FDA declines to approve Aziyo Bio's antibacterial device; shares sink

Elutia

20/03/2023 13:16

** Shares of Aziyo Biologics Inc  AZYO.O , a regenerative
medicine co, slump ~49% to $1.9 premarket     
    ** Co says the U.S. Food and Drug Administration (FDA) has
declined the clearance application for its device intended to
securely hold a cardiac implantable electronic device or
neurostimulator
    ** AZYO received a 'Not Substantially Equivalent' (NSE)
letter from the FDA, citing issues related to drug testing -AZYO
    **  An NSE letter is issued when FDA, based on the
information submitted, determines that the device is not
substantially equivalent to the already legally marketed device
    ** Co says it does not plan to appeal the decision, and
intends to work with FDA to provide the additional data
requested 
    ** The device, CanGaroo RM Antibacterial Envelope, contains
antibiotics which reduce bacterial colonization on it -AZYO  
    ** Up to last close, stock down ~10% in the past 12 months 

 (Reporting by Mariam Sunny)
 ((Mariam.ESunny@thomsonreuters.com;))