Will Martin, IRRAS - Intracranial Fluid Management System | LSI USA '24

Will Martin  0:04  
Will. I'm Will Martin president and CEO of IRRAS. I'd like to thank LSI for the opportunity to be able to tell our story. Nine minutes goes by very quick, so I'm going to jump right in. Got a lot of exciting updates to share at Eris. We focus on the world of stroke. Everyone's well aware of the burden of stroke, one of the largest health burdens globally, almost $200 billion in annual cost, just in the US alone. When you think of stroke most often, you're probably envisioning ischemic stroke, blockages of blood flow to the brain accounts for about 87% of total stroke volume. Ateris, we spend more of our time focused on the world of hemorrhagic stroke, active bleeding within the brain. While hemorrhagic stroke accounts for a much smaller percentage of total stroke volume, still causes, drives a significant percentage of total stroke deaths, 50% of total stroke deaths. These patients are critically ill with very little opportunity for improvement. Only 20% of patients with hemorrhagic stroke can be independent at six months, and those rates really haven't improved. In the world of ischemic stroke, there's been significant innovation. Hundreds of billions of dollars have been invested in driving innovation in ischemic stroke now, using wire and catheter, can chase clot to the forest deepest reaches of the brain, but in the world of hemorrhagic stroke, still dealing with dated, antiquated technology that hasn't improved for decades, passive drainage to bring down swelling is the standard of care. Those drains can become blocked up to 50% of the time, unacceptably high rates of infection and inefficient drainage and infection leads to extended treatment times and significant economic impact. At Eris, we're focused on bringing innovation to the world of neurocritical care, treating patients with traumatic brain injury, intracranial bleeding, intracranial infection. Since I presented here last time, we've delisted our company from being publicly traded in Sweden. We're now operating as a privately held us company just down the interstate in San Diego. Have a direct sales and Education team both in the United States as well as Germany and other commercial partners globally to be able to bring our innovations to a sizable market opportunity in the areas of just intracranial bleeding and traumatic brain injury, our primary areas of focus two and a half billion dollar market opportunity just In the EU and US alone, as our system brings the opportunity to irrigate directly into the intracranial space. We're also exploring further expansion into the world of intracranial drug delivery, delivering agents that may struggle to cross the butterbrain barrier, that opens up another even more sizable future market opportunity for the company. We're targeting this market opportunity with our era flow system, instead of a passive drainage solution that is the standard of care for these critically ill patients today. Era flow is a proactive therapeutic solution that provides not only the required fluid drainage, but also automated irrigation and tailored treatment based on the patient's intracranial pressure system. Is FDA cleared here in the US as well as CE marked and is commercially available in both regions. So the automated irrigation of era, flow is really the secret to improve patient outcomes. So take a look at the benchtop video on the right, the orange catheter is a market leading passive ventricular drain. Solid particulate very quickly begins to build up at the drainage holes that impacts the ability to remove toxic materials. Whereas, with era flow, the irrigation keeps the drainage holes free from blockage formation, the irrigation also helps to dilute the toxic material that is collected in the ventricles or other parts of the intracranial space. That dilution helps to keep the solid particulate in suspension, and leads, ultimately to enhanced removal of that toxic material in the US. We now have treated more than 1500 patients with the Aeroflow system, 30 plus leading stroke centers, with another 10 to 15 evaluating the product at any given time, this growing commercial validation is a sign that the system is being adopted by leading neurosurgeons and giving patients such as the one you see here, who was treated a couple miles away at one of the local stroke centers and did a patient testimonial video with us. Giving patients options that they previously did not have. In addition to that commercial validation, we're also have seen significant clinical validation of the technology's impact. Over 20 peer reviewed manuscripts now confirm the versatility and the effectiveness of the airflow system across a wide variety of pathologies, anything from a subdural hematoma, which is a collection of blood between the brain and the skull, to more severe bleeds, including intraventricular or intraparincremal hemorrhage, where generally an aneurysm has ruptured, all the way through a variety of brain infections, either ventriculitis or abscesses. The era flow system, with its ability to irrigate drain and provide targeted delivery of antibiotic medication or thrombolytic medication, has shown significantly improved results for these critically ill patients. A couple of snapshots of this collection of clinical data, most recently published by Dr Andrew Carlson and the team at the University of New Mexico, was a retrospective analysis looking at ear flow versus patients treated with passive drainage in their intensive care unit. With ear flow the catheter was in place for four days, whereas with passive drainage just under nine days again, cutting the time to ventricular clearance also by 50% and a 0% need to replace the drain, compared to almost 40% with a passive, external ventricular drain, those types of clinical improvements and reduction in complications are important, but this was also the first published literature out to an extended follow up period that showed improved functional outcomes with the airflow system. At 90 days, 86% of patients achieved good outcomes with ear flow, compared to only 37% of patients with passive ventricular drainage get the toxic blood outside of the intracranial space. Patients are going to do are going to do better and also improving that blood clearance reduces the need for follow on surgery for shunt placement, which is also confirmed in a statistically significant fashion by this study. Another snapshot done by Dr Ali Paul from Albany Medical College showed again, approximately a $18,000 reduction in per patient expense with airflow treatment reducing time in the ICU from almost 15 days to about eight and a half days, with elimination of catheter occlusion that requires replacement. Here in the US, we have a small focus team of territory managers and clinical nurse educators, but last year, at this meeting, I announced that we were initiating a commercial partnership with Medtronic here in the US. That partnership has, throughout the last calendar year, more than doubled our commercial presence. So in combination with the Medtronic team of territory managers, our team of clinical nurse educators helps to support and onboard the new customers, and that will continue to be one of the large growth drivers for our country or for our company, because last year, we did just over 4 million in revenue. We're projecting to do just under 10 million of revenue this year, as we move from a validation story to a commercial execution story, you know, emerging from the pandemic. We had a product that all of our neurosurgical intensive care units were converted to covid units, right? We went from a survive and advance type of mentality to as a company, to one that is now looking to accelerate. We have a product that has been commercially and clinically validated, we have a significant market opportunity, and now it's a matter to build upon these results and execute clinically with our team as well as our partners at Medtronic. At this point, now that we have taken the company private, later this year, we will initiate one additional fundraising round that is projected to take us through cash flow breakeven and contact information is there. It's much easier for for many investors to invest in groups that are privately held in the US, as opposed to publicly traded on a European exchange. If anyone is interested in learning more, I would love to discuss it with you. So thank you very much for the time today and have a great week. You.