RECELL® System Feasibility Study Results

For Treatment of Diabetic Foot Ulcers Presented at 11th Annual Congress of the Japanese Society of Limb Salvage & Podiatric Medicine

AVITA Medical announced 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 SkinTM 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 RECELL® 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 reports 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.


Reference

[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.
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