AZIYO: FDA asks more data on device submitted

 On March 16, 2023, the Company received a Not Substantially Equivalent determination from FDA. The notice defined the outstanding items that need to be addressed in order to obtain market clearance. The items relate to drug testing, primarily a request by FDA to modify an in vitro drug release assay employed as a manufacturing control. As a result, the Company does not expect to appeal the decision, as it believes the most expeditious path forward is to work with FDA to provide the additional data requested.

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