Bonalive receives FDA breakthrough device designation for bone graft substitute
Click Here to Manage Email Alerts
Bonalive Biomaterials Ltd. has been granted FDA breakthrough device designation for its Bonalive orthopedics granules, a bone graft substitute designed to protect against microbial infection, according to a press release.
Bonalive orthopedics granules utilizes S53P4 bioactive glass to fill bony voids and gaps, and the resorbable granules are replaced by bone to aid in the healing process, according to the release.
“With antimicrobial resistance increasing worldwide, efforts are required to find new ways of coping with microbial infections,” Fredrik Ollila, chair, founder and CEO of Bonalive Biomaterials Ltd., said in the release. “We are pleased that our proposed indications for use meet the FDA criteria for designation as a breakthrough device.”
Click Here to Manage Email Alerts