Periodic Reporting for period 2 - zLOCK (The first true minimally-invasive Spinal Fusion System)
Période du rapport: 2023-04-01 au 2025-03-31
Spinal fusion is a surgical procedure performed for addressing spinal instability in degenerative conditions. Pathologies such as, ruptured disc, a slipped vertebra, or spondylolisthesis, can lead to such instability. There are over a million such procedures performed annually, a fairly common procedure.
Today, the standard way of stabilizing a spinal segment for its fusion is by placement of a pedicle screw construct. This involves placing 4 screws, 2 into each of the vertebra, then connecting them by a rigid rod, creating a sort of an artificial bridge in the segment.
This method has been used for the last 30 years. Although advances were made in pedicle screw systems, it is still invasive, complex to place and can cause severe complications when the screws are misplaced.
Placement of these artificial bridges apply various forces on the vertebrae and surrounding tissues that may result in adverse events and even require a painful revision surgery. These procedures cause patients a huge distress, and tremendous economic cost to the healthcare systems.
ZygoFix's zLOCK eliminate the need for screws and rods by utilizing the spine's natural bridge. The zLOCK implant is inserted to the posterior joint of the spinal segment (called the Facet joint) and locks it's motion from within. Its unique characteristics enable it to conform to the specific joint anatomy during insertion, provide a solution aligned with our anatomy, and a simple insertion procedure.
With the EIC Accelerator project, ZygoFix aims to complete the necessary upgrades and validation activities to accelerate the time-to market of zLOCK. zLOCK will be the first spinal fusion implant technology, capable of insertion and internal fixation of the facet joint, thereby simplifying and reducing the risks of pedicle screw spinal fusion.
Today, the standard way of stabilizing a spinal segment for its fusion is by placement of a pedicle screw construct. This involves placing 4 screws, 2 into each of the vertebra, then connecting them by a rigid rod, creating a sort of an artificial bridge in the segment.
This method has been used for the last 30 years. Although advances were made in pedicle screw systems, it is still invasive, complex to place and can cause severe complications when the screws are misplaced.
Placement of these artificial bridges apply various forces on the vertebrae and surrounding tissues that may result in adverse events and even require a painful revision surgery. These procedures cause patients a huge distress, and tremendous economic cost to the healthcare systems.
ZygoFix's zLOCK eliminate the need for screws and rods by utilizing the spine's natural bridge. The zLOCK implant is inserted to the posterior joint of the spinal segment (called the Facet joint) and locks it's motion from within. Its unique characteristics enable it to conform to the specific joint anatomy during insertion, provide a solution aligned with our anatomy, and a simple insertion procedure.
With the EIC Accelerator project, ZygoFix aims to complete the necessary upgrades and validation activities to accelerate the time-to market of zLOCK. zLOCK will be the first spinal fusion implant technology, capable of insertion and internal fixation of the facet joint, thereby simplifying and reducing the risks of pedicle screw spinal fusion.
During the reporting periods, Zygofix conducted a pivotal clinical trial in Palermo, Italy and Gustrow, Germany. Zygofix attended all procedures done in this study, carefully observing each case and gathering surgeon feedback to identify opportunities for optimizing the zLOCK system and surgical technique. From the observations and feedback, ZygoFix has designed additional instruments to include in the instrument set, simplifying the procedure. These instruments have been validated in pre-clinical studies and are now used in clinical cases. Additionally, Zygofix adapted existing instruments to enhance their functionality. These ongoing improvements help ensure that the zLOCK system and surgical technique allow for seamless procedural experience for surgeons.
During the first reporting period ZygoFix carried out 16 in-human trials in Germany and Italy. Based on the results achieved, zLOCK has huge potential to significantly reduce the expenses generated by spine surgeries thus creating a more sustainable health system.
In January 2024, Zygofix submitted the zLOCK in tandem with a facet screw, achieveing 510k clearance in April 2024. A subsequent special 510(k) clearance for a shorter version of the screw was granted in September 2024. This regulatory milestone represents a crucial step toward commercialization and has facilitated the completion of multiple in-human cases in the United States.
In January 2024, Zygofix submitted the zLOCK in tandem with a facet screw, achieveing 510k clearance in April 2024. A subsequent special 510(k) clearance for a shorter version of the screw was granted in September 2024. This regulatory milestone represents a crucial step toward commercialization and has facilitated the completion of multiple in-human cases in the United States.