Acutus Medical is building an entire EP product line around its AcQMap system. The technology is designed to enable imaging, visualization, planning, and ablation all in one system.Acutus Medical
Acutus Medical has landed on the radar of some of medtech's most reputable analysts, including Needham & Co.'s Mike Matson. MD+DI chatted with Acutus Medical President/CEO Vince Burgess to learn why the company is turning heads.
AcQMap received a CE mark in May 2016 and subsequently launched in Europe. FDA cleared AcQMap in October 2017 and the Carlsbad, CA-based company launched in the United States in early 2018.
MD+DI: What, in your view, has put Acutus Medical on the radar this year?
Burgess: We’re working in one of the most high profile spaces in all of medical devices, which is arrhythmia management. Of the markets over $1 billion in revenues in medical devices, only four or five markets of that size are growing over 10% per year and atrial fibrillation (Afib) management is one of those. So it’s a large market and it is also growing very quickly, which gets people’s attention. It’s growing in part because of demographics, atrial fibrillation is a disease of the aging and we have an aging population.
There also has been an explosion of diagnostic products and capabilities that allow people to be much more aware of the presence of atrial fibrillation and connecting the dots between not feeling very well and their iWatch telling them they’re in Afib. … Most importantly of all, what drives people’s attention to this market is we still have a lot of room to get better with the therapies that we provide … to get in there and treat these patients.
[Johnson & Johnson] and Abbott [via its acquisition of St. Jude Medical] have been at it for 25-plus years and they have done a nice job developing this field ... but in spite of their best efforts, the success rates for Afib ablations at one year hover between 50% and 75%, which means the risk of failure is between 25% and 50%.
With stenting, those use to be the same numbers and industry worked together with physicians relentless to improve safety and efficacy in that space to improve the success rate of stenting procedures. And electrophysiology and the industry that supports it hasn’t been able to go stride for stride with their colleagues [to achieve the same improvement].
MD+DI: It's clear that Acutus Medical has a platform that offers an "all in one" solution for arrhythmia management, but as you mentioned, there are some big players in the space. What is Acutus doing that allows the company to stand up to the big guys like J&J, Abbott, Medtronic, and Boston Scientific?
Burgess: Acutus Medical started out as an imaging and image-guided therapy company providing a completely different approach to imaging the heart as compared to what all of the other players do. All the other players, when they create their diagnostic map to inform their therapy, they all do it, in the same way, which is inserting a three-foot-long mapping catheter from the groin to the heart with one or more electrodes at the end and poking it around inside the heart. Each time they touch the tissue it collects information … then reconstructs synthetically an anatomical and electrical map of the patient’s heart to give the physician some sense of what the anatomy looks like and some sense of what the electrical conductivity of the heart looks like, but it is a very complicated and manual and crude way to go about it because every physician does it a little differently and everyone gets different readings, so there are lots of variables and poor reproducibility.
You have to ask yourself, is the shortcoming in the therapy or is the shortcoming in the imaging that guides the therapy Better imaging almost always eventually improves outcomes and improves safety and allows more physicians to be more consistently skilled.
So instead of poking around with an electrode three feet away and trying to stitch together an anatomical map and electrical map of the heart, we insert a non-contact catheter that drops right into the left atrium or the right atrium, or both, and is placed there as a mapping device. Any physician can do it with one case of training.
We had a cardiologist's 9-year-old son come in and he did it just as well as his dad (in a simulation lab). Over the course of about a minute, the mapping system provides an exquisitely detailed and accurate anatomical and electrical map of the patient's heart from the inside out. That's our core differentiator.
So with that information you know more about the patient’s anatomy and electrical patterns, you also, after you ablate a little bit, can go back and very quickly remap the heart after you’ve started to ablate so you treat, map, treat, map, treat, map and that guides you to, we think, what will eventually be a faster, more personalized procedure that has the potential to create less damage to the heart muscle. ...We give you the opportunity to confirm each physician’s own ablation strategy and each physician’s own ablation results while the patient is still on the table.
MD+DI: Surely there is an economic benefit to that as well?
Burgess: With between 25% and 50% of procedures not being successful … there are a lot of people who need some kind of a redo procedure, and that costs a lot of money. A recent study shows the costs incurred by the hospital system between the first ablation and the second for repeat hospital visits, drugs, etc., averages $40,000 just for what happens between the two ablations, not including the procedures themselves.
The current version of our product is particularly well suited for patients that are coming back in for their second, third, and even fourth ablations. We need to do better. The physicians are phenomenal and the EPs are phenomenal with the tools that are available to them today, we think they just need better imaging and mapping tools.
MD+DI: 2019 has been a particularly strong year for your company, with a large financing round in June and the publication of the UNCOVER AF data, not to mention partnerships and the technology's integration with Stereotaxis' robotic navigation system. Given all of these milestones, how would you characterize Acutus Medical's year overall?
Burgess: It’s really been an exciting couple of years, I joined two years ago, about the time we made the strategic decision that the level of differentiation we provide with our mapping system was sufficient to justify building an entire EP company out around it. Usually, you build a better mousetrap and flip it out to another company for use in their product line. We decided to take this core innovation and fill out an entire EP product line and we are well along the way to do that. We have the vast majority of products that they use in an average EP procedure either inhouse or acquired or in-licensed. As we exit this year … we will essentially be a full-service EP company.
MD+DI: Is there anything I haven't asked that you would like to add about Acutus Medical or the arrhythmia management/ablation market?
Burgess: The existing incumbents in this space have done a nice job of developing this field from what we call EP 1.0 to EP 2.0, which is an intracardiac approach with 3D mapping systems … we’re focused on taking EP to what we call EP 3.0, which is highly personalized care for each patient with a system that gives exquisitely detailed mapping images to allow a wider array of physicians with varying expertise and skill to come in and provide safe and effective care. We're leading the charge into EP 3.0.
Check out a recent case using Acutus Medical's AcQMap that was streamed live into the annual meeting of the Society for Cardiac Robotic Navigation in Nice, France from Rotterdam, the Netherlands.