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

Benefits Beyond Closure™

Expedite the healing process with early treatment at a cellular level

RECELL uses a small piece of the patient’s skin to create a multi-phenotype suspension of Spray-On Skin™ Cells.1 The application of different cell types stimulates healing and repigmentation throughout the wound bed.2,3

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:

KERATINOCYTES
regenerate the epidermis4,5

Dermal FIBROBLAST
depost new extraceullular matrix proteins4

MELANOCYTES
produce melanin to allow restoration of natural pigmentation5

TREATING MORE with Less

Caring for your patients means more than closing the wound. With RECELL, you can expedite the healing process with early point-of-care treatment of thermal burn wounds and full-thickness skin defects providing the best possible outcomes for patients. Designed for donor sparing, significantly less donor skin is required with similar healing outcomes versus conventional autografting.

%

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Average less
Donor Skin for
DPT BURNS6

%

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AVERAGE LESS DONOR
SKIN FOR FULL-THICKNESS
BURNS WHEN USED
IN COMBINATION WITH
AUTOGRAFT7

%

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AVERAGE LESS DONOR
SKIN FOR FULL-THICK
NESS SKIN DEFECTS
WHEN USED IN COMBINA
TION WITH AUTOGRAFT8

STEP-BY-STEP Immediate Cellular Delivery

Cost-effective point-of-care regenerative therapy
in a single procedure8,9

Clinical benefits of RECELL can lead to cost savings.9

Reduced donor skin requirements can result in fewer surgical
procedures for definitive closure, decreased length of stay, and
reduced resource use, translating to potential cost savings.9-12

%

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UP TO 50% REDUCTION
IN DEFINITIVE CLOSURE
PROCEDURES9

%

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UP TO 47% REDUCTION
IN LENGTH OF STAY
FOR BURNS <50% TBSA9

%

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UP TO 39% TOTAL
COST SAVINGS9

HOW THE RECELL SYSTEM WORKS

Patients treated with RECELL Spray-On-Skin™ Cells
versus standard of care for small deep partial-thickness
and full-thickness burns experience shorter hospital
stays to help allow a faster return home.9

Patients treated with RECELL Spray-On-Skin™ Cells versus standard of care for small deep partial-thickness and full-thickness burns experience shorter hospital stays to help allow a faster return home.9

Resources that support you and your patients

HCP Resources

DOCUMENTS

 

Treating with RECELL

The RECELL Autologous Cell Harvesting Device Procedure Guide outlines the steps for efficient delivery of Spray-On Skin™ Cells.

View the RECELL Procedure Guide >
Optimizing the Healing Process

Learn more about the steps to take after your patient has been treated with Spray-On Skin™ Cells, as well as helpful information to share with patients and caregivers on how to care for their wounds during and after the healing process.

View Aftercare Dressing Guidelines
RECELL System Health Economics Study Summary
2023 RECELL System Reimbursement Guide
Treat Early
REIMBURSEMENT SUPPORT SERVICES

AVITA Medical is committed to providing comprehensive RECELL reimbursement support through the RECELL Access Program. This program delivers the value of a direct, one-stop reimbursement resource for patients, surgeons, and hospital facilities.

 

Staffed by reimbursement experts, the program offers a range of services, including:

  • Pre-authorization services
  • Insurance appeals supoort
  • RECELL reimbursement questions

 

To learn more, contact us at:

Telephone: (833) 674-1688

FAX: (661) 749-9430

Email: [email protected]

References

1. Wood FM, Giles N, Stevenson A, Rea S, Fear M. Characterisation of the cell suspension harvested from the dermal epidermal junction using a ReCell® kit. Burns. Published online November 12, 2011. doi:10.1016/ j.Burns.2011.03.001.

2. Navarro FA, Stoner ML, Lee HB, et al. Melanocyte repopulation in full-thickness wounds using a cell spray apparatus. J Burn Care Rehabil 2001;22:41–6.

3. Navarro FA, Stoner ML, Park CS, et al. Sprayed keratinocyte suspensions accelerate epidermal coverage in a porcine microwound model. J Burn Care Rehabil 2000;21:513–8.

4. Freedberg I, Tomic-Canic M, Komine M, et al. Keratins and the Keratinocyte Activation Cycle J Invest Dermatol 116:633-640, 2001.

5. Hirobe T. Keratinocytes regulate the function of melanocytes. Dermatol Sin. 2014;32(4):200-204.

6. Holmes JH, Molnar JA, Carter JE, et al. A comparative study of the RECELL® device and autologous split-thickness meshed skin graft in the treatment of acute burn injuries. J Burn Care Res.2018 Aug 17;39(5):694-702.

7. Holmes JH, Molnar JA, Shupp JW, et al. Demonstration of the safety and effectiveness of the RECELL® system combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries. Burns.2019;45(4):772-782. Care Res. 2018;39(5):694-702.

8. Instructions for Use. RECELL® Autologous Cell Harvesting Device.

9. Kowal S, Kruger E, Bilir P, et al. Cost effectiveness of the use of autologous cell harvesting device compared to standard of care for treatment of severe burns in the United States. Adv Ther.Published online May 7, 2019. doi: 10.1007/s12325-019-00961-2.

10. Foster K, Bilir P, Kruger E, et al. Cost-effectiveness of RECELL® Autologous Cell Harvesting Device (ACHD) versus STSG for treatment of severe burns in the United States. Presented at the American Burn Association 2018 Annual Meeting, April 2018.

11. Carter JE, Carson JS, Hickerson WL, et al. Length of Stay and Costs with Autologous Skin Cell Suspension Versus Split-Thickness Skin Grafts: Burn Care Data from US Centers [published online ahead of print, 2022 Sep 14]. Adv Ther.2022;10.1007/s12325-022-02306-y. doi :10.1007/s12325-022-02306-y.

12. Carson JS, Carter JE, Hickerson WL, et al. Analysis of real-world length of stay data and costs associated with use of autologous skin cell suspension for the treatment of small burns in U.S. centers [published online ahead of print, 2022 Dec 5]. Burns. 2022; S0305-4179(22)00299-6. doi: 10.1016/j. burns.2022.11.007.

Important Safety Information (UNITED STATES)

Indications for use:

The RECELL Autologous Cell Harvesting Device is indicated for the treatment of thermal burn wounds and full-thickness skin defects. The RECELL Device is used by an appropriately licensed and trained healthcare professional at the patient’s point of care to prepare autologous Spray-On Skin Cells 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 and full-thickness skin defects after traumatic avulsion (e.g., degloving) or surgical excision (e.g., necrotizing soft tissue infection) or resection (e.g., skin cancer) in patients 15 years of age and older.

CONTRADICTIONS:

RECELL is contraindicated for the treatment of wounds clinically diagnosed as infected or with necrotic tissue present in the wound bed. RECELL is contraindicated for: 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:

Autologous use only. Control infections on wounds prior to application of the cell suspension. Excise the necrotic tissues on wound bed prior to application of the cell suspension. 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 acute full-thickness burn wounds or full-thickness skin defects after traumatic avulsion (e.g., degloving) or surgical excision (e.g., necrotizing soft tissue infection) or resection (e.g., skin cancer). 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 >320cm2, 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 articulating joints, and in patients younger than 28 days of age (neonates). The safety and effectiveness of RECELL plus autografting have not been established for application in combination with meshed autografting on full-thickness skin defects after traumatic avulsion (e.g., degloving) or surgical excision (e.g., necrotizing soft tissue infection) or resection (e.g., skin cancer): on the hands and genitalia.

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.

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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