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AVITA Gets FDA IDE Approval Of Soft Tissue Reconstruction Pivotal Clinical Trial

AVITA Medical (AVMXY.OB) on Monday announced that the FDA has approved the company's Investigational Device Exemption (IDE) application to conduct a study of the Autologous Cell Harvesting Device RECELL in combination with meshed autografting for the treatment of acute soft tissue injuries, defects, and reconstruction.

The study is expected to start in 6 months.

The RECELL System was approved by the U.S. FDA in September 2018, for use in the treatment of acute thermal burns in patients 18 years and older.

The total product sales of RECELL System in the year ended June 30, 2019, were
A$7.7 million compared to A$1.19 million in the prior year.

AVMXY.OB closed Monday's trading at $7.12, unchanged from the previous day's close.

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