ZygoFix

The problem

We all want to live life to the fullest. Chronic back pain is a leading limiting factor that may have substantial negative influence on our quality of life. For these people, spinal fusion surgery may be a life changer and is often recommended by their physician.

The purpose of the procedure is to relieve the pressure applied on the nerves and stabilize that area of the spine. The standard procedure today is to drill 4 long screws into the spine and connect them together using rigid rods to create an artificial bridge between vertebrae.

These screws (called pedicle screws) are invasive – requiring 6 incisions, complex to place and may result in injury when misplaced.

6% of patient with fusion surgeries undergo a revision surgery due to complications. 50% of these complications are associated with the implants used such as a misplaced screw. 

The market seeks a simpler and less invasive methods to stabilize the spine for fusion.

The solution

While surgeons are creating an artificial screw bridge, most of that bridge exists naturally in our spine's anatomy. Our vertebrae are connected by 2 small posterior joints (called facet joints). If we can lock these joints' motion, we essentially create the same bridge, just far less invasive and complex.
 Left - Illustration of the external bridge built with screws and rods; Right – the natural bridge and facet joints circled

Now the challenge. Facet joints, like other joints, are not straight. They include a curve, which is different in every instance. So a rigid implant cannot be suitable.

                                 Several examples of facet joint curves (in CT scans)

This challenge was the drive behinde ZygoFix's innovation. The zLOCK implant is the first implant to have the ability to shape itself automatically according to the joint's anatomy. The implant is designed as a combination of rigid and flexible elements, providing the ability to withstand the loads applied on the facet joint while also being capable to fit itself to the specific joint anatomy it is being inserted into. Keels located on both sides of the implant, anchor into the joint bones and immobilize it.

The zLOCK Implant

             Ability of implanted zLOCKs to take shape of facet different facet joins

The system includes a set of dedicated tools to perform the surgical procedure with a percutaneous approach (via a small incision in the skin). 

This patented technology can also be utilized in other joint fusion applications.

zLOCK's Advantages

zLOCK's design provides several advantages beneficial to all:

• It is less invasive – a pedicle screw construct requires 2-3 incisions per side when placed in minimally invasive setting. zLOCK requires only 1 incision per side.
• The procedure is quick and simple – eliminating the complexity and risks of screw placement and its connection. 
• As the implant customizes itself automatically, its placement is simple and straightforward.
• And, due to the fact that it is completely 3D printed, we maintain low and attractive COGS.

So it’s a smaller incision for the patient, a simpler and shorter procedure for the surgeon, and shorter usage of the OR (beneficial to hospitals, payers). Low COGS allows for higher margins and will also drive competitive pricing that benefits the customers.

IP Protection

ZygoFix's Intellectual Property is protected by 3 submitted patents. The first patent protects the implant design and is granted in the EU and under review in USA, Japan, China and Brazil. The other patents are in PCT stage and provide wider protection for similar designs and the used surgical tool.
Big Potential

An average pedicle screw construct (4 screws and 2 rods) used to stabilize one segment or a vertebral pair costs $3,500 in the US.

The zLOCK implant is inline with market trends to minimize invasiveness in spine and in general surgery. zLOCK allows to take spine surgery a step forward by minimizing it and providing an alternative to the screw bridge (pedicle screw construct).

Achievements and Recognition

Our zLOCK system is outstanding and different in the spine market. We have received several recognitions to support this:

    1. Spine Technology Awards – awarded in 2017 for best minimal invasive technology.

    2. Horizon 2020 seal of excellence – the prestigious European grant program has awarded ZygoFix with a seal of excellence for zLOCK along with winning PH-1 grant of €50,000.

    3. Market traction – 50+ inquiries from surgeons and distributors interested in use/ distribution from 18 different countries, 20+ from US.

An Experienced Team

Ofer Levy, CEO – 15+ years' experience in medical device industry; deep understanding of medical device development and lifecycle; Former Vice President of Qsite Regulatory and Quality; MBA Tel Aviv University, BSc mechanical engineering Ben-Gurion University.

Uri Arnin, Co-founder, CTO - Serial entrepreneur; 20+ years’ experience in medical device industry; 29 issued patents and 39+ pending (all in spine); formerly CTO Impliant (world’s first facet replacement device), founder and CTO ApiFix (MIS scoliosis correction system). 

Prof Yizhar Floman, Co-founder, Medical Director - Chairman and Director of the Israel Spine Center, Assuta Hospital, Tel Aviv; former Chief of Spine Surgery, Hadassah Hebrew University Medical Center, Jerusalem; President of the Israel Orthopedic Association.

Our board is led by the chairman and CEO of the Trendlines Group, Todd Dollinger, who has led several exits in medical device.

And our advisory board includes experienced surgeons and business executives that are well connected to the US market and guide us toward it.