Mads Matthiesen Presents CathVision at LSI Europe '23

Transcription

Mads Matthiesen  0:05  
I'm the CEO of CathVision. I'm also the co founder of the company 14 years ago when I was a an engineering student observing cardiac ablation procedures in the US. So heart disease is a leading cause of death. Strokes are the third leading cause of death in the US with around 150,000 strokes per year. Heart failure is a common and very costly condition, with around 6 million patients in the US, and around 30 billion healthcare cost annually. Atrial fibrillation, abbreviated AF or AFib, is a very common cardiac arrhythmia that precedes around 1/4 of lethal strokes. Around one in four of us above the age of 40 suffer from AF and it's a lifestyle disease that's growing from 2030 estimates I will add another 5 million patients worldwide each year. The problem is that the first in line treatment, anti rhythmic drugs are not really curative, and we have a need to potentially cure and alleviate more patients with cardiac arrhythmias including AF. A therapy called ablation therapy, which serves to eliminate the focus from plating on the inside or the outside of the actual heart is offered to approximately one in 10 patients. A bigger problem is that only 50% of patients with persistent atrial fibrillation has a long term freedom from arrhythmia after the first procedure. So in our field, there is a very clear and understood unmet medical need of improving outcomes. And we can also see we need to do much more ablation procedures going forward. We have developed a system that lives in the operating room and that replaces a very archaic old legacy group of systems called EP recording systems. We record low noise intracardiac signals and ECG to provide better data for physicians that gives them more accurate information to take the critical decisions of when to treat and when enough treatment has been delivered. We have validated pristine data, around 5x improvement over existing marketplace, which allows physicians to see what they could not otherwise see, that drives the therapy decisions. We have as the only system real time analytics, which helps to interpret these heart signals and tell the physician whether or not treatment has been delivered or when and where to treat more. So altogether, we empower electrophysiologist to cure cardiac arrhythmia. Just to really reiterate on the value proposition, when you're looking from the hospital and the healthcare systems point of view, we need to increase the volume of ablations. And we need to improve clinical outcomes. We have software modules in our cardiolytic suite that serve to specifically increase the speed and the confidence in the volume procedures. We have something called PBR analyze, I'll come back to and we have clinical software that can help improve clinical outcomes, called the fast algorithm and second complexity. So we have analyzed the procedural flow for AF ablation and I won't bore you with all the details, but there are four critical steps during this procedure, where we have one real time analytical module for each step. We call them PBI analyzer, AF Freedom Fast and Signal Complexity. PBI analyze and Signal Complexity FDA 510K cleared. AF Freedom is a very ambitious software that can predict long term outcome and fast is a module that can guide the physician where to treat to dramatically improve clinical outcomes. To give you a sense of why signal quality matters. On the top left, you see an existing system today with a classic amount of baseline noise that is seen in all these operating rooms. On the bottom you see our system recording signals at the exact same time, visualizing a signal does not otherwise visible. And this is critical. There. For all arrhythmia. There are different signals that the physicians are looking for. And if you cannot see the true signal from catheters inside the heart, he won't treat or cure the patient. The problem today is existing systems apply what we call knotch filtering a lot of digital filtering, which distorts the actual signals. So the red signal in the middle on the right panel is a distorted signal from the original shape on the top and our system on the bottom preserves the original mythology with minimal noise on the baseline. This was the patient at Cleveland clinic that I observed with our system. So we've been in more than 10 US hospitals. This was around a 30 year old female patient who had what's called an accessory pathway from the atrium. So the ventricle, which causes arrhythmia, which really disturbs the daily life, we are able to visualize some sequence called unipolar signals which are otherwise drowning in noise. And in this female patient that was the sensory pathway visible in between the atrium and in between the ventricle and the atrium. And the physician was able to see a very small signal on the ablation electrode, which meant this is where the pathway was, as opposed to any nearby electrodes that are not ablating Were applying therapy would not be successful. So this patient walked out and have not had recurrences since. More dramatically when ablation energy is delivered today, there are huge side effects. Cryoablation is a freeze of the tissue where the electrodes come in contact with freezing balloon, and this causes huge artifacts. So this is how it looks like in the lab today without classic filtering. This is how it looks with classic filtering. And with our system, you can actually visualize the underlying underlying signals that really drive the decisions on whether enough therapy has been delivered or not. PBI analyzer is the machine learning based analytical tool to analyze if pulmonary vein isolation is complete. This is the cornerstone ablation for all AF ablations. This has been validated in a prospective multicenter study in Europe where we met our primary endpoint and we just installed this at NYU in the US two weeks ago. As the first as the first sight internationally. We have licensed our way exclusively into the fast algorithm developed in Toronto, which does signal analysis to analyze focal sources of atrial fibrillation, which will suggest where to ablate in the atrium in addition to the pulmonary veins, which is the standard of care today. This was prospectively tested in a randomized control trial in Toronto. It was a little bit underpowered, so it didn't mean it's p value. But we are continuing to work with validating how we may bridge the gap from the 50% outcomes we see with standard of care today. We have completed for clinical studies in the last two years, we have met our primary endpoints we're currently recruiting in one in Europe, and we are working on a very ambitious module that can predict long term freedom. We are selling our software on a volume based software subscription model is therapeutic software software that will inform what when to treat where to treat and when enough has been delivered can justify a price point at up to two and a half 1000 US dollars per procedure. And we are selling the software as such and if we were if we had the market installed base like the market leader GE had today, it would cause a dramatic change in the existing revenue for this product category that is currently selling US capital equipment. We are selling it as software and we are having the first paying customers coming on board now. We were FDA cleared with the base system a year ago we were FDA cleared with the PBI licensing complexity just heard one and a half months ago, we've had clinical evaluations at Cleveland Clinic, Hopkins, NYU, Langone Houston, Methodist, IU, Valley Health and others. We have excellent feedback, we've been able to permanently replace the existing systems in the market. And the key goals for us to reach next year is to really prove repetitive use everyday all procedures in 20 hospitals is to publish our clinical results. We have five manuscripts coming right now and as to prove our software based business model, which is completely changing the premise of our product category. We are currently closing at 12 million US round we have approximately nine of those secure already from existing owners, we are seeking 3.7 million from new investors. And we believe we are hitting some m&a triggers next year and we will assess during next year whether m&a or follow on investment will be would be the path would be the path forward. We have a management team, where we have delivered everything from idea to FDA clearance, four clinical studies completed. We have an experienced board of directors with industry experience in the EP ablation space. And if any of you are interested in hearing more, I'm here afterwards. Thanks for your attention.