Ross O'Neill Presents Neuromod at LSI Europe '23

Transcription

Ross O'Neill  0:05  
Good afternoon, ladies and gentlemen. I've just been told we're ahead of schedule so I can take as long as I want to talk. So I think the organizers might be sorry, they said that to me. So I'm here to tell you about neuro mods. We are an Irish growth stage medical device company. We're headquartered in Ireland in Dublin. And we have us offices in Illinois, we employ about 50 people at this stage. And we are the inventors of Lenire which is the first and only FDA approved and CE marked by modal neuromodulation device for the treatment of moderate severe and catastrophic tinnitus. So Lenire is a is a device as prescribed by ENTs and audiologists. But it's a home use device itself as administered by the patient in the comfort and privacy of their own home. They use it for 30 to 60 minutes per day, for a minimum of 12 weeks. And the device essentially delivers sound through bluetooth headphones combined with trigeminal nerve stimulation, that's a non invasively using an intra oral electrode that we call the tongue tip. So, about 6% of the adult population suffer from moderate severe and catastrophic tinnitus. And so, we we engaged the BCG Boston Consulting Group to do a do a report on the you know, the value opportunity in this market segment. And their analysis showed that there are about 550 million people in the developed world suffering from this more bothersome end of the of the tenders of scale. They they estimate that the the total global retail market value for a product like linear is over $5 billion. And the the dynamics are very much in our favor. There's there's actually a very well established clinical pathway for tinnitus patients within en ti and audiology. The doctors are there, the patients are already in their care, the problem and the challenge to unlocking the opportunity has been that the doctors have not had an effective treatment to prescribe these patients until now. So it's largely self pay market. So hearing aids hearing devices tend to be largely self play with limited with limited reimbursement. But the current standard of care for tinnitus is includes hearing aids which are not effective for these more bothersome forms of tinnitus, and also CBT and psychological counseling, which are simply too burdensome and too slow to really deliver any meaningful benefit for this untreated population. That means that there's practically no competition for for this segment. And unlocking the opportunity has the ability to grow the total global hearing market by up to 30%. So it's currently at around 17 between 17 and 18 billion retail globally. So you're talking about adding a $5 billion untapped opportunity. On top of that. At this point, the company has completed all major development milestones. We have a uniquely effective product that slots very neatly into anti and audiology practices. We have demonstrated consistent efficacy and safety and tip patient tolerability now in 1000s of patients, and that includes, you know, multiple clinical trials, large scale clinical trials and also a growing body of real world evidence. So we've done three large scale clinical trials, the first two were published in high high tier internationally recognized peer reviewed journals Nature and Science. And the third large scale clinical trial was designed in collaboration with the FDA. It was a controlled trial where we we compared by modal versus sound therapy, and that was the basis for our de novo approval in March of this year. So that's currently in peer reviewed and will be published later this year or early next year. We have we have as I said FDA approval we're the first and only treatment for this this category, moderate severe and catastrophic tendonitis, and we also have have CE marking. For Europe. Our manufacturing is fully transferred fully industrialized, ready to scale. Our supply is supply chain is completely project protected. Our third party logistics are fully in place. We're protected by a rock solid IP position. We have 134 patents granted in 37 countries, they span across four patent families which have date back to 2010. So we have the earliest and largest IP portfolio in this space. And then most importantly, at this stage now we have a proven and scalable commercial model. So we have rapidly growing revenues, we are very tightly tracking our commercial and clinical KPIs. And they are exceeding all expectations. So, Lenire is very attractive, very attractive proposition to private practice audiologists and ENTs. And there are multiple reasons for that is helps them to expand their practice. So it allows them to add a revenue line that wasn't there before. So now there, they can see tinnitus patients, they can hire more more staff and see these patients and get a direct revenue line from them. But it also, the feedback we're getting from all our partners is that it also drives synergistic growth into our existing revenue lines. So the more tinnitus patients they see the more hearing aids they see the more balanced patients they see, because they're they're such co occurring comorbidities between those conditions. Lenire also enables clinics to clinically specialize to differentiate themselves from their competition, that is going to become more and more and more important as time goes on. Because there are some adverse industry headwinds that are kind of coming down the tracks like a steam train for for private practice audiologists and ENTs. And they are the over the counter legislation in the US. The the entrance from the the of the big box retailers to Costco is the best buys. And also then third party payers, these insurance companies who are coming in. So Lenire helps differentiate and protect from these headwinds. In addition, it also has the added advantage that it attracts a much younger profile of patient into that kind of lifelong care of expert audiologists. So the tendency is patients tend to be in their 20s 30s 40s. And so audiologists are getting them in the door kind of one to three hearing aid sales cycles earlier than they would normally be coming in. So a lot of these patients do have have a concomitant hearing loss. So there are multiple upsell opportunities for audiologists. So this is why we are getting very, very strong provider demand from both audiologists practices and the ENTs practices in the US. And the really smart movers and the recognized leaders in audiology, retail are recognizing these adverse headwinds, they know that this is coming down to track, they know that over the counter, big box and third party are just going to put more and more pressure on their on their margins. And they're, they're driving their profits down. And so the smart movers are getting into moving into clinical specialization now ahead of that. So if you want to if you want to become more specialized in clinical audiology, there's three places you can go, you can go tinnitus, you can go pediatrics, you can go balance, pediatrics is relatively small balance requires a lot of upfront capital investment for the practice. So tinnitus is by far the largest and easiest to get into. And that's why, you know, we're seeing that a lot of of audiologists are pushing now to get access to Lenire. So we're, we're now we've we got FDA approval in March, and we've just completed our Phase One rollout. We did this with 14 clinics. And we did it in a way where we could track our commercial KPIs very tightly, and our clinical KPIs, and that we could, you know, iron out any kinks that were in our clinical or commercial processes. We're now as we speak, we have two training events in the US where we're onboarding our phase two partners, that's an under 50 doctors across 29 practices. And our aim was to follow that up, we're gonna follow it up with 50 practices in February. And our target was to get to over 150 practices by the end of 2024. We now have over 500 additional practices who are pushing hard to get Lenire, because you know, the word is spreading from these audiology, retail leaders, you know, wash, wash, a great addition to the practice, linear is and so we're getting an unprecedented demand from from the from the providers. So we're looking at how can we ramp this up more aggressively now, you know, go beyond that 150 and see how many of these 500 coming on board by the end of end of next year. So there are two aspects of our commercial our US business one is the is the private practice, but the other is governmental services. So the Department of Veteran Affairs is the largest purchaser of hearing instrument Slowly they and tennis is their number one and fastest growing cause of service connected disability. So if you look at their annual benefits reports, which I obsessively do every year, you will see that it's it's, it's growing much faster than any of the other conditions. So right now there are over 2.7 million veterans that have that have tinnitus, it's costing the agency over $4.9 billion annually in compensation payments alone, and then the treatment will be on top of that. So we, this is obviously a huge opportunity for us, we want to get in there and help these guys. And the we're trying to, you know, establish support for Lenire at both the executive level and at the grassroots level. And we're getting very, very good traction at both. I'm glad to say that we've made our first sales into four of the major VA hospitals so far, so but it takes a bit of time. So we're working through the process of getting on their, their, you know, their Federal Supply Schedule, and the RO systems etc. So with overtime, we'll hope to dramatically ramp sales in the VA. The US DoD is also another major player in the governmental services side. It's a tennitus. This is one of the largest disabilities affecting mission readiness among active military personnel. So we We've also established partnerships with Walter Reed and other DoD hospitals in addition to the VA ones. So the short term growth focus is going to be on the US and we obviously that's where we're, we're, we're seeing that the fastest uptake, but we are continuing to expand commercial availability in Europe. And we're looking to Canada, Australia, and Asia for our real growth opportunities in 2025. So that's it. So if anybody wants to talk to me, you know further about Neuromod or Lenire, I'd be happy to do so here. My contact details are also I'll also be around if if you want to grab me for a coffee. All right. Thank you