Fred Colen, Neovasc - Treatment of Advanced Heart Disease | LSI Europe '22

Transcription

Fred Colen  0:05  

Thank you very much. And good morning, everybody. pleasure for me to be here today. And to give you an update on Neovasc. First of all, I may be coming across to you quite convincing, but let me assure you, I cannot predict the future. And that's essentially what this says in a lot of legal terminology. So always be careful in investing and collect your own facts. The company has two core products in cardiology, I'm going to focus today on the Reducer, which is also the brunt of our efforts at the moment in terms of what we are developing and investing our cash on. The Reducer product on the left is a device that we'd refractory angina. It's a minimally invasive product to treat angina. We are commercial in Europe. We have we have been included in the European guidelines for the treatment of refractory angina. In the US, we have a breakthrough status by the FDA and we are in our pivotal clinical IDE study in the United States. I'm very proud to be surrounded by really a phenomenal and experienced leadership team. And really an organization that I'm in total extremely proud of very dedicated organization to bring these these products to the market and to focus on refractory angina for the treatment of these patients. What is refractory angina, it's actually a huge problem that is not really understood and and recognized well. I really believe and we really as an organization are proud of that to be at the forefront of what we believe to be a next revolution in interventional cardiology in the proper treatment of angina to begin with. When you look at angina, it comes in two different categories. The first one is basically obstructive coronary artery disease. It happens in a lot of patients, these patients get stunted or bypassed. What a few people will talk about is that there's still a lot of patients that still have angina, after stenting and bypass in the range of 20 to 30% of patients still have angina after these treatments. The other group of patients are the ones that do not even have coronary artery obstructions, and have angina that's the second group. And there are no good treatment options. For those patients. Either the remaining refractory angina patients was going to obstruction or the ones that don't even have coronary obstruction. Here's what we do, we have a device that is an hourglass shape that we put in the coronary sinus. So we don't treat anything in the coronary arteries, we basically go into coronary sinus and put a restriction the outflow of the blood that comes out of the myocardium. And when you do that, and the device gets proper endothelial eyes, after four to six weeks, we create basically a back pressure in all of the micro vasculature, all of the micro vessels in the myocardium that because of the back pressure that we create, because of this outflow mechanism, they open up a little more, they stand open a little more, and they get better oxygenated, and that reduces angina for these patients. We have a first randomized placebo controlled study that was done was published in the New England Journal of Medicine. A few years ago, this study was actually successful. I don't know how many randomized placebo controlled clinical trials in cardiology, there have been that have been successful, most were not successful. I was was successful. Basically, when you go through the details, you will see that there was a huge sham effect in range of about 40% of patients that believed to feel better after they believed to have been treated, but they were not treated. However, the treatment effect was reduced, it was about 70%. So it was a statistically significant improvement over the sham procedure, which is really a very unusual and very positive finding. Now, we are in with the FDA in the breakthrough device status. We are enrolling in the Coursera to clinical study in the United States. That's all pivotal study. It is a novel, randomized, placebo controlled clinical trial. We are going to be enrolling about 380 patients in North America that's in the US and in Canada. And I'm very pleased to tell you that just yesterday we received the approval from the Canadian authorities to also actually start the introduction of the study and to treat patients in Canada. So we're very, very pleased with that. We are already enrolling patients in the United States in about 12 centers and that's growing as we speak. We're very proud to have a really renowned card geologists like Dr. Greg Stone and Dr. Tim Henry being the PIs for this clinical study. I really like to just give you a little bit more background on microvascular disease what what is this? You know, how do we really get to treating angina? Again, here's the slide that I showed you before. It's the obstructive and a non obstructive coronary artery patients that we differentiate in. When you look particularly in the second one, the non obstructive note, we have an option has been available for that these patients get angiograms, oh, your coronary y's are wide open, there's nothing we can do, as opposed to the first one that gets stents are bypassed, they get treated, but then they still may have refractory angina. And that's typically how we identified the population in the first category. And the second category is very interesting. And here you see a picture of what you typically look at. You do coronary arteries, the big three veins, you see very clearly on the left hand side, the LCD, the circumflex. And the right coronary artery, the big coronary arteries is basically what interventional cardiology has been about in the last 2530 years, that has been the focus of our treatment. It's basically the big arteries that run over the heart that provide blood to the myocardium. What nobody ever talks about, is all these micro vessels that are underneath those, and there's no treatment being done on those, not in the last 25-30 years. So basically, when you look at coronary artery treatments, it's what we call the tip of the iceberg. The reducer has been included in the European guidelines as a to be option for treatments. So the device already that we have commercially in Europe is being recognized by the European guidelines. And what's also very important in the guidelines is that there is a recommendation to do more flow measurements do really flow measurements to find out is it a coronary artery disease issue? Or is it a micro vascular issue and to differentiate between those two? There are systems available to do those diagnostics. The one does one from core event that's Abbott and as a Philips system that provides wires and microcatheters to really identify the flow in the coronary arteries and identify Does this patient have coronary artery disease or micro vessel disease. And here's a typical example of that. These are the systems that are now available to do diagnostic testing. On the left here you see at baseline, the patient has CCS class three angina, severe angina FFR was point nine which is normal, that means the coronary arteries are wide open see of all, which is basically the Flow Reserve how much more blood can can be provided into the myocardium. And the patient is going to be active is only 1.7. So only 1.7, more times blood goes to the myocardium under activity. And the IMR does basically the resistance in the network, meaning in a microvascular was quite high 40. And you see four months later, after the implementation of the reducer, those flow numbers have changed. Now the patient is CSSP as one angina down FFR point nine two good and not change because we didn't do anything to the coronary arteries. CEFR, now 3.2 almost doubled the amount of blood being pumped into the myocardium under activity and the resistance in the micro network 12 versus 40 before so you can see clearly and objectively now the effect of the reducer. There are all kinds of other studies going on by investigators in the field to look at the same thing. When you use these new diagnostic tools. Can we see what we do so that was very exciting for us. And just last week at TCT Dr. Banai, our medical director presented his first 10 patients of the ino gaff population, meaning these patients have no coronary artery disease, have no treatment options, but have angina. And here is the preliminary data on this first 10 patients. And you see again, FFR, which is a measure for coronary flow performance in the coronary arteries is unchanged. But IMR resistance in the microvasculature goes drastically down. See of all the Flow Reserve how much more blood goes in when your active goes dramatically up. And are also goes a medically up I won't explain IRR. At the same time, the six minute walk test for the patient improves dramatically. And the CCS class is obviously reduced dramatically as well. So we have a lot of objective measures that are coming to the forefront. Now. It's no longer just subjective data. Seattle, Angela questionnaire all of these things show major improvements for the patient with the reducer device. So we're really really excited about this technology where we can in a much more optimal way to treat and patients now was coronary artery disease, obstructive or non obstructive? Because we treat microvascular disease from a reimbursement stamp point we are doing really well. In the US clinical pivotal trial, we are already getting reimbursed. That's already in place. We have inpatient outpatient reimbursement in place with CMS. We actually also introduced specific codes now in the CCS system for refractory angina. It didn't exist before. It was just angina but not refractory angina. That is also know, there were really leading the field and we're leading the field now and really looking at these issues for these patients. In Europe, we have an you'll be one reimbursements. In several years in Germany, we have a dedicated high cost of excluded devices reimbursement in the UK, we were the very first one to get reimbursement in France and there are new PreSonus shafts Tassie to our process with the very first company in the world that actually got reimbursed in France as well. And now we're working on countries like the Netherlands, Belgium and Italy. And here are milestones. Really, the top line is the most important for us as a company. It's all about getting us approval as the next major step in terms of value creation and progress for all therapy. Last but not least, in terms of financials, when you look at the end of the second quarter, we had almost $38 million of cash in the bank, we are well funded, we have cashed till about mid 24. Here you see the outstanding shares were traded on NASDAQ and TSX. And yet, when you look at our market cap in the market, the company is valued publicly at about $20 million. So we are valued at $20 million, which is about half the amount of cash we have in the bank. That is a fate that many US publicly traded companies have at the moment. It is very difficult financial markets. So we believe that there is a big opportunity for investment in our company. We believe that we are completely undervalued as relates to where we are, where we're going, and we believe this to be a great opportunity for investment. Thank you very much.