Periodic Reporting for period 1 - zLOCK (The first true minimally-invasive Spinal Fusion System)
Período documentado: 2022-04-01 hasta 2023-03-31
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 costs to the healthcare system.
ZygoFix's zLOCK eliminates 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 its 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 costs to the healthcare system.
ZygoFix's zLOCK eliminates 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 its 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.
In order to reach the commercial stage, the zLOCK procedure must be made simple and reproducible. This is achieved by the continued collection of clinical feedback and improvement of the system accordingly.
During the first reporting period, ZygoFix continued to improve the zLOCK system. In order to accomplish this, ZygoFix has attended each clinical case, noting where the zLOCK system and surgical technique can be optimized based on observation of the case and feedback from the surgeons. Based on the feedback received in clinical cases, ZygoFix has designed additional instruments to include in the instrument set, which simplifies the procedure even further. These instruments have been validated in pre-clinical studies and are now used in clinical cases.
By continuing to improve the zLOCK system and surgical technique ZygoFix ensures that the procedure is as seamless as possible for surgeons to perform.
During the first reporting period, ZygoFix continued to improve the zLOCK system. In order to accomplish this, ZygoFix has attended each clinical case, noting where the zLOCK system and surgical technique can be optimized based on observation of the case and feedback from the surgeons. Based on the feedback received in clinical cases, ZygoFix has designed additional instruments to include in the instrument set, which simplifies the procedure even further. These instruments have been validated in pre-clinical studies and are now used in clinical cases.
By continuing to improve the zLOCK system and surgical technique ZygoFix ensures that the procedure is as seamless as possible for surgeons to perform.
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.