NORTHRIDGE, CA and CAMBRIDGE, UNITED KINGDOM--(Marketwired - May 15, 2014) - Avita Medical Limited (ASX: AVH) (OTCQX: AVMXY)
- Clinical study interim results demonstrate ReCell® superiority as treatment for hypopigmentation.
- Statistically significant pigment restored in patients' hypopigmented scars treated with ReCell.
- Results support the Company's commercial strategy for use of ReCell in aesthetic plastic surgery.
- Study results delivered at key European conferences, enhancing ReCell industry profile.
Regenerative medicine company Avita Medical Limited "Avita Medical" (ASX: AVH) (OTCQX: AVMXY) is pleased to announce that its product, ReCell, has been proven in a clinical study in Germany to provide clinically superior results for the treatment of hypopigmented scars.
The ongoing study by German-based Associate Professor Dr Matthias Aust, found that areas treated with ReCell combined with a scar treatment technique called medical needling showed statistically significant repigmentation, while the areas treated with medical needling alone and not treated with ReCell, did not.
The results of the study were presented by Mr Richard Bender, a student of Dr Aust, in a presentation entitled "Combination of Medical Needling and ReCell -- a promising method?" at the VDAEPC (Association of German Aesthetic Plastic Surgeons). The presentation was awarded the conference's "Best of Europe" prize and as a result has been selected to be delivered as a German keynote lecture at the European Association of Societies of Aesthetic Plastic Surgery (EASAPS) in November 2014.
Avita Medical VP Research & Technology Mr Andrew Quick said that the results of the clinical study provide further demonstration of the benefits of using ReCell to treat hypopigmented scars and that the aesthetic plastic surgery conferences are an excellent platform to share the beneficial outcomes with medical professionals.
"This is a particularly important study for ReCell as it is a randomised controlled design with an objective measure showing statistically significant repigmentation outcomes," Mr Quick said.
In the study, each of the 18 participants had some hypopigmented scar area treated with needling, and other hypopigmented scar area treated with a combination of needling and ReCell. In the 12 months following the ReCell treatment, the participants were monitored using a medical device that detects levels of melanin in the skin.
Medical needling, or percutaneous collagen induction, is a scar treatment approach that improves many properties of scar tissue, but often does not restore pigment, particularly for large scar areas. Dr Aust hypothesized that adding ReCell to the scar treatment would result in greater repigmentation than can be achieved with the needling alone, and the results have shown that he was correct.
Associate Professor Dr Matthias Aust said: "The clinical study carried out by my research group found that the combination of the two procedures, needling and ReCell, shows positive results.
"We believe that we have found a method for preparation of the treatment site without removing any skin tissue, and that with both needling and ReCell, we can reliably achieve improvement in repigmentation."
Avita Medical Interim Chief Executive Officer Mr Tim Rooney said that the clinical study results were important in providing definitive evidence to clinicians that ReCell is an effective treatment for hypopigmentation.
"Dr Aust's results clearly show that ReCell is an effective method for repigmentation and we're proud that the presentation has been selected to be delivered later this year at the EASAPS."
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.