Ofer Levy, ZygoFix - Spinal Fusion Re-Imagined | LSI Europe '22

Transcription

Ofer Levy  0:08  

All right, good afternoon. It's a pleasure to be here to present our company's ZygoFix, and it's novel solution for spinal stability and fusion. My name is Ofer Levy, I'm the CEO of the company and I've been involved in disruptive medical devices for most of my life. My partners, Professor Phil Oman, where your name and our investor Trendlines have successfully commercialized orthopedic system, and have recently sold off their company AbyFix to US based ortho pediatric in a successful exit. So I'm going to be talking about back pain and spine surgery. So I do apologize if you're moving uncomfortably in your chair. Okay, let's begin. spinal fusion is a surgical procedure performed for 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 stabilizing a spinal segment for its fusion is by placement of a pedicle screw construct, you can see also on the screen. This involves placing four screws to into each of the vertebrae, then connecting them by rigid rods, creating 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 constructs, it is still invasive complex to place and can result in severe complications when the screws are misplaced. Now, spinal fusion, unlike hip replacement, or other orthopedic procedures that have become routine tends to be avoided as much as possible. Patients are admitted for spinal fusions, when all else has failed, it's a last resort. 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? ZygoFix utilizes our spines Natural Bridge, instead of creating an artificial one. By locking these posterior joints called the facet joints, 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 instance to another. So rigid implant is not suitable. ZygoFix delivers a unique solution. Our implant is both rigid and bendable. The 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 and creating a customized result. A set of kills or fence that you can see in the picture, anchor into the joint bones and provide the required stability. When 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, long lasting surgical solution. This is where zLock fits in the continuum of care. Of course value should be measured at 360 degrees. zLock brings value to the entire spine care ecosystem for the surgeon being able to bridge the gap from non fusion to fusion surgery with a small addition. also reducing the challenges of the big procedure. And being able to build and code for fusion brings value in outpatient and ASC clinics for the strategics Zielke opens a new niche for those patients who are not screw candidates also in outpatient and ASC clinics for the payers being able to reduce the cost of hospitalization and or time and most importantly, the patient enjoying a less invasive, less traumatic procedure with long lasting result. And by the way, our implant is completely 3d printed, which allows us to maintain very competitive production costs. Our system is CE certified and has been in clinical use for over four years under clinical studies and showing great outcomes. Today we're conducting a multicenter study centered in Germany, Italy and Israel that will serve our regulatory reimbursement and marketing purposes. The company is focused on Delivering zLock for a lumbar spine stabilization with an available market of $1.3 billion. But zLock is a platform technology that can be used in other joint fusion applications. In spine there are additional two applications, cervical and si or sacrum ilium. And we plan to pursue these applications following the FDA clearance of our system estimated in the first quarter of 2024. The Z Lock is led by a team of experts in medical device development and commercialization and spinal implants. Specifically, I've already introduced our co founders and our investor trend lines. Our chairman Nick Vishuddha. Ex-VP of external innovations from Johnson and Johnson brings tremendous value, as he led m&a processes from all side as a surgeon and an entrepreneur, as a strategic and as a VC. Camp company has recently won the European grant prestigious European grant EIC for its innovative technology and potential to disrupt the spinal fusion market. Under this grant, we were awarded 2.2 million euros for driving the system into the market with an additional 3.2 million euros allocated for equity investment. Further to the grant. We're looking to raise $4 million to drive the system into the market, widen our clinical use and obtain FDA clearance. We're looking for new partners to join us in taking spinal fusion to the 21st century. And I would love to talk to you more about it. Thank you very much