LaunchPad Medical, Inc. announced that it has been awarded a $2.5 million Direct-to-Phase II Small Business Innovation Research (SBIR) grant (1R44NS115386) from the National Institute of Neurological Disorders and Stroke to advance the development of Tetranite®, its bone adhesive biomaterial technology, to improve cranial flap fixation procedures. The clinical use of this product is expected to enhance bone healing, reduce infection rates, and improve the cosmetic outcome of these procedures for patients while eliminating the need for metal fixation hardware.
Brain surgery often involves performing a craniotomy, a procedure by which a portion of the skull is temporarily removed using bone cutting instruments. A specialized drill cuts the skull allowing the surgeon to circumscribe a “flap” of bone enabling access to the brain. The process produces a kerf line, or continuous gap between the bone flap and the rest of the skull. As part of the surgical closure process, the flap is secured into place with cranial plates and screws. The kerf line is not typically sealed, which may compromise the ability of the flap to integrate with the surrounding bone. An open kerf line can also leave a pathway for the leakage of cerebrospinal fluid (“CSF”), which increases the overall risk of infection.
“Infection rates in published literature range up to 21%, which can result in meningitis, subdural empyema, or cerebral abscesses,” said Brian Hess, CEO of LaunchPad Medical. “CSF leaks increase the risk of infection by as much as 13 times and have been reported to almost double the healthcare cost of the original procedure.”
In a prior large animal study consisting of 41 skeletally mature sheep, biomechanical testing was performed to show both the immediate and sustained adhesive strength of Tetranite. Histological and histomorphometric analysis was also conducted to evidence the osteointegration of the cranial flaps over a two-year period. The results of this study were recently published in the Journal of Neurosurgery. Dr. Kevin T. Foley, the lead author of this publication and Professor of Neurosurgery at the University of Tennessee Health Science Center as well as Chairman of the Semmes-Murphey Clinic, said “This research demonstrates the ability of Tetranite to safely and effectively repair cranial defects without the use of conventional hardware. In fact, the study showed that Tetranite produces a better, stronger bond between a bone flap and the surrounding skull than do plates and screws, with fewer complications.”
“Having worked with this material as part of LaunchPad Medical’s pre-clinical research team, I foresee the use of Tetranite in many surgical applications such as cranial bone flap fixation,” said Eric J. Woodard, Chief of Neurosurgery at the New England Baptist Hospital.