Endosense, which today announced CE Mark approval in the European Union for its 3rd-generation TactiCath Quartz device, is the only company aside from BioSense Webster with a catheter that can sense the force being applied to heart muscle during cardiac ablation procedures. Unfazed by competition with the 300-lb. gorilla in the room, Keltjens told MassDevice.com that the situation has its advantages.
"This is very serious player, a committed player. They will build substantial value. And if the number 1 player in the marketplace puts its full corporate weight behind this kind of new technology, it just makes it a bigger pie," Keltjens told us during the annual Heart Rhythm Society meeting in Boston last month.
Not to mention the possibility of an acquisition, although Keltjens downplayed that speculation during our chat. He’s got good reason to, at least according to analysts at Leerink Swann, who believe Endosense has a shot at going it alone and staking a claim as the #2 player in ablation catheters – notwithstanding the heat from J&J and St. Jude Medical (NYSE:STJ). And Endosense also has irons in the fire with industry titans GE (NYSE:GE) and Siemens (NYSE:SI) to integrate the TactiCath technology into their cardiology lab offerings.
The TactiCath Quartz device has already been used in patients at 3 sites in Europe, according to a press release. Keltjens told us the device is the result of Endosense’s commercial experience with previous iterations of the device, which has been on the market across the pond for about 2 years.
"We learned so much about the business, about the technology, that we actually embarked about 6 to 8 months ago on a significant project leading to a 3rd-generation technology," Keltjens told us last month.
The TactiCath Quartz device is approved for treating atrial fibrillation and supra-ventricular tachycardia in all nations that recognize the CE Mark. Keltjens said Endosense is already gearing up for a launch in Europe and Latin America. Force-sensing technology "looks very promising given the benefits, which include more durable lesion creation and potentially shorter, safer and more effective procedures," according to the Leerink analysts.
"Endosense’s contact force-sensing technology ‘adds another layer of information that is important’ to physicians," according to the analysts. "In Europe, [contact force sensing] is becoming a standard approach."
The day we sat down with Keltjens, cardiac ablation was making news at the HRS conference with the results of a study showing that it is safer and more effective that standard drug therapy for arrhythmias. Here’s an edited transcript of our chat:
MassDevice.com: How did you come to join Endosense?
Jan Keltjens: To keep it at 40,000 feet, I’ve got a medical device background. I actually got involved with electrophysiology in 2007, 2008, part of 2009 when I was CEO of CryoCath. And of course that ended very well – the company got acquired by Medtronic. It’s nice and rewarding to see here [at HRS 2012] the prominence the product gets and all the things we’d promised simply becoming true.
I made a detour into AngioDynamics (NSDQ:ANGO), but then late last year I decided to move back to Europe. An investor in CryoCath again also turns out to be an investor in Endosense – that’s the link. And 1 thing led to another, I joined in September last year. I enjoy being back in the fray.
MassDevice.com: The Endosense technology is interesting – it’s a pressure sensor in what’s basically a standard ablation catheter?
Jan Keltjens: Well, I wouldn’t say it like that in the midst of the R&D department, but that’s essentially it. It’s not just an ablation catheter, however. It has irrigation and then we’re adding to it a feature called a force sensor, real-time force sensing.
Very early on we pioneered what we now call the P1, Product 1, 1st-generation technology. That’s the product that’s commercially available at this point in time. But we learned so much about the business, about the technology, that we actually embarked about 6 to 8 months ago on a significant project leading to a 3rd-generation technology. The release of that platform is now also imminent, I think within the next 4 weeks you will see the first commercial cases and CE Mark and all that. That’s going to be the horse we’re going to ride to the finish line, if I can say it like that.
We’re going to increase the commercial support in the market, so we are expanding some more direct presence, working together with our distributor to drive utilization and drive sales in Europe and Latin America. All, of course, while we’re waiting for U.S. approval, which is the Holy Grail.
MassDevice.com: You’ve been on the market in Europe about 2 years. Where are you on the regulatory pathway in the U.S.?
Jan Keltjens: We’ve initiated an [investigational device exemption] study in the U.S. I’d say full enrollment is imminent. That’s wrapping up, it’s a matter of days, not even weeks, until that’s done. It’s a non-inferiority study comparing this against the only approved device in the market, the Biosense Webster ablation catheter. There’s a 12 month follow-up and then we plan to submit for PMA approval. So we think we could be in the market in the middle of 2014.
So we got first CE Mark approval in Europe with a study that’s called Toccata. It actually did 2 things: It gave us approval in Europe and we could go commercial, but frankly also the results were so encouraging that it gave us the courage to go for a big financing round and start an IDE trial.
MassDevice.com: What’s the financing behind the company?
Jan Keltjens: It’s privately funded. It’s venture capital. We have 2 financing runs now behind us. We are in a 3rd and, we believe, final financing run as we speak.
People ask me a lot what do we think about the fact that Biosense Webster is the market leader and produces similar technologies, competing technologies.
But I think on balance it’s good news. This is very serious player, a committed player. They will build substantial value. And if the number 1 player in the marketplace puts its full corporate weight behind this kind of new technology, it just makes it a bigger pie and I think it’s good.
MassDevice.com: Do you think there is any chance that Biosense Webster would view you as an acquisition target?
Jan Keltjens: Well, 1st of all I’m not going to sit here and speculate on who looks at us. One of my philosophies is you don’t sell companies. What you do as a management team is you build a company. You build a business, and then at some point the proposition may become so compelling that one of the big ones is trying to take you out.
That could be theoretically Biosense Webster, because they want to lock up the segment. I’m not going to speculate on whether they want to do it or not.
Apart from the fact that we are pioneering force-sensing, which is sometimes underestimated, is the fact that we think that by the time we get to the market we’ll be only the 2nd approved device in the U.S. in this space. For now it’s a 1-horse race, it’s Biosense Webster. And I think it’s going to be a little bit of a neck-to-neck race with St. Jude Medical (NYSE:STJ), but I would not be surprised if we pulled ahead of them and that we are the 2nd approved device.