Wesley Jones, Vonova - Expandable Neural Interface Device | LSI USA '24

Wesley Jones  0:03  
Leslie, good afternoon. I'm Wesley Jones, CEO and co founder of Vonova, and today I'm going to introduce you to the future of brain interface. At vonnova, we're developing a breakthrough catheter platform making it easy for neurologists to obtain high resolution data of neural activity and brain function without the risk or discomfort of drilling through your skull, similar to the transeptile catheter and how it expanded the cardiac ablation market. Vannova aims to transform our approach to brain interface, addressing a $2 billion market opportunity and giving new hope to millions of patients with drug resistant epilepsy and other chronic neurological disorders. See, the reality today is the brain is still this mysterious and complex Marvel. Understanding as intricate electrical patterns and 86 billion neurons is key to unlocking cures to epilepsy and other neurological disorders. However, the reality today is we just simply don't have enough data to fully understand the underlying mechanisms of these diseases. Our anatomy that's designed to protect our brain is also the barrier to understanding it, non invasive imaging techniques like this functional MRI and surface scalp electrodes can only tell you the approximate regions of activity and at a low resolution. That's because the skull is a formidable barrier and acts like a piece of insulation preventing these high resolution signals from being recorded outside of the skull. Our only way to get that data is to literally get through the skull and put electrodes directly on the brain. But this is neurosurgery. It's no joke. It first requires cutting your scalp, drilling through your skull to expose a layer, what's called the dura, and then cutting that dura, it protects the brain back, folding it back to implant the electrodes. The biggest risks with these types of procedures are bleeding, infection and even brain damage. Shown here are there two standard techniques for acquiring this data, subdual grids on the left and stereo EEG, or depth electrodes on the right. Now, although both of these have been shown to be quite effective in gathering this data and driving treatment paths, especially for drug resistant epilepsy. There still remains this invasive barrier and people willing to undergo this surgery, just for data, for instance, subdural grids have been reported to have up to a 49% complication rate, so it's no surprise that 99% of these patients eligible for these procedures are never referred or never elected. So today, it's time to step into the future. The Cerebro Atlas system is our platform technology that offers a less invasive back door to the brain surface. It'll offer a higher resolution, spatial, temporal resolution equivalent to existing subdural grids, without that risk or discomfort of drilling through your skull, simplifying access to care by equipping the abundant neuro interventionalist with a new tool to get this data. Now this novel concept was invented by our co founder, Dr Jose Morales, who's also a neuro interventionalist, when he first observed this large unmet need while caring for epilepsy patients. Because the reality of these epilepsy patients is they have very little hope of a normal life after medications have failed them. 40% of the 50 million patients worldwide continue to live with uncontrolled seizures and their only treatment path invasive surgery, just to get data and tell you what your treatment options are. So it's no surprise that the vast majority are never getting treated, and thus live on with their chronic disabilities in fear when the next seizure is going to happen, imprisoned by their epilepsy. So they are ry and the Y of O Nova, which, if you're interested, translates to new hope. Now my story begins as a medical device engineer specialized in minimally invasive catheter based technologies. I spent a decade developing 11 of these products to market for Medtronic and acuteness, medical and the treatment of heart arrhythmia. Now, the challenge of regular heart activity is very similar to the challenge of regular brain signals. You have to first find where the irregular signals are coming from map and then alter or remove them. Well, going back several decades, in the case of the heart that used to require open chest surgery, until this unsung hero came about, the transeptile catheter that used your body's natural venous pathways through a vein in your leg to get access to left atrium expanded the cardiac ablation market to $4 billion size today. Now at vlnova, we're developing an. Analogous technology, the Cerebro Atlas system, is our platform technology, the less invasive pathway to get that high resolution data from the brain surface, but it will also be designed to not just record, to also stimulate. It consists of two devices, the Cerebro catheter, which is the platform technology, and the Atlas device, which is the brain interface that it delivers in our procedure, a neuro interventionist advances our catheter through a vein near your arm all the way up to this large vein at the crest of your brain. It's called the superior sagittal sinus, the same place where Synchron places their stent. Now, once we're in place there under fluoroscopy, we align our exit port and use a stabilizing balloon to control the penetration of a dilator across the dural wall and into the subdural space. Now, once access is confirmed under fluoro we'll advance our delivery catheter over the guidewire dilator, remove the dilator, allowing the advancement of our brain interface. The Atlas device then unfurls to cover a large area of 20 centimeters squared, consisting of 36 electrodes designed specifically for according local field potential. Now at volnova, We're revolutionizing the approach to brain interface, introducing safety and affordability to make the diagnosis and treatment of drug resistant epilepsy and then other chronic neurological disorders more available than ever before. Now, I know that was a great animation, but this is no longer science fiction. We validated this novel procedure through in vivo and cadaveric experiments with our Scientific Advisory Board, including Dr Gary duckweiler, who's the Chief of neuroradiology at UCLA, and a pioneer of catheter based interventions. He ran the first safety studies for the now standard aneurysm coils. We've also demonstrated the performance of cerebral Atlas in silico With special thanks to the virtual Brain Project, which have a phenomenal model that uses real human data and machine learning to reconstruct the brain function in what's called a virtual brain twin. Happy to share more about that later, and shown here, the Cerebro Atlas demonstrates superior spatial temporal resolution as expected, than the existing scalp or surface electrodes. Our target market, drug resistant epilepsy to begin with a $1.8 billion market opportunity with existing reimbursement and half a million patients in the US alone, waiting for answers, answers to where are my seizures coming from, and what are my treatment options? Our catheter platform and subdural grid will be first put into the system through a class two de novo pathway, and we've confirmed that the FDA were eligible for breakthrough designation. Then that same subdural grid, which is also designed for delivering energy, will be packaged into a follow on class three system. Now our objective with this catheter approach is to reduce the complication rates to less than 5% and increase the resources available to perform these procedures. This will be done by providing level four centers, a new service that utilizes very abundant neuro interventionalists, which outnumber neurosurgeons 10 to one. Now, Dr Morales and I have been busy over the last three years putting together a first class team of medtech professionals with startup to exit experience totaling $800 million in exits between all of us. So after three years, we're on the cusp of a complete paradigm shift. Our platform technology has the potential to transform our approach to brain machine interface, computer interface, but ultimately to get these drug resistant epilepsy patients to care sooner, we will also unlock the market potentials of computer interface, neuromodulation, subdural hematoma, drug delivery, all these opportunities downstream, because we are the platform opportunity. So the time to build is right now, because when you run out of hope, it's a very powerful thing, and that's the mission of von Nova giving new hope to millions of patients, first with drug resistant epilepsy, and then opening up the door and the floodgates for other chronic neurological disorders. Thank you. Applause.