NORTHRIDGE, CA and PERTH, AUSTRALIA and CAMBRIDGE, UNITED KINGDOM--(Marketwired - May 30, 2016) - Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY)
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Study will evaluate preliminary safety and effectiveness in a cohort of up to 24 patients
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Innovative regenerative technology will use patients' own skin cells to try to close chronic Diabetic Foot Ulcer (DFUs)
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DFUs represent a significant new potential patient population for Avita Medical
The first patient suffering from a Diabetic Foot Ulcer (DFU) has been enrolled in a clinical trial in the UK aimed at evaluating the feasibility of the medical device ReGenerCell™ in the safe and effective treatment of this widespread complication of diabetes, Avita Medical said today.
Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specializing in the treatment of wounds and skin defects, said the new research takes Avita into a significant new indication area, after the recent release of positive study outcomes for ReGenerCell™ in the treatment Venous Leg Ulcers (VLUs). The DFU clinical study has now started at Manchester Royal Infirmary, with London's King's College and Northwick Park hospitals to join shortly. DFUs are a common and growing complication of diabetes, and can often lead to amputation amongst the UK's 4 million diabetics, whose condition costs the NHS £10bn a year to treat.(1)
The Company said the first patient had been treated at the Manchester Royal Infirmary and that the study aimed to enroll up to 24 patients with DFUs, who will each be followed over a 26-week evaluation period. The ReGenerCell™ device enables medical professionals to create an autologous suspension of skin cells, which is then applied to the patient's wound to trigger healing. The treatment will be evaluated as an adjunct to standard care treatments, such as debridement, cleansing, dressings, and offloading. As well as the key outcome measures of incidence of healing and rate of wound closure, the study will also explore patient and physician satisfaction, the Company said.
"We are keen to evaluate any treatment that has the potential to improve patient care and at the same time reduce cost," said Mr. Tawqeer Rashid, Chief Investigator and Consultant Vascular Surgeon at Manchester Royal Infirmary. "With this study we will be evaluating the clinical benefits of the ReGenerCell™ treatment for patients whose quality of life is often severely reduced."
The Company said it had embarked on the study following many successful patient outcomes, indicating that the regenerative approach could be a very effective means of treating DFUs, which are typically long-term open wounds resistant to most standard treatments. Pioneering work at a wound clinic in Italy achieved complete wound closure for three DFUs of four within 50 days of treatment(2), and similarly successful outcomes have been shown in DFU patients treated in the UK, notably those treated by Dr Harvey Chant at the Royal Cornwall Hospital, the Company said.