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Endophys Holdings LLC |
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June 10, 2019 Issue |
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CEOCFO MAGAZINE |
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Bringing to market a single-use disposable Pressure Sensing Sheath and a small, easy-to-use Blood Pressure Monitor, Endophys Holdings LLC is shortening the Time Needed to Establish Blood Pressure Monitoring during Highly Invasive Procedures |
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Co Founder, President
Endophys Holdings LLC
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – June 10, 2019
CEOCFO: Dr. Purdy, what is the concept behind Endophys Holdings, LLC? Dr. Purdy: Let me start by saying that I am a physician. I was on the faculty at UT Southwestern Medical School for thirty plus years. I was an interventional neuroradiologist in my practice, so I worked a lot with catheter based procedures during my career and felt that there was a need for better blood pressure monitoring during highly invasive procedures. The type of technology that we were using for a long time was standard anesthesia type set ups, where they would put a small catheter in the radial artery of the patient and hook it up to a type of pressure monitoring system called a Wheatstone Bridge transducer. First of all, it was analog type technology and my feeling was that as we were continuously putting catheters in patients femoral arteries to do catheter based procedures, that it would be very good for patients if we could figure out a way to use that femoral artery catheter, both to monitor blood pressure and to do those procedures, so we would not have to start the line in the radial artery and take the extra amount of time and the extra set up to do it. Therefore, over a period of a few years I investigated pressure monitoring technologies and started development of a femoral artery sheath that could be used for the same kind of procedures that I had been doing my whole career, but that had a small fiber optic pressure sensor imbedded in the wall of that catheter, such that it was possible to simultaneously and robustly monitor blood pressure at the same time as you were using that sheath for doing procedures.
CEOCFO: What did you learn about technology so that what you knew your vision could actually be done? How did you develop the knowledge or did you work with someone on the technology part? Dr. Purdy: I had previously written a group of patents for a type of device called a detachable coil that is used in treatment of aneurisms in the brain. My patents were licensed by Johnson & Johnson, so as a result of that I had a royalty stream coming to an account that I had at UT Southwestern, basically to do what I wanted to do with within the confines of the University of Texas rules and had something to do with our mission at UT. I hired an engineer in Minneapolis and we spent a couple of years looking at pressure technology and then settling on fiber optic pressure sensors as the most likely technology to be able to imbed into the wall of a catheter and use that sensor to measure pressures.
CEOCFO: Where are you today with the equipment? Dr. Purdy: The equipment is basically an electronic box that the optical fiber from the sheath plugs into and then it displays pressure. It also connects to a patient care monitor and displays pressures via an arterial input line in the patient care monitor. We also have three different sizes of sheaths that have the sensors in them that have been FDA cleared and our box (Blood Pressure Monitor, or BPM) has been FDA cleared for use. We have been actually selling these devices since 2015. We started in 2015 and then found that we needed to make a modification and then really fully entered the market with our first sheath in 2016.
The way that the sheathes are sized is both by their length and the outer diameter of the catheter that they can accept. The system through which catheters are sized is called French sizes. Three French equals one millimeter. Therefore, we have a six French sheath that is twelve centimeters long. We also have an eight French sheath that is eleven centimeters long and we have an eight French sheath that is twenty- five centimeters long, all three of which are cleared through the FDA and they are now on the market.
CEOCFO: We took notice of Endophys from a recent FDA clearance. What have you added to the mix? Dr. Purdy: The most recent FDA clearance was on our twenty-five centimeter eight French sheath. The development of this device extends from about 2008 to currently and sort of in the middle of that process the first sheath that we did was a six French sheath. About that time, as I said, in 2016, it was about the time that the newest type of stroke intervention came onto the market, which was the use of a device called a Stent-Triever that you put up in the artery in the brain that has the blood clot in it and use it to pull the clot out of the brain and that spectacularly reverses many patient’s symptoms. Those devices require 8 French catheters. We are only focused on the neural market right now, because that is what I know something about. The sheaths are ubiquitous in invasive catheter-based procedures and so we have every intention to develop a full product line for cardiology and for interventional radiology in other areas of the body and also for pediatrics. It is just that everything costs and everything takes time to develop.
CEOCFO: Are you seeking funding, partnerships or investment? Dr. Purdy: When I was in UT Southwestern I reached the point where I needed more resources to go forward and there was a private equity firm in Dallas that was interested in us called Sowell and Company, and they invested in the company and are our source of financing since that time. They intend to keep this internal.
CEOCFO: Are doctors looking for better equipment in this area or is it more that they will be happy or are happy to find out what you have? Dr. Purdy: I think that in general, our experience has been that when we first talk to physicians, they feel that the technology they are using has been good. However, there are drawbacks with the data, and I try to advance the idea that we do not have perfect technology to start with to monitor blood pressure. As I said earlier, the problem with having to start a radial artery (artery in the wrist) catheter in order to monitor invasive blood pressure is that it takes time, it takes money and it has a lot of drawbacks to it in terms of possible sources of error in the measuring techniques. Many physicians do not really know what they do not know about blood pressure because it has not changed in more than 50 years.
I do not say they are out there clamoring to get this, but when they do get it, many are really surprised to see how this helps them, in particular, the fact that the pressure monitoring technology is in the sheath, which is something they were going to use to be able to access the artery to do the procedure in the first place. That is a great advantage in cases that are urgent such as stroke. We do not really have any presence in the cardiology market yet, but heart attacks and trauma where there is a lot of bleeding, that you do not have time to waste starting a radial artery catheter and going through that whole process, when you can just stick our sheath into the artery leg anyway and you have blood pressure monitoring and an access point at the same time. Once they start using it and get the advantage of it they realize that it has a real advantage in critical situations.
CEOCFO: How does cost compare with what is available today? Dr. Purdy: If you look at what is being done for monitoring blood pressure and simultaneously doing a procedure, what we do is we take the devices and interventions that are done by anesthesiologists putting the patients to sleep and the devices and interventions that are done to get the arterial access to do the procedure, our sheath is more expensive than the current sheath technology, but when you take the time cost and the device cost for both of those purposes, they wind up being fairly similar. We do not feel that we have a cost advantage, although we do not think we have a cost disadvantage over existing technology.
The real advantage that we bring to the table is time advantage and a robust monitoring advantage. In our device the fiber optic component measures pressure five hundred to one thousand times a second, down to a one tenth of a millimeter of mercury. Therefore, every concurrent device that they use to monitor pressure are analog devices and they do not even do discreet individual pressure measurements. They really generate a wave form and the top of the wave for is called systolic and the bottom of the wave form is called diastolic. However, all of the in-between pressures need measurement as well.
CEOCFO: What is someone purchasing or leasing and then what is, if anything, recurring for them to purchase? Are there disposables with the machinery? Dr. Purdy: The sheath is a single use disposable item. The sensor that is imbedded in the sheath and the sheath itself is a single use device. What we call our BPM, our Blood Pressure Monitor box; the electronic piece is capital equipment. It hangs on a pole or the table-side is used as an interface to the patient care monitor.
CEOCFO: How are you reaching out? Dr. Purdy: At this point, what we have done so far is through a sales force. We have a sales force that primarily goes to the neuro interventional market and has been marketing to them so far. We have not really made an effort yet to get any particular penetration in other areas. We could; it is just a matter of being a startup and growing.
CEOCFO: Why is Endophys Holdings, LLC important? There are so many new ideas. Why does yours stand out? Dr. Purdy: My opinion is that, as I said a little while ago, I think that the practitioners do not know what they do not know. What has been long term considered okay in practice has many disadvantages. It hasn’t changed since before I was in medical school in the 1970’s. For instance, we have a cardiologist who uses our device and who has found that even though the standard stuff that cardiologists have been using for some time is to place a catheter in the heart to do a procedure, and they monitor the pressure through that catheter. What he has found is that the degree of dampening of the pressure in that catheter in the heart is much larger than he previously appreciated, because the only way you can appreciate that would be to have another way to monitor pressure and compare them and our sheath let him do that. In some cases in cardiology, if you are looking at a lower blood pressure through that catheter that is in the heart, it may cause you to alter your therapeutic approach. You may feel like the pressure is too low for you to do an intervention that you want to do or it may cause you to change the drugs that you are administering during the course of the procedure. That is why the value proposition, as an investor would say, in our device, is that it makes your decision-making process more robust and in some cases enables you to do something that you could not otherwise do. In stroke intervention, the catch phrase that people use is, “Time is brain,” and that every minute lost in the course of getting a clot out of a patient’s brain costs that patient in terms of lost cells in the brain, lost neurons and in terms of lost functionality.
The people who do economics of medicine have estimated that every minute lost in getting a clot out of the brain of a stroke patient ultimately costs the healthcare system one thousand dollars. The literature suggests that the patients that are done under general anesthesia have better outcomes, because they hold more still and they are easier to just go up in there where their stroke is and reverse it. It’s more straightforward for the interventional physician if they are basically following the procedure and what is going on. These are confused patients that are in the middle of having a stroke. Therefore, the value proposition here is that we save time and it is better medicine. Anesthesiologists administer the anesthetics; if they are going to be giving drugs that sedate the central nervous system, there are blood pressure effects from those and they want to have invasive blood pressure monitoring. However, in many centers right now these cases are being done with a blood pressure cuff because they do not have the time to waste to insert an arterial line. Even if you are a superb anesthesiologist starting your arterial line, it takes at least five to fifteen minutes and sometimes thirty to forty five or longer. This means even though our sheath is more costly than the standard sheath, it impacts the course of the procedure that is being done.
The same would be true for someone who comes into the emergency room with a gunshot wound and internal bleeding, who you need to get under control from hypotension, but you also need to stop the bleeding and if you can have invasive blood pressure monitoring and just get him on the table and get going, then that saves time and it makes it a safer procedure. Similarly, for instance, in small children, and I am talking about very small children, their arteries are really small and putting a needle into their radial artery in their wrist is not trivial thing. There are many of these in pediatrics but they do not have the kind of numbers of patients that you have for stroke and heart attack. But there is a crying need for it. Many sheaths are not sized for the pediatric population yet. That is certainly in our headlights.
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“The value proposition here is that we save time and it is better medicine. Anesthesiologists administer the anesthetics; if they are going to be giving drugs that sedate the central nervous system, there are blood pressure effects from those and they want to have invasive blood pressure monitoring. However, in many centers right now these cases are being done with a blood pressure cuff because they do not have the time to waste to insert an arterial line.”- Phillip Purdy, M.D.
Endophys Holdings LLC
Contact: Phillip Purdy, M.D. 214-801-0578
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Pressure Sensing System, Endophys Holdings LLC, Pressure Sensing Sheath, Phillip Purdy, M.D., Bringing to market a single-use disposable Pressure Sensing Sheath and a small, easy-to-use Blood Pressure Monitor, Endophys Holdings LLC is shortening the Time Needed to Establish Blood Pressure Monitoring during Highly Invasive Procedures, CEO Interviews 2019, Medical-Biotech Companies, Pressure Sensing Systems, Pressure Sensing Access System, Femoral artery sheath, Fabyr-Perot pressure sensor, miniaturized fiber-optic channel, blood pressure monitor, Endophys Holdings LLC Press Releases, News |
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Phillip
Purdy, M.D.