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
Excerpt from the Press Release:
LOWELL, Mass.–(BUSINESS WIRE)–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.
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.
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