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

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

Pediatric Scalds

In the U.S., it is estimated that 30% of burn patients are within the ages of one to 15 years old, and approximately 45% of the pediatric burn injuries are from scald burns. [2] A scald is damage to the skin caused by a wet heat, such as boiling water or steam.

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Pivotal

Enrollment has commenced in our trial seeking to demonstrate that treatment with the RECELL® System of partial-thickness burn injuries within 72 hours can safely and effectively increase the incidence of healing at day 10 when compared to a standardized wound dressing in pediatric patients.

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 IDE to FDA in May 2020 to determine safety and effectiveness of the RECELL® System for repigmentation of stable vitiligo lesions.


Feasibility

Received FDA investigational device exemption (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.

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. EB is estimated to afflict approximately 3-8 million people in the United States, [5] and there currently is 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.

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

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.
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