RevBio, Inc. has secured a $2.4 million Phase II SBIR grant from the National Institute of Neurological Disease and Stroke (NINDS), part of the NIH. The two-year grant will support a 20-patient pilot clinical trial to evaluate the safety and effectiveness of TETRANITE®, a bone adhesive biomaterial. This adhesive will be used for immediate fixation of cranial flaps and bone fusion after craniotomy procedures in brain surgery.
The FDA has approved a clinical trial for the stand-alone use of TETRANITE, a bone adhesive designed to replace metal plates and screws. The trial is being conducted at the Semmes Murphey Clinic in Memphis, Tennessee, and Brigham and Women’s Hospital in Boston, Massachusetts. The first five patients have been successfully enrolled, with one already showing over three months of healing after cranial flap surgery using TETRANITE. Dr. L. Madison Michael, a neurosurgeon at the Semmes Murphey Clinic, reported good bone and soft tissue healing, with radiographic images confirming the bone flap’s continued adhesion without complications.
Dr. Timothy R. Smith from Brigham and Women’s Hospital emphasized the importance of improved bone healing and cosmetic outcomes for brain surgery patients, aiding in their recovery and self-esteem.
RevBio, Inc., is a clinical-stage medical device company developing TETRANITE, a synthetic, injectable, self-setting bone adhesive for dental, cranial, orthopedic, and animal health applications. The technology is still awaiting commercial approval.
