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65-Patient, Randomized, Controlled Study of Venous Leg Ulcers at up to Five European Centres
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Leg Ulcers Characterised by High Treatment Costs; Major Burden on Patients and Health Care Systems
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Large and Growing Market in Need of New Treatment Options; US$25 Billion Lower Limb Management Market in US
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Significant New Market Opportunity for ReCell
NORTHRIDGE, CA, USA and CAMBRIDGE, UK I August 1, 2013 I Regenerative medicine Company Avita Medical Ltd. (ASX: AVH) (PINKSHEETS: AVMXF) (OTCQX: AVMXY) announced the initial enrollment of three patients in the RESTORE trial, a multi-centre, randomized European clinical trial evaluating the use of ReCell® Spray-on Skin® in the management of patients with venous leg ulcers. The company believes the management and treatment of lower limb ulcers (LLUs) represents a large and growing market opportunity for ReCell.
LLUs: A Significant and Costly Healthcare Problem
Lower limb ulcers (LLUs), which include venous leg ulcers (VLU) and diabetic foot ulcers (DFU), are a major healthcare problem in developed countries due to their prevalence, high cost of treatment and significant impact on patient quality of life. LLUs afflict nearly 1.5% of the general population in OECD countries and up to 3% over the age of 70 years. Venous ulcers account for 75-85% of all leg ulcers and are anticipated to increase in prevalence with the growing elderly population.
The expense of treating LLUs imposes a major financial burden on healthcare systems globally. In the US alone over 6.5 million people suffer from LLUs with associated treatment cost estimated in excess of US$25 billion; the UK National Health Service (NHS) estimate cost of treatment of LLUs at £2-3 billion per year with similar prevalence and expense documented throughout other European countries. The costs to patients include associated morbidity, pain, lack of mobility and lost work days and wages.
Current treatment options include compression therapy, skin grafts and regular dressing changes; however, such options are costly and there is currently no effective or definitive treatment for LLUs. ReCell offers a promising potential to address this major unmet clinical need.
ReCell: The RESTORE Study
The RESTORE study is a randomized, controlled trial designed to evaluate the effectiveness of ReCell for the treatment of chronic venous leg ulcers and is targeting enrollment of 65 patients. The study is based on positive preliminary results achieved with the use of ReCell in the treatment of over 50 VLU patients as previously published (e.g., Giraldi et al, 2012; De Angelis et al, 2013).
The initial three patients in the RESTORE study, each of which have had unhealed ulcers for a minimum of 12 months, were enrolled under Investigator Mr Paul Hayes, consultant vascular and endovascular surgeon at the Addenbrooke’s Hospital in Cambridge, UK. Following a two-week observation period, patients will be randomly assigned for treatment with ReCell or the current standard of care and will be followed for a minimum of 12 weeks post-treatment. It is anticipated that additional study centres in Denmark, France and Germany will participate in the trial.
“Chronic wounds, of which venous leg ulcers are the most common, are a major burden to patients, health care professionals, and health care systems globally,” said William Dolphin, CEO of Avita Medical. “Preliminary results with the use of ReCell have been extremely encouraging and we are confident that this study will demonstrate the clinical efficacy of ReCell in treating lower limb ulcers. Chronic wounds represent a large and growing market throughout the world and we believe that ReCell will provide an important treatment option for a large segment of this population. The chronic wound market represents a major market opportunity for the company and one for which there is currently no effective solution.”
ABOUT AVITA MEDICAL LTD.
Avita Medical ( http://www.avitamedical.com/) develops and distributes regenerative products for the treatment of a broad range of wounds, scars and skin defects. Avita’s patented and proprietary tissue‐culture, collection and application technology provides innovative treatment solutions derived from a patient’s own skin. The Company’s lead product, ReCell® Spray‐On Skin™, is used in a wide variety of burns, plastic, reconstructive and cosmetic procedures. ReCell is patented, CE‐marked for Europe, TGA‐registered in Australia, and SFDA‐cleared in China. ReCell is not available for sale in the United States; in the U.S. ReCell is an investigational device limited by federal law to investigational use. A Phase III FDA trial is in process.
SOURCE: Avita Medical
Post Views: 169
-
65-Patient, Randomized, Controlled Study of Venous Leg Ulcers at up to Five European Centres
-
Leg Ulcers Characterised by High Treatment Costs; Major Burden on Patients and Health Care Systems
-
Large and Growing Market in Need of New Treatment Options; US$25 Billion Lower Limb Management Market in US
-
Significant New Market Opportunity for ReCell
NORTHRIDGE, CA, USA and CAMBRIDGE, UK I August 1, 2013 I Regenerative medicine Company Avita Medical Ltd. (ASX: AVH) (PINKSHEETS: AVMXF) (OTCQX: AVMXY) announced the initial enrollment of three patients in the RESTORE trial, a multi-centre, randomized European clinical trial evaluating the use of ReCell® Spray-on Skin® in the management of patients with venous leg ulcers. The company believes the management and treatment of lower limb ulcers (LLUs) represents a large and growing market opportunity for ReCell.
LLUs: A Significant and Costly Healthcare Problem
Lower limb ulcers (LLUs), which include venous leg ulcers (VLU) and diabetic foot ulcers (DFU), are a major healthcare problem in developed countries due to their prevalence, high cost of treatment and significant impact on patient quality of life. LLUs afflict nearly 1.5% of the general population in OECD countries and up to 3% over the age of 70 years. Venous ulcers account for 75-85% of all leg ulcers and are anticipated to increase in prevalence with the growing elderly population.
The expense of treating LLUs imposes a major financial burden on healthcare systems globally. In the US alone over 6.5 million people suffer from LLUs with associated treatment cost estimated in excess of US$25 billion; the UK National Health Service (NHS) estimate cost of treatment of LLUs at £2-3 billion per year with similar prevalence and expense documented throughout other European countries. The costs to patients include associated morbidity, pain, lack of mobility and lost work days and wages.
Current treatment options include compression therapy, skin grafts and regular dressing changes; however, such options are costly and there is currently no effective or definitive treatment for LLUs. ReCell offers a promising potential to address this major unmet clinical need.
ReCell: The RESTORE Study
The RESTORE study is a randomized, controlled trial designed to evaluate the effectiveness of ReCell for the treatment of chronic venous leg ulcers and is targeting enrollment of 65 patients. The study is based on positive preliminary results achieved with the use of ReCell in the treatment of over 50 VLU patients as previously published (e.g., Giraldi et al, 2012; De Angelis et al, 2013).
The initial three patients in the RESTORE study, each of which have had unhealed ulcers for a minimum of 12 months, were enrolled under Investigator Mr Paul Hayes, consultant vascular and endovascular surgeon at the Addenbrooke’s Hospital in Cambridge, UK. Following a two-week observation period, patients will be randomly assigned for treatment with ReCell or the current standard of care and will be followed for a minimum of 12 weeks post-treatment. It is anticipated that additional study centres in Denmark, France and Germany will participate in the trial.
“Chronic wounds, of which venous leg ulcers are the most common, are a major burden to patients, health care professionals, and health care systems globally,” said William Dolphin, CEO of Avita Medical. “Preliminary results with the use of ReCell have been extremely encouraging and we are confident that this study will demonstrate the clinical efficacy of ReCell in treating lower limb ulcers. Chronic wounds represent a large and growing market throughout the world and we believe that ReCell will provide an important treatment option for a large segment of this population. The chronic wound market represents a major market opportunity for the company and one for which there is currently no effective solution.”
ABOUT AVITA MEDICAL LTD.
Avita Medical ( http://www.avitamedical.com/) develops and distributes regenerative products for the treatment of a broad range of wounds, scars and skin defects. Avita’s patented and proprietary tissue‐culture, collection and application technology provides innovative treatment solutions derived from a patient’s own skin. The Company’s lead product, ReCell® Spray‐On Skin™, is used in a wide variety of burns, plastic, reconstructive and cosmetic procedures. ReCell is patented, CE‐marked for Europe, TGA‐registered in Australia, and SFDA‐cleared in China. ReCell is not available for sale in the United States; in the U.S. ReCell is an investigational device limited by federal law to investigational use. A Phase III FDA trial is in process.
SOURCE: Avita Medical
Post Views: 169
