Ofer Levy Presents ZygoFix at LSI USA ‘23

Transcription

Ofer Levy  0:05  

Spinal fusion needs to be rethought. Why have we been spending decades building artificial bridges when our anatomy holds the key to spinal stability? So good afternoon, I'm Ofer Levy. I'm the CEO of ZygoFix, and I will share with you not only how we rethought spinal stability, but actually reinvented it, leveraging the ingenuity of our spines anatomy. But first, I will start with the people. Because as we all know, the true key to success of any startup lies in its team. For medical device startup. It is focused on these three core pillars. It is medicine, engineering, and business. Precisely the identity of Zygo fixes leadership topped with a proven track record. My partner's, Professor Yizhar Floman, former president of the Israeli Orthopedic Association, Uri Arnin, who holds dozens of patents in spine specifically, and our investor trendlines have successfully commercialized orthopedic system, and recently sold off the company Abby fix us based or pediatrics. Our chairman, Nick Pachuda. SVP of external innovations from j&j brings a tremendous track record, as he led m&a processes from all sides as a surgeon and an entrepreneur, as a VC and as a strategic. I have been bringing disruptive medical devices most of my life as an engineer, project manager and the consultant. And today this team is bringing the next generation of spinal fusion. So spinal fusion is a surgical procedure performed for addressing spinal instability in degenerative conditions. There are over a million such procedures performed annually, so it's a fairly common procedure. Today, the standard way of providing stability for fusion is by placement of a pedicle screw construct. This involves placing four screws to into each of the vertebrae, then connecting them by a rigid rod, creating a sort of an artificial bridge in the segment. This method has been used for the last 30 years. Although advancements have been made in pedicle screw systems, it is still invasive, complex to place and can result in severe complications when the screws are misplaced. Now, spinal fusion, unlike hip replacement, and other orthopedic procedures that have become routine tends to be avoided as much as possible. This also has to do with the amount of revision surgeries and new pathologies that can develop around the surgical site such as screw misplacement. So let me ask you, if you're a candidate for spinal fusion, which would you prefer placed in your back this implant or this one?

Zygo fix leverages our spines Natural Bridge instead of creating an artificial screw based one. By locking these posterior joints called the facet joints. You can see here in the animation, we're providing the required stability for fusion in a much simpler and less invasive way. Of course, these joints are not straight, and their articulation changes greatly from one case to another. What you see on the screen, by the way, is a CT slide from a specific patient and the red dotted line represents his specific geometry of his percent joint. So as you understand a rigid implant is not suitable. Like a fixed delivers a unique solution. Our implant is both rigid and bendable. implant is designed as a matrix of columns with bendable connecting elements. When a straight implant is introduced into the joint, it simply follows its path bending as it is advanced, providing a customized result, a set of kills or fence on both sides of the implant, anchor into the joint bones and provide the required stability. As miniature as it may seem Zero fields a huge unmet gap. We're looking into the continuum of care of chronic back pain. Conventional non invasive therapy is available for mild pain only. The big procedure with the screws and rods is a last resort. It is obvious that there is a treatment gap, which is also an opportunity to provide a simpler, less invasive, minimally invasive solution for spinal fusion. This is where the lock fits in the continuum of care. Of course, value should be measured at 360 degrees. Zero brings value to the entire spine care ecosystem for the surgeons being able to bridge the gap from non fusion to fusion surgery with a small addition. Also being able to build and code for fusion in outpatient and ASC clinics is valuable for the strategics. Zero opens a new niche for those patients who are not screw candidates also in outpatient and ASC for the payers, reducing the costs of OR and hospitalization time. And most importantly, the patient enjoying a less invasive, less traumatic procedure with long lasting outcomes. And by the way, our implant is completely 3D printed, which enables us to maintain very low and competitive production costs. Our system is CE certified and has been in clinical use for five years showing long term pain reduction. Today we're running a multicenter clinical study centered in Germany and in Italy that will serve our regulatory marketing and reimbursement purposes. We're currently focused on developing Z lock for lumbar spine stabilization and fusion. But Z lock is a platform technology that can be used for other joint fusion applications. Looking in spine Zero can be used in cervical and in SI or sacrum ilium joint fusion applications. We plan to pursue these applications following the FDA clearance of our lumbar system estimated at q2 of 2024. Zygo fix was awarded the prestigious European grant EIC for its innovative technology and potential to disrupt the global spinal fusion market. Under this grant, we were awarded 2.2 million euros for driving the system into the market and an additional 3.2 million euros allocated for equity investment. Further to the grant we're looking to raise $6 million to support our clinical growth, FDA clearance and initial commercial use. We're actually at the end of two weeks road trip here in the US conducting several labs in preparation for FDA submission. Amongst other we had a first cadaver lab with leading us surgeons here. These are nationwide known surgeons all were excited to see the system and are waiting to see it in the market. And amongst other one of the feedback that I've received from one of the surgeons was that the system was that the procedure was easier than than the way that he that I have described it to him. So maybe I should improve my description. But this was a great compliment to receive. So we're looking for new partners to join us in taking the spinal fusion to the 21st century. And I would love to speak to you about it in more details. Thank you very much.