Aziyo Bio hits record low as FDA declines to clear antibacterial device

Elutia

20/03/2023 15:12

(Updates)
    ** Shares of Aziyo Biologics Inc  AZYO.O  slump ~64% to
record low at $1.35 in morning trading
        ** Stock of regenerative medicine co set for its biggest
one-day pct drop if losses hold     
    ** 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
    ** The device, CanGaroo RM Antibacterial Envelope, contains
antibiotics, which have been shown in preclinical testing to
reduce bacterial colonization on the envelope - AZYO 
    ** Co received a 'not substantially equivalent' (NSE) letter
from the FDA, citing issues related to drug testing    
    ** 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  
    ** Including session's moves, stock down ~72% in the past 12
months 

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