Dan Rizzuto, Nia Therapeutics - Precision Neurostimulation Therapy | LSI USA '24

Dan Rizzuto  0:03  
All right. Hello. It's great to be here. I'm excited to talk to you guys about Nia Therapeutics. Nia is building the leading neuro stimulation company for the treatment of memory loss. And our vision is to augment human cognitive performance through integration with advanced AI. highlights here, we're focused on treating $100 billion market of memory loss it afflicts over 27 million Americans, and it's just a devastating condition with doesn't have good solutions. Currently, our team, which is came out of the University of Pennsylvania has uncovered the neural signatures of memory loss and developed a precision neurostimulation therapy that's been validated by multiple clinical studies. Memory loss due to traumatic brain injury is our first clinical target, which represents a $32 billion serviceable market. And we've prototyped the device have started showing functionality in an in vivo large animal model, and we have a strong competitive advantage and a path to commercialization. So one in 12 People have memory loss and that's this can be caused by multiple indications can be caused by a traumatic brain injury most people don't know but memory loss is the number one residual symptom of having a traumatic brain injury. It can also be caused by mild cognitive impairment or Alzheimer's disease, neurodegenerative conditions, and even healthy aging, and no effective treatments exists today. It's devastating patients have trouble with the activities of daily living. They forget appointments and events, they have trouble with complex tasks like finances and cooking. They often end up unemployed and they withdraw from social activities due to embarrassment about their condition. So Nia is developing the world's first personalized therapeutic device for memory loss. This is the smart neurostimulation system. It includes a cranial implant with leads in the brain for sensing and stimulating brain activity. It includes an earpiece, which resembles a cochlear implant that provides power to the implant because the implant does not have an embedded battery. And it also acts as a communications hub with our data platform in the cloud that has our secure AI platform for personalizing the therapy for each patient based on the patient's unique patterns of brain activity. Or art, artificial intelligence algorithms can predict periods moments of memory loss that stem from any underlying disease state. This is a therapeutic strategy that was developed with $23 million from DARPA at the University of Pennsylvania. It's based on over 25 years of research from Dr. Michael Kahana, one of the world's leaders in the study of human memory. And our as mentioned before, our algorithms predict these momentary lapses in memory based on the unique patterns of electrophysiology in each patient. This figure shows the patterns of brain activity that you can see in patients as they perform memory tasks, highlighting the regions that are involved in both good memory, but also in poor memory when memory fails. And as I mentioned, multiple clinical studies from our team have validated that our approach is actually effective. We've demonstrated verbal memory improvements in neurosurgical patients undergoing neurological monitoring with implanted electrodes will go in and perform memory tasks with these patients will record brain activity and stimulate the brain during the performance of these memory tasks. And in randomized controlled blinded study designs, we've shown that we can reliably improve verbal memory in humans and TBI patients. In fact, we've shown that four out of the eight patients with a history of moderate to severe TBI who participated in our studies, and these are shown in the figure at the left received clinically significant improvements in verbal memory with our personalized AI stimulation approach. And recent work has demonstrated that we can improve this degree of efficacy even further through more precise surgical targeting of the electrode. So we've prototyped the commercial device and demonstrated its in vivo performance in a sheep a large animal model. I'm showing the prototypes, right these are not the final devices, but the cranial implants on the left, which is for sensing and stimulating the brain The depth lead on the right which resembles a DBS lead for Parkinson's disease. But as a few more contacts, our eventual human version of the deputy will have 16 contacts compared to the typical four contacts in a DBS lead for Parkinson's disease, and the early prototype of our earpiece that is used for providing power to the unit and integrating with our data platform in the cloud. So we've shown we're not improving memory in the sheep, I'm sorry to tell you, but we are showing that the device performs well and it's safe. And so how do we show that the device performs performs? Well, we've implanted the device in a sheep as you can see, in the left hand, illustration of our surgical approach with two leads in the brain, one in the right hemisphere, a Nia lead and one in the left hemisphere and off the shelf Medtronic lead. And we can actually classify and predict whether the ship is moving using an embedded accelerometer to train our AI algorithms. The same AI algorithms that predict whether you are experiencing a memory lapse or not can predict movements in the animal with very high accuracy, I'm showing an AUC area under the curve of point nine three, which is a near perfect prediction, not as good as your prediction of the ability to predict whether or not the animal is moving or not. So this shows again, we're not interested in movement. But this shows that the entire functionality is working sensitive recordings in the animal providing power and the ability to extract the signals, send them up to our data platform and integrate with our AI algorithms in the cloud. The addressable market is huge 100 million as I mentioned earlier, total addressable market. We believe the serviceable market just in TBI is represents a $32 billion service market. And we believe we can acquire about 10% of that market, which represents a substantial business opportunity. And that's just the beachhead. If we're successful, and we've chosen TBI because the chances of success in TBI will be greater than in Alzheimer's for our first indication. If we're successful in TBI, we'll use that as a beachhead to then enter other markets that are even larger. And the global neuro stem market, I probably don't have to tell you, but it's rapidly growing. It's a $5.7 billion market today that's growing at a 15% clip. Reimbursement pathway is favorable. We're piggybacking on existing reimbursement codes for DBS for Parkinson's and epilepsy, we believe the same codes will cover our device, we do have to obtain coverage from the payers, of course, and we have developed our plans to do this. And we're planning to obtain breakthrough device designation as well which could unlock increased Medicare payments as part of the N TAP program. And what's our competitive advantage here? So it's generating massive brain datasets that will increase the pace of therapy innovation, we're going to be generating datasets at a pace that nobody else in the market is doing. And these data are going to be incredibly valuable to anybody who are creating therapies for the brain. And as I mentioned, our connected device collects data from every patient and our AI algorithms continually improve the therapy. There is competition emerging, but nobody's there yet. Right? There are device based therapies that are being going through clinical testing, but nobody has received approval for TBI. There's nothing for Alzheimer's, there are emerging therapies, but it's a little bit of a horse race right now. We We've assembled a powerful technical team that's developed our prototype, and our founders, including me and my co founder, Mike Kahana, have known each other for 25 years. So I'm out of time, but I've really appreciated the opportunity to talk to you guys today. We have a timeline for commercialization, obviously, but I'd want to thank you for your attention here today.