Avita Medical Release: ReGenerCell Skin Regeneration Technology Decreases Size And Pain In Chronic Wounds
CAMBRIDGE, UNITED KINGDOM--(Marketwired - April 19, 2016) - Avita Medical (OTCQX: AVMXY) (ASX: AVH)
- Clinical Data Shows ReGenerCell™ Significantly Decreases Wound Size and Patient Pain With Shorter Treatment Periods
- Approach Offers Great Potential Savings for Addressing Massive and Growing Diabetic Foot Ulcer Prevalence
- Various Cases Show ReGenerCell™ Succeeded in Closing Wounds Where All Other Treatments Failed
Findings from top clinicians presented at the 4th Annual Skin Regeneration Symposium (SRS) at the University of Cambridge showed that ReGenerCell™, which uses Avita Medical's proprietary technology, positively affects chronic wound size and associated pain whilst reducing the time required for wound healing.
The RESTART session, attended by around 140 clinicians and researchers, focused on the treatment of chronic wounds, particularly Venous Leg Ulcers and Diabetic Foot Ulcers, where closure of such wounds is challenging. This issue is exacerbated by co-morbidities including ischaemia, infection, renal failure, neuropathy and burns. Many speakers emphasised the massive cost to public health systems of treating chronic wounds, and noted that Avita's regenerative medicine approach offered great potential savings. In the UK alone, 1.65% of the population aged over 65 have VLUs, costing the NHS more than £ 1bn pa (A$1.84bn).
Mr Harvey Chant, Consultant Vascular Surgeon at Royal Cornwall Hospitals NHS Trust, explained that the UK is projected to have about 4 million diabetics by 2025, of whom up to 25% will suffer from DFUs. "Chronic wounds take months, if not years, to heal," he said. "Healing these ulcers in good time will significantly improve patients' quality of life. Coupled with other treatments, such as vacuum assisted closure, dermal substitutes and topical oxygen therapies, ReGenerCell™ offers a cost-effective solution, successfully moving these patients away from the extensive wound care they have been receiving for years."
Mr Paul Hayes, Consultant Vascular Surgeon at Addenbrooke's Hospital in Cambridge, gave more details of the recent randomised trial he ran on VLUs using ReGenerCell™. He explained that most of the treated participants within the large-ulcer subgroup saw at least a 40% reduction in wound size by 6 weeks after ReGenerCell, whereas most of the Control wounds reduced less than 40%. Achieving 40% closure after six weeks is important because this threshold has been shown to be a predictor of complete wound closure.
"During the trial, we saw a real difference to overall wound size in patients treated with ReGenerCell™ -- on average, their wounds reduced by 9cm2 compared to 1cm2 in the control group, " Mr Hayes explained. "Pain was reduced in the treated group and there were notable improvements in quality of life."
Dr Tomas O'Neill, Royal Victoria Hospital, Belfast Health and Social Care Trust, UK, presented on the use of Avita's autologous skin cell suspension to an 81-year-old patient's chronic VLU, on which all non-surgical treatments had failed. Angioplasty successfully improved blood flow but the ulcer remained static for 4-6 weeks, with the patient suffering severe pain during and after dressing changes.
"After treatment with ReGenerCell™ the patient noted the absence of pain as the single greatest impact on her quality of life and is no longer bedbound but walking independently with a stick, Dr O'Neill said. "As we now start to do more cases, we are seeing the benefits of this device in chronic wounds emerging."
ABOUT THE 4TH ANNUAL SKIN REGENERATION SYMPOSIUM
A total of 140 experts from around the world attended the 4th Annual Skin Regeneration Symposium (SRS), which explored the latest advancements in skin repair, regeneration and restoration and the impact this has on patients. Keynote presentations were delivered by international experts from the fields of burns, trauma, chronic wounds and aesthetics during the two-day session at the University of Cambridge's Moller Centre, April 12-13.
The educational event, hosted by Avita, provided a forum to showcase research and present robust clinical evidence of Avita's pioneering ReCell® technology, supporting Avita's commercialization drive, by providing the data required by medical professionals and regulatory authorities, as well as drawing from Avita's clinical bibliography of more than 60 abstracts and peer-reviewed publications. In recent months, the Company has published positive data from randomized trials in the areas of pigmentation and venous leg ulcers, while an FDA-approval trial in burns has just completed enrolment.
ABOUT AVITA MEDICAL LIMITED
Avita Medical develops and distributes regenerative products for the treatment of a broad range of wounds, scars and skin defects. Avita's patented and proprietary collection and application technology provides innovative treatment solutions derived from a patient's own skin. The Company's regenerative product portfolio includes ReCell® for burns aimed at plastic reconstructive procedures, ReGenerCell™ for chronic wounds and ReNovaCell™ of restoration of pigmentation and cosmesis. ReCell®, ReGenerCell™ and ReNovaCell™ are patented, CE-marked for Europe. ReCell® is TGA-registered in Australia, and CFDA-cleared in China. In the United States, ReCell® is an investigational device limited by federal law to investigational use, and a pivotal U.S. trial is well underway aimed at securing FDA approval.
To learn more, visit www.avitamedical.com.
ReGenerCell™ is a medical device which enables clinicians to safely and rapidly create a treatment solution for unresponsive chronic wounds from a patient's own skin. ReGenerCell™ significantly reduces the healing time of wounds and leaves the patient with skin with similar elasticity, texture and pigmentation to surrounding skin, with limited scarring.
Using a small sample of skin, the device enables the production of a Regenerative Epithelial Suspension (RES™). The autologous suspension contains the multi-phenotype cells and wound-healing factors essential for natural healthy skin regeneration and healing. The procedure performed at the patient's bedside takes about 30 minutes from collecting the biopsy to treatment of the affected area.
In cases of chronic wounds, including diabetic foot ulcers and venous leg ulcers, the suspension is sprayed or dripped onto the skin. ReGenerCell™ has been used safely in thousands of treatments worldwide.
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