Pipeline: Regenerative Dermatology

EXPLORING POTENTIAL APPLICATION IN REGENERATIVE DERMATOLOGY

We are exploring the use of the RECELL System technology platform for gene therapy involving genetically modified skin cells related to skin disorders such as genodermatoses and rejuvenation. For general information about our science and technology, please contact our Medical Affairs team.

Epidermolysis Bullosa

Epidermolysis Bullosa (EB) is a group of rare and incurable skin disorders caused by mutations in genes encoding structural proteins resulting in skin fragility and blistering, leading to chronic wounds and, in some sub-types, an increased risk of squamous cell carcinoma or death. Dystrophic EB is estimated to affect 3-8 million people[1], and there is currently no FDA-approved treatment.

Currently, AVITA Medical and scientists at the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine are collaborating on preclinical research to establish proof of concept and explore further development of a spray-on treatment of genetically modified cells for patients with EB, with potential applicability to other genetic skin disorders. The partnership pairs AVITA Medical’s patented and proprietary Spray-On Skin™ Cells technology and expertise with the Gates Center’s innovative, patent-pending combined reprogramming and gene-editing technology to allow cells to function properly.

Rejuvenation 

More than 3 million aesthetic procedures are performed in the U.S. annually aimed to improve skin tightness, texture, and evenness in skin tone. [2]

  1. Prevalence estimate for DEB from ‘Epidemiology of Inherited Epidermolysis Bullosa Based on Incidence and Prevalence Estimates from the National Epidermolysis Bullosa Registry’; Fine J, JAMA Dermatol. 2016;152(11):1231-1238; Estimates based on dressing & other costs for adults and 10 year olds – ‘Management of chronic wounds in patients with dystrophic epidermolysis bullosa: challenges and solutions’, Rashidghamat and Mellerio, Chronic Wound Care Mgmt and Res, 2017, Vol :4 Pages 45—54; Genodermatoses & Rare Skin Disorders Network. Source of image: “A case of a patient with severe epidermolysis bullosa surviving to adulthood”, Hubail et al, International Journal of General Medicine, 2018, Volume 2018:11, Page 413
  2. Source: 2018 Plastic Surgery Statistics Report, https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf

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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©Copyright 2022 AVITA Medical. All Rights Reserved.
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.
©Copyright 2022 AVITA Medical. All Rights Reserved.