Pipeline: Overview

ADVANCING OUR PROPRIETARY TECHNOLOGY PLATFORM

Focused Pipeline with Strong Growth Potential and the Power to Improve Patients’ Lives

We are currently exploring the potential of our novel technology platform to harness the regenerative properties of a patient’s own skin across a number of skin-related indications. Supported by a substantive body of clinical evidence and peer-reviewed publications, our late-stage pipeline is focused on use of the RECELL® System for preparation and delivery of Spray-On Skin™ Cells for treatment of injuries and skin defects. Additionally, we are in the early stages of evaluating the RECELL® System as core enabling technology for treatments involving genetically modified skin cells.

RECELL® Technology Platform

SOFT TISSUE RECONSTRUCTION: Pivotal

Soft Tissue Reconstruction

Acute full-thickness skin defects that require soft tissue reconstruction can include traumatic wounds such as abrasions and degloving, which is a type of injury where the skin is removed from the underlying tissue.

Skin grafting is the standard of care for full-thickness, soft tissue reconstruction. In 2017, approximately 80% of acute wounds that required skin grafting were non-burn-related injuries accounting for more than 200,000 procedures in the U.S. [1]

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Pivotal

Enrollment has commenced in our trial evaluating the safety and effectiveness of the RECELL® System in combination with meshed autografting for patients undergoing reconstruction of skin defects not associated with a burn injury.

The study’s two primary effectiveness endpoints are:

  • Superior donor skin sparing, evaluated by comparing the actual expansion ratios (donor area to treated area) used in RECELL® treatment versus conventional autografting
  • Non-inferior incidence of healing by eight weeks post-treatment

VITILIGO: Feasibility and Pivotal

Vitiligo

Vitiligo is a disease affecting approximately 6.5 million people in the U.S. resulting in loss of color, or pigmentation, in patches of skin that impacts the quality of life for those living with the condition. [3], [4]

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Pivotal

Submitted Investigational Device Exemption (IDE) to FDA in May 2020 to determine safety and effectiveness of the RECELL® System for repigmentation of stable vitiligo lesions.


Feasibility

Received FDA IDE approval in December 2019 for a feasibility study to evaluate the RECELL® System and Melanocyte Keratinocyte Transplantation Procedure (MKTP) for repigmentation of stable vitiligo lesions.

REGENERATIVE DERMATOLOGY-Epidermolysis Bullosa: Early-Stage Research

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[5], and there is currently no FDA-approved treatment.

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Early-Stage Research

Entered into sponsored research agreement with the Gates Center for Regenerative Medicine at the University of Colorado in November 2019 to focus on proof of concept and development of a spray-on treatment of genetically modified cells for EB patients with potential applicability to other genetic skin disorders.

REGENERATIVE DERMATOLOGY- Rejuvenation: Early-Stage Research

Rejuvenation

More than 3 million aesthetic procedures are performed in the U.S. annually aimed at improving skin tightness, texture, and evenness in skin tone. [6]

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Early-Stage Research

Engaged in discussions for a rejuvenation sponsored research agreement.

CHRONIC WOUNDS: Exploration

Chronic Wounds

A significant number of chronic wounds, such as diabetic foot ulcers and venous leg ulcers, fail to heal, which can lead to pain, drainage, odor and infection, as well as impacting quality of life. [7], [8] In the U.S., 49% of all skin grafts are for chronic wounds. [9]

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Exploration

Several international studies have assessed the use of the RECELL® System for the treatment of chronic wounds.

  1. © Procedural Data 2017 Millennium Research Group. Transmission or publication is prohibited. Reprinted with permission. Millennium Research Group, Inc. (“MRG”) makes no representation or warranty as to the accuracy or completeness of the data (“MRG Materials”) set forth herein and shall have, and accept, no liability of any kind, whether in contract, tort (including negligence) or otherwise, to any third party arising from or related to use of the MRG Materials by Customer. Any use which a Customer or a third party makes of the MRG Materials, or any reliance on it, or decisions to be made based on it, are the sole responsibilities of Customer and such third party. In no way shall any data appearing in the MRG Materials amount to any form of prediction of future events or circumstances and no such reliance may be inferred or implied.
  2. American Burn Association, NBR Advisory Committee, National Burn Repository 2016 Report
  3. Advances in Vitiligo: An Update on Medical and Surgical Treatments. A. Dillon, et al. J Clin Aesth Derm. 2017
  4. Willingness-to-pay and quality of life in patients with vitiligo. Radtke, et al. BJD. 2009
  5. 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
  6. 2018 Plastic Surgery Statistics Report, https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf
  7. Guest, J.F., Fuller, G.W. and Vowden, P. (2018), Diabetic foot ulcer management in clinical practice in the UK: costs and outcomes. Int Wound J, 15: 43-52. doi:10.1111/iwj.12816
  8. Guest, J.F., Fuller, G.W. and Vowden, P. (2018), Venous leg ulcer management in clinical practice in the UK: costs and outcomes. Int Wound J, 15: 29-37. doi:10.1111/iwj.12814
  9. © Procedural Data 2017 Millennium Research Group, transmission or publication is prohibited. Reprinted with permission. Millennium Research Group, Inc. (“MRG”) makes no representation or warranty as to the accuracy or completeness of the data (“MRG Materials”) set forth herein and shall have, and accept, no liability of any kind, whether in contract, tort (including negligence) or otherwise, to any third party arising from or related to use of the MRG Materials by Customer. Any use which Customer or a third party makes of the MRG Materials, or any reliance on it, or decisions to be made based on it, are the sole responsibilities of Customer and such third party. In no way shall any data appearing in the MRG Materials amount to any form of prediction of future events or circumstances and no such reliance may be inferred or implied.

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.