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Completion of Enrollment in Study to Evaluate the Safety and Preliminary Effectiveness of ReCell for the Return of Pigmentation in Vitiligo Patients
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Vitiligo Affects Approximately 1-2% of Worldwide Population; 2-5 Million in US and 18.5 Million People in OECD Countries
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No Current Medical Standard-of-Care for Skin Pigmentation Disorders; Significant Psychosocial Effects on Patients and Families
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Significant New Market Opportunity for ReCell; ReCell Now Actively Being Studied in Additional Large Commercial Markets Including Burns and Chronic Wounds
NORTHRIDGE, CA; USA and CAMBRIDGE, UK I August 21, 2013 I Regenerative medicine Company Avita Medical Ltd. (ASX: AVH) (PINKSHEETS: AVMXF) (OTCQX: AVMXY) today announced that the Netherlands Institute for Pigment Disorders (Stichting Nederlands Instituut voor Pigmentstoornissen or SNIP) has reached the target enrollment in a pilot randomized clinical trial evaluating ReCell® Spray-on Skin® in patients with skin pigmentation disorders including vitiligo. Treatment of skin pigmentation disorders represents a significant opportunity for ReCell — a large market currently with limited safe and effective treatments.
Vitiligo: An Incurable Pigmentation Disorder with Significant Psychological Effects on Patients
Skin pigmentation disorders, including vitiligo and piebaldism in which patches of the skin lose their pigment, affect a large number of people worldwide and constitute a major medical and social problem. It is estimated that approximately 1.5% of the global population is afflicted with vitiligo alone, representing a market of 18.5 million people in OECD countries. In the United States, anywhere from 2-5 million people suffer from vitiligo. Half the people who have vitiligo develop it before age 20; most develop it before their 40th birthday. The disorder affects both sexes and all races equally.
Vitiligo can be a psychologically distressing condition which has a significant impact on quality of life and self-esteem. There is currently no medical standard-of-care for vitiligo. A publication in the British Journal of Dermatology (Gawkrodger et al, 2008) suggested ReCell as a promising new solution for the treatment of vitiligo without the need for special facilities.
ReCell Trial: Completion of Patient Recruitment
The study is a randomized, blinded-observer, within-patient controlled trial designed to evaluate the safety and effectiveness of ReCell® for the return of pigmentation in vitiligo patients. The initial phase of the study has met its target enrollment of 10 patients. The study is comparing the use of ReCell in combination with laser treatment to laser treatment alone. Patients have regular follow-up visits scheduled up to 6 months post-treatment. Unpublished interim results have been highly encouraging. Albert Wolkerstorfer, M.D., of the Netherlands Institute for Pigment Disorders, the Principal Investigator of the study, noted, “We are pleased to have completed enrollment in the study and believe ReCell offers promise as a potential therapy in the management of stable and segmental vitiligo patients.”
“The data from this controlled trial will provide strong clinical data on the effectiveness of ReCell in the management and treatment of vitiligo and other skin dyspigmentation conditions. This study, and other clinical trials under way or starting, are an important part of our overall regulatory and commercial strategy to bring ReCell to the broadest number of patients in need of new treatment options,” said William Dolphin, Ph.D., CEO of Avita Medical. “We are very supportive of SNIP’s interest in investigating this further and are confident that this study will be demonstrative of ReCell’s value in providing a real treatment option for this very substantial market.”
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: 222
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Completion of Enrollment in Study to Evaluate the Safety and Preliminary Effectiveness of ReCell for the Return of Pigmentation in Vitiligo Patients
-
Vitiligo Affects Approximately 1-2% of Worldwide Population; 2-5 Million in US and 18.5 Million People in OECD Countries
-
No Current Medical Standard-of-Care for Skin Pigmentation Disorders; Significant Psychosocial Effects on Patients and Families
-
Significant New Market Opportunity for ReCell; ReCell Now Actively Being Studied in Additional Large Commercial Markets Including Burns and Chronic Wounds
NORTHRIDGE, CA; USA and CAMBRIDGE, UK I August 21, 2013 I Regenerative medicine Company Avita Medical Ltd. (ASX: AVH) (PINKSHEETS: AVMXF) (OTCQX: AVMXY) today announced that the Netherlands Institute for Pigment Disorders (Stichting Nederlands Instituut voor Pigmentstoornissen or SNIP) has reached the target enrollment in a pilot randomized clinical trial evaluating ReCell® Spray-on Skin® in patients with skin pigmentation disorders including vitiligo. Treatment of skin pigmentation disorders represents a significant opportunity for ReCell — a large market currently with limited safe and effective treatments.
Vitiligo: An Incurable Pigmentation Disorder with Significant Psychological Effects on Patients
Skin pigmentation disorders, including vitiligo and piebaldism in which patches of the skin lose their pigment, affect a large number of people worldwide and constitute a major medical and social problem. It is estimated that approximately 1.5% of the global population is afflicted with vitiligo alone, representing a market of 18.5 million people in OECD countries. In the United States, anywhere from 2-5 million people suffer from vitiligo. Half the people who have vitiligo develop it before age 20; most develop it before their 40th birthday. The disorder affects both sexes and all races equally.
Vitiligo can be a psychologically distressing condition which has a significant impact on quality of life and self-esteem. There is currently no medical standard-of-care for vitiligo. A publication in the British Journal of Dermatology (Gawkrodger et al, 2008) suggested ReCell as a promising new solution for the treatment of vitiligo without the need for special facilities.
ReCell Trial: Completion of Patient Recruitment
The study is a randomized, blinded-observer, within-patient controlled trial designed to evaluate the safety and effectiveness of ReCell® for the return of pigmentation in vitiligo patients. The initial phase of the study has met its target enrollment of 10 patients. The study is comparing the use of ReCell in combination with laser treatment to laser treatment alone. Patients have regular follow-up visits scheduled up to 6 months post-treatment. Unpublished interim results have been highly encouraging. Albert Wolkerstorfer, M.D., of the Netherlands Institute for Pigment Disorders, the Principal Investigator of the study, noted, “We are pleased to have completed enrollment in the study and believe ReCell offers promise as a potential therapy in the management of stable and segmental vitiligo patients.”
“The data from this controlled trial will provide strong clinical data on the effectiveness of ReCell in the management and treatment of vitiligo and other skin dyspigmentation conditions. This study, and other clinical trials under way or starting, are an important part of our overall regulatory and commercial strategy to bring ReCell to the broadest number of patients in need of new treatment options,” said William Dolphin, Ph.D., CEO of Avita Medical. “We are very supportive of SNIP’s interest in investigating this further and are confident that this study will be demonstrative of ReCell’s value in providing a real treatment option for this very substantial market.”
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: 222
