Fergal Ward, Capri Medical - Hermetically Sealed Smart IPG Injectable | LSI Europe '24

Fergal Ward 00:00
I want to talk to you today about sleep apnea. So sleep apnea is a disease where the soft tissue in the back of your throat and your palate rolls back and obstructs your breathing during sleep. Your normal oxygen saturation is around 95%, and because of the restricted breathing, that reduces down to 70 to 80%. Patients have these what are called apnea events. It's like an involuntary movement where the patient gasps for air. These can vary between five and up to 30 per hour. Mild is like five to 15, moderate is like 15 to 30, and then severe is greater than 30. So sleep apnea has a 2x increased risk of sudden cardiac death, a 2x increased risk of stroke, and a 5x increased risk of cardiovascular mortality. The incidence is enormous. There's almost a billion people around the world with some degree of sleep apnea, half of which, or almost 45%, which is 425 million, have medium to severe sleep apnea, and only 20% of patients in the US today are diagnosed.

So a little overview of Capri Medical on the market. So CPAP, these respirator-type machines, are the primary treatment option today. ResMed is the market leader, and they provide these respirator-type machines. Unfortunately, the compliance isn't very good with CPAP, with almost 50% non-compliance with CPAP machines. That's 700,000. So there's 2 million prescriptions every year in the US alone for CPAP, and 700,000 of those fail. The next treatment option is neurostim. So there are 500,000 patients eligible every year for a neurostim device in the US, but only 30,000 today receive one. That's a 6% market penetration for moderate to severe sleep apnea, and Inspire, the market leader, has fantastic results. These guys are like the pioneers in the space. They invented the market, they developed the market, and they've got great results: a 68% reduction in sleep apnea events. It's a tremendous solution.

Capri Medical, while we are a disruptive innovation, is developing an injectable approach for neurostim devices. The previous devices, the Inspire-type devices, are pacemaker-like devices involving a two-hour procedure. This is a 20-minute procedure in an outpatient clinic with same-day results. That means that the patient can walk into the clinic and receive therapy the same day. Quite often, it takes two months to turn on the Inspire device. We've seven patents to date. We've got good acute feasibility data, showing a 74% reduction in apnea events across seven patients.

Okay, so just a little bit about our capital model. We've raised almost $20 million to date in Series A. We have a world-class leadership team with deep business, scientific, and operational experience. We've received four industry trade awards. We have nine patent families, and our total addressable market (TAM) is $11 billion. We'll get into a little bit about that later, with an estimated 2028 approval also in the market. It's interesting; Apple just last week announced sleep apnea detection on its next-generation Apple Watch. This is amazing. This is going to bring sleep apnea awareness from 20% today up to a more significant level. However, there's a structural scaling issue, at least for surgical devices. Patients today, MDs today, they're reimbursed at a higher rate for sinusitis procedures or tonsillectomies in multiples of orders of magnitude than for a neurostim procedure. So we need to change this. We need to make it as accessible as a sinusitis procedure.

Again, the first line of therapy is the CPAP machines. This is what they look like. They're uncomfortable, very loud. If you want to travel, you need to bring an extra suitcase. And they create, unfortunately, intimacy problems in relationships. It's literally like sticking your face out of a moving car at 15 miles an hour.

Okay, so let's look at the patient pathway again. There are 17 million moderate sleep apnea patients in the US today, with 2 million prescriptions of CPAP devices. 700,000 of those patients will fail CPAP on an annual basis. So that means that there are 500,000 patients every year eligible for a neurostim device. So converting that into a TAM, that's a significant market opportunity: an $11 billion TAM. Today's market revenue is $6 billion, and if we only treat 15% of the TAM, that's a significant $1.7 billion opportunity.

Okay, so how do we do that? Right? So if we plot efficacy on accessibility, efficacy is the highest efficacy treatments with accessibility. Surgical or minimally invasive procedures, while neurostim devices are the most effective treatment option, whereas CPAP machines are less effective but more accessible. So at Capri Medical, we're focused on this box. Our mission at Capri Medical is to make the most effective OSA treatment accessible to everybody. We're doing that by completing our acute feasibility study this year and PMA by the end of 2028.

So our solution is an injectable, 20-minute procedure, and we're moving the location from an operating room into an outpatient office or site. It's simple, fast, and effective, and it radically reduces our time, costs, and revision rates. This is the implant here. It's a smart IPG, hermetically sealed with advanced bioelectronics.

So a little look at our clinical data to date. We've completed seven patients so far, one of those being a control patient. We've three more enrolled and expect to complete 10 patients by the end of November, and we're averaging a 74% AHI reduction. That's a little bit better than the market, but it's within statistical norms: 100% for patients. Our key trial criteria was 100% of our patients with a 50% greater AHI reduction, and we're achieving that with no serious adverse events reported. It is a percutaneous solution. It's an injection into the base of the tongue. We are achieving full, unrestricted airflow and not bilateral protrusion of the tongue, which is very important because we need to open up both airways. We firmly believe this is a best-in-class solution. It's more accessible than anything else. It enables increased incentives for the medical doctors. It has all the advanced technical features that you expect from the next-generation device, but most importantly, it's safe. It has, we believe, the lowest procedure risk of any implantable device.

Driving the company is myself, Fergal, the innovator. I've raised $20 million to date and have 12 patents under my name. I'm joined by Ricardo Val, our Chief Medical Officer and President. Ricardo has exited four neurostim companies to Medtronic to date. Capri will be his fifth, maybe not Medtronic, but somebody else. Again, it's a very disruptive innovation. It's minimally invasive, injectable, outpatient, with strong IP. It's a very large TAM. It is a best-in-class solution. It's simple, most importantly, safe. It's effective and accessible. Thank you.