Brief: Bonesupport To Submit A De Novo Application In April 2020

BoneSupport Holding AB

23/03/2020 07:08

March 23 (Reuters) - Bonesupport Holding AB  BONEX.ST :
    * COMPANY WILL SUBMIT A DE NOVO APPLICATION TO US FOOD AND
DRUG
ADMINISTRATION (FDA) TO OBTAIN A MARKET APPROVAL FOR COMPANY'S
ANTIBIOTIC-RELEASING PRODUCT CERAMENT G
    * APPLICATION CAN POTENTIALLY RESULT IN AN APPROVAL AT
LATTER END
OF 2020
    * DIALOGUE WITH FDA HAS RESULTED IN CERAMENT G BEING GRANTED
DESIGNATION AS BREAKTHROUGH DEVICE
    * CO HAS DECIDED TO SUBMIT A DE NOVO APPLICATION IN APRIL
2020

Source text for Eikon:  ID:nWkr1t951Q 
Further company coverage:  BONEX.ST 

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