may also be applied to the donor site.

CONTRADICTIONS:

RECELL is contraindicated for the treatment of patients with a known hypersensitivity to trypsin or compound sodium lactate solution (Hartmann’s Solution). The skin sample collection procedure specified for use of RECELL should not be used with patients having a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidone-iodine, or chlorhexidine solutions.

WARNINGS:

Autologous use only. RECELL is provided to the healthcare professional sterile and is intended for single use. Do not reuse, freeze, or re-sterilize device components. Handle using aseptic technique. Do not use RECELL or device components if packaging is damaged or there are signs of tampering. Do not use RECELL or device components beyond the stated expiration date indicated on the adhesive Lot # and Expiration Date labels on the outer box packaging. Choose a healthy skin sample donor site that shows no evidence of lack of pigmentation or surrounding cellulitis or infection. For optimum cell viability, the skin sample should be processed immediately after harvesting. Do not use silver sulfadiazine or other cytotoxic agents on the ablative laser prepared RECELL treatment areas. If a skin sample is harvested and processed according to these instructions, it should require between 15 and 30 minutes of contact with the Enzyme. Contact in excess of 60 minutes is not recommended. The Enzyme is derived from animal tissue and, although strict controls have been implemented in the manufacturing process to minimize the risk of pathogen contamination, a small risk of contamination exists and absolute freedom from infectious agents cannot be guaranteed. Contaminated materials and waste must be disposed of using appropriate biohazard waste receptacles.

PRECAUTIONS:

The safety and effectiveness of RECELL has not been established for repigmentation of: vitiligo lesions appearing on lips, eyelids, plantar surface of feet, or palmar surface of hands; vitiligo lesions with recent history (within 12 months) of Koebnerization, confetti-like or trichrome appearance; and patients with a history of keloid formation.

INSTRUCTIONS FOR USE:

Consult the Instructions for Use prior to using RECELL. For complete Important Safety Information, refer to Instructions for Use.

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