Amir Danino Presents Innoventric at LSI USA ‘23

Transcription

Amir Danino  0:05  

Thank you Scott and Kelly for the great opportunity to present here at LSI. My name is Amir Danino. I'm the founder and CEO of Innoventric, and I'm going to present the Trillium device for the solution of tricuspid regurgitation. So what is tricuspid regurgitation, and we just heard a very good explanation about it. Tricuspid regurgitation is a backflow of blood coming from the right ventricle into the right atrium and the venous system of a patient. You can see in the picture before you the green arrow depicts the right are the correct blood flow direction. And with tricuspid regurgitation, you get also backflow of blood in the direction of the black arrow into the venous system of the patient, therefore causing congestion and elevated pressures. tricuspid regurgitation is highly prevalent, over 250,000 patients joined the circle annually, and that's in the US alone. tricuspid regurgitation has two treatment options. One is the open heart surgery. So open heart surgery is rarely carried out because it has high surgical mortality rates. The other option is medication. However, tricuspid regurgitation is not solved by medication. It's only managed by medication, and patients treated with medication have 60% mortality rate over a three year time timeframe. So we need something less invasive in order to treat tricuspid regurgitation. And this has been done in the past 20 years, dozens of companies dozens of projects have attempted to transcatheter ly treat the native tricuspid valve and replace it. And still today there are not a single device on the market for replacing transcatheter li the tricuspid valve and why is that? So some of the reasons are here before you and I will say just a few. It's a huge valve. It's constantly growing. It's constantly moving, and it has delicate structures such as the cord, a tendon A and the valve leaflets. We take a totally different approach, we've developed the Trillium device. The Trillium is a stent graft extending from the superior vena cava to the inferior vena cava. It has affinest Several fenestrations on the sidewall of the stent graft, and these fenestrations are covered by uni directional valves. Now, the procedures, the procedure looks like this. So we deliver a guide wire coming from the femoral vein all the way up to the superior vena cava over this guide wire, we deliver a 24 Ferencz delivery system. The procedure is strictly fluoroscopy based, no need for Echo guidance. Once the device is in place, we pull back on the outer sheath, it's an self expandable device immediately starts to operate and to abolish the backflow of blood from reaching the patient's Venis system. This eliminates the congestion. This also reduces the elevated pressures in the venous system of the patient. It's a very simple straightforward procedure takes less than 10 minutes to perform. And there's absolutely no need for Echo guidance, therefore no need for transesophageal echo and no need for general anesthesia, which is really big for patients. We have implanted the Trillium device in 26 patients so far 17, out of which, as part of the first human clinical study conducted in Germany, Belgium, Spain and Israel. We have 100% technical success and technical success in the study is, is defined as the ability to deliver the device the place deployed, take the delivery system out with no malfunctions. And that's really something that you can accomplish in the first in human study, only with a very simple device and procedure. The average implementation time throughout these 26 implementations is six and a half minutes there is absolutely no valve replacement out there that does that so simply and with such a short implementation time, all patients in the study are reduced from torrential severe massive TR all the way down to mild TR all patients demonstrate with reduced central venous pressure. What do we see when we follow up on these patients so all patients present with improved clinical capacity. So it's quality of life using the KCQ questionnaire, leg edema is reduced six minute walking distance, the functional capacity of patients is also improved. But most importantly, these patients come to the hospital not Much less even within six months post procedure we see 30% reduction in heart failure hospitalization rates, and that's very big for patients, their families and the hospitals. It's all about treating patients. And it's really getting very exciting when we're treating patients that have no other options. So this is just an example of a patient we've implanted last month in Barcelona clinical. It's a 68 year old patient that had previous open heart surgery so could not get a redo. The patient was treated for tricuspid regurgitation transcatheter li he received the cardio band, which is an annular ring running across the annulus of the tricuspid valve and the patient was in the cargo van did not solve TR for this patient, and the patient was not eligible for any other transcatheter technology. Also, this patient could not undergo general anesthesia. We treated the patient with no transesophageal echo with no general anesthesia. The procedure took nine minutes to perform. And the central venous pressure dropped from 29 millimeters of mercury to nine millimeters of mercury which is really the normal level. The patient lost 7.5 kilogram kilograms of excessive fluid and was discharged home. We have a strong patent portfolio containing 15 patents in five patent families. The main patent is already approved in the US Europe, China and Australia we have additional patents to cover the entire cross cable tricuspid regurgitation landscape. Our leadership leadership team has vast experience in technology engineering, business development, including previous M&A's and in clinical application in Clinical Affairs. Our team of world renowned cardiologist that we work with include Professor chattery Hall, former head of Cardiology at Mayo Clinic, Professor Bill Abraham, one of the top five US cardiologists, professors to find where hey and Professor Joseph Barton neck from Belgium, Professor Philip Lourdes who is also the lead PI in our first in human clinical study, Professor Joseph prodesk, abou and many more. So, what have we done so far in what are we going to do? We've raised over $12 million as part of the seed round and a round of investment and in addition to the $12 million. We were also acknowledged multiple times by the Israeli innovation authority, and also by the European Commission adding $4 million in non dilutive funding. These funds have served us in getting from concept by the way the company started in 2017. So getting from concept to the completion of our first in human clinical study. And we are now looking to raise additional A2 round for the amount of $10 million. These $10 million will take us all the way through an early feasibility study that we are about to start now in the US and will provide us with FDA approval and Id approval for the US pivotal study. We have just last week signed a term sheet with the European Commission for additional 4 million euros. So if this was interesting for you, and you there's another slide I can't seem to get to it. Great. Thank you. If you're interested in in learning more about us, these are our contact details. We're here today. We're here tomorrow and we would love to talk to you. So thank you very much