NORTHRIDGE, CA and PERTH, AUSTRALIA and CAMBRIDGE, UNITED KINGDOM -- (Marketwired) -- Jan 14, 2016 -- Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specialising in new treatments for wounds and skin defects, announced today that it has signed distribution agreements for Japan and South Korea for its ReCell® device.
In Japan, Avita will be represented by INDEE Medical, a new venture created by a group of experienced executives to specifically focus on the regenerative medicine sector, which has shown significant growth and interest since the November 2014 implementation of the Pharmaceutical and Medical Device Law, which has significantly cut the time it takes to gain marketing approval in Japan. INDEE Medical is assembling a team with a strong pedigree in the medical device sector and has a clear plan for managing ReCell® in its entry to the world's second largest healthcare market by value.
In South Korea, Avita will be represented by TRM Korea, a Seoul-based company that for the past 25 years has distributed leading products focused on wounds, aesthetics and reconstructive surgery. South Korea has a burgeoning aesthetic sector, and one of the world's highest per capita usages of plastic surgery. As such, Avita believes that South Korea will be fertile territory for the repigmentation and reconstructive benefits of the ReCell® device.
"Japan and South Korea are two markets that we have been very enthusiastic about entering, as we know that both have significant potential for our ReCell® device," said Avita CEO Adam Kelliher. "We are committed to supporting both distributors in securing appropriate product registration and marketing authorisations. Both of our new partners have the expertise and focus needed and we look forward to building up robust sales when we come to market."
In Japan product registration will be through the Pharmaceutical and Medical Devices Agency (PMDA) and in South Korea by the Korean Food and Drug Administration (FDA).
ReCell® is CE-marked for Europe, TGA-registered in Australia, and CFDA-cleared in China. The Company already has distributors in France, the UK, China, Taiwan, Turkey and Saudi Arabia, which complement the Company's direct sales force in Australia.
ABOUT AVITA MEDICAL LIMITED
Avita Medical develops and distributes regenerative products for the treatment of a broad range of wounds, scars and skin defects. Avita's patented and proprietary collection and application technology provides innovative treatment solutions derived from a patient's own skin. The Company's lead product, ReCell®, is used in the treatment of a wide variety of burns, plastic, reconstructive and cosmetic procedures. ReCell® is patented, CE-marked for Europe, TGA-registered in Australia, and CFDA-cleared in China. In the United States, ReCell® is an investigational device limited by federal law to investigational use, and a pivotal U.S. trial is well underway aimed at securing FDA approval. To learn more, visit www.avitamedical.com.
FOR FURTHER INFORMATION Avita Medical Ltd Adam Kelliher Chief Executive Officer Phone: +44 (0) 1763 269770 [email protected] Avita Medical Ltd Tim Rooney Chief Financial Officer Phone: + 1 (818) 356-9400 [email protected] Avita Medical Ltd Gabriel Chiappini Company Secretary Phone +61(0) 8 9474 7738 [email protected] UK/EU Instinctif Partners Gemma Howe/Sue Charles Phone +44 (0)20 7866 7860 [email protected] USA The Ruth Group Lee Roth, Investor Relations Kirsten Thomas, Public Relations Phone: +1 (646) 536-7012 / +1 (508) 280-6592 [email protected] / [email protected] Australia Monsoon Communications Rudi Michelson Investor Relations / PR Phone: +61 3 9620 3333 [email protected]
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