ZygoFix Receives CE Clearance for its zLOCK Spinal Fusion System

Rhea-AI Summary

ZygoFix has received the CE mark for its innovative zLOCK Spinal Fusion System designed for chronic back pain treatment. This minimally invasive system utilizes a screwless design, enhancing safety and reducing surgical invasiveness with only two incisions needed compared to traditional methods. The zLOCK system has been in clinical use in Hungary and Israel for over three years, demonstrating high satisfaction among patients and physicians. ZygoFix also secured ISO13485 certification and plans to conduct a pivotal study in the EU to gather more clinical data.

Positive

• CE mark received for zLOCK Spinal Fusion System indicates regulatory approval for market entry.
• Minimally invasive approach reduces the number of incisions required, enhancing patient safety.
• High levels of patient and physician satisfaction reported from clinical use over three years.
• ISO13485 certification achieved, affirming quality management in medical devices.

Negative

• None.

MISGAV, Israel, June 28, 2021 /PRNewswire/ -- ZygoFix has obtained CE mark for its minimally invasive screwless spinal fusion system for the treatment of chronic back pain, the zLOCK Spinal Fusion System.

ZygoFix completed the certification process and received CE mark for its zLOCK Spinal Fusion System for lumbar spine after demonstrating its safety and efficacy in clinical studies. Together with this certification, ZygoFix also received ISO13485 certification.

The zLOCK system's miniature 3D-printed implant utilizes the spine's anatomy for spinal stability, rather than traditional external screw-based stabilization. Its unique features combine rigid and bendable elements that enable the implant to withstand loads applied through the spine, while conforming to each patient's anatomy during implantation. The procedure eliminates risks associated with improperly placed screws, is less invasive (2 versus 6 incisions), simple to use, and suitable for outpatient implantation.

The zLOCK system has been in clinical use for more than three years in Hungary and Israel with high levels of patient and physician satisfaction.

ZygoFix CEO Ofer Levy remarks: "Receiving CE Mark is a key event for the zLOCK system as a minimally invasive and safer solution for back pain sufferers. ZygoFix is opening a multi-center pivotal study in the EU to collect further clinical data."

About ZygoFix

Founded in 2017 by successful spine entrepreneurs, Prof. Yizhar Floman and Uri Arnin (co-founders of ApiFix, acquired in April 2020 by OrthoPediatrics), ZygoFix has developed the zLOCK system, a screwless, outpatient implantable spinal fusion system. The company is a portfolio company of The Trendlines Group (SGX: 42T) (OTCQX: TRNLY) and has received further funding from the Israel Innovation Authority, Agriline (a trust of which Vincent Tchenguiz is a discretionary beneficiary), and additional investors.    

Contact: Ofer Levy, CEO ZygoFix
Email: ofer@zygofix.com  
phone: +972522664981

View original content:https://www.prnewswire.com/news-releases/zygofix-receives-ce-clearance-for-its-zlock-spinal-fusion-system-301320845.html

SOURCE ZygoFix

FAQ

What is the zLOCK Spinal Fusion System by ZygoFix?

The zLOCK system is a minimally invasive screwless spinal fusion device designed for treating chronic back pain.

When did ZygoFix receive the CE mark for the zLOCK system?

ZygoFix received the CE mark for the zLOCK system on June 28, 2021.

What are the benefits of the zLOCK system over traditional spinal fusion methods?

The zLOCK system reduces surgical invasiveness, minimizes risks associated with screws, and requires fewer incisions.

How long has the zLOCK system been in clinical use?

The zLOCK system has been in clinical use for over three years in Hungary and Israel.

What are the next steps for ZygoFix following the CE mark approval?

ZygoFix plans to initiate a multi-center pivotal study in the EU to collect further clinical data.