Rick O'Connor, Invicta Medical - Sleep Apnea Treatment | LSI USA '24

Rick O'Connor  0:00  
Steve, today, we're going to talk about the world's first and only injectable therapy for sleep apnea. So what is the challenge? Sleep is essential to our health. We all need it. We all know that and sleep with apnea is the single largest cause of poor sleep in this country, over 78 million patients suffer from sleep apnea in this country, 420 4 million worldwide have moderate and severe sleep apnea, and every year, $67 billion is lost in economic output due to sleep apnea. The two current market leaders of Inspire and ResMed. ResMed developed CPAP, and has been quite successful, but roughly half their patients refuse to use or fail to use it. Inspire medical the new player in the block market cap of $5 billion their procedure requires a two hour surgical intervention and six to eight months for the therapy to be optimized. Our solution, we offer an outpatient injectable stimulation therapy to treat and expand all OSA indications. Our landmark stimulation therapy is demonstrably better than the current market leaders nixoa and inspire our patients achieve same night results. We just won the Best abstract award four months ago in Australia, in the sleep society. CEO Rick O'Connor done quite a lot of startups. Most recent one was spinal modulation acquired by Abbott for DRG stimulation. We have a very robust IP portfolio. We have 35 patents and patents pending. We have a very compelling reimbursement plan. We have world renowned KOLs and a proven management team. So what is sleep apnea? It's basically a disease of poor flow, and we all have sleep apnea to some degree. A patient that's healthy would have zero to four events in an hour, which is an ahi event where you have an apnea hypopnea index. Bottom line is either no flow or limited flow. And a mild patient may have five to 1015, events per hour. A moderate is 15 to 30. Against severe is 30 events per hour, resulting in poor sleep. The current treatments for sleep apnea include these things. First line therapy is CPAP. That's what is a wide spectrum therapy. It works great, and it's been proven. Second line therapy are things like oral appliances and membrane advancement devices. And then you have last line therapy, which is surgical intervention, which historically was slicing and dicing your oral cavity to create airway inner flow. Inspire came along with hypothesis, nerve stimulator, and that's new, new player on the block. Let's talk about Inspire. Again. I have incredible respect for Inspire. They created a market where one did not exist previously, and they've been very successful. They've taken a market to a 90% CAGR year over year for seven years to last line therapy. It's proven. It's growing rapidly. Yet we think Inspire is way too invasive. The current approach requires a drug induced sleep, endoscopy, screening. They screen out half the patients before they can qualify for the device, because it doesn't work for half of them. They then go through a two hour surgical intervention where they make three incisions, two inch incision here to skeletonize a hypoclosy nerve, wrap a cuff around the hypoglossal nerve tunnel. It create a pocket for the pulse generator and then intercostal sensing respiratory and nixoa has a similarly invasive procedure that's submandable. We believe these procedures are all way too invasive. There are challenging procedures, but more importantly for the patient, it's long time to wait. They don't even have the device turned on for two months, because the healing takes so long, it's so traumatic, and then it takes six additional months for the Thera to be optimized, because it's so foreign to have that much energy pulsing your tongue. People can't sleep with it, plus it's expensive, and we think all these reasons are why it's a limited patient pool. So what is Invicta, the world's first injectable. This animation will walk you through the user experience and the key anatomy we're talking about here. You'll see the patient's muscles at the upper airway, the genoglossus, and the nerves that control that contraction, the hypoglossal nerve, and you'll see the muscle below the hyoid bone, sterno, Omo, thiohydroid, and the nerves that control the contraction of those muscles to answer cervicalis. This is a video. It's actually two years old. Our device is smaller than this, but you can see it's quite small. We do an outpatient local anesthesia injection, as shown here, insertion, deployment, and then stimulation, causing contraction of the genioglossus, then you have the caudal traction phenomenon, where we actually cause caudal traction, which is the hyoid that go down. Either one of these things work independently or together. We control each one independently, and we don't need both. We think about only 30% of the patients will need both implants. The vast majority will be just one. This is showing the patient supine, showing you the two of them working in harmony the bullfrogging effect of your throat, which is a healthy airway opening. That's what we do when we're awake. So. That's the video. So what is our platform? It's built on these three pillars. We have the outpatient injectable. We just saw the animation has done local anesthesia injection. It takes 10 minutes skin to skin to do this. The wearable, the patient goes home, puts on the wearable. There's no adhesives, there's no buttons. You can do with your eyes closed in four seconds, and that wearable talk to the cloud, allowing for healthcare, economic and patient monitoring, therapy and physician monitoring. We believe this platform is the quickest it's the most effective, highest compliance and lowest cost therapy. Let's talk about our landmark clinical evidence demonstrating our therapy. We've had six studies underway or completed in six different centers in three countries, studies one through six, we've completed 50 patients as of this week, all 50 patients, no incisions, no adverse events, and immediate response to therapy. We just finished studies one and two. Last year, we enrolled 14 patients in those two studies, one in Vanderbilt and one in Australia. Those were delivering of ultrasound injectables. And then we have four studies enrolling right now worldwide, and those are ultrasound guided delivery to AMSA and HGN we've done 22 patients total there, and we just got approval to do subacute overnight studies. We've done eight of those patients just yet. So let's talk about how it works. A patient, a physician will place an upper nasal endoscopy in the upper airway in the oropharynx looking down. And this picture here is showing you the closed airway on the left, which is a fully apneic patient, a snapshot of their airway being closed and with stimulation on the airway opens. We have a video, but I don't have time for that again. OSA is about flow, and we take patients from no flow to unrestricted flow. Sleep experts, all of them have never seen this before. We're taking a fully closed airway and returning it to normal, unrestricted flow, and we're doing it with either target which is better than we expected. So on the left, you have the hypoglossal nerve stimulation. You turn on stem, and you go from an apnea to full, full flow, and 400 500 milliliters per second. On the right is the answer, cervicalis. The same results. This is that same data set. In a sample size of about eight patients collected last year, you have both targets, both landmark results. Either target returns patients to normal, understated flow. On left, you have HGN and the right answer, cervicalis. So let's talk about Invictus, superior qualities compared to other nixoas and inspires out there. We do non invasive screening using ultrasound. We are the only injectable approach, no incisions, no scalpels, no stitches. We can treat all phenotypes. We use nerve stim now. We call nerve stimulation localization to optimize placement. We have unparalleled multipolar electronic repositioning. We can treat two targets or more with a scalable architecture. We're focused on the AMSA and the HGM, we get same day results, and we're by far the lowest cost. The Tam, as you know, is huge if you just focus on last line therapy and the second line therapy, that's a $13.5 billion tam in the United States alone. Of course, it's much bigger, if you could look at the CPAP, another 15 billion. We're seeking a series B raise of $45 million that will lead to OS revenue. Our mission with this revenue is this capital is to develop, finish the commercial platform development. It's underway right now. Begin and start. Start and Finish our chronic feasibility study, have o US commercial launch, and then get us pivotal ID approval. And those are the milestones over that timeline of notes, nixoa went public at Milestone Two in victim medical our proprietary OSA therapy is the quickest to deliver. It's the most effective, it's the highest compliance, and it's the lowest cost. Russell, sleep tonight. I.