Video Transcription
Rick O'Connor 00:03
Good afternoon. I am Rick O'Connor, the CEO of Restera (FKA Invicta Medical). We are introducing the world's first and only injectable sleep apnea therapy. Our mission is to provide you all with restful sleep tonight. If you're here to listen to Invicta Medical, you're in the right room. Today, we're introducing our new name, Restera, which speaks to what we're doing therapeutically. Restera offers, again, the first outpatient injectable sleep apnea solution that can treat all indications of OSA. We've had incredible market traction. Our product is very disruptive. Again, it's an outpatient injection that can be delivered to two targets or more. We have unrivaled therapeutic results in our outcomes to date, and we have incredible traction. As of this year, we went from zero publications to seven publications in peer-reviewed journals with high impact factors showing the efficacy of our therapy. We have 35 patents and patents pending worldwide, and we have a fast go-to-market strategy. The market opportunity in the United States is vast. That's a $23 billion TAM right now, and growing. Our platform unlocks even greater market share with fast reimbursement and a faster market strategy. Our team is full of serial entrepreneurs. We've done this before and have had multiple exits, and we have strategic investors and a great board. I myself have been in medical devices for over 30 years, developing and commercializing countless implantable devices for cardiac and neuro. I started my career in the US Air Force, developing and testing next-generation fighters, and I've been in medical devices since. My first company was Lectus, which was acquired by Baxter. It was a revolutionary robotic platform that's now a market leader. After that, I was at Venture Tech, where we got acquired by Abbott in the cardiac defibrillation platform. After that, I was at Guidant, which was acquired by Boston Scientific in the cardiac space as well. Then I was at Spinal Modulation, which was acquired by Abbott; that was a pioneering dorsal root ganglion pain therapy. Our board is a fantastic board. They're seasoned operators and investors and have been successful in med tech exits, and we're working with the world's most renowned sleep research institutions across the world, including Australia, the United States, and Europe. Our management team is incredible. We've been very lucky to have this team. We've all done this before. We've done neurostimulation, injectables, wireless—the whole bit—and we're just doing it again. Collectively, we've commercialized 21 products to date in the implantable space. We have over 70 years of experience in neurostimulation and sleep therapy among us, and we've had 150 different FDA approvals for the devices we've developed in our careers. Again, this team has done it before.
So what is sleep apnea? Sleep apnea is the cessation of airflow while you sleep, causing you to awaken and gasp for air. It's measured in something called the apnea hypopnea index, or AHI. What that does is measure roughly how many interruptions an hour you have. We all have some interruptions; zero to four is considered normal interruptions per hour, but when you have 15 plus, that's moderate. 30 plus is severe. Now, put that in context: 30 events per hour means that you're waking up 30 times, gasping for air. It's a miserable experience. When I was a kid, we used to tease my dad because we would watch him sleeping and then bolt up gasping for breath in a cold sweat. At the time, I thought it was funny and weird. I didn't know what it was. He had severe sleep apnea. My dad died early. He was chronically fatigued, and OSA basically killed him. We are here to offer a new solution. This problem is a global epidemic. Over 1 billion people have it worldwide, and it's growing rapidly. The lost economic output right now due to sleep apnea, actually OSA, is $67 billion—that's people falling asleep on the job, falling asleep while they're driving and crashing, and being unable to go to work. Of the current therapies in the market, the leader is CPAP. About 50% of the people who use CPAP refuse to use it. It's unpleasant. You have to fix a hose to your face and have positive pressure. Again, it's not well tolerated, but it's very effective. There's a new player called Inspire that developed a hypoglossal nerve stimulation that's very invasive. It requires a two-hour procedure and six months before they get to effective therapy. The fact that people are going to that shows you how much they don't like CPAP. There is a desperate need for a new solution, and we've been studying this market, and we think we have a groundbreaking solution. There are far more patients and not enough ENTs to treat the disease. Yes, right now, 80,000 people have selected to have the Inspire procedure to avoid using CPAP, and that market continues to grow rapidly. They're willing to go for a two-hour procedure, where they slice open your neck, expose the hypoglossal nerve, wrap something around it, and then do another incision at your throat, at your collar, and they have to wait six months before they get effective therapy. It's incredible. There's so much hunger for a new therapy that's both effective and scalable and that can be delivered by more than just ENTs. And this is where we come in. Our revolutionary platform—we're racing to get to market as fast as possible. We have shown unprecedented clinical results, which I'll get to in a minute. This platform is the same injectable therapy. We offer two power options. We have a traditional implantable can where the battery provides the power, and we have the wireless device. Our wireless device is fully injectable, and there is no onboard battery. We have been working in this now for about a year. It works phenomenally. Our Gen 1 device is going to be in humans this spring, which is the beginning and the end of our chronic feasibility study next year. Remarkably, this strategy gets us two great products in the market faster, and we get to treat a broader market faster. These products are complementary on the regulatory pathway. This is going to show you an animation of our platform. Here you have the anatomy of the upper airway. You have the muscles above the hyoid bone here, which is the genioglossus in particular. Here you have the hypoglossal nerve. This is a picture of our device. It's very small. It fits through a small needle. It's flexible, and remarkably, this can be delivered in five minutes. We've done it 58 times—a local injection. You inject, the device is delivered, and you're done. There's no surgery. There's no scalpels. We apply power, and contraction of the genioglossus happens, and we open the airway at a level never seen before. And this is Restera.
Let's talk about our landmark clinical evidence. We have completed six studies in the last two years; all of our publications are coming out. This has come out this year—seven as of this month—in peer-reviewed, high-impact journals recognizing our pioneering results. We have had zero adverse events. We have treated 58 patients, and we have shown that we can treat all candidates of OSA—that means lateral wall collapse, complete concentric collapse, high BMI. Nobody else can do this. Remarkably, we have shown that the very first night of injection, the first night of delivered therapy, you get results, and we're getting an AHI reduction the very first night, which is not even optimized, at 63% AHI reduction—never seen before. This next slide shows you what we're doing. This is a look at the upper endoscopy during sleep. This patient has severe apnea, and you'll see here we just turned stimulation on. The airway is open fully. The person has returned to normal, unobstructed flow. The stimulation is off, and the airway is shut. They have no airflow going on whatsoever. Stimulation is on, and it's open fully. This has never been seen before. We can repeat this time and again. We are getting three times the level of opening of Inspire or Nexo. This is CPAP-level efficacy without CPAP. We have to give credit where credit is due: Inspire Medical has created an incredible market. They've done a fantastic job. There was never a market in implantable stimulation for OSA. They've created this market, but their procedure is very invasive and very long, and there's not enough ENTs to deliver it. There needs to be a solution that can be delivered faster and cheaper and can be delivered by non-ENTs. They've had a keg of 88%.
Let's quickly look at the US market. There's a $23 billion TAM right now, and if we just go after the current surgical market, which is 3.6 million people, the top pillar there, that's a $9 billion TAM. We're going to go after that in the second tier market, which is GLP-1 candidates and/or appliance candidates. That's a $23 billion market. We believe we can be competitive against CPAP on compliance, costs, and efficacy. That market is $38 billion. It is a huge market right now. In the United States, 54 million people have been diagnosed with OSA—that's highly underdiagnosed. We are seeking a Series B of $20 million to start and complete a chronic feasibility study of 30 patients, and this will enable us to get IDE pivotal trial approval and begin to do limited US sales.
Rick O'Connor 10:05
Restera offers an unparalleled solution in sleep. We have by far the quickest solution. We're delivering our device in five minutes consistently. Our therapy is by far the most effective. We're three times more effective than Inspire and Nexo and providing CPAP-level performance without air pressure. We have the highest compliance. There's no hoses to fiddle with, there's no mask to fiddle with, no buttons to press. It just works. And we have the lowest cost. We can do our device for half the price of Inspire. And we have a very comfortable gross margin. We're here to provide you restful sleep tonight. Probably half of you in this room have sleep apnea, and our goal is to allow you and your spouse to sleep well and get no more kicks in the shin in the middle of the night. Thank you. Applause.
