Sam Owen Presents Otolith Labs at LSI USA '23

Transcription

Sam Owen  0:05  

My name is Sam Owen, I'm the CEO of Otolith, we have developed the very first symptom management treatment for chronic vertigo. And I need the clicker. So let me tell you about the market. In a word. It's enormous. And we have a standard of care opportunity. With just 2% market penetration, we will have over $500 million in revenue. And there are currently zero symptom management treatments for chronic vertigo. We're doing this with a device that will give us a recurring revenue model. It's got very high margins. And we spoke with many payers and have strong support because it is such an expensive problem for them. We have very strong market protection as well. We are the first to develop this of any kind. So we're going through the de novo process. And because we have such broad patents, we can take that language from our patents, incorporate it into de novo classification, and have lasting protections for many fast followers. So let me tell you about how vertigo patients are typically cared for right now. When vertigo first comes on. It's a very scary experience. Am I having a stroke? What's going on, I go to the ER. And very quickly, you're given an MRI note, this is not a stroke. It's a peripheral vestibular disorder. Well, guess what we don't want you in the ER, we really don't have much for you. Here's some Antivert or some valium or something just basically knocks you out, go home, sleep it off. And hopefully in two days, you're going to be fine. Usually that happens, but for millions of people, they're still vertiginous. And so the first specialist they see is the ENT. Now the ENT is going to hear a natural history, they maybe do another $2,000 MRI test, make a diagnosis and prescribe physical therapy, maybe they think it's migrants send you off to a neurologist, they basically just want you in their office, you try some sort of therapy, maybe it works, maybe it doesn't quite often it doesn't. And you're right back in another ENT, the average chronic vertigo patient has seen over five specialists only 20% report getting an accurate and timely diagnosis. This revolving door of medicine, we'll get to that later. Basically, people will eventually just become these self care experts going online. Just seeing like, oh, there's a doctor in Colorado to help this one person, I'm going to fly out there because this is debilitating my life. These self care experts are willing to do just about whatever it takes. But inevitably, they have another escalation event and they're right back in the ER, this revolving door of medicine has a costs, it's $60 billion in the United States. This is the delta between what patients are with vertigo cost versus what people without vertigo cost. This was a 50,000 patient study compared to a 30,000 patient control. So this is real quality data here. So let me tell you about the vertical market. In the United States, roughly 16 to 32 people million people will have vertigo. But we're where focus is on the chronic vertigo population, that's roughly four to 5 million people. And that's where we have the standard of care opportunity. If you just look at the the cream of this group, just the people are spending over $5,000 a year out of pocket or payers are spending over $5,000. Just that alone is $8.6 billion. And again, most of this is not actually effective treatment. This is just going to the doctor again and again, expensive tests. Just trying anything that's out there because there is nothing to treat this condition. So let me tell you about what it is we are doing. In the inner ear you have a set of acceleration sensors called your vestibular system. This is used for eyes stability, balance, spatial awareness. And Vertigo is caused when there's some sort of dysfunction there some sort of asymmetry. What our technology does, is it floods that vestibular system with informational masking and essentially drowns out that vertiginous signal. So think of it like if you're trying to sleep, but there's traffic or dogs barking or people talking, what you can do is you can turn on a fan, which creates this white noise and drowns out these distracting signals and lets you sleep. To be clear, your ears still work perfectly fine. But because you're able to mask these distracting signals, your brain is able to compensate and just move on. That's what we do, but for the vestibular system, and the effect is instantaneous. And if you imagine your your arm itches and you scratch it, that's the exact same sensation. How quickly scratching relieves that itch. That's how quickly we work it is it is instant. It seems to last indefinitely as long as that stimulation is applied the masking is is is helping people who have the vertigo. There's never been any serious adverse events in any of our clinical trials. Very easy to use. It's a simple wearable device it's used, integrated with the headband, and just has to be applied to the mastoid right behind the ear. And you still have the size of it in the future, we can integrate this with just about any head worn wearable right now it's with the headband, but you can put it with hats, headphones, really anything. So we've had lots of studies over COVID, we had at home real world data, with, with people using our device in their daily lives. We've had over 200 people with chronic vertigo with this, but here's his real apples to apples comparison we had between our placebo, basically our effective dose to help people with their vertigo 65% of the time, or 65% of people said that it helped more than half the time with their episodes. And then we haven't been Placebo, which is an identical device. And all we had to do is change the frequency because it is a very precise frequency that you see is the fact that just by changing that frequency, the placebo only had a 20% response rate. I mean, this is a huge improvement. So we have all sorts of statistical and clinical significance. We have a pretty clear path for the FDA at this point. But I mean, these are numbers, this is great for publication. This is great for the FDA, let me show you what this improvement actually means. And hopefully there's some volume somewhere. 

Video playing  6:27  

  I was hospitalized for a week was with the Mayo Clinic down in Florida for a while very, very balanced problems. Frequently falling over being able to walk, keep food down, people would mistake me for being drunk, I was able to drive and not just a private stopping a passenger, they were workman's compensation and the insurance company want to be on permanent disability. That's where I came across the auto law. It was instant, very quick, I noticed the difference almost straightaway. I'm back at work now. And I'm back at work full time on a full salary. After three years, I wear it daily, I use it daily, I rely on it, I can say more than I rely on my phone, it works for me. Like

Sam Owen  7:16  

It's pretty rewarding what we get to do. So I'm going to try and run through this quick what do we own, we own the entire spectrum of the therapeutic frequency. So basically anything that comes after us it's going to be a placebo, it's going to be a dangerous level of vibration, or it's going to be the effective dosage which we own launch product. Again, very simple thing. Something that you could wear out in public still be inconspicuous, you see someone wearing a headband. That's how small we've been able to get it. So people are comfortable wearing this everywhere. What we're going to market with is something that is basically a three month replaceable pod. This way we make sure the device never lose calibration. Again, we have to make sure that it is putting up the right frequency. It avoids any sort of obsolescence but it also gives us a recurring revenue stream. The big hockey stick numbers. I mean, the takeaway is this, if we can hit 2% market penetration, so one in 50 of the people who currently have no treatment options, if we can hit that number, we will have revenues above $500 million, and we're a multi billion dollar company. We spoken with a lot of pairs at this point we took advantage of the early pair feedback program UnitedHealth Group Humana Cigna, basically they all agree on the same things. This is an expensive problem. There's nothing to treat these patients. We love your placebo. If your results continue to show like this, you're going to have reimbursement. We got a great team of clinicians, researchers, engineers where we're lacking we bring in a great group of medical advisory boards. These are really the top names in the vertical research space that are on on board with us. You talk with any NT if there's any EMTs in here, you hear treatment for vertigo, you get EMTs very, very excited. We just raised our Series A what I'm here to do is talk with people who are more late stage postmarket to make sure that as we get ready for a series B over the next year and a half, we're not going after certain milestones and it turns out we're going after the wrong milestone so if you guys are seriously be invested into this interested in this please talk with me because I'd love to understand what milestones you guys are looking for. And that's me