Jim Peacock Presents Nocira at LSI USA '24

Jim Peacock  0:04  
pleasure to present to you Nocira today, the topic of this presentation will be migraine. So the odds are if it's not you, it's someone in your family or someone very close to you that's affected by migraine. Just to really get into that marketplace, it's one of the largest unmet needs in all of clinical medicine. It's the number one cause of disability. Actually, in the world of middle aged adults, it just recently beat up back pain. For that honor. number four reason of all ER visits. It's a major women's health issue. 20% of women are disabled, at some point in their life with migraine, three to one prevalence versus men. It also means it's a major mental health issue at over 6%. And it affects about as many people as diabetes and osteoarthritis or asthma combined. There's also very big overlap with opioid misuse, anxiety, depression, and medical discharge from the military. So the problem is, is that 50 million prescriptions a year, still are ineffective for 68% of migrants. There's very big contraindications to drugs or side effects. There's a been a renaissance in new drugs, just turn on the television see a migraine commercial, if you've never seen one five years ago, you can't you can't go without seeing one today. But those have mostly made drugs more tolerable, more usable by more people, but not really improve the efficacy. And there's been a new onslaught of devices as well, the first ever in the last five years, they haven't really moved the needle. No serious the first ever FDA awarded breakthrough device for treating migraine. And we have over 400 migraines treated by over 200 patients in six trials that have shown it's by far faster acting and more effective than all other devices and drugs for migraine. In fact, over 90% of our patients are relieved in only 20 to 30 minutes. It's highly personalized medicine. And that involves AI and there's a very big digital health component to this that we'll get into in a minute. It's non invasive, safe, easy to use, even pleasant to use, in fact, and there's no significant contraindications other than as you'll see why some issues in the ear someone might have. We've raised $18 million to achieve what we've done so far. And we're raising a Series C right now $22 million. to Now commercialize, including through FDA path, which are just entering is a breakthrough device. This is differentiated from all of the devices with respect to where, how and why it works differently than other products, but also in the context of reimbursement. It's one of the reasons why the with the onslaught of new devices for the first time ever, they haven't really done well, this has been a really big reimbursement problem. There are electrical in nature, and they've been squirreled under a code called 10s, which doesn't pay well at all and many of them have gone over the counter. They also haven't moved the needle that far. And there's a reason for that. And that's because they target one branch, as you can see on this slide. When one tries to target a branch of the vagus nerve at the neck, another one a branch of the trigeminal nerve at the forehead. These are separate mechanisms and the how it might help to treat migraine. But in the nerve, our inventors discovered a very unique confluence of multiple nerve mechanisms that connect between pressure centers in the ears, and parts of the brain that control pain and other migraine symptoms. That involves trigeminal and involves vagus involves another one called glossopharyngeal. Right there, we just covered the inner ear, the middle ear and the outer ear and also vestibular nerve. So these are all multiple mechanisms that can simultaneously be stimulated by monitoring or sorry, modulating pressure changes into here. Now the one of the leading causes of migraine for getting a headache is barometric pressure changes. This explains that mechanism of why it's a trigger for migraines. And the basic premise of neuromodulation is that a nerve pathway that can be part of a problem can be harnessed in a different way to turn off that same problem. So this aligns directly with the problem of migraines starting in the first place caused by barometric pressure changes. So the system itself is a discrete Home Health Home Use device. This is the device right here. You can see it on the screen. It has soft, comfortable earbuds, very similar to audio earbuds. There's a downloadable phone app that will control the device and it personalizes it gathers information about the distribution of pain in the head, and it will personalize which ear it does pressure modulation and what patterns it will modulate pressure in the ears, both at the beginning of a headache and insight to during therapy. The average treatment lasts between 20 to 30 minutes. And the majority of our patients headaches gone in that timeframe. You can see this is a we're going to talk about more in a minute, that distribution of head pain and we do a time lapse video as part of one of our digital health assets and gathering that data. And you can see the headache dissolve away from the head over time. proofs in the pudding in this world that we live in and medtech. This is a busy graph, but it shows all the primary products in drugs and devices in migraine at the primary endpoint in this space, which is to our pain freedom, it means what percentage of migraines are pain free gone in two hours. The blue bars are the devices in the market. The red are the leading drugs in the market. Trip hands is a class of drugs that have been the standard of care for 30 years, we still are today. The latest and greatest new drug that was acquired for $12 billion dollars recently as the furthest right red bar, but is proof for prevention. And for acute treatment. It's the only drug that you can use for both. And it has more tolerable than triptans. You see, on the far left, we have double digits improvement and efficacy versus all those drugs and devices. But no, not only that, but achieves that in 20 to 30 minutes. So this is rapid, rapid, complete pain relief. It also has an existing reimbursement code that pays really quite nicely for us, but still at a price point that's well below the brand drugs that we also perform. So when you look at in our world, you look at value, which is medical effectiveness and cost effectiveness. And compared to that $12 billion drug that's on top left of that slide and other drugs that are the latest and greatest brand drugs in the space. We're more cost effective and by far more medically effective. Our patients are plagued by migraines for years and desperate for relief. If any of you've had them or have some close to you, you're you feel like your life's over almost. And when someone's migraines gone in 20 minutes or less. It's a dramatic, very emotional thing. I've personally been there and seen 18 migraines go away, three weeks ago was gone, when five minutes, you're talking about people crying, tears of joy, that they finally found that kind of relief. There's a big pipeline conversation we can have about this involving the personalization, the wearable integration, and also AI involvement in this and other indications is a big conversation as well. You can see a few of those here. This is again an example of some of our digital health assets. These are three trial patients that you can actually see their migraine dissolve away from their head. The one on the far left is what's called the unilateral migraine and the middle is bilateral on the far right is called an ocular migraine. And you can see over time how the migraine response to the therapy and goes away just these three patient examples. The first time we ever put this together, our key opinion leaders biggest names in the world of migraine learn more about migraine. In their own words, from seeing these three patients, some things they'd never knew about migraine before. So it's very powerful tool that we'll have in this data. No one's ever gathered this kind of information before. Our team is deeply experienced serial entrepreneurs and very successful across them. And both in tech and med tech. And our key opinion leaders are literally world renowned biggest names in in the world of neurology and the anti that are champions for us. Again, as I mentioned, we're raising $22 million to enter the FDA path now we have a meeting with them called a sprint for breakthrough devices next week. And we expect to be FDA approved within the year. Heavily published now or I should say treated in the press the word of Anessa has gotten out and we've won multiple awards, including the neurology Company of the Year. And just this last slide here is some comps in our space. So there there have been big valuations in this space. I want you to pay attention in particular the far left column that's got migraine to our pain freedom rate. And if you look at those pain freedom rates, and we're at the bottom compared to that, the one at the top is the $12 billion acquired drug or 21% pain freedom rate at two hours versus 67% at 30 minutes. Thank you very much.