NORTHRIDGE, CA and CAMBRIDGE, UNITED KINGDOM--(Marketwired - Oct 18, 2013) - Avita Medical Ltd. (
- Positive Results From Interim Update on 20-Patient, Randomized, Controlled Study of Restoration of Pigment in Hypopigmented Burn Scars
- Continued Positive Data From Repigmentation Trials to Form Basis for PIII Pivotal IDE Submission With US FDA
Regenerative medicine Company Avita Medical Ltd. (
Positive interim results on an investigator-led study on ReCell® for the restoration of pigment in hypopigmented burn scars were presented by Principal Investigator Dr Matthias Aust, Specialist in Plastic and Cosmetic Surgery, Malteser Hospital in Cologne, Germany.
Dr Aust's presentation highlighted excellent repigmentation outcomes from the randomized, within-patient controlled pilot study of 20 participants with hypopigmented burn scar. The robust study design compares ReCell treatment to both positive (medical needling) and negative (no treatment) controls, utilizing objective measurements of melanin (pigmentation), self-reported satisfaction ratings of participants and evaluations by a physician blinded to treatment.
In a separate address, Professor Jean-Paul Meningaud, Head of the Department of Plastic Surgery, University Hospital Henri Mondor presented positive results achieved using ReCell® in combination with mechanical dermabrasion, lipofilling and platelet-rich-plasma in the remodelling of burn scars.
William Dolphin, PhD, CEO of Avita Medical said, "The fields of Aesthetics and Reconstructive surgery are large and important markets for Avita. A growing body of clinical data, such as included in the presentations by Dr Aust and Prof Meningaud, clearly demonstrate the efficacy and applicability of ReCell in the restoration of pigmentation and improved scar remodelling. These data, in combination with results from other pigmentation studies currently underway on the treatment of Vitiligo and dyspigmented scars, will form the basis for the submission of a pivotal Phase III IDE (Investigational Device Exemption) trial with the US FDA in 2014."
ReCell is currently undergoing clinical investigations around the world for indications in plastics, aesthetics, chronic wounds and burns.
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.