ZygoFix Announces FDA Clearance of zLock Lumbar Fixation System and Files for IPO

May 07, 2024 18:29 CST Updated 18:29

ZygoFix

Orthopedic Implant Manufacturer

Source: Bone Future; Editor: Sophia

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On May 6, 2024, ZygoFix Ltd., an Israeli medical device companyZygoFixAnnounced that itszLock Lumbar Fixation SystemAlready received FDA approval. The company stated that the FDA approval was supported by evidence from ongoing European clinical trials, marking a significant advancement in spinal fusion technology.

# Development Background

Spinal fusion is a common surgical procedure in spinal surgery.Generally applicable to spinal deformities, spinal weakness or instability, and herniated discs.

Successful fusion requires a large number of viable osteoblasts, sufficient osteoinductive growth factors, an osteoconductive matrix for bone growth, blood vessels, a mechanically stable environment, and an appropriate inflammatory response.

Standard fusion surgery typically involvesPlace pedicle screws and short rods in the treatment segment to maintain spinal stability.。

ThesePedicle ScrewThe purpose isForm a solid bridge between adjacent vertebrae, as a stable form. Placing the pedicle screw structure requires at least4-6 bilateral incisions, and may lead to related complications due to incorrect positioning.

AndLumbar Fusion SurgeryIt is a surgical procedure that focuses on the diseased vertebra, performing bone grafting from the upper to lower normal vertebrae, allowing the diseased vertebra to form a bony fusion with surrounding segments to become a mechanical whole. This technique is an essential spinal surgery method, often performed alongside nerve decompression.

ZygoFix evaluated the current technology for rethinking spinal stability and designedzLOCKA series of products embedded with the required "flexion capability" to penetrate any joint, adhere to its geometry, and provide natural stability.

# zLock System

zLock Lumbar FixationSystem:Due to joint degeneration, the shape of the lumbar facet joints varies significantly.zLock System UtilizationThe congenital skeletal structure of the spineSecurely lock the connecting joint. According to ZygoFix Ltd., the company's implant willAdapt to the anatomical structure of the joint。

Compared with traditional technologies, zLockWith the following advantages:

Made of rigid titanium, it can be used during the implantation process.Adjust its shape, adapting to the anatomical structure of synovial joints and maintaining its strength to resist the loads applied by the joint;
No need to insert pedicle screws,Surgeons can leverage the natural structure of the vertebrae to provide spinal stability.；
Reduce program complexity and simplify the surgery;
Fewer Incisions and Less Trauma——Only 2 incisions are needed, while traditional surgery requires 4-6 incisions;
The implant does not protrude from the joint, eliminating or reducing tissue agitation;
Adapting to the patient's natural anatomical structure;Minimally invasive and suitable for outpatient settings.

With the excellent interim clinical results from ZygoFix's ongoing multi-site clinical study, zLOCK lumbar fixation offers a new minimally invasive stabilization option.

Nicholas Pachuda, Chairman of the Board of ZygoFix, said:

"Receiving 510(k) clearance demonstrates ZygoFix's commitment to innovation and addressing unmet needs of patients suffering from degenerative spinal conditions. We look forward eagerly to bringing our minimally invasive, life-changing solutions to patients in the United States."

In addition to the zLock lumbar fixation system, ZygoFix has also developedzLockSacrumHip Stability System, zLock Cervical Stability System。

The zLOCK system has been clinically applied for lumbar facet joint fusion since April 2018. Mid-term results show a significant and sustained reduction in back and leg pain.

About ZygoFix Ltd.

ZygoFixFounded in 2017, ZygoFix is an innovative spinal technology company. ZygoFix aims to improve the clinical outcomes of spinal fusion in the most minimally invasive manner by providing solutions that conform to natural anatomy.

ProductzLOCKBased on a miniature implant, spinal fusion and spinal stability can be achieved without screws. Moreover, the unique structure made of rigid titanium can adjust its shape during implantation to accommodate the challenging anatomy of synovial joints while maintaining its strength to resist applied joint loads.

The main figures currently leading the team include:

CEO，Ofer Levy，With 15 years of experience as an engineer, product manager, and consultant in the medical device industry; possessing in-depth knowledge of medical device development and lifecycle;

Co-founder and Chief Technology Officer, Uri Arnin, a senior expert in the spinal implant industry with 30 years of experience in the medical device sector; holds 29 authorized patents and has 43 patents pending; former Chief Technology Officer of Implant (the world's first facet joint replacement device); Chief Technology Officer of Spine 21 (the world's first remotely controlled spinal implant); Founder and Chief Technology Officer of ApiFix (acquired by Orthopediatrics in April 2020).

Co-founder, Medical Director, Professor Yizhar Floman, Chairman of the Israeli Orthopaedic Association, member of the International Society for the Study of the Lumbar Spine, European Spine Society, and North American Spine Society; Chairman and Director of the Israel Spine Center; former Director of the Spine Surgery Department at Hadassah Hebrew University Medical Center in Jerusalem.

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