Avita Medical Presents More Positive ReCell Repigmentation Trial Results

NORTHRIDGE, CA and CAMBRIDGE, UNITED KINGDOM--(Marketwired - June 11, 2014) -

Regenerative medicine company Avita Medical Limited “Avita Medical” (ASX: AVH) (OTCQX: AVMXY) is pleased to advise that new positive, statistically significant results have been obtained in a ReCell® Spray-on Skin® trial in patients suffering with depigmented skin lesions.

Avita Medical’s lead product, ReCell, a single-use autologous cell harvesting technology, has been used successfully in place of costly permanent laboratory facilities, which require special licensure, in the treatment of patients with vitiligo or piebaldism.

Avita Medical Interim Chief Executive Officer Timothy Rooney said that similar to recent results reported by German-based Associate Professor Dr Matthias Aust, these new results highlight ReCell as an innovative and effective treatment for a large, under-served population.

“It’s estimated that around one in 200 people will suffer from vitiligo. In Europe alone that represents more than 3.7 million patients, which signifies a substantial market opportunity for ReCell,” Mr Rooney said.

ReCell technology works through the delivery of viable, pigment-producing cells harvested from a piece of the patient’s own normally-pigmented skin and is administered by spraying the cells onto the affected area.

The study involved 10 patients who participated in a randomised, within-subject controlled pilot trial facilitated by the Netherlands Institute for Pigment Disorders (Stichting Nederlands Instituut voor Pigmentstoornissen or SNIP).

Albert Wolkerstorfer M.D. from the SNIP who was the Principal Investigator of the trial and is also affiliated with the University of Amsterdam, said that the results of the study were certainly a positive indication that ReCell can be used effectively in the treating patients suffering from vitiligo and piebaldism disorders.

“The study has provided positive clinical data on the tolerability and effectiveness of ReCell in the management and treatment of these disorders when combined with CO2 laser treatment, compared to administering CO2 laser treatment without ReCell,” Dr Wolkerstorfer said.

In both vitiligo and piebaldism, the cells that are responsible for skin pigmentation no longer function as they should, resulting in uneven skin pigment and discolouration in patients. There is no universally accepted medical standard of care for the disorders and patients are usually provided with a combination of topical and phototherapy treatments.

Mr Andrew Quick, Avita Medical’s VP of Research & Technology said the company understands the importance of clearly demonstrating the clinical benefit with ReCell as shown through well-designed controlled studies.

“We would like to thank Drs Wolkerstorfer and Komen for their work over the past two years in the robust design and completion of this study. Although the number of subjects was limited, ReCell treatment resulted in statistically significant improvements relative to the two control conditions in each patient. We look forward to the opportunity to engage a widening range of clinicians who can offer ReCell to their patients as a feasible option for restoration of pigment.”

Avita Medical has approval to market ReCell in Europe, Australia and China. A complete restructure of the European marketing team was undertaken recently with four new members recruited. A recruitment program is also underway in Australia to expand the commercialisation and marketing effort outside of Western Australia. With the addition of these new sales and marketing resources, the team will be focused on delivering the sales tactical plan and marketing strategy, building customer relations and achieving sales momentum.

ABOUT AVITA MEDICAL LIMITED

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 United States, ReCell is an investigational device limited by federal law to investigational use. A Phase III FDA trial is in process.