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.
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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.
These procedures are typically conducted during craniotomy surgeries for conditions such as aneurysm treatment, brain tumour removal, deep brain stimulation, or intracranial pressure relief. A kerf line is created when part of the skull is removed and later reattached, but current methods do not fill or seal this gap.
Tetranite acts as a regenerative bone adhesive applied within the kerf line, which is created when part of the skull is removed and later reattached, but current methods do not fill or seal this gap.
The treatment instantly secures the bone flap in position, fills the space between the flap and the skull, and creates a biological pathway for bone cells.
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By GlobalDataThis can support improved fusion and healing of the cranial flap, potentially addressing complications such as cerebrospinal fluid leaks and compromised stability, which are known limitations of plate and screw systems.
The FDA has authorised up to 15 clinical sites to take part in the study. RevBio is in the process of selecting these sites in collaboration with its neurosurgical advisory board members.
The IDE approval was granted after favourable outcomes from pivotal preclinical studies, surgeon handling assessments, and the earlier pilot clinical trial (T-RESTORE I).
RevBio CEO and founder Brian Hess said: “This pivotal IDE trial allows us to conduct the final testing required for the commercial approval of our lead indication in the $10bn market of targeted bone glue applications. The fact that RevBio now has two active pivotal stage programmes highlights our ability to scale this technology as a platform.”
In December 2024, RevBio received approval from the FDA to expand an ongoing clinical trial of Tetranite.
