RevBio announced that it was awarded a $2.4 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Neurological Disease and Stroke (NINDS), which is part of the National Institutes of Health (NIH).
This two-year grant (1R44NS135736-01A1) will allow the company to complete a 20-patient pilot clinical trial to examine the safety and efficacy of the company’s bone adhesive biomaterial called TETRANITE and it will be used to immediately fixate cranial flaps and enable bone fusion following craniotomy procedures associated with brain surgery.
FDA already approved this clinical trial for the stand-alone use of TETRANITE to replace metal plates and screws. This clinical trial is being conducted at the Semmes Murphey Clinic in Memphis, Tennessee, and Brigham and Women’s Hospital in Boston, Massachusetts. And the first five patients have already been successfully enrolled, with the first patient having had more than 3-months of healing following the flap closure surgery involving TETRANITE.
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“Bone and soft tissue healing have progressed well, especially given the size of this bone flap. All radiographic follow-up images show continued adhesion of the bone flap to the surrounding skull with no complications.”
-L. Madison Michael, MD, Co-Director of Cranial Base Surgery for the Methodist Brain and Spine Institute and practicing neurosurgeon at the Semmes Murphey Clinic in Memphis, Tennessee
“Advanced techniques have led to longer-term survival rates for patients who undergo brain surgery. Having just been through a very traumatic experience, improved bone healing through the revascularization of the flap and better cosmetic outcomes are important for patient self-esteem and for helping them move on with their lives.”
-Timothy R. Smith, MD, PhD, MPH, Director, Computational Neuroscience Outcomes Center and practicing neurosurgeon at Brigham and Women’s Hospital in Boston, Massachusetts
