RevBio Expands Globally into the United Kingdom with its Second Cranial Flap Fixation Clinical Trial for its Regenerative Bone Adhesive

This Clinical Trial will Demonstrate the Use of TETRANITE® to Reintegrate Cranial Bone Flaps for Improved Clinical Outcomes

RevBio, Inc., announced that it has received approval from the Medicines and Health Regulatory Agency (MHRA) to conduct a 15 patient pilot clinical trial to use TETRANITE^® to reintegrate bone flaps, which are portions of the skull that are temporarily removed by neurosurgeons to perform brain surgery. This clinical trial is designed to demonstrate that TETRANITE can reintegrate these bone flaps with the surrounding bone to improve cosmesis, increase flap stability for patient comfort, and help prevent cerebrospinal fluid leaks, which can cause significant pain and lead to serious infections.

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Dr. Kumar Abhinav (left) and Dr. Mario Teo (right) have to date conducted three cases in the 15 patient clinical trial. The images above show the seamless restoration of cranial flaps using TETRANITE in this clinical trial.

Mario Teo, MBChB (Hons), BMedSci (Hons), PhD, FRCS (Neurosurgery), and Kumar Abhinav, BSc (Hons), MBBS, MD, FRCS (Neurosurgery) are conducting this study at North Bristol NHS Trust (NBT) in the United Kingdom. NBT provides healthcare to the residents of Bristol, South Gloucestershire and North Somerset, offers specialist services for the wider region and beyond, and serves as a regional center for neuroscience.

“The background scientific work coupled with the promising recruitment thus far indicates that TETRANITE could play an important and exciting role in the future of craniotomy procedures,” said Dr. Teo.

The first five patients—three of which have already been enrolled—will receive TETRANITE in addition to the standard of care plates and screws to fixate their bone flaps. This unique arm of the study is designed to demonstrate that TETRANITE can be used adjunctively with standard metal fixation hardware and can facilitate bone regeneration in the kerf space (i.e., the area of bone that is lost around the perimeter of the cranial flap due to the cutting tools used to create the flap). The kerf space is typically left unfilled and represents a critical size bone defect since it will not spontaneously fill with new bone. The remaining ten cases in this clinical trial will use TETRANITE on a stand-alone basis without plates and screws similar to the ongoing U.S.-based cranial flap clinical trial, which has enrolled 18 of the planned 20 patients. Many of these U.S. patients have now been followed for more than 6 months and none of these patients have had any device-related complications.

The NBT Adult Neurosurgery Department has a long history of innovation. Originally located at Frenchay Hospital in the outskirts of Bristol, many of the founders were trained by the pioneering American neurosurgeon, Harvey Cushing. During World War II, the American Medical Corp was stationed with the neurosurgeons of Frenchay Hospital who treated close to 5,000 soldiers who sustained traumatic head and spinal injuries in the war. Due to this long history of expertise, neurosurgeons from around the world have received advanced training at the Bristol Hospital Department of Neurosurgery.

“Based on our initial cases, we believe TETRANITE could obviate the need for plates and screws for cranial fixation,” said Dr. Abhinav. “This product could provide patients with a much more rapid, mechanically robust solution which would lead to more optimal cosmetic outcomes.”

About RevBio, Inc.

RevBio, Inc., is a clinical stage medical device company engaged in the development and commercialization of TETRANITE^®, a patented, synthetic, injectable, self-setting, and osteoconductive bone adhesive. The company is initially developing this technology for use in the dental, cranial, and broader orthopaedic markets as well as applications in the animal health market. RevBio's TETRANITE technology is not yet approved for commercial use.

About North Bristol NHS Trust (NBT)

North Bristol NHS Trust (NBT) runs healthcare services from Southmead Hospital, Cossham Hospital, Bristol Centre for Enablement as well as satellite sites across Bristol, North Somerset and South Gloucestershire in the United Kingdom. As well as providing high-quality healthcare to the local population, NBT is a center of excellence in the South West and beyond in a range of services and major specialties including neurosciences, orthopedics, and plastic surgery. NBT’s pioneering treatments and advances in care have won international recognition, placing it at the forefront of medical knowledge. NBT forms part of the Bristol NHS Group, a group of NHS Hospitals which manages in excess of £100 million in research funding per year.

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