Avita Medical Ltd. (ASX: AVH), the regenerative medicine company, announced today that it has launched ReCell Spray-On Skin for the treatment of chronic leg ulcers, a market estimated at over US$1 billion.

Image of lesion prior (left) and 28 days post- treatment with ReCell® Spray-On-Skin™. (Photo: Business Wire)

ReCell® used in the treatment for chronic ulcers was presented at the International Flebology Conference (CIF), held in Ferrara, Italy, from the 29 Sept - 1 October 2011. Over 230 vascular surgeons from throughout Europe attended the congress.

Dr Giuliano Magi, M.D., and colleagues in a presentation entitled “Autologous transplantation of epidermal cells in difficult to treat ulcers of the lower limbs” reported results from their work at the S. Giuseppe Hospital in Arezzo, Italy, on treatment of an initial 10 patients suffering from unhealed chronic ulcers as part of a larger ongoing study. The patients’ ulcers had previously been treated during the preceding 24 months per the current standard of care, including compression therapy alone or in combination with skin grafts. Depth, area, volume and extent of ulcers prior to and post-treatment with ReCell were objectively quantified using a 3D laser scanner.

Of 10 patients included in the pilot study, 1 was lost to follow-up due to an unrelated accident. Of the remaining 9, complete (100%) healing was achieved in 8 patients and approximately 90% re-epithelialization was achieved in the remaining patient at the 4-week endpoint.

Dr. Magi, lead investigator of the study, stated, “ReCell has demonstrated a very high success rate in the treatment of chronic leg ulcers. Although we have only a limited sample size, the outcomes in these recalcitrant ulcers are clinically outstanding and cost-effective for the healthcare system. Furthermore patients report an immediate decrease in pain and are resuming normal activities straight after the ReCell procedure making it more acceptable to the patients themselves.”

Dr. Jean Luc Gerard, a vascular surgeon at the H. Mondor Hospital in Paris, France, an attendee at the congress, said, “The treatment with ReCell appears to yield extremely positive results and represents a potential breakthrough in the cure of difficult-to-heal leg ulcers. I will be using ReCell in my clinic in the near future and am optimistic that similar outstanding results may be achieved.”

Treatment and management of diabetic, venous and pressure ulcers imposes significant costs to the health care systems of developed nations, and current treatments are only moderately effective; complete healing of for leg ulcers is achieved in approximately 25 – 50% following up to 20 weeks of treatment. Approximately 1.0-1.5% of the population in OECD countries suffers from leg ulcers at an annual cost estimated at nearly US$20 Billion.

ABOUT RECELL® SPRAY-ON SKIN™

ReCell allows in-theater preparation of a spray-on suspension consisting of cells derived from a small (2x 2cm), thin (0.15-0.20mm) biopsy of a patient’s own skin that is sufficient to cover an area up to 80 times the size of the biopsy. The ReCell suspension contains basal keratinocytes, melanocytes, fibroblasts and Langerhans cells. The metabolically responsive epithelial cells migrate across the wound surface, leading to regeneration of skin of normal color and texture. ReCell requires only a minimal donor site and is immediately available as a cell-based spray at the patient’s bedside.

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 U.S. ReCell^® is an investigational device limited by federal law to investigational use.

ABOUT AVITA MEDICAL LTD.

Avita Medical () is a publicly listed medical technology company that develops and distributes regenerative and tissue-engineered products for the treatment of a broad range of wounds, scars and skin defects. Using patented and proprietary tissue-culture, collection and application technology, the company is able to provide innovative treatment solutions derived from a patient’s own skin. The company’s lead product, ReCell^® Spray-On Skin, has been designed for use in a wide variety of burns, plastic, reconstructive and cosmetic procedures.

This news release may include forward-looking statements that involve risks and uncertainties. You can identify these statements by the use of words such as “anticipate”, “estimate”, “expect”, “project”, “potential”, “intend”, “plan”, “believe”, “target”, “may”, “assume” or similar expressions. These forward-looking statements speak only as at the date of this release and are based on management’s expectations and beliefs concerning future events. Forward-looking statements are necessarily subject to risks, uncertainties and other factors, many of which are outside the control of Avita Medical that could cause actual results to differ materially from such statements. Avita Medical makes no undertaking to subsequently update or revise the forward-looking statements made in this release to reflect events or circumstances after the date of this release. This document is intended to provide background information only and does not purport to make any recommendation upon which you may reasonably rely without taking further and more specific advice.

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