Will Martin Presents IRRAS at LSI USA '23

Transcription

Will Martin  0:05  

I'm Will Martin, President and CEO of IRRAS. And I appreciate LSI for for having me here to tell, to tell our unique story. You've heard a lot over the last couple of days about stroke. I've heard a lot about time is brain heard a lot about the need to improve outcomes in these patients, but we haven't talked a lot about are the most critically ill patients, those in the neuro ICU with intracranial bleeding with traumatic brain injury, how to innovate and how to improve outcomes for these patients and at IRRAS that's our that's our focus neurocritical care. We're a unique Swedish American company. Our seed money was generated through key Swedish business persons when our inventing physician, a Greek neurosurgeon was studying at the Karolinska Institute in Stockholm. So instead of engaging US investors, US venture investors for our Series A and Series B, we actually took a unique route and went public on one of the secondary NASDAQ markets in Stockholm. So we are publicly traded in Sweden at this point. But 90 plus percent of what we do as an organization is based just a few miles down the road in San Diego. We have direct sales and education teams in key markets around the world. And as I'll talk here, in a few more slides, are commercially approved products, we actually now have a commercial partnership in place with Medtronic here in the United States. We're focused on that neurocritical care market, primarily on patients with intracranial bleeding, and traumatic brain injury. These are the sickest patients in the neurocritical care unit, only about 20% of these patients can live independently at six months after hemorrhagic stroke. hemorrhagic stroke may account for 15 to 20% of total stroke volume, but it accounts for almost 50% of total stroke death. And it creates an attractive market opportunity for us approximately two and a half billion US dollars in the US and Europe alone in these core areas of focus. And as our system provides automated irrigation, we're now seeing the ability to expand into targeted drug delivery for agents that can't cross the blood brain barrier. And that will allow us to exponentially increase the market opportunity moving forward. Those that came before me, Caitlin from brainspace. Those who participated in the fireside chat last night, outline this problem very clearly. So I won't spend much time. But if you slip on the sidewalk outside because it's wet, have intracranial bleeding, you're going to go to a local hospital and be treated in a rather antiquated fashion. Right, the latest tools now had been on the market for decades. The standard of care is a passive drain that uses gravity to Drain off excess fluids to try to remove those toxic blood materials. These catheters become blocked approximately 50% of the time they have to be replaced, they have to be flushed, they need external manipulation, which leads to unacceptably high rates of infection and also extended time and significantly increased cost to treat these patients. Our system IRRAflow is CE marked and FDA 510 K cleared to not only provide this needed fluid removal but also automated irrigation and continuous patient monitoring. So what says IRRAflow do in terms of the impact of its automated irrigation, the orange catheter is a market leading ventricular drain solid particulate very quickly collects and clots at those drainage holes compromising needed fluid removal with IRRAflow you can see the automated irrigation helps to keep those drainage holes free from blockage formation. But the irrigation also helps to dilutes the surrounding area, you can start to see the substrate background change over time. And the picture on the right you can very quickly see that the viscous material of chronic blood clot within the brain on the left compared to the diluted drainage after air flows automated irrigation. And so the impact of IRRAflow is combinate combination of irrigation and drainage has now been shown in more than 15 Peer Reviewed clinical manuscripts. And as a company we've started to evolve into more of the head to head prospective comparative clinical trials. The most recent clinical study looking at chronic subdural hematomas from the thought leading group in Buffalo, New York, led by Dr. Adnan Siddiqui and Dr. Alok Levy, the current president of the Congress in Neurological Surgeons showed that when comparing comparing IRRAflow to conventional ventricular drainage, irrigation with airflow what we call active fluid exchange resulted in statistically improved hematoma clearance rate. You're diluting and washing away that blood more Additionally, as well as reduced catheter related infections, less internal external manipulation, the ability with each irrigation bolus to wash the distal end of the catheter and prevent bacteria from colonizing the smaller dataset 20 patients in each arm but it also showed trending towards reduction and catheter placement, duration, length of stay and seizure activity that likely would have been proven significant with a larger dataset that will continue to build upon. The system itself is a true razor razor blade model comes with a small piece of capital equipment that we generally will sell but if needed will lease or do a disposable utilization placement agreement with hospitals. But more than 80 plus percent of our revenue is being generated and will continue to be generated by single use disposables, averaging 4000 US dollars per patient. Here in the US, we have a dual lumen catheter that's placed inside the brain, as well as the secret of the system a digital pump that controls the automated irrigation as well as the patient's fluid removal based on evolving condition. As I mentioned earlier, we are commercially available in key markets around the world. Yet over the past couple of years, of course, our commercial trajectory has been impacted by the COVID 19 pandemic neurosurgical ICU has been converted to COVID units and were approximately a year and a half, probably behind our early projections. And we spent much of the pandemic period where we couldn't travel and couldn't engage customers at our desired levels. By seeding the market with the quote unquote razors getting as many IRRAflow control units into the market with our global distribution partners with hospitals in the United States to prepare for increasing revenue moving forward as more patients are being treated. So over the last several years since the system has been commercially available each quarter we've increased the global install base and we're now starting to see the impact in growing revenue. Last year we did approximately $4 million US as a Swedish publicly traded company this is noted on the slide is 40 million sec, we have communicated to the market our expectations to grow that to north of 35 million in US revenue by the end of 2025 with the transition to cash flow, breakeven and profitability in 2025 as well. A lot of this future looking growth will be driven in the United States. In the fourth quarter of last year, we announced a commercial partnership with Medtronic, the world's largest medical device company. This pilot is underway where a number of Medtronic territory managers are now selling our IRRAflow system to their customers. Now, our Aris sales and Education team supports them handles the training as well as much of the customer interaction during patient treatments. This partnership immediately doubles our commercial presence in the United States. And as the partnership grows and evolves, we're mutually explore the expansion to more Medtronic territories throughout the course of this year. So what we end up with is an investment thesis that now is focused on commercial execution. We have a product that's been validated clinically, we have a product that's being adopted by key sites on both sides of the Atlantic, a growing pool of clinical evidence, and now post pandemic. Through our own direct teams as well as our partnership with Medtronic. We're focused on growing that commercial presence and driving that razor razor blade model with repeat orders of our higher margin consumables. Now, as a publicly traded company, we estimate approximately 20 million in additional investment will be required. In order to get us through our goals that have been stated in 2025. We have active, ongoing fundraising efforts, our lead investors own about 60% of the company at this point, they're looking for a companion strategic or institutional investor, to potentially engage in a private placement or a pipe that will then open up all public and private opportunities for the company moving forward. If you're interested. My contact information is on the screen. We have a wide variety of social media channels. Reach out to me here at the conference, or let's connect directly. Thank you very much. I appreciate the opportunity to tell you the story.