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FDA Approves RevBio's Pivotal Trial for Cranial Flap Bone Glue
The novel regenerative adhesive aims to improve outcomes for craniotomy procedures.
Jan. 28, 2026 at 9:15am
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RevBio, Inc. has received investigational device exemption (IDE) approval from the FDA to conduct a multi-center randomized controlled pivotal clinical trial for its TETRANITE bone adhesive. The trial will evaluate TETRANITE's ability to immediately fixate cranial bone flaps and enable bone fusion in craniotomy and cranioplasty procedures, which could improve cosmesis, increase flap stability, and help prevent complications like cerebrospinal fluid leaks.
Why it matters
Current standard treatments for securing cranial bone flaps, such as titanium plates and screws, have limitations that can lead to complications. RevBio's TETRANITE adhesive aims to provide a more effective solution that could significantly improve outcomes for patients undergoing cranial restoration procedures.
The details
The pivotal trial, known as RevBio's T-RESTORE II, will enroll up to 204 patients, with half receiving TETRANITE and the other half receiving standard plate and screw fixation. TETRANITE is designed to immediately fixate the bone flap, fill the gap between the flap and surrounding skull, and provide a biological bridge to enable bone fusion. This could help prevent complications like cerebrospinal fluid leaks that can occur with current methods.
- RevBio received IDE approval from the FDA in January 2026 to conduct the pivotal clinical trial.
- The T-RESTORE II trial is currently recruiting clinical sites and is expected to begin enrolling patients soon.
The players
RevBio, Inc.
A clinical-stage medical device company developing TETRANITE, a synthetic, injectable, self-setting, and osteoconductive bone adhesive.
Timothy R. Smith, MD, PhD, MPH
Director of the Computational Neuroscience Outcomes Center and practicing neurosurgeon at Brigham and Women's Hospital in Boston, Massachusetts.
Brian Hess
CEO and founder of RevBio, Inc.
What they’re saying
“This novel regenerative adhesive has the potential to change how cranial restoration procedures are performed and significantly improve outcomes for patients.”
— Timothy R. Smith, Director, Computational Neuroscience Outcomes Center and practicing neurosurgeon
“This pivotal IDE trial allows us to conduct the final testing required for the commercial approval of our lead indication in the $10 billion market of targeted bone glue applications.”
— Brian Hess, CEO and founder
What’s next
RevBio is actively recruiting clinical sites to participate in the T-RESTORE II pivotal trial, which is expected to begin enrolling patients soon.
The takeaway
RevBio's TETRANITE bone adhesive represents a potential breakthrough in cranial restoration procedures, offering a more effective solution than current standard treatments and the possibility of significantly improving outcomes for patients.
