Amir Danino Presents Innoventric at LSI Europe '23

Transcription

Amir Danino  0:05  
Hello, everybody. My name is Amir Danino. I'm the founder and CEO of Innoventric. And I'll present the Trillium cross cable technology to solve tricuspid regurgitation. So what is tricuspid regurgitation? It's not moving for some reason. Okay, tricuspid regurgitation is a backflow of blood coming from the right ventricle into the right atrium and the venous system of the patient. It leads to congestion and elevated pressures in the venous system of the patient. And tricuspid regurgitation is a highly prevalent disease with 4.5 million patients currently in the United States and Europe, with 500,000 patients joining the circle annually. Now there are only two treatment options available for tricuspid. regurgitation patients. The first medication which does not solve tricuspid regurgitation, medication only alleviate symptoms. And the second option is open heart surgery to treat the regurgitant valve. However, surgery is rarely carried out because of the high surgical mortality. And minimally invasive technologies are needed to treat tricuspid. regurgitation currently, and in the past two decades, dozens and dozens of technologies. By the way, this is just a drop in the ocean of the technologies that were developed for tricuspid regurgitation. These were developed. Many of these technologies no longer exist, but those who do exist still haven't reached the market. And there is not a single device on the market currently today to treat tricuspid, regurgitation. transcatheter and well, we have to ask ourselves, why is that? The reason is that the tricuspid valve is extremely difficult and complex environment to fixate and seal against. We've developed the Trillium device. The Trillium is a stent graft extending from superior to inferior vena cava with valves situated on the sidewall of the stent graft. Now, this is how the procedure looks like. Sorry, again. Okay, so we deliver a guide wire coming from the femoral vein into the superior vena cava. Over this guide wire, we deliver a 24 fringe delivery system, this delivery system is strictly fluoroscopy. Based, situated and positioned. Once we pull back on the outer sheath, the device which is self expandable is deployed and fixates to the superior and inferior vena cava. Now, the valve block the backflow of blood from reaching the Venis systems of the patient, and this really solves tricuspid regurgitation without interfering on the native tricuspid valve. It's a simple straightforward procedure takes less than 10 minutes to perform, and he does not require transesophageal echo. Therefore, it does not require general anesthesia. We have performed 34 implantation so far 20, out of which, as part of the first in human clinical study that was completed three months ago, we have 100% technical success with an average implementation time of six minutes, there is absolutely no device for valve replacement on the market or outside the market that can replace a valve within six minutes. We are taking patients with severe massive and torrential tricuspid regurgitation, all the way down to mild tricuspid regurgitation. And we are taking the venous pressure from 29 millimeters of mercury on average to 20 millimeters of mercury on average. And that's really big for patients. So what do we see when we follow up on these patients for a longer period of time, these patient tricuspid regurgitation patients come to the hospital very often, they get hospitalized for heart failure every few months, either for IV diuretics or for taking out fluid from the abdominal, usually using paracentesis. Now in our study, the patients had 62% of heart failure hospitalization rate in the six months prior to the procedure. Six months after the procedure, we already see a decrease in the heart failure hospitalizations by two thirds. And this persists throughout one and a half years by which we see a 73% reduction in heart failure hospitalizations. Now this is big for patients, their families, the health system and for the payer which may save up to $200,000 per patient But not only that we are treating tricuspid regurgitation patients very efficiently. We are also treating tricuspid regurgitation patients that are not addressed by any other technology, patients with a very progressive state of disease, like increased cardiac changed or enlarged cardiac chambers. Because of the progressive state of the disease patients with pacemaker leads, as you can see in the image before you patients with prior repair or replacement that did not work for patients. Now patients that we treat our or the technology that we use is agnostic to anything happening on the tricuspid valve because we are not intervening on the native tricuspid valve. This is why we can treat this patient population which no other technology can treat. And while all the other technologies are fighting for the 50% of the patient population, which is the earlier stage we can treat the entire tricuspid patient population. Okay. I want to show a case that really proves these statements. This is a case that we performed here in Barcelona seven months ago. It's a 68 year old patient with for heart failure hospitalizations in the year prior to the treatment, the patient was denied surgery and any other transcatheter treatment. Now we treated this patient in a nine minute procedure. With no general anesthesia. The patient was discharged from the hospital one week later, with seven and a half kilograms of excessive body fluids just taken spontaneously out of the body. And the patient now over six months later did not return to the hospital living with excellent quality of life. We have 20 patents in five patent families. With the main patent already approved in the US, Europe, China and Australia. Additional nationalities will follow. We have a patent portfolio which really protects the cross cable technologies. Our leadership has overseen 75 years of accumulated experience in taking structural heart devices from concept to the market. We have vast experience with growth and previous m&s. Our amazing team is very enthusiastic and really dedicated to the mission of treating tricuspid regurgitation patients and our world renowned physicians like Professor chattery Hall, former head of cardiology from Mayo Clinic, and Professor Philip Lawrence, who is the most prominent tree cut tricuspid regurgitation researcher in the world today are all very enthusiastic about the technology and dedicated for the cost. So what have we done so far? And what are we aiming to achieve? We have raised over $12 million in previous rounds. By the way the company was established in 2017, late 2017. And these $12 million have gotten us this far. In addition to that we've raised $4 million in non dilutive funding from the Israeli innovation authority that has acknowledged the company for three consecutive years. And from the European Commission, we are looking to raise $18 million as part of an a two round and these $18 million will take us through an early feasibility study which we are about to start in the United States and will allow discussions with the FDA for an idea approval for the pivotal study. Now, we have already signed a term sheet with the European Investment Bank for $5 million out of bat and we are gaining interest from strategic investors to be part of this round. And we are looking for the lead investor that will allow us to close this round. So if this is interesting to you, we are here today tomorrow. These are our contact details. Thank you very much