Jagi Gill Presents Pontix Medical at LSI USA '23

Transcription

Jagi Gill  0:06  

What if I told you that headaches are the second leading cause of disability in the country? And worldwide? What if I told you migraines are one of the major contributors to the headache and there's approximately 60 million people that are impacted with migraines in the US. A quarter of all those people don't respond to medical treatment. So there's the opportunity. And the opportunity is how do we design a system that targets the nerves that are involved in the pain management pathways associated with those people that suffer from migraine. And that's what we focus for the last year and a half on at pontics is developing a system that's got two handmaidens to it. The first is the implant. You probably can't see that in the back, but this is our implant. It's a micro stimulator that's got electrodes on one side, and circuitry under the side and this is inserted under the skin for targeted nerve stimulation. The other component is that we've uncoupled the energy source and that was our breakthrough. Most of the neuro stimulation that you see in the market today has an implanted battery or pulse generator to drive the stimulation. We thought that was horrible. So we've uncoupled that and our form factor is a necklace. The necklace has a pendant which has the battery that drives the energy and the necklace delivers a wireless recharging capability. We think that this first unchain technology provides a new way of thinking of neuro stimulation. You don't have to have this barbaric surgery where you have to put in a battery and a neuro stimulation electrode. This allows you to the mobility allows you the freedom and it also allows us a host of other targeted nerves that we can afford to go after in terms of pain management. Some of you may suffer from a migraine or know people, this is the world that they live in. Typically there's a warning of a migraine coming on it's called the prodrome you don't feel very well you've got the chills, you got body aches, you got fatigue. And then in about a third of the people, there's moves into an aura, there's a visual disturbance, I couldn't be able to look at these lights right now. I have an auditory disturbance that lasts for a little period of time. Then the thunderclap of pain comes on, it's debilitating. migraine pain is typically unilateral, It's throbbing. And most of that pain is in the front of the head. It's a hot poker going through your eyes. The only salvation you have is you have to go to a quiet room, it needs to be dark and needs to be void of any stimulation. And oh, by the way, you have to be there for about four hours to three days until that wave of pain subsides. And then there's a letdown for about a day or so you don't feel very good, you're depressed you have weakness. So how do you treat these people today? This is what's available. You typically have a board of medication, all oral medications, typically and that's intended to reduce the severity of migraine. If that doesn't work. Oh, by the way, you have to add on to that cocktail and that cocktail is to preventative medication. These are anti epileptics and depressive so not only do they attenuate your brain, they wreak havoc with your with your kidneys and your liver. One in four won't respond to this medical treatment. And therein lies the opportunity of how else are you going to address their pain typically today, it's through neuro stimulation or nerve decompression. That specific segment of that market speaks to a $3 billion total addressable market. This is the nerdiest slide of them all. There is good debate about what triggers migraines. There is no debate about what's the migraine generator where's it all start from? In the midbrain. There's a cluster of cells. And don't say this after too many libations but it's called the trigeminal cervical complex. Those cluster of cells are the depot the convergence of two major nerves in your head neck. The first nerve is the trigeminal nerve, they're paired nerves they give all the innervation to your head, neck and your neck that comes in again to this complex within the midbrain. On the other side, there are occipital nerves. These are nerves that are in the back of your head. They do not carry pain information. The trigeminal nerve carries pain and other sensory information the occipital nerve does not. There's where you can take care of an imbalance. If you can overstimulate one nerve, it'll mask any information of the other nerve. Our brain, believe it or not, is very is not very good at multitasking. It responds to the highest stimulation, the highest threshold that's being given. And that's what we process. This is what you see in patients that have an active migraine. This is a PET scan and a PET scan measures your brain activity cellular activity. So in the picture in the middle, you have the eyes to the bottom of the screen and the back of the head to the top of the screen and in that cross section in that midbrain you have that trigeminal cervical complex, so that's where the migraine is starting. So if you can have that as the therapeutic target, you'll be able to depress any of the pain signals being appreciated. So how is this done? Typically, there's an approach to go and target the occipital nerves, these nerves come right off the spinal cord, and then they pierced the muscles as is attached to the base of your skull. We want to take care of this asymmetry this imbalance between these two nerves. So when you're having a migraine attack, your trigeminal nerves are on fire. You have the severity and the onset of the migraine pain. Your occipital nerve is quiet, no, no pain signals there. If you can stimulate the occipital nerve, again, you if you create an imbalance that it's in favor of having any kind of positive pain management. This has been done today. Many of the companies that have spinal cord stimulators, they use these off label to target occipital nerve stimulation. So the spinal cord stimulators, it'll, it's ill equipped and not designed for specific targeted nerve stimulation. That being the case, the approach is to put the electrodes under the skin at the base of the head stimulating these occipital nerves. There is a lead that is attached to the electrode that lead is tunneled through your neck through your back. And as you can see in the schematic that's attached to a battery, or pulse generator, and oh, by the way that's in your flank. So you get two surgeries, to be able to deliver that therapy and two very significant surgeries, you can see the picture of a young lady there that's got those leads coming out of her neck that then need to be tunneled through. So it's not a very attractive surgery for either patient or physician. Good news, bad news. If you look at the results, all the publications suggest this kind of works in 85% of the patients, when you look at long term follow up in excess of a year 85% of the patients have favorable pain management with this therapy. And again, keep in mind, they had failed everything else. That's the good news. Here's the bad news. You have two invasive surgeries and all the morbidity that's associated with those surgeries. You also have the complications, the bleeds, and this is the case of anything that has a lead that leads going to fracture that leads going to break inevitably. So how do you manage that because you'll have underwhelming results. This is where we come in. We have designed again, that microstimulator that we think is going to be an is the smallest functional stimulation that's put under the skin. We also have designed the circuitry where the electrodes can be modified on demand. So in the event that the implant migrates, you still have the covering of the field because you can stimulate and activate the electrodes. Specifically, our secret sauce is captured in the middle, we have designed a battery that's connected to a necklace that delivers the radio frequency. So we've been able to move energy from a battery through the air and penetrates the skin of an implant targeted for the peripheral nerve, in this case, the occipital nerve. That's important, not only not only in terms of delivering the therapy, because if you think about these patients, they need to have a robust quality of life which they don't enjoy today. We spent the last year and a half focusing on achieving these milestones. We have a functional implant system. We are approaching design freeze within the next month. We have three patents that are pending for our system. We've had conversations with the FDA to secure a de novo 510 K pathway, we are refining our clinical study. And this is all done in a quality management system. I'm here today to share with you that we're in the process of raising capital $12 million will be for our Series A financing that will allow us to go through our de novo clinical study. It will also allow us to start our product pipeline for our second application for diabetic neuropathy. I have the good fortune of having these advisors support me and there's a balance of the implanters in this market. It's split between neurosurgeons as captured by Dr. Nick Bolus and the interventional pain Doc's that also implant these. That's by Dr. Eric Grigsby. Dr. Kissoon is a headache neurologist at Mayo that's helping us with the trial design. I should have introduced myself, I'm Jagi Gill, I'm the founder and I've had the experience of being in startups. This will be my third startup, the two others, we've successfully exit with an acquisition. I've also been at a large company running sales organizations and doing m&a. I'm joined again by individuals that have had experience in product development design for manufacturability and the capital markets as well. I'll leave you with this. We started this enterprise, thinking about the patient, thinking about this specific patient that as I described with you, the migrant experience is really a prisoner of their own disease. They have to go away for three days and they may have to go away for three days in a quiet room for three or four times a month, that's what chronic migraine is. It's a horrible existence. So we wanted to give back that mobility and control. We're doing that by providing a outpatient procedure. They're going to be in Twilight, light sedation, and we're going to insert the implant under the skin. We have, again, the first wearable and wireless energy source, which opens up that mobility. And then through an application on the phone, these patients will be able to control their stimulation parameters, because in some experiences, the migraine pain is worse than others. And it goes back to our central thesis that we wanted to give back the control to them that they lost through this debilitating disease. I thank you for your privilege of your attention, and I'll close up now. Thank you