March 23, 2020 / 7:13 AM / 14 days ago

BRIEF-Bonesupport To Submit A De Novo Application In April 2020

March 23 (Reuters) - Bonesupport Holding AB:

* 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: Further company coverage: (Gdansk Newsroom)

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