Validation of a novel, small molecule-based osteoinductive lumbar fusion implant

Project SummaryOverlumbar spine fusions are performed each year in the USwhich result from a number of spinal pathologies that include degenerative lumbar slipslumbar stenosisdegenerative scoliosis and fracturesIn the USan aging populationhigh smoking ratesincreasing obesityand longer life expectancy together will increase the number of lumbar spinal fusion procedures byover the next decadeSuccessful lumbar fusion has been associated with improved outcomes in patient qualify of lifeConverselydiminished healing results in increased morbidity and decreased quality of life for the patientMoreoverthe burden to the healthcare system for a failed lumbar spine fusion procedure increases the overall cost substantiallySpecificallyan extra $is spent per patient for a lumbar non union surgery resulting in over $billion per year spent on treating these patientsTreatment options that promote fusions are limitedwith only a few treatment modalities available to cliniciansIn additionnewer treatment modalities based on biologic growth factors have had a number of significant drawbacks including increased cancer risk and asurgical revision rateIn response to this unmet needFusologicsLLCa regenerative medicine company based in SyracuseNew Yorkis commercializing ZetaFusea novel surgical implant with proven ability to promote bone growth by activating a novel molecular pathway in mesenchymal stem cellsBased on the discovery of a novel mechanism of action to induce bone growthZetaFuse drives osteogenesis via the local administration of an implant that contains a small molecule drug combined with a collagen and calcium ceramic composite carrierIn additionZetaFuseleverages components with well established clinical safety profilesIf validatedZetaFusewould empower clinicians with a with a safe and effective tool to promote bone formation and enable successful and cost effective lumbar fusion procedures absent the significant drawbacks of current therapies for a growing patient populationIn this Phase I proposalwe will build on the successful results of our rabbit posterolateral fusion studywhich demonstrated proof of concept with a research prototype of ZetaFuseto generate and validate a commercial grade prototype of ZetaFuse as a viable local bone growth therapy for patients requiring lumbar spine fusion proceduresThis proposal consists of two AIMsoptimization of the ZetaFuse osteogenic carrierandvalidation of the ZetaFuse implant in relevant in vivo studiesIf successfulthis proposal will demonstrate commercial proof of concept for the ZetaFuse implant and establish the foundation for a Phase II proposal to support remaining preclinical development in preparation for human trials Project Narrative Bone growth is critical to a favorable fusion rate and good prognosis in thepatients who undergo lumbar spine fusion procedures to treat degenerating discsspondylolisthesislumbar stenosis and scoliosisOver the next decadeas the aging US population growsthe number of lumbar spine fusion surgeries performed yearly is estimated to increase bywhich means that there is an urgent need for technology that can safely create new bone leading to a successful fusionThe current treatment options are limited and fraught with complications that result in poor patient outcomes and an increase healthcare expendituresIn response to this unmet needFusologicsLLCa New York based regenerative medicine companyis commercializing ZetaFusea novel surgical implant that has demonstrated the ability to promote bone growth by activating a novel molecular pathway using components with well established clinical safety profiles