Validation of a novel, small molecule-based osteoinductive lumbar fusion implant - Project Summary
Over 450,000 lumbar spine fusions are performed each year in the US, which result from a number of
spinal pathologies that include degenerative lumbar slips, lumbar stenosis, degenerative scoliosis and
fractures. In the US, an aging population, high smoking rates, increasing obesity, and longer life expectancy
together will increase the number of lumbar spinal fusion procedures by 100% over the next decade.
Successful lumbar fusion has been associated with improved outcomes in patient qualify of life.
Conversely, diminished healing results in increased morbidity and decreased quality of life for the patient.
Moreover, the burden to the healthcare system for a failed lumbar spine fusion procedure increases the overall
cost substantially. Specifically, an extra $80,000 is spent per patient for a lumbar non-union surgery resulting in
over $7 billion per year spent on treating these patients.
Treatment options that promote fusions are limited, with only a few treatment modalities available to
clinicians. In addition, newer treatment modalities based on biologic growth factors have had a number of
significant drawbacks including increased cancer risk and a 44% surgical revision rate.
In response to this unmet need, Fusologics, LLC, a regenerative medicine company based in Syracuse,
New York, is commercializing ZetaFuse™, a novel surgical implant with proven ability to promote bone
growth by activating a novel molecular pathway in mesenchymal stem cells. Based on the discovery of a
novel mechanism of action to induce bone growth, ZetaFuse drives osteogenesis via the local administration of
an implant that contains a small molecule drug combined with a collagen and calcium ceramic composite
carrier. In addition, ZetaFuse™ leverages components with well-established clinical safety profiles. If validated,
ZetaFuse™ would 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 population.
In this Phase I proposal, we will build on the successful results of our rabbit posterolateral fusion study,
which demonstrated proof-of-concept with a research prototype of ZetaFuse, to generate and validate a
commercial-grade prototype of ZetaFuse as a viable local bone growth therapy for patients requiring lumbar
spine fusion procedures. This proposal consists of two AIMs: 1) optimization of the ZetaFuse osteogenic
carrier, and 2) validation of the ZetaFuse implant in relevant in vivo studies. If successful, this 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.
