US-based bone adhesive company RevBio has received the Food and Drug Administration’s (FDA) investigational device exemption (IDE) approval to conduct a clinical trial of its cranial flap bone glue.

The randomised, controlled, pivotal, multi-centre trial will assess the company’s Tetranite for reintegrating cranial bone flaps during brain surgery.

The T-RESTORE II trial will involve up to 204 patients. Half of them will be given Tetranite treatment while the other half will receive conventional cranial plate and screw fixation.