MISGAV, Israel, May 6, 2024 /PRNewswire/ -- ZygoFix Ltd. a portfolio company of The Trendlines Group Ltd. ('Trendlines') announced that it received regulatory clearance from the United States Food and Drug Administration (FDA clearance) for its zLOCK Lumbar Facet Fixation System. This achievement was supported by compelling clinical evidence from the company's ongoing European clinical study, marking a significant advancement in spinal fusion technology..

以色列米斯加夫，2024年5月6日/PRNewswire/-ZygoFix Ltd。趋势线集团有限公司（“趋势线”）的一家投资组合公司宣布，其zLOCK腰椎小关节固定系统已获得美国食品和药物管理局（FDA）的监管许可。这一成就得到了该公司正在进行的欧洲临床研究的有力临床证据的支持，标志着脊柱融合技术取得了重大进步。。

Spinal fusion, a common surgical procedure performed for degenerative spinal conditions such as Spondylolisthesis, Spinal Stenosis, and degenerative disc disease, traditionally requires placement of 4 screws and 2 rods, creating an artificial bridge, to stabilize the segment. The conventional invasive approach requires precise placement and building of bridges intraoperatively.

脊柱融合术是一种针对退行性脊柱疾病（如腰椎滑脱，椎管狭窄和退行性椎间盘疾病）进行的常见外科手术，传统上需要放置4个螺钉和2个杆，形成一个人工桥，以稳定该节段。传统的侵入性方法需要在术中精确放置和建造桥梁。

ZygoFix's revolutionary zLOCK system harnesses the spine's innate bone structure to securely lock its connecting joints. Unlike traditional methods, the company's innovative implant adapts to the joint's anatomy during insertion, offering unparalleled stability with a minimally invasive, simple procedure that can be performed in outpatient and ASC environments..

ZygoFix革命性的zLOCK系统利用脊柱固有的骨骼结构来安全锁定其连接关节。与传统方法不同，该公司的创新植入物在插入过程中适应关节的解剖结构，具有无与伦比的稳定性，可以在门诊和ASC环境中进行微创，简单的手术。。

With CE certification and six years of clinical utilization yielding long-term pain reduction and bone growth, ZygoFix's zLOCK Lumbar Facet Fixation System is positioned to revolutionize spinal fusion surgery.

凭借CE认证和六年的临床应用，可长期减轻疼痛和骨骼生长，ZygoFix的zLOCK腰椎小关节固定系统将彻底改变脊柱融合手术。

ZygoFix CEO Ofer Levy remarked, 'Receiving 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.'.

ZygoFix首席执行官奥弗·利维（Ofer Levy）表示：“获得FDA批准的zLOCK腰椎稳定系统是一个令人兴奋的里程碑，我为努力实现这一目标的团队感到骄傲。该系统引起了美国市场的极大兴趣，这一许可为我们将变革性解决方案引入美国市场铺平了道路，促进了与领先外科医生的合作，并加强了患者护理。”。

Dr. Nicholas Pachuda, ZygoFix Chair, added: 'Obtaining 510(k) clearance is a testament to ZygoFix's commitment to innovation and addressing the unmet needs of patients suffering from degenerative spinal conditions. We eagerly anticipate offering patients our minimally invasive, life-changing solution in the United States.'.

ZygoFix主席Nicholas Pachuda博士补充道：“获得510（k）许可证证明了ZygoFix致力于创新，并解决了脊柱退行性疾病患者未满足的需求。我们热切期待在美国为患者提供微创、改变生活的解决方案。”。

Dr. Isador Lieberman, Orthopedic & Spine Surgeon at Texas Back Institute, commented: 'The simplicity and minimally invasive nature of the zLOCK system provides a new tool in the surgeon's offering. For the right patients, zLOCK can provide a great alternative to pedicle screws.'

德克萨斯州背部研究所整形外科和脊柱外科医生伊萨多·利伯曼博士评论道：“zLOCK系统的简单性和微创性为外科医生提供了一种新的工具。对于正确的患者，zLOCK可以为椎弓根螺钉提供一个很好的替代品。”

About ZygoFix

关于ZygoFix

ZygoFix Ltd. is a spine device company, a portfolio company of the Trendlines Group (SGX: 42T) (OTCQX: TRNLY), and has been supported by the Israel Innovation Authority and the European EIC program, alongside The Trendlnes Group and investors worldwide. The Company's inventions enable internal joint stabilization while conforming to the joint's anatomy..

ZygoFix Ltd.是一家脊柱设备公司，是Trendlines Group（SGX:42T）（OTCQX:TRNLY）的投资组合公司，得到了以色列创新局和欧洲EIC计划以及Trendlnes Group和全球投资者的支持。该公司的发明使内部关节稳定，同时符合关节的解剖结构。。

Contact Information

联系方式

Ofer Levy, CEO ZygoFix

Ofer Levy，ZygoFix首席执行官

ofer@zygofix.com

ofer@zygofix.com

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SOURCE ZygoFix

ZygoFix来源

Company Codes: OtherOTC:TRNGF, OtherOTC:TRNLY, Singapore:42T, OTC-PINK:TRNLY

公司代码：OTHERTC:TRNGF，OTHERTC:TRLY，新加坡：42T，OTC-PINK:TRLY