A Novel Bioresorbable Bone Adhesive Used to Fixate Cranial Flaps and Reduce Infection Rates

Project Abstract LaunchPad Medical (“LPM”) is a medical device company that was established to commercialize the novel Tetranite® (“TN”) wet-field bone adhesive product. TN is a synthetic, injectable, adhesive, cohesive, self-setting, and bioresorbable calcium-based biomaterial for cranial use. The current state of the art materials for cranial flap fixation are titanium screws and plates or clips; however, hardware fixation results in many complications that often necessitate reoperation. These complications include hardware loosening over time, skull disfiguration, cerebrospinal fluid (“CSF”) leaks, and infections. The instruments used to remove the bone flap and access the brain during craniotomy inevitably create a gap (“kerf”) between the bone flap and the surrounding cranial bone. Titanium fixation does not fill this gap. The result is an open channel for CSF leaks, treatment for which almost doubles the cost of the original operation. CSF leaks are also associated with an increased infection risk of 13x. TN can fill the kerf to provide a water-tight seal to block CSF leakage, create a better cosmetic contour, and fixate the bone flap, alleviating the need for metal in the cranium. There is currently no material in the medical device market that addresses all of this issues simultaneously. Results from a 2-year pivotal animal study have demonstrated TN’s effectiveness in fixating the flap and providing better bone healing than conventional hardware fixation. Consequently, the use of this innovative biomaterial has the potential to improve patient outcomes and reduce the overall cost of healthcare. The goal of the Direct-to-Phase II SBIR project is to develop a novel delivery kit for TN that will allow for its eventual introduction to the clinic as well as to demonstrate that CSF leak after craniotomy can be addressed by TN. Funding will be used to (1) design and develop production-ready prototypes of a cranial flap fixation kit that comprises a cranial flap positioning tool and a semi-automated mixing and delivery system, (2) validate with surgeons in a mock surgical cadaver trial the effective use of the cranial flap fixation kit, and (3) conduct an acute animal study using the delivery system to prove that TN provides a seal that prevents CSF leakage and withstands bacterial colonization in the relevant clinical time window. Building on successful animal studies already conducted, this Direct-to-Phase II project will enable a complete adhesive-based cranial flap solution to advance into human clinical trials via the submission of an IDE to FDA. Clinical study evidence will allow market entry of a single product for cranial flap fixation that has the potential to significantly reduce CSF leaks and infection rates for the 210,000 patients annually undergoing craniotomy. LaunchPad Medical Abstract 1 of 1Project Narrative Although bone flap replacement with titanium plates and screws is the current standard of care after craniotomy, the procedure is associated with high morbidity, often resulting in cerebrospinal fluid (“CSF”) leaks. These leaks frequently lead to devastating infections and result in huge costs to the healthcare system; the treatment required for CSF leak almost doubles the cost of the original craniotomy. To address these problems LaunchPad Medical has developed Tetranite®, an adhesive biomaterial that bonds bone to bone in a wet field and has the potential to simultaneously fixate the bone flap and provide a water-tight seal for CSF leaks; this will improve patient outcomes and reduce the overall cost of healthcare.