Innovative regenerative technology using patients’ own skin cells significantly reduced size of wounds caused by diabetic foot ulcers in all patients

VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative medicine company, announced today favorable results from an open-label feasibility study of the RECELL® Autologous Cell Harvesting Device (RECELL® System) for the treatment of diabetic foot ulcers (DFUs). The data, presented by Mr. Tawqeer Rashid at the 11th annual meeting of the Japanese Society of Limb Salvage & Podiatric Medicine (JSLSPM) June 28-29, 2019, in Kobe, Japan, evaluated the clinical performance of the RECELL® System, which uses a small amount of a patient’s own skin to prepare Spray-On Skin™ Cells at the point-of-care, in patients with DFUs that had not responded to standard care treatments.

“Chronic wounds, such as diabetic foot ulcers, significantly impact the lives of patients,” said Mr. Rashid, Consultant Vascular and Endovascular Surgeon, Manchester Royal Infirmary. “There is a real need to find new ways of treatment, and the RECELL® System shows promise in potentially enhancing the healing of diabetic foot ulcers, including recalcitrant ulcers that have not responded to standard-of-care therapies."

The 26-week, single-arm, observational study included 16 patients treated at three hospitals in the United Kingdom, including Manchester Royal Infirmary, Kings College Hospital and Northwick Park Hospital. Patients enrolled in the study had chronic DFUs ranging in size from 5-33 cm2, with and without infection, and with varying depths, inclusive of bone and tendon exposure, that had failed to heal with standard-of-care treatments. Study investigators used the RECELL® System to prepare Spray-On Skin™ Cells using a small amount of each patient’s own skin, that were then applied to the DFUs.

Key results from the study include:

  • 100% of patients experiencing a reduction in DFU wound size following treatment with Spray-On Skin™ Cells, with an average wound size reduction of 83% at week 26
  • 50% of the patients had DFU wounds heal completely, with a median time to healing of 14 weeks, despite the range of severity of ulcers
  • Treatment using the RECELL® System provided an acceptable safety profile
  • High patient and physician satisfaction scores were reported following treatment utilizing the RE-CELL® System

“We are pleased with the results of the diabetic foot ulcer feasibility study, which demonstrate the potential versatility of the RECELL® System as a meaningful treatment option to heal chronic wounds,” said Dr. Michael Perry, AVITA Medical’s Chief Executive Officer. “AVITA is committed to continued exploration of how this innovative regenerative technology may further advance patient care in areas with significant unmet medical need.”

According to recent data collected by the World Health Organization, the Harvard T.H. Chan School of Public Health, and Imperial College London, diabetes now affects 422 million adults globally at a cost of $825 billion per year.1 National Institute of Health data report that approximately 25-30 million global diabetics suffer from DFUs, a widespread complication of poorly controlled diabetes.2 DFUs can remain as open wounds for years, limiting patients’ mobility and lifestyle, and risking infection, often leading to amputation if not treated effectively.

ABOUT AVITA MEDICAL

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION™ (RES™), an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point-of-care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 7,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, acute wounds, scars and vitiligo. The RECELL System is TGA-registered in Australia, CFDA-cleared in China, and has CE-mark approval in Europe.

To learn more, visit www.avitamedical.com.

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1 Zhou, Bin et al. "Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants." Lancet 2016; 387: 1513–30. Published Online April 6, 2016. http://dx.doi.org/10.1016/ S0140-6736(16)00618-8.

2 Raghav, Alok et al. "Financial burden of diabetic foot ulcers to world: a progressive topic to discuss always." Therapeutic Advances in Endocrinology and Metabolism: January 2018; 9(1): 29-31. U.S. National Library of Medicine: National Institutes of Health. Published Online December 12, 2017. doi: 10.1177/2042018817744513.

Contacts

U.S. Media Sam Brown, Inc. Christy Curran Phone: +1-615-414-8668 christycurran@sambrown.com

O.U.S. Media Monsoon Communications Sarah Kemter Phone: +61 (0)3 9620 3333 Mobile: +61 (0)407 162 530 sarahk@monsoon.com.au

Investors Westwicke Partners Caroline Corner Phone: +1-415-202-5678 caroline.corner@westwicke.com