Avita Medical Shares Rise 13% After New FDA Approval for Recell System

By Chris Wack

Avita Medical shares were up 13% at $16.60 after the company said the U.S. Food and Drug Administration has approved its premarket approval supplement for the use of its Recell System to treat full-thickness skin defects.

The regenerative medicine company said the expanded indication represents a broad label of full-thickness skin defects, such as wound injuries after traumatic avulsion, surgical excision, or resection, dramatically expanding its market opportunity at least five times.

Commercial launch will begin July 1.

The Recell System was first approved in the U.S. for the treatment of severe burns in 2018. The system is an autologous cell-harvesting device that prepares, produces and delivers a regenerative cell suspension using a small amount of a patient's own skin.

The PMA supplement received prioritized review through the FDA's Breakthrough Device program. The FDA grants the Breakthrough Device designation to medical devices that provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

June 08, 2023 10:56 ET (14:56 GMT)

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