Robert Hamilton Presents Neurasignal at LSI USA '24

Robert Hamilton  0:00  
Robert. My name is Robert Hamilton, CEO and founder of neurosignal. Today we're going to be talking about the development and the solution for an automated cerebral blood flow assessment device, originally for the management of stroke. So I really wanted to start out with a patient's story to reinforce the dedication of the team to this really big problem. This is Michelle. She's a 44 year old preschool teacher here in Southern California who unfortunately suffered a number of Tia events and was eventually admitted to a local hospital. She went through the normal battery of tests to understand why she was having these strokes, well, as part of any stroke workup, you're going to get a transthoracic echo to understand what's going on in the heart, and as part of that, you're looking for what's a PFO, which is the hole between the upper chambers of the heart. Standard of care, tte missed this in her but luckily, the hospital had recently acquired our technology identified the significant right to left shunter PFO. The clinical team determined that this was a significant enough PFO that she went on to closure a few months later, and I'm happy to report she is doing well. This is just one example of many of the patients we have helped and highlights the importance of giving technicians or giving healthcare professionals the access to technology that they need to make the right diagnostic at the right time. So as a quick summary, neuro signal has commercialized a fully autonomous transcranial Doppler system, originally for the management of stroke within neurocritical care neurology. However, there are a number of different applications, through stroke and traumatic brain injury, spanning neurocritical care, neurology, cardiology and others. We have successfully commercialized now, to date, over 80 of our third generation systems. We are based in Los Angeles, and this this system is backed by a tremendous amount of clinical evidence that I'll be going through some of today. There are over 180 references for this technology. But as we all know, it's not just about clinical evidence. Unfortunately, it is paired with a great reimbursement model. So there are five existing CPT codes, great coding coverage and payment across private and public reimbursement. From the standpoint of a data pipeline, we have a great data pipeline set up, and have protected the technology with 47 issued patents here in the US and around the world. So as I mentioned, there's a number of different applications for the technology, but really I wanted to focus the team on cryptogenic stroke and its management. So when we're all in our mom's womb, we have a PFO between a hole in the heart, between the upper chambers of the heart. And most of us set closes when we're born. Unfortunately, in 25% of us it doesn't so 25% of us in the audience still have that hole there. Now for most of us, it's benign. It will never impact our lives. But in cryptogenic stroke, or in ischemic stroke, we know it's a leading cause of that stroke, and so we've seen from partners from Gore Abbott and others, that the closure of this PFO in these stroke patients, in selected patients, is excellent at reducing secondary stroke risk. Now, so if PFO is an important part of cryptogenic stroke workup, how do you diagnose it? Well, it makes sense that you would probably look at the heart to diagnose the hole in the heart. Well, it turns out that over meta analysis, many of these showed that the standard of care tte is actually very insensitive, less than a corn coin flip, at identifying this hole in the heart. If you look at these same meta analyzes, transcranial Doppler is much more sensitive at identifying this hole in the heart, believe it or not, so why isn't TCD used more well, TCD is a technology from the early 1980s that uses low frequency ultrasound to look at blood flow in the brain. So as those bubbles cross that PFO, they end up in the brain, and you can see them and visualize them there. But TCD, despite being in the guidelines, a requirement by the Joint Commission, is not used in a vast majority of hospitals. Only 8% of hospitals in the US actually use transcranial Doppler, and it's because it's so difficult to use now, through advancements you saw in the last session, whether it's thrombectomy or PFO closure, the need for transcranial Doppler has expanded dramatically in the last few years, and so we have developed the first fully autonomous transcranial Doppler allows any healthcare professional to actually acquire this data. Again, it can be used within neurocritical care, but expanding that for a number of different indications. The platform itself is a cart based ultrasound that you see there on the right or your left, and then it connects to our cloud platform as well as the EMR and PAC systems for these. Hospitals. From a business model perspective, this gives us a lot of flexibility. So right now, we have a CapEx model that allows us to sell the capital into the hospitals, and then there's a reoccurring revenue piece as well, not only on the disposable kit, but from a software and service perspective, these allow us to be very flexible in the different hospitals that we work with from a commercialization standpoint, although not the focus of today's talk, it is important to note that this data is very unique, and we are aggregating 10s of 1000s and hundreds of 1000s of these cases to date by collecting this dynamic cerebral hemodynamic information that is missed by every single PAC system in the US and around the world, from a market opportunity perspective, very focused. Start within cryptogenic stroke neurology and neuro critical care, obviously, when you add things like vasospasm, cerebral monitoring or these things go north of a billion dollars quickly. I wanted to quickly talk about some of the robust clinical trials and the momentum that we have over the last six months. This is the largest prospective study that was using our technology that was published last fall, showed that in this across these six sites, that we detected three times as many PFOs as standard of care tte. And if you look at the large PFOs, the ones that were should traditionally be referred to cardiology foreclosure, it was nearly 3x 2.7x so what we saw from this study was that somebody with no ultrasound experience can deploy this and identify a significant number of PFOs that are missed by traditional workflows. Clinical trials are great. However, we know that we need more information than that, so I'm proud to say that some of the largest IDNs in the country now have deployed this technology, published and presented the results that echo that of the bubble study that I previously showed. Just in the last six months, we've had very robust support for this, not only in the bubble study last October, but in a very flattering editorial that accompanied that. Recently, the AHA, citing our data, moved TCD within the workflow for cryptogenic stroke, and just a few weeks ago, there was a nice piece in the AHA supporting the replacement of tte with our robotic solution for the screening of PFO. Now, as we would all like, we wish clinical data was enough, but it is paired with a great business model. In addition to the guideline support as well as the requirements from the Joint Commission, we have five existing CPT codes, though they're often combined on the inpatient and outpatient sides, great coverage, again, from a coding coverage and payment perspective, all the way up to $1,500 per use of the device. This is paired with a reimbursement model on the unlocking of therapeutic access, which you saw in my patient case study at the very beginning. So this, partnering with IDNs has really given us the ability to leverage that a number of partners, which is very exciting, as we've commercialized now across a wide variety of hospitals. Revenues from last fall, when we really launched commercially, $2 million last year, expanding to nearly six, six and a half million this year. Well on track for that. I would like to talk briefly about near opportunities, near term opportunities, as we have closed a number of clinical trials, this finished a few years ago, and for large vessel occlusion. So once you get the ultrasound into these locations, the ability to measure cerebral hemodynamics is very important and opens up a lot of different opportunities. This obviously expands the market dramatically outside of just neurocritical care and neurology. So here we are fully funded today, here looking for partners excited about this area of medicine, and whether that's on the individual investor side, or the strategics from the pharma and medtech side. Thank you very much. Applause.