Amir Danino, Innoventric - A Solution for Treating Tricuspid Regurgitation | LSI USA '24

Amir Danino  0:03  
Hello everyone, my name is Amir Danino. I'm the founder and CEO of Innoventric. And I would like to present to you our cross cable solution for tricuspid regurgitation. So what is tricuspid regurgitation tricuspid regurgitation, also referred to as TR is a backflow of blood coming from the right ventricle into the right atrium and the venous system of patients it leads to congestion in the venous system and also is associated with reduced cardiac output. There are currently 4.5 million patients suffering from tricuspid regurgitation in the United States and in Europe. Now, the treatment options for tricuspid regurgitation or either medication which does not solve TR it only alleviate symptoms and open heart surgery. But open heart surgery is offered to a very scars portion of the patient population because of the associated mortality rates. So it's clear that we should have a minimally invasive solution for tricuspid regurgitation. And indeed, in the past two decades, dozens and dozens of companies you see here, just a drop in the ocean, have attempted to solve tricuspid. regurgitation. percutaneous LEE Well, still today, there is just one single device recently approved on the US market. And we have to ask ourselves, why is that? Why so many companies so many projects, so many billions of dollars and not a solution on the market? Well, the tricuspid valve is a very complex anatomy to seal and fixate the valve against. This is why we've developed the Trillium device. The Trillium is a stent graft extending from superior to inferior vena cava with several fenestrations on a tie wall. These fenestrations are covered by uni directional valves. The procedure looks like this. We deliver a guide wire coming from the femoral vein going all the way up into the superior vena cava. Over this guide wire we deliver an eight millimeter 24 four inch delivery system. Now the procedure is strictly for Rosco P based no need for Echo guidance no need for general anesthesia. Once we pull back on the outer sheath, the self expanding device fixates into the superior and inferior vena cava and the valve start to operate immediately according to the pressure gradient acting on them, abolishing the backflow of blood from reaching the venison system and preventing the congestion. Now it's a simple straightforward procedure takes less than 10 minutes to perform and does not require transesophageal echo or general anesthesia. We have performed 36 implementations with this technology so far 20 out of wages as part of the first in human clinical study conducted in Europe, Germany, Belgium, Spain and Israel. We have seen an average implantation time of six minutes there is absolutely no valve replacement on the market or outside the market that can replace a valve within six minutes. We've taken patients with severe massive and torrential tricuspid regurgitation all the way down to mild and we saw a reduction in central venous pressure from 29 millimeters of mercury on average to 20 millimeters of mercury. But what do we see when we follow up on these patients for a longer period of time. So one of the most significant implications of tricuspid regurgitation is the heart failure hospitalizations associated with it. We saw in the study in the six months prior to the procedure 62% of heart failure hospitalizations, meaning that all patients had at least 62% of patients had at least one heart failure hospitalization in the six months prior. Well in the six months post we already see a reduction down to 25% of heart failure hospitalizations, and this persists through one year, one and a half years where we already see a 73% reduction in heart failure hospitalizations. Now this is very significant for the patients for their families for the health system, but also for the payer which may save up to $200,000 per patient. But not only that we're treating tricuspid regurgitation very efficiently. We're also treating a patient population which is otherwise ineligible for any other treatment options. For example, we treat patients with very large anatomies large cooptation gaps large and large valves. We treat patients with pacemaker induced TR. We treat patients with previous failed prior procedure on their tricuspid valve like repair or replacement. These patients have no treatment option but because we are agnostic to anything happening on the native tricuspid valve we can treat these patients in addition to high or prohibitive risk for transesophageal echo or general anesthesia. We're a Built to treat this 50% of the patient population. And while all the other technologies are aiming for the earlier stage cohort of patients were able to treat the entire patient population. This case really exemplifies everything that I've just presented. It's a 68 year old patient that has undergone two previous open heart surgeries has undergone one repair percutaneous repair of his tricuspid valve and all did not work for him. He had four heart failure hospitalizations in the year prior to the procedure and was facing end of life. We treated this patient with no general anesthesia in a nine minute procedure. One week later, the patient lost seven and a half kilograms of excessive body fluid. And now over a year from this procedure, the patient did not return to the hospital and does not suffer from TR symptoms. Now it's cases like these that really create the very large and growing fan base for this technology. And you can see all the procedures that we have done just recently, and what the people who actually use this technology think of it. We have received the FDA approval for an early feasibility study which we are now initiating in the United States with the best structural heart centers in the United States. In addition to three very strong clinical centers from Germany, we have 34 patents in five patent families. And we are already approved in Europe, US, China, Japan, Canada, Australia, and more. Our leadership team has over 75 years of accumulated experience in r&d, Clinical Affairs, regulatory affairs, and also business development and previous m&a Is this beautiful team that I love working with is responsible for everything that we've just seen. They're very dedicated for the cause of treating tricuspid regurgitation patients. Our team of world renowned physicians include people like Professor Jeffrey hole, former head of Cardiology at Mayo Clinic, Professor Bill Abraham, one of the top heart failure specialists in the United States, and Professor Philip Lourdes who is the most prominent tricuspid regurgitation researcher today. So where are we and what are we aiming to get? We have raised over $12 million. So far, this has got us this far. In addition to that we've raised $4 million in non dilutive funding from the Israeli innovation authority and the European Commission as part of the horizon Europe project. We are currently raising our B round that will take us through the early feasibility study, the ID approval for the people that have study in the United States and Europe and will allow us to initiate the people to study now this round is already at advanced stages. So if this is interesting to you, please reach out to me these are my contact details. Thank you very much.