Neil Bodick, Gate Science - Neurostimulation & Nerve Blocking for Post Surgery Pain | LSI USA '24

Neil Bodick  0:04  
So I'm Neil Bostick, I'm the CEO of Gate Science. This is our first trip to LSI. And with me is our Chief Commercial Officer, Laura Wynn, who are we will stand so that they can recognize us. Okay. Very good. So gait is concerned with surgical pain. We're focused initially on orthopedic surgical pain, which is not a solved problem, in spite of very substantial investments. Chronic pain persists. And the opioid crisis, the opioid dependence, emergent from surgery is not going away. To this point, therapeutics have focused on what's post operative pain. As an acute event, we're taking a different tact, we're thinking that there is a cycle between chronic and acute pain that actually better describes the pathophysiology. This is the trajectory of pain after a major procedure. pain persists for 14 days, and chronic pain ensues. To this point, the existing therapies, mostly sustained release have effect for three to five days, leaving something which has been termed the therapeutic gap. The gap is a hazard as a cornerstone of therapy, opioids. We can think of two different mechanisms that are involved in this process of post surgical pain. There's the acute phase, and there's a chronic phase, there must be some transition between those two, because the pathophysiology of those two entities is different. We have adequate therapies for both acute and chronic nerve lock works extraordinarily well. And neurostimulation is very well proven in chronic procedures. Our construct our therapeutic construct is to combine these two modalities in a single device to close the therapeutic gap. Keep this image in mind. We believe that we are essentially creating a new therapeutic space, which is transitional pain, with Relay. This is a system that has two components. On the right is the baton, which has the ability to deliver both pharmacologic therapy and nerve stimulation. On the right is the device that controls nerve stimulation is controlled by the patient over time. Here's a bit of detail on the baton. You see there are electrodes and the port for delivery at the distal end and there's a pulse generator. And the device is wireless Bluetooth enabled to connect it to gatekeeper and waterproof for bathing. The system fits seamlessly into standard clinical routines. Prior to surgery. The baton is placed near a nerve Plexus or a nerve root and a pharmacologic nerve block is delivered following surgery neurostimulation is activated in the recovery room. After discharge for up to 28 days, the patient is controlling neurostimulation with the relay device. gatekeeper is the has interesting potential. This device is with the patient for the entire episode of pain and the patient is controlling the effects with a gatekeeper. But gatekeeper is keeping a record of both pain and motion. gatekeeper linked to the cloud and linked to other systems can create a patient profile which is as descriptive in detail of the entire episode, that patient profile can be combined with 1000s of others in the cloud, and serve as substrate for machine learning to actually manage pain, consider the following possibility. The patient has physical therapy at four o'clock at 11am. gatekeeper informs the patient that it might be a good idea to turn up the amplitude of the nerve stimulation, because pain is going to ensue. So, in terms of revenue projections, we won't go into deep detail here, but we have new rules for a new market. Pricing is an order of magnitude lower than other neurostimulation devices, which are typically 5000 $10,000, that sort of thing. That is a striking difference commercially. And Laura has worked extensively with applied policy at a group of CMS retirees to establish codes that are not depend upon neuromodulation which are notoriously difficult to instantiate. We have filed seven provisional patents and we have a freedom to operate of note. Our portfolio is has been developed by ivorie al Rifai. He's the head of IP at Cooley. Where are we? We're following the de novo pathway. Work we have established our IDE. We're in a pilot study right now. We'll have readouts from that shortly, which will guide the design of a pivotal study. And following FDA review, we expect to have approval in 2026. The team let's see I have founded two companies. One is now a division of Eli Lilly. The other went public and was subsequently acquired. Laura has developed the strategy for launch for nine different orthopedic products. Okay. Our it effort is being led by Ira Kirschenbaum. Ira was actually one of the founders of Medscape, which became Web MD. And he's also the editor of a very interesting new journal called Jelly. And he's the chair of orthopedics at Bronx care, and brings extraordinary perspective to our development process. Sanjay Sinha grew up on a tea farm in India and became one of the world's leading regional anesthesiologist. He's a very inventive guy. And he's responsible for the therapeutic construct, behind relay. To this point, we've raised $12 million most, mostly from clinicians. And we are looking to raise a modest series A of $10 million to get us through FDA approval, and some other studies supporting commercialization. We go back to this image. This is powerful if in fact we do create a new market. How could that happen? We have clinicians treating chronic pain, pain, clinicians treating acute pain and the space in between. We're going to migrate those clinicians into transitional pain. Thank you