ZygoFix's zLOCK Lumbar Facet Fixation System Bags US FDA Approval

ZygoFix Ltd, a portfolio firm of The Trendlines Group Ltd (Trendlines), has acquired regulatory approval from the US Food and Drug Administration for their zLOCK Lumbar Facet Fixation System. This success was reinforced by strong clinical evidence from the company's ongoing European clinical investigation, which represents a substantial advancement in spinal fusion technology.

Spinal fusion, a popular surgical treatment used to treat degenerative spinal disorders such as spondylolisthesis, spinal stenosis, and degenerative disc disease, typically involves the implantation of four screws and two rods to construct an artificial bridge and stabilize the segment. The traditional invasive technique necessitates precise bridge placement and construction intraoperatively. ZygoFix's breakthrough zLOCK system uses the spine's natural bone structure to secure its connecting joints. Unlike traditional procedures, the company's unique implant conforms to the joint's structure during insertion, providing exceptional stability in a minimally invasive, easy operation that may be performed in an outpatient or ASC setting.

ZygoFix's zLOCK Lumbar Facet Fixation System is poised to transform spinal fusion surgery, having achieved CE certification and producing long-term pain relief and bone development after six years of clinical use.

ZygoFix CEO Ofer Levy, said: "Receiving US FDA clearance for our zLOCK Lumbar Stabilization System is an exciting milestone, and I am very proud of the team that has worked hard to achieve this goal. The system has garnered significant interest in the US market and this clearance paves the way for us to introduce our transformative solution to the US market, fostering collaboration with leading surgeons and enhancing patient care."