Video Transcription
Mauro Sette 00:02
So I am here presenting Medyria. We are solving the problem of 12 million people that every year are suffering from angina pectoris. Angina pectoris is a serious disease that can evolve into myocardial infarction and must be investigated with angiography. Angiography is a diagnostic procedure, and if you take 100 patients going into angiography, 50% will have an obstructive disease that today guidelines say shall be investigated with FFR, fractional flow reserve. It is a pressure measurement. But then the other 50% will have a clean artery. So a negative angiography, a clean artery, can also hide a disease, which is called INOCA. So it's still ischemia with non-obstructed coronary arteries. This shall be investigated with flow, deriving a coronary flow reserve and with microvascular resistance, which is the quintessential measurement for INOCA. If we look at patient eligibility and the market size today, FFR is practiced in more or less 11% of the patients. So if you look at the 4 million geographies, it is a tiny piece of the cake, but still gives a 1 billion US dollar market value. If we expand from coronary artery disease to INOCA to the full patient population, then we can serve 100% of the patients. We can help 100% of the patients, so 4 million patients in the US and Europe every year. And that's why we have developed the PICA, the physiology catheter for truly full physiological assessment. How is the PICA composed? You have a micro catheter with our proprietary blood flow velocity sensor and a pressure sensor, so we can measure FFR, all the pressure-based indexes, also hyperemic and non-hyperemic. We can measure coronary flow reserve, and we can measure microvascular resistance without using dye, without doing thermal dilution, without using a bulky pump to generate flow. We just insert the catheter, and we measure as simply as you see here. We will need very little training for this operation, and the measurement is direct and immediate. We also have a component of machine learning algorithms, artificial intelligence, to get the best ever measurement and independence from the user. So the user, even if they are not well trained or capable, will make a very good measurement. Our positioning: today, there are seven, eight, and more companies working only in coronary artery disease; they only offer FFR measurement. The need of the market is to offer FFR and blood flow velocity-based measurement, and this is what we want to serve. Abbott and Philips today are the only two suppliers on the market with this type of solution. But we want to position the PICA as the best-in-class, the easiest-to-use device that will actually trigger the adoption and trigger the patient benefit for this type of diagnosis. If you compare the PICA measurement with the thermal dilution on the right and the Philips measurement, we are the most accurate. Thermal dilution has a problem of repeatability because you need to inject the dye using a bolus thermal dilution, which creates variability in the measurement. The Philips device is a bit better, but it is impossible to be used. Only four cardiologists on the planet are able to use the Philips device, while Medyria is very easy to use, and we have a 6% variability in the measurement, which will be the best in class. The market that we are addressing: there are 4 million procedures in Europe and the US, which will drive almost a 5 billion US dollar market. But if you go worldwide, it is much bigger. We're talking about 10 million procedures performed every year. Our path: we are going through a 510(k) clearance type. We have already had a pre-submission meeting with the FDA, which we agreed upon, and we have identified the predicate device. We are fully financed to arrive at that point. Before the clearance, we're going to perform a first human study just to prove the advantage of using our device. After the FDA approval, we're going to roll out sales in the US, tackle Europe, and go for global expansion. For doing this, we have opened a fundraising for 9 million euros. The technology is patented. We have five patent families covering the technology, and they are all based on our technology, which is the blood flow velocity measurement and the integration of this technology in different medical devices. The exit strategy is a full acquisition by a global strategic company that is active or non-active in interventional cardiology and would like to use the PICA to enter into this growing market of interventional cardiology. We're backed by a top management team and engineers that are fully dedicated to working in the company, a very premium top board of directors, and a very strong and motivated advisory board, and you could recognize some of the true KOLs in cardiac physiology in this world. So we are committed to improving patient outcomes. I want to thank you for your attention, and I still have two minutes that I want to give you for questions, if there are any, and here is the device. Actually, we have a sample here. If you want to know more, just come and talk to me, and then we can discuss it. Ah, please.
Mauro Sette 06:01
So what's the... there are obviously other people doing pressure and flow rate measurement with optical fibers in the cath lab and so on. What would you say is the biggest differentiator of your company? What makes you the best? Okay, so
Mauro Sette 06:15
the direct measurement of blood flow velocity is what we are doing. So we don't need... and I would say that Abbott is doing thermal dilution, so it's indirect, and the other company doing direct measurement is Philips, with the ultrasound device, which they have proven with the combo wire to have very poor usability. Now there are rumors they are coming out with a new device. Let's see if they are solving the usability problem. Besides those, we are the only ones making a direct measurement without needing dye or dilutions.
Mauro Sette 06:47
Thank you. Thank you.
