RegulatorySpine

ZygoFix Receives CE Clearance for its zLOCK Spinal Fusion System

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

SOURCE ZygoFix

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Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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