NORTHRIDGE, CA and CAMBRIDGE, UNITED KINGDOM -- (Marketwired) -- Apr 27, 2015 -- Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specializing in the treatment of wounds and skin defects, announced today that it has received a CE Mark for a new ReCell device for the treatment of burns. This enhanced ReCell product offers treatment of up to a 1,920cm2 surface area; a 6-fold greater coverage than previously possible from the first generation product. The original ReCell device, covering 320cm2, allowed clinicians to treat only approximately 1.5% of an adult's total body surface area (TBSA). With the new device, ReCell is better aligned to meet grafting requirements of burn victims.
"This CE Mark approval represents an important step in realizing the full potential of Avita's best-in-class regenerative product portfolio. ReCell is now better positioned to address the needs of the burn patients and we look forward to commencing commercial activities across Europe, and a corresponding uptick in revenue," commented Adam Kelliher, Chief Executive Officer of Avita Medical.
The CE Marking is a legally-required mark for a product that is intended for sale in the European Market and declares that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.
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.
FOR FURTHER INFORMATION: Avita Medical Ltd Adam Kelliher Chief Executive Officer Phone: +44 (0) 1763 269 772 Email: [email protected] Avita Medical Ltd Tim Rooney Chief Financial Officer Phone: + 1 (818) 356-9400 Email: [email protected] Avita Medical Ltd Gabriel Chiappini Company Secretary Phone:+61(0) 8 9474 7738 Email: [email protected]
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