OM:BONEXBiotechs
Shifting CERAMENT V To FDA De Novo Review Might Change The Case For Investing In Bonesupport Holding (OM:BONEX)
BONESUPPORT has already shifted its U.S. regulatory route for CERAMENT V for bone infection from a 510(k) submission to the FDA’s De Novo pathway, extending the formal review period from 90 to 150 days while transferring substantial existing clinical and pharmacological documentation.
This move suggests CERAMENT V could, if cleared, create a new product category in the U.S., echoing how CERAMENT G previously established a distinct regulatory class and potentially underscoring the uniqueness...