Periodic Reporting for period 1 - ZygoFix (True Minimally Invasive Spinal Fusion System) Reporting period: 2019-02-01 to 2019-05-31 Summary of the context and overall objectives of the project The lumbar spine is the site of many back injuries and conditions, ranging from disc problems to degeneration and spinal arthritis. Current procedures for disorders of the lumbar spine are based on pedicle screw constructs, a costly and highly invasive solution leading frequently to complications and re-operations. Zygofix has developed the zLOCK system, a miniature implant that achieves spinal fusion without screws, in a safer, less invasive and more cost-effective solution. With the market seeking to reduce open spinal fusion procedures, our objective is to improve global healthcare and patient quality of life by providing an innovative solution for minimally invasive posterior stabilization and becoming a leading manufacturer of implanted instrumentation for spinal fusion procedures. The system, covered by one patent granted and two PCT applications, has been successfully validated in pre-clinical studies and a First in Man clinical study. This feasibility study was performed to assess the technical, commercial and financial elements required for a successful commercialization of zLOCK. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far During the Feasibility Study we defined all steps to optimize the zLOCK system, identified manufacturers and designed and established the production and assembly line. We have also defined the clinical trial to be performed for the validation of our product and get the CE mark, needed to reach the market. The second part of the feasibility report present the results of a detailed market study, confirming the adequacy of the commercialization strategy previously defined. Work in this phase included refining our business model and identifying competitors, market barriers and regulations needed for commercialization. Additionally, we present an update of the FTO and IP strategy implemented to protect our innovation. We also performed a detailed forecast for zLOCK to demonstrate the economic viability of the project. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) The zLOCK’s unique construct adjusts its shape during implantation to accommodate the challenging facet anatomy and maintains its strength to resist the joint’s applied load and shear forces. zLOCK utilizes the natural anatomy of the spine, allowing for shorter and less invasive surgery without using pedicle screws and rods. Moreover, zLOCK will have a major social impact by helping increase efficacy in spinal fusion procedures, reducing the associated clinical risks, which will have a positive impact for global healthcare. zLOCK miniature facet implant
