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The Least Invasive Spinal Fusion

The zLOCK System

The zLOCK system is a miniature implant that achieves spinal fusion and spinal stability without screws. The zLOCK implant is inserted inside the facet joint and anchors into both superior and inferior bones to immobilize motion.

Facet fusion has been utilized in the past for indications such as spinal stenosis and facet arthritis. Its success rate has been reviewed in the literature and demonstrated a high rate in obtaining fusion six months post-op[1].

The zLOCK’s unique construct, made from rigid titanium, adjusts its shape during implantation to accommodate the challenging facet anatomy and maintains its strength to resist the joint’s applied load and shear forces.

With zLOCK, the surgeon utilizes the natural construction of the vertebrae to provide spinal stability, and thereby eliminates the need to insert pedicle screws.

This radical design is enabled due to emerging 3D printing technology.

Due to its unique design and placement, zLOCK provides numerous advantages:

The zLOCK miniature facet implant

Simpler procedure - No screws reduces procedural complexity
Less traumatic procedure - only 2 incisions (one on each side of the spine)
Efficient bone growth and fusion (implant has porous texture)
Flexible design fits most any anatomy
Suitable for outpatient setting - Percutaneous, minimally invasive approach

No screws required. The procedure requires only one percutaneous incision per side.

X-ray taken following a dynamic cadaver study. zLOCK’s features are clearly seen as both implants take its specific joint shape

Orthopedics This Week's Spine Technology Awards has selected zLOCK one of the best new spine technologies for 2017

[1] S. Rajasekaran, at el.; Translaminar Facetal screw (Magerl’s) fixation; Neurology India 2005 (Vol 53) 523

Indications for Use

The zLOCK system is indicated for the treatment of the following:

When used in adjunct to an intervertebral front cage:

Degenerative spondylolisthesis up to grade 2
Mild to moderate degenerative disc disease (DDD)
Degeneration of the facets

When used stand-alone:
1. Degenerative Spondylolisthesis grade 1
2. Moderate to severe Stenosis
3. Degeneration of the facets

zLOCK achieves facet fusion minimizing the invasiveness and challenges associated with pedicle screws

zLOCK can complement anterior cages as a minimally invasive solution for posterior stabilization in such procedures, or it can be placed stand-alone for facet fusion for the above mentioned indications.

zLOCK implant with some flexion

Background

Disorders of the lumbar spine (lower back) such as degenerative disc disease, spondylolisthesis (slipped vertebra), and narrowing of the spinal canal (stenosis) may result in severe back and leg pain.

Depending on the severity, lumbar spinal fusion surgery may be recommended. This procedure typically involves (1) placing an anterior “cage” in the disc space and (2) providing additional posterior support using pedicle screws and a short rod to stabilize the spinal motion in the treated segment to improve the chances of achieving solid bony fusion.

The purpose of pedicle screws is to form a solid bridge between adjacent vertebrae as a form of stabilization. Placing pedicle screw constructs require at least four bilateral incisions. They may have associated complications due to incorrect positioning. Although the pedicle screw construct is a 70-year-old technology, it still leads the posterior fusion instrumentation market.

ZygoFix leverages the natural vertebral bridge anatomy. Fusing the facet joint produces a natural bridge. The procedure is significantly faster, simpler and less invasive compared to current pedicle screw fixation.

Market

Fusion is the 5th most frequent procedure in the OR[2], with ~400,000 annual zLOCK applicable procedures worldwide, the potential market exceeds $1 billion.

With the market seeking to reduce open spinal fusion procedures, ZygoFix’s zLOCK system provides an innovative solution for minimally invasive posterior stabilization.

[2] HCUP Statistical Brief #186

Clinical Study Feedback

“Patient doing extremely well and reports no pain! I can hardly believe it... I could discharge the patient even today!
Practically no blood loss.”

Study principal investigator (1 day after FIM surgery)

News

ZygoFix featured in the news:

"Q&A with ZygoFix" Read the article>

"Israeli Med-Tech Startup Aims to End Chronic Back Pain" Read the article>

FIRST-IN-HUMAN: ZYGOFIX’S SPINAL FACET JOINT FIXATION SYSTEM

"10 Best New Spine Technologies for 2017" Read the article>

About

ZygoFix is a part of The Trendlines Group.

Team

Ofer Levy, CEO

15 years experience in the medical device industry as an engineer, product manager, and consultant; deep understanding of medical device development and lifecycle; MBA, Tel Aviv University, B.Sc., mechanical engineering, Ben-Gurion University of the Negev.

Uri Arnin, Co-founder, CTO

Serial entrepreneur in the field of spinal implants; 30 years’ experience in medical device industry; 29 issued patents and 43 pending (all in spine); former CTO, Impliant (world’s first facet replacement device); CTO, Spine 21 (world’s first remote-controlled spinal implant); founder and CTO, ApiFix.

Prof. Yizhar Floman, Co-founder, Medical Director

Chairman and Director, Israel Spine Center, Assuta Hospital, Tel Aviv; former Chief of Spine Surgery, Hadassah Hebrew University Medical Center, Jerusalem; President, Israel Orthopedic Association; member of numerous organizations, including Scoliosis Research Society, International Society for the Study of the Lumbar Spine, Spine Society of Europe, and the North American Spine Society.

Board of Directors

Todd Dollinger

Todd Dollinger brings decades of medical entrepreneurial experience to ZygoFix. Since 1991, Todd has been intricately involved with medical device start-ups bringing them form ideation to commercialization, IPOs and exits.

Todd is the Chairman and CEO of the Trendlines Group.

Barak Singer

Barak Singer has over 15 years of experience in management, business development, investment banking, and venture capital.

Among others, Barak served as VP Business Development at Can-Fite BioPharma (NYSE: CANF) and CEO of its subsidiary Ophthalix, VP Business Development at Xenia Venture Capital, and was a Co-Founder and CEO at Or Capital Healthcare Partners.

Advisory Board

Jon Luedke

Over 20 years experience in the US medical device industry. Successful commercialization and revenue generation at Zimmer Spine, Centinel Spine, Wenzel Spine and most recently Prosidyan which exclusive rights were acquired by DePuy Synthes in June, 2018. Mr. Luedke is currently, President & CEO of Spineway USA, Inc., a French based publicly traded company that treats severe spinal column pathologies.