Rapid Medical CEO Ronen Eckhouse discusses the Company’s latest innovations, the plan for bringing its novel neurovascular devices to market, and Rapid’s strategy for competing in the market for neurovascular devices in an interview with SmartTRAK.
To listen to the interview, click on the following video. A transcript of the interview is also provided below, as is a link to download the transcript.
SmartTRAK: Anne Staylor here with BioMedGPS and today I'm interviewing Rapid Medical CEO Ronen Eckhouse. Ronen, thank you so much for talking with me today.
Ronen Eckhouse: It's my pleasure. Thank you so much for having me.
Last time I talked to you was at LINNC in 2018 in Paris. So I thought we should catch up and see what's new with Rapid Medical since I talked to you last. I know in April you announced that Rapid Medical raised 20 million dollars and then, in May, you received FDA clearance for the Comaneci device.
So, congratulations on the exciting news.
RE: Thank you.
Those are pretty big milestones. Can you provide a quick overview of that device for the listeners, and then just tell us what your plans are for commercialization of the Comaneci in the US, OUS.
RE: Good. Thanks for your kind words. We are very excited and having exciting times. The Comaneci, it's a remodeling mesh. It's something in a hybrid between a balloon and stent. The idea is that, unlike a stent, you leave nothing behind and the patient can be free of that. There's only coils and the aneurysm. Unlike a balloon, you don't obscure the flow. It's much easier to work with, it doesn't move around, it's very stable, it's very one-to-one responsive. It's something in between and, ideally, we will replace, at the end game, both of these devices. Probably there's a lot of aneurysms that still need a stent, but maybe in some places you can avoid a stent and use a Comaneci instead of the balloon.
So, that's what the Comaneci device is about. It's been used in, probably, around 3,500 cases in Europe to date. Very successfully been adapted, very nicely. Also, been used in a lot of stuff we never thought of, because of its unique design, in a lot of off-label work.
In the US, you asked about our plans. So, we are setting up a small sales team, starting to promote. We probably have something between three and five people that we spread about on the US team and will help us with the commercialization of Comaneci, but also with our TIGER study of the TIGERTRIEVER device.
You mentioned that it's being used off-label. Is that something you can talk about? How are physicians in Europe using this device in surprising ways?
RE: Vasospasm is one way, which we did not think about but apparently the control of the device, where you can apply a very gradual and controlled pressure on the vessel. It is something that physicians found very helpful. The whole vasospasm treatment, or endovascular treatment of vasospasm, there's a lot of question marks and unknowns, and I think we're still early on that. But, as far as I can understand from physicians, Comaneci brings a very good set of features that are beneficial. It has a nice surface area and, again, the gradual pressure, which makes it a lower delivery system. So, there's a few things about it that can make it very good tool for that, but that's something we did not expect. Other example are flow-diverterplasty to open up a flow-diverter that doesn't-
Oh, if it's occluded?
RE: If it doesn't open well. So, oftentimes the Pipeline or the Stryker Surpass, either on curves or on the proximal or distal end the device doesn't open up as well, and you need a balloon or a Comaneci to really do an angioplasty.
Is that like the fish-mouthing they talk about?
RE: Yes, yes.
So when those devices fish-mouth, that's really solving a problem.
RE: Right, right.
First, vasospasm. Let me make sure I understand. So, if the vessel is spasming, the slow, gradual expansion, does it kind of dilate it?
And then it just slowly takes the spasm away after... Is that what happens, theoretically?
RE: First of all, I think we don't know exactly. One way to treat endovascular vasospasm is to apply a lot of force with a balloon and break up the muscles, in a way, and completely change the vessel itself. That's one option. There is another option that people talk about here and there, in that you deploy a stentriever and leave it there for five, ten minutes, maybe together with IA therapy, but do a more gradual expansion of the vessel. Comaneci is something in between. Again, the nice thing about it is that can be very safe and very gradual. This is something we hear from physicians.
I know that WEB has come out in the United States. Do you think that will affect, at all, the adoption of what you're doing, because the use of coils are decreasing slightly? So, how do you think, if at all, the WEB device or intrasaccular devices could affect that use of the Comaneci?
RE: First of all, when you start from zero, there's so much to do that it might affect you in the long run. It's hard for me to say. What I hear about this, maybe coil usage will decrease but it is very gradual. I think coils, as far as I understand, with all respect to all the intrasaccular devices, coils is still probably the best and most stable solution out there. So I think coils are here to stay. Maybe a little bit less than what we have, but they're here to stay. So, that's one answer and I think Comaneci's a great solution for that. A great scaffold for coiling, but it can also be a good scaffold for a WEB so we've seen some usage of that in Europe. It can help put the WEB in the right place, or it can protect the parent vessel in the stent.
Correct me if I'm wrong, but if it's temporary, then it just allows it to kind of set in the aneurysm? Is that kind of the thinking behind it? It starts to embolize, is that the thinking behind it?
RE: Yes, yes.
So you're going to have three-to-five people in the US, you said. Salespeople.
RE: Probably. In the near future, but that's going to grow as we roll out more devices. As our portfolio grows, we expect the sales footprint in the US to grow, as well.
What about OUS for Comaneci?
RE: OUS, Comaneci has been available for a few years. As I told you, it's used quite frequently. We are puffing up our sales team. We have a small team in Germany, which we hired a few more people and we're, other places, working mostly through distributors.
Well, in terms of ramping up for the US, is that kind of a model? Are you leveraging your knowledge learned from your launches in Europe, or is it completely different here?
RE: Yes and no. On the clinical front, it's the same, so we're leveraging everything we learned in Europe. I think we understand the device much better. We understand how it works in the brain much better. We also know how to sell it, I think, in a much better way, for the kind of benefits it brings. So, we learned a lot in Europe and are utilizing all of that in the US. That said, the US is very different. The systems are different--the health care system is different, the way physicians think is different, on the clinical side but also on the business side, and there's a lot of things that are a bit different in the US, which makes this interesting.
Well, reimbursement is certainly one thing. Is this affected at all by the US reimbursement system? Is it reimbursed underneath the other codes that are existing for neurovascular devices?
How about TIGERTRIEVER? What's new with TIGERTRIEVER? I know, last time I talked to you, you had anticipated bringing that device to the US market in 2020, so where's that at?
RE: We are doing the TIGER IDE trial, which should be around 185 patients, and we're, I think, a little bit past the midway point. That's going quite well. We're adding centers, and so far the feedback has been very positive. If we hit the 2020 mark or not, it's not only dependent on us, it's also the FDA. I do expect to finish the trial by then, and so far it looks that we will. So, that's about the TIGERTRIEVER. We also see nice utilization in Europe. There's more competition for TIGERTRIEVER than Comaneci in Europe because there's more stentrievers out there in the market, although the TIGERTRIVER is very different. It does go for the same indication. I think last time we also talked about the TIGERTRIEVER 13.
And the 17, yeah. So, I was going to ask you; that's for more distal?
Where's that at? I think it's been launched in Europe, right?
RE: Yes. The 13 has been launched in Europe, and we are promoting what we call the DVO, the distal vessel occlusion. We think that's really where this market will be, and we look at ourselves as the pioneers of the DVO market. This is something that some physicians completely agree on. Some people say, 'I will never treat anything that's more distal, and then, too, it's more dangerous.' Our belief that if you have the right device and the right risk profile, there's a lot more to be done. The TIGERTRIEVER, for various reason, we believe is a much more... it's a safer platform. Easier to deliver, smaller. There's a lot of reasons why this should work better on distal vessels, and we are seeing that in Europe.
There was some discussion here at the meeting about what vessels you treat, and is it better for those very distal vessels. You cause less harm by just using TPA rather than use a device.
RE: TPA doesn't come for free, as well.
Well, that's true. That's not risk-free, either. So the study, the research you have to date and your experience in Europe, how does that, as far as the risk-benefit, how has that played out?
RE: We have not shown anything clinically yet, but the initial feedback is very, very positive, and it looks very safe. Much safer than a stentriever, because your ability to control the amount of force you're exerting on the vessel is critical when you're going distal. We don't know of any reports of bleeds or complications with the device so far. So, we have a very good feeling about this, but I cannot tell you that we did a head-to-head comparison. It looks better. But the feedback we hear is that, yes, physicians will tell us, 'When I use a standard stentriever in these kind of lesions, I get bleeds now and then. My experience with TIGERTRIVER 13 so far has been much better.'
What part of the brain are they working in that they've had a good experience with?
RE: It depends on the physician. Some of them go very distal, almost to the skull. These are physicians who are used to treat AVMs, in the very distal anatomy. The delivery catheter is a catheter that goes for an AVM, it's a 1.3 French delivery catheter. So, physicians who are comfortable working in distal areas in the brain will use TIGERTRIVER 13 very distally. M12. I don't know if that's really M12, but as distal as you can imagine.
Very, very far. Yeah.
RE: Very, very far. Others who are more conservative might go to M3 or M4, so it's really dependent on the physician, but it seems that the technology allows itself to be used in the very distal regions of the brain.
Are you studying that formally to see how it performs? Are you doing any kind of clinical?
RE: Yes, we are starting a few registries in Europe, in a few centers.
How many patients have been treated with TIGER 13 so far?
RE: We don't know exactly, but probably around 200.
That's a pretty good sample size. What about the 17? Don't you have a 17 you're working on?
RE: Yeah. So, 17, that's part of the standard TIGER family. That’s under study in the US.
That's part of the IDE?
When do you think those devices will reach the US market? The 17, it's further along.
RE: The 17, we talked about. The 13, that's a good question. We are thinking about different ways to get it approved in the US. I cannot say anything specific yet.
I understand. Now, one of the things that's kind of a hot topic here is they keep talking about the first-pass success, first-pass effect. Have you looked at TIGERTRIEVER? Is that part of the TIGER study, what percent of your embolizations are first-pass?
RE: We have some data from Europe, and it looks very, very good. The reason, we think, is you get better clot integration with the TIGERTRIEVER because of the high radial force on demand. So you can actuate it to have very nice clot penetration, and then take the whole clot out. It's still not comparison, head-to-head data, but we think we're in very good shape on that front. I know there's a lot of talk about first-pass effect. I think the other part is TICI3. These two...
RE: Together, but not necessarily. Some people will say 'TICI3, that's the real important goal.’ Others will say, 'Well, I want it out on the first time,' which is great, but TICI3 is also very important. So I think, on these two fronts, from what we see in Europe, we're in very good shape, but I cannot say anything about the US yet. But we do see that.
What we see with TIGERTRIEVER, which might be a little bit different than other devices, is that there is a learning curve. If you really want to utilize the device, there is some steps that you need to understand. Once you get that, it's really a powerful device. It can be used beautifully in achieving on the first-pass effect, TICI3 and so forth, but there is some learning curve because it's an active device.
As far as your strategy for when you come to the US, are you working toward an extensive training program? What are your plans in terms of training for that kind of device?
RE: We have training, which we are utilizing in the trial. We're not working on commercialization plans yet, because that's still some time ahead, but we do have a lot of things we're doing in Europe.
As far as commercialization, I would imagine it's a little daunting because of these huge companies that are already established. What is your strategy there? Are you talking to any of the big companies? Are they interested in your device? Are you going to partner? Distribute? How are you going to gain penetration, move forward?
RE: It's a very small market. Everybody knows everybody, and everybody talks to everybody, so I think we all know each other and talk to each other. But we always like to focus on the things in our control, and that's what our shareholders want as well. That's why we're building our own small commercialization team of really selected and great people. That's the same in Germany. We're trying to build our own. Our basic strategy, the way we attack what you just said, is just have different devices that do different things. For some physicians, like Comaneci, they immediately understand why this is different than anything else in the market. Comaneci was approved under de novo indication because there's nothing like that.
As I said, we like to focus on what we can do, and in my opinion the role of the small companies is to bring the new devices, the exciting devices, the things that other people are not willing to try and do, and we try and do it.
What about your portfolio? You mentioned your portfolio, I think... your pipeline. I know you've got your hands full with Comaneci and TIGERTRIEVER, but is there anything you can discuss that's on the horizon?
RE: We have a new device, which is called Columbus. Columbus is an active guide wire with a deflectable tip--14-wire, super soft, very, very nice, and that will be launched in Europe soon. It's CE Marked. We've done a handful of cases, and the feedback has been super positive. That will come to the US soon, as well.
What are the big differentiators on that, compared to other types of guide wires? Do you see that as having a distinct feature or anything that would-
RE: The feature is that it's... I can do in situ shaping. So, a very small, elegant control on the outside. It almost looks like a standard wire, but if I want to shape the tip, I can just use the handle and shape the tip as much as I want. If I want it to be straight, it's straight. If I want it to be a pigtail, it's a pigtail. Instead of taking the wire out and reshaping it every time, or taking another if I need a straight wire, I'll take a new wire out of the box, I just have this one wire that I can play with as much as I want.
I didn't realize they had to do that every time. Is that common? They have to take the guide wire out, reshape it, put it back in?
Well, that sounds like you did a smart thing, there! Anything else in the pipeline that you can talk about? I keep asking people about this because there was so many talks on transradial. Is there anything in that are, or another area, that you're looking at?
RE: There's a lot of stuff we're looking at and thinking. I think our different braiding, very unique braiding technology can lend itself to a lot of stuff, and we just need to choose. So we're now thinking about what will be our next platform... and there are a lot of things we're thinking.
As far as your priorities, you have a lot. What are your short-term goals, given that you have all these things right in front of you that you have to accomplish? What's most immediate and, basically, what's next for you?
RE: For us, the big thing, and that goes back to the fundraising is going west. Is establishing ourselves in the US. Doing it the proper way with the proper centers. First Comaneci, then probably Columbus, the wire, then TIGER. So, doing that step-by-step and really establishing ourselves in the US, that's the most important thing.
All right. Well, thank you so much for talking to me, Ronen.
RE: Sure. Thank you, too.
If you would like to download a transcript of SmartTRAK's interview with Ronen Eckhouse, in which he discusses the Company’s latest innovations, the plan for bringing its novel neurovascular devices to market, and Rapid’s strategy for competing in the market for neurovascular devices, please click the button below.