Avita Medical Ltd (RCEL)

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Avita initiates European ReCell trial in lower limb ulcers. November 20, 2012.

Avita Medical (ASX:AVH; OTCQX:AVMXY) has initiated a multicenter, randomized control study on the use of ReCell Spray-On Skin in the treatment of venous leg ulcers at up to five European centers in the UK, Germany, France and Denmark.

Up to 80 patients will be enrolled in the study. Study protocols have been submitted for approval by the relevant ethics review boards at each center. It is anticipated that enrolment in the study will begin during the first quarter of 2013.
In preliminary open-label studies, ReCell was used at four European centers to treat approximately 80 patients suffering from venous leg ulcers and diabetic foot ulcers. Results have been encouraging. Over 70% of patients showed complete healing of the wound within seven-to-12 weeks after a single treatment with ReCell.

With the current standard of care treatment, the company said it would be expected that about 43% of these wounds would have achieved closure during this period, indicating that ReCell appears to yield a highly significant positive effect on wound healing. Pain, a critical indicator of quality of life, was reported as being significantly reduced or eliminated within 72 hours after the ReCell treatment.

These data have been submitted as separate papers for publication in peer-reviewed journals.

“The early results achieved in the treatment of chronic ulcers with ReCell are highly promising,” CEO William Dolphin said in a statement, adding that these are hard-to-heal ulcers that pose an enormous burden on healthcare systems and seriously impact on patient’s quality of life.

ReCell is approved for use in Europe, Australia and other markets, with over 4,500 procedures conducted to date, mainly for burns. “Improved leg ulcer treatment will provide tremendous relief for ulcer patients, potentially deliver significant cost savings to financially stressed healthcare systems and may open additional very large markets for ReCell,” Dr. Dolphin said.


http://biotuesdays.com/2012/11/20/avita-initiates-european-recell-trial-in-lower-limb-ulcers/