NORTHRIDGE, CA and CAMBRIDGE, UNITED KINGDOM--(Marketwire - February 13, 2013) -
Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY
- SUCCESSFUL COMPLETION OF ISO QUALITY RECERTIFICATION AUDIT
- RECEIVES ISO 9000, ISO 13485 AND MED DEVICE DIRECTIVE RECERTIFICATION
- FREE TO CE MARK ALL REGENERATIVE AND RESPIRATORY PRODUCTS FOR SALE IN THE EUROPEAN UNION
Regenerative medicine company Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY) today announced that it has received formal notification of successful completion of the annual ISO Quality Recertification Audit conducted 8-9 January 2013. The Quality Audit, conducted by an independent, external auditor of the European Notified Body, covered all applicable elements of ISO 9001:2008 Quality Management System Certification, ISO 13485:2003 Medical Devices Certification, Medical Devices Directive 93/42/EEC and Canadian Medical Devices Regulation Part for Avita's Class III Medical Devices. No Major or Minor Non-Conformances were identified in the audit.
The ISO Quality Audit is a rigorous and comprehensive recertification audit to all of the required elements of the directives; successful ISO recertification is a requirement in order for Avita Medical to maintain its CE mark on its regenerative and respiratory products for sale within the European Union and Canada as well as a reference for registration in other countries, including the Middle East and Russia.
The audit addressed all phases of Avita Medical's Quality, Manufacturing and Management Systems as well as a comprehensive review and verification of controls on its portfolio of medical products including the Regenerative product, ReCell® Spray-On Skin®, and the company's respiratory products (Funhaler® and Breath-A-Tech®).
Mr. William Marshall, Avita Medical's VP Operations and Regulatory, said: "Avita maintains a strong commitment to the quality of our products and to our customers. We continue to improve and streamline the company's Quality System and we are very pleased with the result of the audit."
"Tight control of Quality and Manufacturing Systems are a prerequisite for efficient operations," said Mr. Timothy Rooney, Chief Financial Officer and Chief Operating Officer. "The company has in place a formal Continuous Improvement system which has yielded significantly improved margins and reductions in operating costs. This is part of an on-going effort to deliver the highest quality products to our customers while maximizing efficiency of manufacturing and operations."
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, chronic wounds, 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 US ReCell is an investigational device limited by federal law to investigational use. An FDA trial on the safety and efficacy of ReCell is in process.