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Filterlex Medical Ltd. |
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August 5, 2019 Issue |
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CEOCFO MAGAZINE |
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Filterlex is developing the next-generation Embolic Protection Device to Reduce the Risk of Stroke of TAVR Patients |
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Founder and CEO Filterlex Medical Ltd.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – August 5, 2019
CEOCFO: Ms. Eli, what is the concept behind Filterlex Medical Ltd? Ms. Eli: At Filterlex our mission is to create the perfect embolic protection device for all left heart interventional procedures. Our product is called CAPTIS®. CAPTIS is a full body embolic protection system for left heart interventional procedures. I am the inventor of the device and I lead the company since mid-2015.
CEOCFO: Would you please explain about full body embolic protection for left heart interventional procedures? Ms. Eli: Over twelve percent of the population over 75 years old suffers from aortic stenosis calcification. This narrows the diameter of the aortic valve and causes decreased cardiac output. This is a very serious heart condition. The two options to treat this condition open heart surgery and TAVR, Transcatheter Aortic Valve Replacement. This is a fairly new procedure. The FDA approved this procedure in 2011. In this procedure the aortic valve is replaced through a catheter, usually inserted through the femoral artery. This is very different from an open-heart surgery as it’s a minimally invasive procedure.
The good news about this procedure and the reason it is very popular right now, is that the patient can actually leave the hospital just a few days after the procedure and return to a normal, even better life after the procedure. The down side is that during the deployment, during the insertion of the new valve, embolic particles are released to the blood stream and when they migrate to the brain they can cause different levels of stroke, from death to highly disabling strokes to even cognitive impairment and also what is known as silent stroke. This is visual on MRI’s and later in life it causes increased mortality and increased risk of stroke.
What we are doing is creating and developing a device that deflects the particles from entering the cerebral arteries, the brain, and then capturing them downstream. Therefore, we are not just protecting the brain, which is what most competitors are doing right now; we are also protecting the rest of the body, for example, the kidneys. This is what we call a full- body embolic protection device for left heart procedures.
CEOCFO: What is the device itself? What is CAPTIS? How big is it? What shape is it? How does it protect? Ms. Eli: The CAPTIS is deployed in the aorta. The aorta is the main blood vessel that carries blood from the heart to the rest of the body. This is the main blood vessel of the body. The first arteries that are extended form the aorta goes to the brain and then the rest of the smaller arteries go to the rest of the body. We are placing the device in the aorta and we are blocking the flow of particles larger than one 115 microns from entering the brain. These are the dangerous particles. Then we are deflecting them to pockets downstream. It is a fairly large device, around twelve inches in length and it is designed to sit in the aorta in a safe way, to anchor itself in a very safe way, so it is as wide as the aorta is, which between an inch, and inch and a quarter. This is the normal size of the body’s aorta. CAPTIS protects the brain. It is like a cap that sits underneath the arteries that goes to the brain. Then we have a cylindrical frame with pockets that sits downstream in the aorta. This is how we capture the particles.
CEOCFO: Does the device stay in the body? What happens after the procedure? Ms. Eli: The device is a “first in – last out”. We place it before we start the TAVR procedure, before we enter with the new valve, and remove it immediately after the procedure is over, after the valve is replaced. Therefore, it is “first in-last out.” It sits in the body for anywhere between ten minutes to one hour. This is in very extreme situations. Usually it would be around ten or fifteen or twenty minutes, no longer than that.
CEOCFO: Where are you in the development process? Ms. Eli: We are in the pre-clinical stage. We are testing the device on animal models and we are preparing for submission for Helsinki IRB (Institutional Review Board) committee to get the approval to perform clinical trials.
CEOCFO: What have you learned so far about the device, about how it works and also the business side of Filterlex? Ms. Eli: When I first drew the design for the device, the way I went about it is a very different story than how usually a startup is started. I am coming from the TAVR industry. I have been an imaging expert and a clinical specialist for imaging for this specific procedure and other cardiac interventional procedures. I knew the background in terms of the clinical aspects and the need. I left the previous imaging company and the idea of the embolic particles during TAVR kept nagging my brain. I new a couple of the devices that were in development at that time and I even played with one of them in one of the conferences and it did not sit very well with me. I was very apprehensive of the efficiency of the two devices that were out there. When this kept nagging me, I went and looked at all the patents in this field, in the embolic protection device for TAVR field. I found quite a few of them and I started to study each and every patent and look at the design with what they are trying to do and how the device is going to look and how it is going to operate and how it is going to coexist with a TAVR delivery system.
I could not find a single device that I felt was good enough for this, if I could find it, we would not be talking right now. Maybe we would be talking about a different device, but not about CAPTIS. Therefore, I sat down for about two months and started thinking about the procedures and designing a device that I felt was good enough to work in this specific scenario. It is a very risky scenario; the combination with a TAVR delivery system and the TAVR valve. It is a very high risk surgery in terms that the doctor is actually dealing with the most important valve in the body! If something goes wrong it is devastating, so I sat for two months and designed the new device. Unbelievably, we are still using the same concept today.
We started working and developing the device and pretty soon we understood that this is the correct design. This is the correct concept for this device. This device will go with the TAVR and we are delighted that physicians, industry experts or top executives from the big companies, when they see this device the initial response is, “Wow! This is a best in class device. This should do the trick. This should do the work. This is how this device should be designed.” Everything that I learned worked to manage a company and we have chosen to enter into one of the leading incubators in Israel for medical devices. The owner is a reputable and very famous entrepreneur and investor in medical devices in Israel and he saw us and met us, believed in the company and this gave us the boost to actually create the company and to continue to work, not just at home in the garage, but offices and the whole environment really supported us in creating the company.
CEOCFO: We came upon Filterlex from a press release regarding a recent funding. How far will that take you? Ms. Eli: To mid-2020. We are also looking at additional funding from the Israel Innovation Authority; additional grants. However, the current round will take us to mid-2020.
CEOCFO: There are so many companies to look at in health, so many new ideas. Why should physicians and the investment community pay attention to Filterlex? How ia Filterlex a cut above many others? Ms. Eli: The area of embolic protection devices has been really under the spotlight in the past year or so. The reason is the first device was approved by the FDA the company called, Claret Medical Inc., which was acquired by Boston Scientific Corporation (NYSE: BSX) in July 2018. Until that point physicians were skeptical that this device was needed. They were very apprehensive about it and did not seem to take it very seriously; at least most of them.
Amazingly, once the first device was approved in the US, immediately many physicians wanted to use this device and Claret Medical was selling, I think, to over one hundred hospitals in the first year. It was booming immediately. Today many physicians are using it. However, many physicians are waiting for reimbursement in Europe. In the US reimbursement was approved in October 2018. This also pushed this field forward. Therefore, we are getting a lot of attention from physicians and also from the industry regarding CAPTIS. This is a booming field. As far as we know, a lot of the VC’s are aware of that or the VC’s that already know and have interest in the cardiology field are looking into it.
CEOCFO: What, if anything, might people miss when they first look at Filterlex Medical that they should understand? Ms. Eli: This is a difficult question, because the response that we are getting when we present the device and the physician can touch or the VC executives can touch it and feel and see it; they immediately get what we are trying to do. They immediately get the concept of the device. Therefore, I am not sure I have an answer for that.
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“We are placing the device in the aorta and we are blocking the flow of particles larger than one 115 microns from entering the brain. These are the dangerous particles. Then we are deflecting them to pockets downstream… CAPTIS protects the brain.”- Sigal Eli
Filterlex Medical Ltd.
Contact: Sigal Eli +972-54-669-5900
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Embolic Stroke Prevention, Filterlex Medical Ltd., Embolic Protection Device TAVI, Sigal Eli, Filterlex is developing the next-generation Embolic Protection Device to Reduce the Risk of Stroke of TAVR Patients, CEO Interviews 2019, Healthcare, Medical, Biotech Companies, Global Company, next generation full-body embolic protection for TAVI, next generation embolic protection device to reduce the risk of stroke and other complications during catheter-based structural heart procedures, CAPTIS, left heart procedures, embolic particles, causes of stroke, aortic surface protection, stroke prevention, embolic stroke secondary prevention, Filterlex Medical Ltd. Press Releases, News |
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Sigal
Eli