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Idgar van Kippersluis Presents AMT Medical at LSI USA ‘23

AMT Medical has developed a suture-less medical device that makes open-heart surgery less complex for interventionists and safer for patients.
Speakers
Idgar van Kippersluis
Idgar van Kippersluis
CFO, AMT Medical

Transcription


Idgar van Kippersluis  0:06  


Hi, good afternoon to you all. My name is Idgar. And I'm here to talk to you about a wonderful innovation, that it really has the potential to set a new standards for heart bypass surgery. I want to start out today by showing you a picture of my father. And the reason I'm doing that is that he's actually the motivation that I'm doing this work. My father suffered from severe heart issues and had to undergo bypass surgery a number of years ago. And number of complications occurred in this this procedure, and he actually had to spend about a week in the intensive care unit, and never really recovered to his full self afterwards. I think part of that is just that the old procedure has been just incredibly invasive and can create these traumatic experiences. And so to me, it's a reason to see if I can contribute to bring a product to market that will make this less invasive. As we all know, I think coronary artery disease is still the single largest cause of death. In our world, an incredibly high percentage of people are actually affected by this, I'm sure all of you know someone who has been affected by it. And I'm afraid that a pretty large proportion of people in this room may actually be be faced with it as well, personally. Overall, about a million people need to undergo this surgery worldwide every year, like my father did. And the shocking thing is that the techniques and technologies used for this procedure haven't really changed much in the last 30 years. So there's a real need for innovation in this area to make it less invasive. The problem with the current procedure is that it's it's incredibly invasive for patients. When the ribcage is split open, the patient is put on the heart lung machine, the hardest stop the blood flow is interrupted. As a result, you'll see long hospital stays, you'll see all kinds of complications, and very long recovery times. For surgeons also, it's actually a quite demanding procedure requires a lot of training a lot of skill and experience. And as a result, you'll see that they're the results of the bypass can vary quite a bit with the quality of the surgeon. Now we at AMT medical have created a device that can really create a solution for these issues. It's of course a huge markets and there is not really any successful competitor on the market. So it's it's really a blue ocean. If you compare sort of today's standards, you look at it the this whole process of you know, splitting the splitting open the sternum, stopping the hearts, it's and then having hand suturing with just really a thread and a needle. Some people have described it to me and maybe a bit exaggerated as almost a medieval procedure. And what we're putting, by contrast, in place of this is the use of a heart clip and a laser catheter to make a very safe and standardized bypass connection, which doesn't require any kind of hand suturing. And there's not going to be any blood leakage. So the benefits of this are going to be very clear to both the patients and the surgeon because it's going to make the surgery less invasive. In the first stage, we're going to be applying our solution which is called a ELANA, we're going to be applying it in the open setting to prove its safety. We've already done that with with with 10 patients. But in the open setting already, there are some some clear benefits. The heart doesn't have to be stopped it can be performed on a beating heart. It's really an enabler for the for the off pump solution, which gives much better clinical results for the patients. But also, it's just it's a standardized solution. So the quality of the bypass connection will always be the same and doesn't really depend on the experience of the surgeon. But really the next step and the big promise is that this can be applied in The minimally invasive setting, so you won't have to open the rib cage anymore. It can be done through keyholes between the ribs. And it also lends itself very well to application by by robots. Why is this going to work, and we're actually quite convinced it is going to work because it has been proven before in the brain. The original invention was made by Professor silica, who was actually the father of our current CEO. He was a brain surgeon, and it was developed first in the brain. And it already got CE and FDA approval a long time ago. But even though it saves quite a few lives, commercially, it turned out to be very small markets. So then all the patents were transferred to our new company, AMT medical to further develop developing the solution for the heart. And so we have a very strong portfolio of battens like I said, started out in the brain and took many, many years to develop it further for for the heart. And last year, we had a major breakthrough with the first 10 human patients and the results were very, very promising. On the back of death, we're launching a much larger clinical trial in Europe. And they're also starting in the US later this year with the first patience. So the timeline is such that we are aiming for commercialization in Europe and 25. And in the United States in 26. So during the first 10 in the US, at the end of this year, early next year. And that will be followed up immediately with a larger clinical trial to get the FDA approval. We're doing all of this work with a just terrific team of about 20 people all together, you see the management team lined up here. And we're also at Feist by a great board of clinical advisors. Some of the you know top top medical professionals from from Germany from the Netherlands, but also from from New York, Chicago and UC Davis in California. So it's always very motivating to see that so many of these people actually believe in the product. So this brings me to the final point which is which is our our next investment round. We're going to need 25 million we're going to need that sometime later this year, early next year, to bring to really make the final step with with a ELANA and bring it to market in both Europe and the US. And, you know, we'd be very happy to get to know more, you know, professional investors who share our same enthusiasm for tackling society's biggest killer and making heart surgery a bit better and much less invasive. Thank you very much.


 


 

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