NORTHRIDGE, CA and CAMBRIDGE, UNITED KINGDOM--(Marketwired - Apr 8, 2014) - Regenerative medicine company Avita Medical Limited "Avita Medical" (
The new version of ReCell has been cleared for use and is starting to be sold in the United Kingdom and Europe. Avita Medical is also in the process of submitting an application for review to the Therapeutic Goods Administration (TGA) in Australia, where the product must currently be refrigerated. The timeframe required for regulatory review and approval will be advised.
The regulatory approval and commercial launch of the non‐refrigerated ReCell is part of Avita Medical's ongoing commercialisation strategy for its ReCell 'Spray‐on Skin' technology, which includes improvements in ease‐of‐use to enhance the product's value proposition to the clinical market.
Avita Medical Interim Chief Executive Officer Tim Rooney said the elimination of the inconvenience associated with temperature‐controlled product would be valuable in generating ReCell sales.
"Until now, ReCell has required refrigeration, which often meant it was not immediately on hand in the operating theatre," said Mr Rooney. "The fact that this product can be stored on the shelf until use is a valuable element in providing a more convenient and attractive product, particularly in situations where time is of crucial importance."
Mr Rooney said ReCell would continue to evolve as technology advances and Avita Medical continually assessed and responded to customer needs and preferences.
"Our aim is to develop, trial, register and sell exceptional tools and products that provide benefits to patients and integrate well into clinical practice. I believe this is a positive step in our marketing strategy to increase ReCell sales."
ReCell is used to disaggregate cells from a patient's skin sample and to collect those cells into suspension for reintroduction to the patient. The cell suspension can be used, as determined by physicians, for various applications, including treatment of acute burns, scars, vitiligo and chronic wounds.
The unique enzyme formulation, which is responsible in part for the cell disaggregation process, was subjected to comprehensive ageing and performance testing by an Australian laboratory before it was granted regulatory approval for sale in the United Kingdom and Europe.
Avita Medical plans to phase out existing ReCell product containing the refrigerated or temperature-controlled enzyme and expects, when approved, only the product without refrigeration requirements will be manufactured and sold.
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.