FAST Biomedical | Joe Muldoon, CEO

(Transcription)

Joe Muldoon  0:02  

Good morning. Thanks for your time this morning and the opportunity to talk to you about how we intend to transform heart failure therapy. The burden economically and more importantly, humanly is enormous and heart failure. And everybody in this room knows it. Everybody in this room has somebody they love that has had to deal with heart failure. US hospitalization costs alone are forecast to be $35 billion by 2030. And what's interesting is 90% of the patients that show up at the hospital and get admitted for heart failure, it's due to fluid overload, yet, we don't have a clinically viable way to directly measure what your fluid status is. So when you talk to the clinicians that care for these patients, they say we're making treatment decisions in the dark. What do they do today, they do a lot of things. They do physical exam, they combine it with a lot of surrogate markers, and they try and interpret all of these to assess where the patient's volume status is. The challenge is that individually, and even Collectively, these have been shown clinically to be poor surrogates of what your actual volume status is, and none of them give you the ability to serially track volume. We change that our technology is an inert injectable marker that works in concert with a device. So we give you a bolus injection of our fluorescent marker, it's three milliliters and solution it distributes, we take a very small timed blood draw at about 15 minutes, send it to our lab based device and we have an accurate volume measurement back to the clinicians bedside and 45 minutes. They love that they also love that once you dose that patient, you can get as many volume measurements as you want. Over the next six hours, you need to take an updated blood draw. You don't have to reduce the patient so they can see where they are, they can intervene with therapy, and then they can see if that therapy is working titrated up or down or change it. Some of these patients are Cardiorenal. If you want to know their kidney function, the technology gives you the ability to do that as well, you need to take two more blood draws. We have a fleet of these devices built their performance has been independently validated by the advanced research and diagnostics Laboratory at the University of Minnesota. So we're prepared for our future clinical trial work. And we've completed five clinical trials to date, we've dosed 157 patients, we've given them 205 doses collectively. And we've conducted these trials, over eight different sites in the US and Germany with multiple different treating physicians in increasingly hectic environments. What we've shown is we have metrics that are precise, reproducible, accurate and safe. We've shown we can accurately measure volume as it's going up. And as it's going down with high reproducibility. In the lower right, we showed against a research gold standard, we had point 9992 Correlation over all levels of function was accurate to the research gold standard as it is to itself. Most interestingly, we did a trial in heart failure. It was a small observational study, we did it in Berlin, the Charentais hospital network are experts in the space, we took 50 patients, and showed that the standard of care clinical assessment of volume is wrong 58% of the time, when we say wrong, we mean it was off 10% or more 1% probably doesn't matter. 10% definitely does. And when we gave physicians an accurate assessment, they changed the therapy 80% of the time, often reversing it, patients were actually getting wetter, we felt they were getting drier or vice versa. We think this is likely to deliver superior outcomes. And we saw some signal on that with a 50 patients study, we're not able to prove that in a statistical significant way. We thought the data were good. We knew that was the case when we started sharing it with key opinion leaders around the world. And they said we always suspected we were bad at this. Nobody ever proved it before. We harnessed that enthusiasm and formed a world recognize heart failure Medical Advisory Board. This is the who's who in heart failure, over 2000 peer reviewed publications among them. They are the PI's on all of the major heart failure studies. They're the editors of the leading journals and leaders of the key heart failure societies. We have strong intellectual property on this 42 patents abroad global coverage on the injectable device, math package and methods of use. And we have an experienced management team. Our small team has over 120 years of experience from founding funding commercializing and exiting technologies. Our most recent edition Steve has been designing the right heart failure trial for rapid commercial adoption his entire career And we've surrounded ourselves with deep domain expertise with our board of advisors, Big Pharma device diagnostic and capital markets. Our most recent edition Jim Dylan has been commercializing heart failure devices his entire career, including with St. Jude Medical, and Mr. Cornelius, who's a special adviser to me as the retired CEO and chairman of Bristol Myers Squibb. We have a really strong General Medical Advisory Board. They're the key opinion leaders in cardio, renal and critical care. These are two very logical adjacencies to where we can go outside of heart failure. Next steps we're gonna raise money for and conduct one final approval trial. And it is a rare harmonized approval trial where we get clearance and both US and Europe at the same time. It's a single study 175 patients 15 sites, our endpoints are safety and accuracy only. The review in the US is led by the device side of the house and their 510 K like endpoints. Most interestingly, we invested in market research recently, health advances went out to us academic medical centers established this was a huge pain point for them, and that what they were asking for was a data driven discharge decisions to reduce readmissions rates, optimize length of stay and limit resource utilization, then they were given our product concept and they said, That's it. We don't need to see any more clinical evidence we just needed it approved, so we can bring it in and use it. There's no way this isn't going to help us with these high cost bad outcome patients. So we know the markets there we need to get through this final trial. It completely syncs with what we heard on our own. We were blessed to be a med tech innovator showcase 50 company that afforded us a lot of opportunities, including the ability to present to UCLA health value analysis committee, although we don't have approved product yet. And they said this is going to lower inpatient and post discharge events, lower readmission rates, this is a quote slam dunk. We'd budget $500,000 For the first year. We just needed to get it approved so we can bring it in. Commercialization and pricing. If we do end up commercializing it on our own, we'll do a combination of direct sales and licensing will focus on us academic medical centers. First, the injectable sells for $250 per dose, and the device sells for $45,000. Capitalization to date, we've raised 27 million in equity and we've augmented that with $8 million of non dilutive financing mostly from the NIH. And we're out in the market now with a series B raise of 25 million. That'll get us to the commercial stage in 30 months, we're mostly preparing and executing for that final 175 patient approval trial and then filing for our approval. The business gets big quickly. If you commercialize it yourself and the growth engine is the high gross margins on the injectable exit scenarios are very favorable. CardioMEMS sold for half a billion dollars at the time of regulatory approval. And we could commercialize it further ourselves if we need to. So key takeaways, clinical validation of performance, strong barriers to entry. The vast majority of the products and the regulatory risk is already discharged. We have a clear, harmonized regulatory path with only one trial remaining for strong validated adoption. Thank you