Video Transcription
Jeffrey Lietzke & Emilio Sacristan 00:02
So Vacere Medical treats the world's leading cause of disability and the number two cause of death worldwide, and that's stroke. Stroke comes in two major forms, ischemic and hemorrhagic. On the left here, you see a hemorrhagic, sorry, an ischemic stroke. And that ischemic stroke in the yellow zone is showing downstream blockage. The brain tissue is beginning to die immediately because there's a blockage in a blood vessel in the brain. On the right, in that oval circle, or in the aqueous oval there, you see an aneurysm. When those aneurysms fill up and expand, they very often burst. And a burst aneurysm is an emergency event. Surgical intervention is required, literally, brain surgery. After a successful surgery, the patient is sent to an ICU. Four to seven days after that surgery, the bleeding in the brain from the event triggers something called vasospasm in about a third of these patients, and vasospasm leads to death or disability in 50% of those patients. Dr. Sachs will tell us more in a moment here. But in our first human trial of six patients, the result was 0%. We eliminated death and disability from vasospasm. We're non-invasive. It's a two-minute treatment cycle in an emergency scenario. First, we're in the ICU. We intend to go then to the emergency department and eventually work our way into ambulances. What we're really doing is relaxing the cerebral vasculature and improving blood flow, restoring normal blood flow at a time that is critical to patient outcomes. That's really what we're about: improved standards of care, improved patient outcomes. We're an adjunct technology, right? We add to the current technologies; we do not displace them. But this one device and this one mechanism of action is expected to treat not just vasospasm, but also ischemic stroke. The FDA has given us an IDE for ischemic stroke, which will commence soon. Our study will commence soon at the Cleveland Clinic.
Jeffrey Lietzke & Emilio Sacristan 02:21
Thank you. Okay, so how do we do this? Our central nervous system has a rapid control mechanism to regulate blood flow to the brain. This is what allows us to stand on our head and do a flip without passing out. In this system, the central nervous system controls the blood vessels, the arteries through the facial nerve. The facial nerve comes out of the skull, hits a little knot called the geniculate ganglion, and then spreads into several branches that innervate the smooth muscle of the artery, allowing it to contract or relax the smooth muscle of the arteries. And this is our target. The ganglion is a very convenient target to stimulate because it has the anatomy that allows us to easily trigger the nerve. We do this by placing an electromagnetic coil that looks like a paddle on the side of the face, and we use the ear canal to help us locate it and properly direct it to target the geniculate ganglion because the ear canal points straight to the geniculate ganglion. Then we activate this coil through a sequence of rapid magnetic pulses that cycle through over two minutes, and that actually manages to trigger the facial nerve. The result is widespread vasodilation of the cerebral arteries, which, by relaxing the wall, reduces the chance of bleeding. The pressure goes down, the strain on the vessel wall is reduced, and we can double the blood flow to the brain, which, through collaterals and being able to flow around the clot, will restore blood flow to the brain. In the first clinical trial, which was done at the Mexican National Institute of Neurology and Neurosurgery, patients that had a burst aneurysm had been operated on and were recovering in the ICU. Four to six days later, they developed signs of vasospasm. They were taken to the angiography suite right next door to confirm vasospasm. You could see here, the yellow arrows point to these constrictions where the smooth muscle just contracts and blocks the blood flow. Right then and there, in the angiography suite, we stimulated the patient for two minutes, waited a half an hour, took a follow-up angiography, and you could tell that the blood flow was restored. This happened in all the patients we treated. They all recovered. They all went home within a week; none of them showed any kind of neurological impairment. When we presented this data to the FDA, they were really excited about it. They, along with the NIH, gave us another grant to start clinical trials in the U.S. for stroke, and we were also granted a humanitarian use designation for vasospasm based on this data.
Jeffrey Lietzke & Emilio Sacristan 06:07
So it's a pretty amazing technology. Non-invasively, it makes a terrific difference, first in vasospasm patients, some of the most difficult cases in hospital systems, very vulnerable patients, with a 50% death and disability rate. I love the outcomes, and it's been 10 years of work led by Dr. Sachs. We wanted to protect this, right? So we have an extensive patent portfolio issued in the U.S., in China, and in Europe for our three major patent families. It's a team with a pattern of progress, right? And we all like to see that in ventures. I'll show the team in a moment. We've all had medical device founding, commercialization, and exit experience, but here in this venture, the science is confirmed in a lot of ways, some of which we've shared. We also have 10 peer-reviewed publications. It's safe. We had a healthy human subjects trial that established safety and dose response. It's very convenient; it's always important for this to work in physician workflow, and we do. It's also very convenient in that it's non-invasive for physicians. It's convenient for patients too. We have results, right? We knew the theory. We knew why it worked. We knew that it worked, and we, after permission to study in humans, got the data showing that it does work, and you saw a great image there with yellow arrows a moment ago. It's a platform technology; we are relaxing the vasculature. We are restoring normal blood flow. The FDA saw what we did in vasospasm as part of our IDE application and granted the IDE for ischemic stroke. Cleveland Clinic has approved our protocol. In migraine, we'll commence a study very soon with a strategic partner. Migraine is characterized by vasoconstriction before the migraine headache sets in. So we're excited about prospects in that space. The team is a seasoned team, and we've done a lot in med tech over time. Emilio and I are on the board, as is Gian Savoir, whose family office has funded us to date, Savoir Capital. He's terrific. I love this team. I've worked with Stephanie for 25 years now. Current ways is $6 million, and what we'll deliver on that is an FDA HTE. There's a lot of work to get to that HTE, but we anticipate it by the end of next year. That will allow us to sell, will get us to revenue, will get us data and outcomes, and physician relationships and hospital relationships. We'll also, by the end of next year, have data in migraine from our migraine study, and we'll have data in ischemic stroke, and that study will be completed by December of next year. On the basis of that, we'll grow into 2026. So we're here today to ask everyone to join us in fighting one of the world's leading healthcare problems. Thank you. Applause.
