Or Zigelboim, Pylon Medical - New Carotid Access for Better Treatment | LSI Europe '24

Or Zigelboim 00:02
Hey, thank you everybody for attending. It's a pleasure for me to introduce you to the essence of what we do in Pylon Medical. In a nutshell, we're providing a direct carotid access with a minimally invasive approach. Okay, so what is carotid artery disease? Carotid artery disease occurs when fatty deposits called plaque build on the vessel wall, leading to narrowing that can eventually lead to strokes. This condition is actually related to 265 strokes and 130,000 deaths in the United States each year. Now I want to start with a short story, the story of 500,000 Americans who are diagnosed with carotid artery disease each year; only a third of those patients will be treated. Once a patient is diagnosed with carotid artery disease, what are the main alternatives?

So we have the carotid endarterectomy. It's a relatively long procedure of three hours, in which the physician will make a long incision at the neck, expose the artery, take all the fat and plaque deposits out, and then suture back the skin and artery. This procedure is associated with a high complication rate, including nerve injury at 2.3%, stroke at 1.5%, and myocardial infarction at 0.5%. After three long days, the patient can be discharged back home. Of course, it can only be performed by vascular surgeons.

We have the second alternative, which is transfemoral stenting. It's a minimally invasive procedure that is associated with a relatively higher stroke rate of about 3.1%. The reason for the higher stroke rate is driven by the fact that the stent has to travel all the way from the groin area up to the carotid. By doing so, particles from the outer wall can be dislodged and drift into the brain, causing strokes. The physician also has to cross all those fat deposits with a guide wire and surgical tools, further increasing the risk.

The third alternative is T-car, which is a kind of combination between the two approaches. A smaller incision compared to the endarterectomy is made just above the clavicle, the artery is exposed, a catheter is inserted, and then a stent is placed. This is still a relatively long procedure and still requires quite a lot of hospitalization time due to the incision that is made.

So at Pylon Medical, we are taking the best elements from both approaches by going directly to the carotid with a minimally invasive approach, by working from the carotid. Actually, we are avoiding challenging anatomies and allowing the physician to have better control over the surgical tools, which leads to better outcomes. Of course, we shorten the procedural time by doing the direct access; adopting the minimally invasive approach actually reduces the procedural time to half compared to other procedures, and shortens the hospitalization time, which directly reduces the hospital costs. It can be performed by interventionalists and vascular surgeons as well.

So what actually are we selling? We are selling three things, like a three-in-one kit. We are selling a closure device that is specially designed for the carotid artery. We are selling an aspiration system that helps with proximal protection while delivering the stent. And we are selling a balloon catheter that is specially designed for the carotid artery's needs. Now let's see a movie.

Or Zigelboim 03:33
So as I mentioned, 500,000 diagnosed each year, 130,000 deaths, 40% of all strokes occur due to carotid artery disease. The alternatives: endarterectomy has higher complications, transfemoral stenting has higher stroke rates. T-car is not completely closed. At Pylon Medical, we are going directly to the carotid with a micro-puncture set, placing a guide wire in the carotid. Once the guide wire is in, we can introduce our closure device on top of the guide wire, and then we are placing a suture from one side of the puncture to the other side of the puncture. Once we establish that, we can continue the entire procedure by inserting Pylon's balloon catheters over the guide wire. Now we have flow from the aorta to the brain. We inflate the balloon at the common carotid and block that flow. We still get some backflow from the external to the internal carotid. Then we operate our aspiration system to reverse the flow through our filterized system. Once the blood is reversed, we can insert the filter and continue with a stent. We have stent diagnostics; we can use any stent on the market. The last thing we have to do is retrieve the filter and aspirate all the embolic parts. This is how the system looks on the patient. The last thing we have to do is actually close the puncture hole. In order to achieve that, we are using another tool in our kit that pushes a knot over the puncture and adds a collagen layer on top of that for extra safety.

Or Zigelboim 05:41
The total addressable market is estimated to be 2 billion US dollars. The early doctor market is 300 million. This number represents those for whom a minimally invasive procedure is preferred but currently cannot undergo this procedure due to anatomical conditions. Our cost of goods is 400; average sales price for distribution is 3,015, and hospital price is 5,500.

Or Zigelboim 06:06
We believe that now is the time to approach the direct carotid because there's a high volume transition happening, like Boston Scientific acquiring Cordis Medical. A major change occurs in the center of Medicare, in the reimbursement centers that are allowing and reimbursing the goals, reversing the cask without stenting as a gold standard alongside the surgery. So the company was established a year and a half ago under the MEDX incubator; we managed to raise seed funding, and we successfully tested the device in preclinical trials in our labs. We have strong IP in multiple places in the national and PCT. Our plans for the next couple of years include finalizing the design and doing all the verification needed by 2025. In 2026, we will initiate our first in-human study. To achieve those milestones, we are looking for 5 million US dollars that will be used to hire additional personnel and produce the necessary units. Our team includes some of the top talent in the field alongside seasoned engineers and business consultants that are guiding us on our way to success. Thank you for attending.