- The U.S. Food and Drug Administration (FDA) granted breakthrough device designation to Avita Medical's ( NASDAQ: RCEL ) ( OTCPK:AVHHL ) RECELL System for soft tissue repair and vitiligo.
- The company said under the program, it will receive prioritized review and interactive communication with the FDA through the premarket review phase.
- "We are hopeful that the designations will help ensure timely patient access to RECELL as therapeutic treatments for both soft tissue repair and vitiligo, and we look forward to interacting with the agency in its review of RECELL for these proposed indications," said Avita CEO Jim Corbett.
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Avita Medical's RECELL gets FDA breakthrough device tag for tissue repair, vitiligo