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Avita Gets FDA Approval For Compassionate Use IDE Program Expansion For ReCell

Avita Medical Ltd. (AVH.AX, AVMXY.PK) announced approval from the U.S. Food and Drug Administration or FDA for the expansion of its Compassionate Use Investigational Device Exemption or IDE program for ReCell.

The IDE supplement allows Avita Medical to continue clinical evaluation of ReCell on twice as many patients as originally permitted under the IDE, now allowing for ReCell treatment of a total of 24 patients who have insufficient healthy skin available for standard skin grafting of their injury.

Investigational use of ReCell in these patients may be granted in cases where the treating physician believes that there is no suitable treatment alternative. The IDE also allows the application of ReCell beyond burns and to larger, more serious defects than those previously studied in the U.S.

The FDA approved the initial IDE for up to 12 subjects with life-threatening wounds in April 2014. Under the original IDE, 12 compassionate use cases using ReCell have been conducted with success at several leading institutions, including Wake Forest Baptist Medical Center, Maricopa Medical Center, Walter Reed National Military Medical Center and MedStar Washington Hospital Center.

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