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Ensite Vascular, LLC. receives FDA Clearance to Market their Vascular Closure Devices SiteSeal® and SiteSeal® SV™ to improve Surgical Outcomes
CEO & President
Ensite Vascular, LLC.
Interview conducted by:
Lynn Fosse, Senior Editor
Published – May 11, 2020
CEOCFO: Mr. Reidy, what is the concept behind EnsiteVascular, LLC?
Mr. Reidy: The concept was to develop, patent and obtain FDA market clearance of vascular closure devices that left absolutely nothing behind.
CEOCFO: What is a vascular closure device? What was the problem before Ensite came up with a solution?
Mr. Reidy: The original way, and the recognized ‘gold standard’ of doing vascular closure, whether it is femoral, radial, or brachial is to utilize manual pressure. You simply take a sterile bandage and you hold pressure against the opening after the procedure and you wait for hemostasis to occur and for bleeding to stop and the patient can ambulate. There are many problems associated with manual compression, but mainly the individual pressure variance of health care professionals. When I say variance, I mean that you and I likely hold pressure differently. We may also ‘sneak a peek’, which is basically, “let us see if the patient is still bleeding.” It is very time consuming and it ties up medical professionals unnecessarily, which is expensive. About twenty five years ago, different companies like St. Jude, came up with ideas on a better way to close after a procedure using some form or fashion of a mechanical device, whether that device was a collagen plug, or screen, mesh, stitch, etc., it was still a foreign body of some type.
Whatever the device was, it was used post procedurally and people would quit bleeding rather quickly. The problems could be that some people are allergic or immune compromised against whatever device is left behind and the human body just does not like foreign objects in it. It tries to reject them, whether it is a piece of metal or shrapnel or even sometimes a device that is left on purpose. Therefore, my two partners; a gentleman named Dr. Rex Teeslink, and Griscom BettleIII (Chip), got together about ten years ago at a cardiovascular conference. They met, they talked, they discussed different and hopefully better ways of doing this, and how we can mimic manual pressure, but remove the variability and foreign bodies and also not tie up medical professional’s time. That is how the concept for what we do started.
Basically, our device, when it is removed, has already simulated manual compression, but leaves nothing behind. By not leaving a foreign body behind in the human body, we do not compromise that patient in any way. In addition, as we discovered during our clinicals, it is less painful. It also has few complications afterwards and the patient actually ambulates, gets up and walks, quicker than he normally would. We had an introductory study, then a full clinical study and now we have an additional usability ongoing study with our SV, which is a small vessel device, and both devices are now cleared for marketing. However basically, our main end points were the ability to stop bleeding in a timely manner without inflicting damage to the femoral triangle. If anticoagulants have been properly administered to the patient for a diagnostic procedure we know that the patient can ambulate inside of an hour and for a procedure that is a little more invasive and requires a larger opening, you can ambulate in a few of hours. Of course, this is always up to the administering physician or surgeon.
CEOCFO: How does your device work? Why does it work?
Mr. Reidy: Both of our devices, SiteSeal® SV™, which is the small vessel device and SiteSeal®, the large vessel device, have an optimized contact surface. When I say contact surface, it is the surface that contacts the patient at the wound site. This contact surface is optimized for pressure at the puncture site and it has a patented design. When that pressure is administered to the puncture site properly, blood flow of course continues and then it allows hemostasis to occur. The time to allow the patient to ambulate is of course up to the attending physician.
It is basically the design of the procedure, the fact that it inverts the tissue against itself. Rather than forming a cap, it inverts the tissue and helps to close the incision site. That is because even when you use manual compression, for instance, on the femoral artery and the health care professional presses down and administers pressure to that opening, you are likely pressing against the femoral head. In compressing against that femoral head, you actually spread the opening, rather than closing it. Ours envelops the tissue around the opening and therefore closes it quicker. Since it is not totally occluding the opening, it allows the blood to continue to flow, hemostasis to occur, bleeding stops, and the patient ambulates. That is the main thing.
It also has to do with the pressure that is modulated by the use of stainless steel springs and the combination of pulling that tissue up, pressing down with a modulated pressure with the right design; in other words, the design has more pressure towards the heart than against the heart, in a north/south direction; you have more pressure north than south. The combination of those factors enables the opening to close and stay closed and the patient to be able to ambulate.
CEOCFO: Have doctors been looking for a better way?
Mr. Reidy: They have! There have been many papers and talks given through the years, ever since the very first, what we call, active closure device, approved for marketing by the FDA and used on patients. Ever since then, doctors have been looking for a better device. In other words, one that does not leave something behind, one that does not lend itself to more complications, and one that is easy to use.
There is a doctor named Monica Hunter who once had a quote that said, “The perfect VCD is like Santa Claus and the Easter Bunny; it just does not exist.” That was about eight years ago when she said that. But after we showed her our device, she said ‘you have just found Santa Claus’. With that in mind we have tried and, we believe, succeeded, in developing closure devices that eliminate the problems associated with other devices: the problems mainly being whatever is left behind. However, since doctors are convinced that you should mimic manual pressure somehow, we have succeeded there as well. It is like the adage of “see the need, fill the need.” To develop the product, that is where we are.
CEOCFO: How will you be going to market? How do you get people to believe it works?
Mr. Reidy: First, we are in the midst of working with an investment banker who has taken companies with devices such as ours and married the technology with one of the major players. When I say “major players” I mean a company that is involved in the cardiovascular space, who sells stents and wires and valves and perhaps EP products and such and so on. They do already have an approved closure device and there are probably about twenty-
It is also possible the company that acquires the technology may want the large vessel closure device rather than the small vessel closure device, or the small vessel closure device rather than the large. In which case, those two products will be marketed to companies separately or if we were not to receive what we feel like is the appropriate remunerations for either product, we would withhold those products and go to market ourselves. The way we would go to market is with our own marketing team. We also have folks who are well versed in what is necessary to do this and failing the acquisition of the technology by a large cardiovascular spaced company, we would market it ourselves.
CEOCFO: Then you have it covered whichever way it goes!
Mr. Reidy: We do!
CEOCFO: What is the market potential for this type of device?
Mr. Reidy: Well, the market potential for vascular closure devices worldwide is more than five billion US dollars! The market really breaks down into three segments. About one third to forty percent US and a similar amount in the EU, and then what we call “rest of world” and that includes Japan, China, Malaysia, and Australia; basically Asia, South America, Africa and the Far East.
CEOCFO: Does cost come into play? It should not if the device is better!
Mr. Reidy: No, but reality is what reality is when it comes to capitated health care costs. Therefore, we are very competitively priced. Luckily, the variable cost of our unit is going to allow us to market it at the average unit selling price for competitive devices. We will be cost competitive, even if a company takes us over. Because of the production cost, they could maintain their margins and still market it properly and return sufficient funds to the bottom line.
CEOCFO: What surprised you through the development process?
Mr. Reidy: The length of time that it has taken to get cleared for marketing by the FDA.
CEOCFO: You have been doing this for a long time, yet it still surprised you?
Mr. Reidy: I am not going to knock the FDA, because they are incredibly careful and I am glad they are, because when you finally cleared for marketing you know it is unassailable. However, changes can take place, such as in personnel. For instance, when we did our basic feasibility study, we came back with great data, but we were asked to do a second study utilizing only interventional cases rather than just diagnostic. Therefore, they wanted us to check to see if it caused, A) pain, B) nerve damage or C) excessive bleeding. Luckily, as we thought it would, our study proved that none of those things occurred. However, at the end of the day there was that concern, but also, because of the exclusion criteria from the study; age, sex, morbidity, health conditions, etc. you may screen and obtain permission from 10 patients and only wind up with one.
Since the second study is for what they call interventional verses diagnostic procedures, if the doctor gets into the procedure itself that he thought was going to be interventional and it turns out to be diagnostic, then that one does not count. Just getting the ninety patients necessary for the study proved problematic, and we had two sites. For instance, you could get three in a week and you could get none a week for the next three weeks. That is just the way it is. You have got to be patient; you have got to provide the information and we had to just hang in there! Let us say your interventionalist, the guy in charge of the study, goes out of the country for thirty days; well, we just lost thirty days. It is just so time consuming!
CEOCFO: Why pay attention to EnsiteVascular?
Mr. Reidy: The main reason is that we are the only company, the only vascular closure device company, with products for these applications that can do any part of the anatomy and close it. In other words, the femoral, the radial, the brachial, even the pedal or the popliteal. We have a device for all of those; that is number one. Number two is, we are not restricted by French size. We found in our study, that as good as our closure device worked for the cardiologist, we believe it will also work for the surgeon that is doing structural heart procedures. If you open the femoral large enough it is problematic to get that closed after the surgery and our device can do that! Therefore, if you are a company that is looking to cover all the bases, so to speak, of vascular closure without leaving something behind, we are it, period!
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“Therefore, if you are a company that is looking to cover all the bases, so to speak, of vascular closure without leaving something behind, we are it, period!” Tom Reidy