Regenerative medicine company AVITA Medical (ASX: AVH) has published “favourable” results from an open-label feasibility study of its RECELL Autologous Cell Harvesting Device for the treatment of diabetic foot ulcers (DFUs).
AVITA Medical has positioned itself as an innovative technology developer, intending to address unmet medical needs in burns, chronic wounds, and aesthetics indications.
AVITA’s device uses a small amount of a patient’s own skin to prepare what the company calls “spray-on skin cells” with the recent study focusing on patients with DFUs that have failed to respond to standard care treatments.
Speaking at the 11th annual meeting of the Japanese Society of Limb Salvage & Podiatric Medicine (JSLSPM) in Kobe, Japan last week, Mr Tawqeer Rashid presented data that underpinned the study and declared that RECELL was on the right track to make a big impact, assuming AVITA’s development schedule goes as expected.
According to recent data collected by the World Health Organisation (WHO), diabetes now affects 422 million adults globally at a cost of US$825 billion (A$1.12 trillion) per year.
Additionally, data obtained from the National Institute of Health data reported that approximately 25-30 million global diabetics suffer from DFUs, which are thought to originate from a widespread complication of poorly controlled diabetes.
One of the biggest compounding factors is that DFUs can remain as open wounds for years, limiting patients’ mobility and lifestyle, and risking infection, often leading to amputation if not treated effectively.
“Chronic wounds, such as diabetic foot ulcers, significantly impact the lives of patients,” said Mr Rashid, consultant vascular and endovascular surgeon, at Manchester Royal Infirmary.
He added that “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 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 5-33sq cm, including those with and without infection, and with varying depths. Patients’ DFU’s were also 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.
According to Mr Rashid, 100% of patients included in the study experienced a reduction in DFU wound size following treatment. Furthermore, RECELL achieved an average wound size reduction of 83% after 26 weeks of treatment.
Going further, the study showed that 50% of the patients recovered completely with a median time to healing of 14 weeks, despite the wide range of ulcer severity. Another positive result was high patient and physician satisfaction scores reported as part of the study into RECELL.
“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, chief executive officer of AVITA.
“AVITA is committed to the continued exploration of how this innovative regenerative technology may further advance patient care in areas with a significant unmet medical need,” he added.
As a result of the published results, AVITA shares rose over 7% to $0.45.