Avita Medical Initiates US FDA Study of Its ReCell® Spray-On-Skin™
for Reconstructive and Aesthetic Indications
· FDA pilot study on hypertrophic dyspigmented scars
· Expands indications for ReCell to include Reconstructive and Aesthetic treatments
Northridge, CA and Cambridge, UK, 10 May 2012,—Avita Medical Ltd. (ASX: AVH), (OTC: AVMXYF), OTCQX:AVMXY), the regenerative medicine company, today announced that it has commenced enrolment in the US FDA-approved feasibility study for the use of ReCell® Spray-On-Skin™ in the treatment of hypertrophic dyspigmented scars (raised and/or discoloured scars).
The initial three patients were treated by Dr Rajiv Sood, at the Richard M. Fairbanks Burn Center of Wishard Hospital, Indiana University, Indianapolis, Indiana, for scarring resulting from previous grafting due to burn injuries.
The approved FDA protocol permits the Company to treat 20 patients with scars at up to four U.S. study sites; patients will be assessed for healing and pain on a weekly basis during the initial four weeks post-treatment; at weeks 12 and 24 the treatment site will be assessed for healing and aesthetic outcomes by both the patient and an independent observer.
“Commencement of the FDA scar study is an important milestone for Avita” said Dr William Dolphin, Avita Medical’s CEO. “ReCell has shown the potential to provide significant benefits over current options in the treatment of acute and chronic wounds and for a wide range of skin defects. We are confident that this study will demonstrate the effectiveness of ReCell in the corrective treatment of scars, making ReCell directly applicable and immediately relevant to the very large aesthetic markets.”
The feasibility study is primarily designed to confirm the effectiveness of ReCell for the treatment of scars in a single session in comparison to the current standard of care involving dermabrasion of the scar and often requiring multiple treatment sessions; study endpoints are time-to-healing and aesthetic outcomes. Following completion of the study, Avita will submit the feasibility data and seek FDA approval for a statistically powered, pivotal clinical trial.
The study is funded by the US Department of Defense in partnership with the OSD Manufacturing Technology Program and Rapid Fielding Directorate for the “Limb Salvage and Regenerative Medicine Initiative.” The contract is a Technology Investment Agreement that is focused on the transition of the capability to meet DoD needs. ReCell was selected as it has the potential to will be a quantum advance over the existing ability to treat and re-grow tissue and to substantially reduce the effects and appearance of scarring and thereby profoundly assist in the treatment and rehabilitation of wounded warriors suffering from disfigurement and impeded function due to combat injuries.
Avita Medical (www.avitamedical.com) develops and distributes regenerative and tissue-engineered products for the treatment of a broad range of wounds, scars and skin defects. The company’s lead product, ReCell® Spray-On SkinTM, 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 to investigational use.
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Avita Medical Ltd.
Stella Sung, Ph.D.
Business Development Officer
Senior Vice President
Phone: +1 212-301-7130