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Field Medical Develops New PFA Tech to Treat More Patients · Vanguards of Healthcare by Bloomberg Intelligence

• 0:20
  Speaker 1: Welcome to another exciting episode of the Vanguards of Healthcare series.
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  Speaker 1: My name is Matt Henriksen, the Medical Technology Analyst at
• 0:26
  Speaker 1: Bloomberg Intelligence, which is the in-house equity research platform of
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  Speaker 1: Bloomberg LP. We are pleased to have with us the
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  Speaker 1: executive team from Field Medical, including co-founder Stephen Mickelson and
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  Speaker 1: Chief Executive Officer Mark Turco. Field Medical is a privately
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  Speaker 1: held medical device company developing the next generation of pulse
• 0:45
  Speaker 1: field ablation technology to treat complex arrhythmias, starting with the
• 0:49
  Speaker 1: ventricular tachycardia. Stephen and Mark, thank you for joining us today.
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  Speaker 2: Great to be here. Thanks, Matt.
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  Speaker 1: And so, Stephen, with you founding Field Medical, I have
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  Speaker 1: to ask because you already founded a PFA company called Ferripulse.
• 1:03
  Speaker 1: And Ferripulse, for those in the PFA market, is very
• 1:07
  Speaker 1: well known because Boston Scientific bought it and it helped
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  Speaker 1: Boston create their EP business into what is now a
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  Speaker 1: $ 3 billion plus franchise. So, What drove you to come
• 1:19
  Speaker 1: back to found Field Medical?
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  Speaker 3: Well, you know, I've spent the last 15 years really
• 1:26
  Speaker 3: trying to understand this energy. And I was a practicing
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  Speaker 3: cardiac electrophysiologist in the time. AFib is a huge unmet
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  Speaker 3: need and to improve that technology to make it democratized
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  Speaker 3: and make it available to the masses was difficult. a
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  Speaker 3: major goal. But what I realized is that there's a
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  Speaker 3: huge unmet need for very challenging cases and nobody was
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  Speaker 3: really stepping up. So I thought that was, it would
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  Speaker 3: be something worth doing. And, um, I had some insights
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  Speaker 3: and decided that it was, uh, it was time to
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  Speaker 3: start another company. You know, the, the founding of fair
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  Speaker 3: pulse was in 2011 in my mind. Uh, and the
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  Speaker 3: founding of a field medical was basically 11 years later.
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  Speaker 1: Yeah. And, you know, it's interesting you talked about the
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  Speaker 1: energy because when we're thinking about electrophysiology and we're talking
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  Speaker 1: about pulsed ablation, that is kind of the newest of
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  Speaker 1: the three energies. And so maybe let's just, you know,
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  Speaker 1: for listeners who are new to this space, how does
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  Speaker 1: pulsed ablation or, you know, we'll probably use the term
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  Speaker 1: PFA a lot for the rest of this conversation. How
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  Speaker 1: does that differ from kind of the older technology of
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  Speaker 1: radiofrequency and cryoablation? Well, thermo.
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  Speaker 3: Based destruction of tissue, you know, so ultimately ablation is
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  Speaker 3: an intentional destruction of abnormal tissue that is causing an
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  Speaker 3: electrical problem in the heart leading to tachycardia.
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  Speaker 4: Right.
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  Speaker 3: So thermal based ablation has been around forever and it
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  Speaker 3: is kind of agnostic to what tissue most tissues kind
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  Speaker 3: of die at the same temperature. And you're going to
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  Speaker 3: rely on the physics of heat transfer to get the
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  Speaker 3: job done. And it works very well. And we've refined
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  Speaker 3: that technology over 30, 40 years to some degree. But
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  Speaker 3: the limitations of the technology became pretty apparent. And especially
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  Speaker 3: when we started treating a lot more people with a
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  Speaker 3: nuisance problem like AFib. Pulse field utilizes electricity just like
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  Speaker 3: radio frequency does. But the difference is it really targets
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  Speaker 3: the metabolic architecture of the cells themselves. And so very... brief,
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  Speaker 3: very high voltage pulses can destroy the cell metabolism machinery
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  Speaker 3: and make it very predictable, very fast. And the interesting
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  Speaker 3: thing about it is that the tissue heals faster and
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  Speaker 3: in many ways has huge advantages there. You know, without
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  Speaker 3: going into deep biophysics, you know, the Differences really are about,
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  Speaker 3: you know, strong, very fast, high voltage pulses can be
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  Speaker 3: more precise in many ways and potentially safer.
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  Speaker 1: Yeah, it just sounds like you with using electricity like PFA,
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  Speaker 1: it sounds like you can pinpoint that treatment much better
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  Speaker 1: than you can with using heat, which heat can spread
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  Speaker 1: and then that potentially could damage cells that didn't need
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  Speaker 1: to be treated.
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  Speaker 3: Yeah, collateral injury.
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  Speaker 4: Yeah.
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  Speaker 3: No, no ablation technology is going to be completely free
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  Speaker 3: of of unintentional or collateral problems. But right now, you know,
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  Speaker 3: it looks like there's a promise that we we've improved
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  Speaker 3: the care for our patients, you know, in a meaningful
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  Speaker 3: way by moving away from thermal ablation and towards this
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  Speaker 3: new technology.
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  Speaker 4: Yeah.
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  Speaker 1: And then, Mark, you're you're you're the newbie of field
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  Speaker 1: medical technology. What were the steps from your career that
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  Speaker 1: led you to field medical? I know that your background
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  Speaker 1: is you have some private and you have some large
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  Speaker 1: cap experience as well.
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  Speaker 2: Yeah, no, Matt, thanks.
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  Speaker 4: And one is the electrophysiology field is one of the
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  Speaker 4: most exciting fields now. And it actually reminds me of
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  Speaker 4: my earlier days where I grew up in the interventional
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  Speaker 4: cardiology space. This was the early days, and I'm old enough,
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  Speaker 4: where we were developing drug-eluting stent technology at the time.
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  Speaker 4: And so as I looked afar after my experience with
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  Speaker 4: JC Medical and the J-Valve, which we were fortunate enough
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  Speaker 4: to get across the goal line with Edwards Life Science
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  Speaker 4: for the treatment of aortic regurgitation, this field of PFA
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  Speaker 4: is just one of the most exciting and growing spaces.
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  Speaker 4: And so when I was looking for what to do next,
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  Speaker 4: the opportunity to come and help work with Steven and
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  Speaker 4: our great team in Carlsbad, San Diego, which is where
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  Speaker 4: our company headquarters is.
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  Speaker 2: It was pretty much a no brainer to come and
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  Speaker 2: join the company.
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  Speaker 1: Now, is that you with talking about it being a
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  Speaker 1: no brainer? I was just going to ask, like, what
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  Speaker 1: what drives you to be able to say, OK, I've
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  Speaker 1: done all these great projects. I don't need to do
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  Speaker 1: another one. But it sounds like, you know, you have
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  Speaker 1: that drive. Is it because this technology was a no-brainer?
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  Speaker 1: Are you at the point in your career where you
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  Speaker 1: can just say, I can wait for those no-brainers to
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  Speaker 1: come out? Or do you just want to be there
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  Speaker 1: and you want to be part of the action?
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  Speaker 4: Yeah, I think it's really the ability to drive new fields,
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  Speaker 4: which ultimately enhance patient care and patient outcomes.
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  Speaker 2: That's what it's about. And that's what excites me.
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  Speaker 4: So if I look back to my structural heart and
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  Speaker 4: valve experience, It was about driving the field of aortic regurgitation.
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  Speaker 4: As I know you and your listeners probably are very
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  Speaker 4: well aware, the field of aortic stenosis was very well established.
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  Speaker 4: In the electrophysiology space, as Stephen was just speaking to,
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  Speaker 4: thermal ablation was the big avenue. But we're still having
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  Speaker 4: issues with recurrence. And on the treatment of ventricular tachycardia,
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  Speaker 4: which is a very, very big underserved market From a
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  Speaker 4: patient standpoint, we don't have any purpose-built technologies for the
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  Speaker 4: treatment of VT. And when I had a chance to
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  Speaker 4: look at what field was building and the opportunity here
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  Speaker 4: to build out a new space and a new sector,
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  Speaker 4: it was very exciting to me to try to get
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  Speaker 4: involved and help where I can.
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  Speaker 1: I'm liking this analogy right now of the aortic stenosis
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  Speaker 1: to aortic regurgitation to then AFib to ventricular tachycardia or VT.
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  Speaker 1: The aortic stenosis, $ 10 billion market, pretty much run by
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  Speaker 1: Edwards and Medtronic. And then aortic regurgitation just slowly starting
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  Speaker 1: to pick up. From your experience in that side of
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  Speaker 1: the business, what was it with aortic regurgitation that Or
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  Speaker 1: what was the technology that was needed to start that
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  Speaker 1: acceleration into aortic regurgitation?
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  Speaker 4: Yeah, and that's the beauty here in our discussion, Matt,
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  Speaker 4: is that there's so many similarities in that what the
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  Speaker 4: issue with aortic regurgitation is, is that you have annular
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  Speaker 4: sizes that are very large. And so you needed dedicated
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  Speaker 4: valves to treat that particular pathophysiology. In the field of electrophysiology,
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  Speaker 4: when we look at moving from the treatment of dedicated
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  Speaker 4: technology for atrial fibrillation to ventricular tachycardia, there are different
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  Speaker 4: needs to treat ventricular tachycardia. And Stephen and our team
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  Speaker 4: have been able to now develop out, from a generator
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  Speaker 4: and a catheter standpoint, purpose-built technology to be best in
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  Speaker 4: class for the treatment of ventricular tachycardia.
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  Speaker 1: Yeah. And Stephen, you mentioned earlier that those cases are challenging. So,
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  Speaker 1: What exactly makes it challenging and why hasn't the current
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  Speaker 1: technology have been able to penetrate the treatment of VT?
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  Speaker 3: Well, the patients are a lot sicker, number one. All right.
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  Speaker 3: So these are a lot of people with AFib or
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  Speaker 3: otherwise healthy. And a lot of people with VT almost
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  Speaker 3: universally have a problem with the heart. A lot of
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  Speaker 3: these people have defibrillators and impaired ejection fractions. And so
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  Speaker 3: number one, you have a sicker patient. Number two, it's
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  Speaker 3: a very deep substrate. So the atria might be a
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  Speaker 3: millimeter to four millimeters and sometimes five, but like it's
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  Speaker 3: not very thick and to get transmurality in the atria
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  Speaker 3: is not easy, but it's achievable with radiofrequency. In the ventricle,
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  Speaker 3: it's hard. And the duration of the procedures are quite long.
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  Speaker 3: So the average VT ablation would take four or some
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  Speaker 3: odd hours. It's a very effective therapy. And we know
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  Speaker 3: that now through the last 15 to 10, 20 years
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  Speaker 3: of research have demonstrated that it is better than drugs substantially. Now,
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  Speaker 3: the problem is the procedures are very much like AFib
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  Speaker 3: was in 2010. you know, AFib was a four hour
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  Speaker 3: complex arrhythmia procedure. Everyone, you know, had to have an
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  Speaker 3: extra year of training in order to do it. And
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  Speaker 3: now it is, it is, you know, basically orthopedic medicine.
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  Speaker 3: I mean, don't, don't quote me on that. It's, it's,
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  Speaker 3: it's very scripted and we know how to treat it.
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  Speaker 3: And in the ventricle, you just need, you need a
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  Speaker 3: tool that can really, um, abbreviate those procedures make them
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  Speaker 3: fast make them reliably successful um and you know and
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  Speaker 3: and safer and so uh and those are the things
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  Speaker 3: that we really focused on you know um we had
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  Speaker 3: a blank blank sheet to work with if you could
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  Speaker 3: design the most effective therapy for ventricular substrate what would
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  Speaker 3: it look like what would the catheter look like what
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  Speaker 3: would the machine do And we just started kind of
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  Speaker 3: ticking it off with the engineers until we figured out
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  Speaker 3: what we thought was the best shot. And that's what
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  Speaker 3: field medical is.
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  Speaker 1: Yeah, because you kind of going into my next question is,
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  Speaker 1: you know, we're talking about the four hour treatment. What
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  Speaker 1: are some of the low hanging fruits makes it sound
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  Speaker 1: like it's a very easy problem to solve. But when
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  Speaker 1: you're looking at that four hour treatment for VT, what
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  Speaker 1: are some of those first opportunities to address to kind
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  Speaker 1: of make that from a four-hour procedure to slowly start
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  Speaker 1: making it to a two to three-hour type procedure?
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  Speaker 3: Well, I think if you look at the average times
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  Speaker 3: in our VCAS trial, by the end of the trial,
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  Speaker 3: I mean, we were getting to basically an hour from
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  Speaker 3: skin to skin, maybe an hour and a half. But
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  Speaker 3: it's a combination of technology. It's not just the ablation.
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  Speaker 3: There's a few things that we've looked at in ischemic
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  Speaker 3: substrate ablation. So people who've had heart attacks, who have scars,
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  Speaker 3: And those groups of people, there is an opportunity to
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  Speaker 3: have a very, very fast procedure because you kind of
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  Speaker 3: know where the scar is when you start. But you
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  Speaker 3: still have to map it. The details are there. But
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  Speaker 3: that is the direction. The fact that we have a
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  Speaker 3: wide and very predictable field coverage for the heart, it
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  Speaker 3: appears that the doctors who were working in the VCAST
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  Speaker 3: route took advantage of that and you can see, you know,
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  Speaker 3: those were, you know, very encouraging, you know, results, you know,
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  Speaker 3: for an investigational tool in a small, you know, pilot study. Yeah.
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  Speaker 1: And so you've got that, I mean, so with that,
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  Speaker 1: being able to kind of almost deliver that energy faster,
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  Speaker 1: what was the design change that took place from, for
• 12:57
  Speaker 1: the field medical catheter from the previous generation PFAs? Like,
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  Speaker 1: What did you see that you could say, oh, if
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  Speaker 1: I tweak that a little bit, that allows us to
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  Speaker 1: be able to deliver that energy more efficiently?
• 13:10
  Speaker 4: Yeah.
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  Speaker 3: So, you know, one of the things that we, you know,
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  Speaker 3: we recognized early on was that the speed of energy
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  Speaker 3: delivery was very useful in improving precision. And so we
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  Speaker 3: went with a strategy of very high but low energy.
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  Speaker 3: These are very high voltage but very, very low energy pulses.
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  Speaker 3: And that allowed us to be able to get, you know, larger,
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  Speaker 3: deeper lesions fast. And I think we might be the fastest,
• 13:40
  Speaker 3: you know, application energy out there. Everyone is putting pulse
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  Speaker 3: field over seconds, which sounds like very fast to begin with.
• 13:47
  Speaker 3: But we are fractions of a second. And that allows
• 13:50
  Speaker 3: us to be able to deliver energy when the heart
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  Speaker 3: is like a slow motion camera, basically at a standstill.
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  Speaker 3: And so the geometry is something that we can take
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  Speaker 3: advantage of and make it maybe potentially more predictable.
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  Speaker 2: Oh, it's interesting.
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  Speaker 1: I never thought of it in that perspective because, you know,
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  Speaker 1: if your heart is beating 60 beats per minute, when
• 14:08
  Speaker 1: in a normal situation, I'm assuming it's beating faster during
• 14:12
  Speaker 1: a procedure, a second ablation.
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  Speaker 3: Is, it's done a full, yeah, two. The, the age,
• 14:21
  Speaker 3: you know, millimeters, but the ventricle literally centimeters of, of motion. Uh,
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  Speaker 3: and it's, it's really hard to, you know, it, it,
• 14:29
  Speaker 3: You know, you've got a moving target.
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  Speaker 4: Yeah.
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  Speaker 1: Because, yeah, and that's the thing. It's like I had
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  Speaker 1: the same kind of understanding or the perception of like, oh,
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  Speaker 1: a second is pretty quick. Well, one second, you're done.
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  Speaker 1: But at that point, the heart's already moved full cycle.
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  Speaker 4: I think, Matt, it's also important for folks to understand,
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  Speaker 4: you know, when we're treating in the atrium, that's a
• 14:49
  Speaker 4: pretty thin-walled structure. When we're treating in the ventricle, that's
• 14:53
  Speaker 4: a thick, muscular chamber of the heart. Right. And it's
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  Speaker 4: very different. And when we talk about pulse field ablation
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  Speaker 4: for ventricular, we look at a ratio. We look at
• 15:03
  Speaker 4: the width of the ablation and then the depth of
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  Speaker 4: the ablation. And that will help ultimately to determine how
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  Speaker 4: effective we are in that scar-induced area within the ventricle.
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  Speaker 1: And that makes sense, too, because the ventricles, that's where
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  Speaker 1: all the muscles is that literally pump the blood out
• 15:20
  Speaker 1: of the heart and into the lungs or out of
• 15:22
  Speaker 1: the heart into the aorta to get through the system
• 15:25
  Speaker 1: and everything. So, okay. So we were talking about that,
• 15:30
  Speaker 1: the pulse, the millisecond pulse. And you also kind of,
• 15:34
  Speaker 1: you highlighted the VCAS trial with some of the doctors
• 15:37
  Speaker 1: having the success of getting that time down. Why don't
• 15:40
  Speaker 1: we talk about that trial a little bit? What was
• 15:43
  Speaker 1: it designed for and kind of what were the key
• 15:45
  Speaker 1: results that caught your attention?
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  Speaker 3: Well, it was designed as a pilot study, which is
• 15:49
  Speaker 3: a safety study primarily. And so it's a proof of
• 15:54
  Speaker 3: concept in many ways that the technology is viable, that
• 15:58
  Speaker 3: we're meeting the endpoint before we invest in a large
• 16:02
  Speaker 3: prospective pivotal trial. And unlike our field pulse trial, which
• 16:09
  Speaker 3: was an AFib-focused trial, that was a dosing-focused trial. We
• 16:13
  Speaker 3: kind of had one dose that we wanted to test.
• 16:15
  Speaker 3: We had already kind of gone through one phase of optimization. And, uh,
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  Speaker 3: and that trial was focused on, you know, taking people
• 16:24
  Speaker 3: who had had proven that they were having VT, they
• 16:28
  Speaker 3: had an ICD and, you know, and all comers, all comers,
• 16:32
  Speaker 3: the sickest of the sick. And, you know, and, and,
• 16:34
  Speaker 3: and anyone that was there looking at all their events
• 16:37
  Speaker 3: that they had prior to them, the, the ablation, doing
• 16:40
  Speaker 3: the ablation and then tracking their events afterwards. So we
• 16:43
  Speaker 3: had a comparator. I think that's one of the reasons
• 16:45
  Speaker 3: why Circulation picked up the paper because, you know, being
• 16:48
  Speaker 3: able to utilize the continuous monitoring of an ICD to
• 16:52
  Speaker 3: look at the difference of 94% reduction in VT burden,
• 16:56
  Speaker 3: which I think is real and I think will probably
• 16:58
  Speaker 3: be reproduced in our pivotal trial. You know, I'll keep
• 17:02
  Speaker 3: my fingers crossed there. You know, I'm an optimist.
• 17:06
  Speaker 4: Yeah.
• 17:06
  Speaker 1: And so, yeah, I mean, that is the next step
• 17:08
  Speaker 1: is the Veritas study. Where are we with that? Has
• 17:13
  Speaker 1: that enrollment started yet?
• 17:15
  Speaker 3: We haven't started enrollment. We're hoping to have enrollment by
• 17:18
  Speaker 3: the end of the year.
• 17:19
  Speaker 1: End of the year. Okay. And then so, you know, maybe,
• 17:21
  Speaker 1: you know, I'll start with you, Stephen, just your thoughts
• 17:24
  Speaker 1: on the design of the trial.
• 17:27
  Speaker 2: What is this?
• 17:28
  Speaker 1: Is this a trial because this is VT versus AFib?
• 17:32
  Speaker 1: How do we think about the similarities and differences for
• 17:38
  Speaker 1: the design of that trial compared to some of the
• 17:39
  Speaker 1: other AFib trials that we've seen in the past?
• 17:42
  Speaker 3: Well, you know, so if you look at the PFA
• 17:44
  Speaker 3: trials for AFib, you know, we started off, you know,
• 17:48
  Speaker 3: you know, a fair post-course ran a randomized trial, which
• 17:50
  Speaker 3: was beautiful. And, you know, but the FDA has approved,
• 17:55
  Speaker 3: you know, single arm studies now that a six-month endpoint
• 17:58
  Speaker 3: in AFib, which you don't realize by VT because it's
• 18:01
  Speaker 3: a deadly problem. You know, this kills people, you know,
• 18:04
  Speaker 3: and the, but the, if you look back at all
• 18:07
  Speaker 3: the trials that have been around a six-month timeline is expected.
• 18:10
  Speaker 3: Michelle Kennefick, who is our clinical affairs guru, has had
• 18:16
  Speaker 3: a huge hand in helping to craft the study design
• 18:20
  Speaker 3: along with our scientific advisory panel. And so we've really
• 18:24
  Speaker 3: designed it very similar to the VCAST trial in the
• 18:27
  Speaker 3: sense that we're looking at continuous monitoring pre and post,
• 18:32
  Speaker 3: and the enrollment is very similar. It And so what
• 18:37
  Speaker 3: we expect to see from this as a single-arm study is,
• 18:40
  Speaker 3: you know, ultimately it's about safety for the FDA and
• 18:44
  Speaker 3: making sure that we have efficacy and safety and points met.
• 18:47
  Speaker 3: And I could go into details there, but, you know,
• 18:51
  Speaker 3: I don't want to take up all the time.
• 18:53
  Speaker 1: I always enjoy the details of that conversation, too. But, yeah, Mark,
• 18:56
  Speaker 1: from your perspective, you know, and we're talking about this
• 18:59
  Speaker 1: analogy of aortic stenosis, aortic regurgitation, what do you— How
• 19:05
  Speaker 1: do you see this trial kind of being that aortic
• 19:08
  Speaker 1: regurgitation moment within, you know, for cardiac arrhythmias?
• 19:13
  Speaker 4: Yeah, I think, and my hope is, and as Stephen,
• 19:17
  Speaker 4: you know, said, is that we don't know the results
• 19:20
  Speaker 4: of what we're going to, you know, obtain here, but
• 19:23
  Speaker 4: we really do hope that we can help move the
• 19:25
  Speaker 4: field forward. I do want to put in perspective for folks,
• 19:29
  Speaker 4: you know, the number of patients that are impacted by
• 19:33
  Speaker 4: ventricular tachycardia. So, 50% of cardiovascular deaths occur as sudden
• 19:41
  Speaker 4: cardiac death. And the sudden cardiac death that occurs is
• 19:46
  Speaker 4: due to ventricular tachycardia. So it is a very, very
• 19:50
  Speaker 4: large market. And in treating these patients, you truly need
• 19:55
  Speaker 4: that dedicated technology that's going to be able to go
• 19:59
  Speaker 4: deep enough and wide enough to treat the scar. When
• 20:03
  Speaker 4: Stephen was talking a bit about the specifics of our
• 20:06
  Speaker 4: VERITAS trial, which we hope to begin enrollment by the
• 20:10
  Speaker 4: end of this calendar year, we're going to be evaluating
• 20:13
  Speaker 4: both ischemic cardiomyopathy patients as well as those patients that
• 20:18
  Speaker 4: have non-ischemic cardiomyopathy. The scars in those two patient populations
• 20:24
  Speaker 4: are very different. And we're excited to basically demonstrate, and
• 20:30
  Speaker 4: as we've seen some signals from the VCAST feasibility trial,
• 20:35
  Speaker 4: that we will be highly effective in in reducing the
• 20:39
  Speaker 4: recurrence of ventricular tachycardia in both an ischemic population as
• 20:44
  Speaker 4: well as a non-ischemic cardiomyopathy population.
• 20:47
  Speaker 1: That's interesting. And you were talking about the all-comers and
• 20:52
  Speaker 1: the VCAS trial. It sounds like we're doing an all-comers
• 20:55
  Speaker 1: type of approach for the VT and the VERITAS trial
• 20:59
  Speaker 1: as well. Is that something where you'll have to have
• 21:03
  Speaker 1: separate substrates or cohorts within the trial to say, This
• 21:07
  Speaker 1: was the total population, but for those with the ischemic,
• 21:11
  Speaker 1: are you anticipating that you're going to have to do
• 21:15
  Speaker 1: that type of subgroup analysis?
• 21:17
  Speaker 2: Yeah.
• 21:17
  Speaker 4: The FDA wants us powered for both populations, and we
• 21:21
  Speaker 4: will be powered to both look at ischemic and the
• 21:24
  Speaker 4: non-ischemic population as we enroll in the trial. And we'll
• 21:29
  Speaker 4: have to have pretty close to equal numbers of patients
• 21:33
  Speaker 4: out there.
• 21:33
  Speaker 3: Yeah.
• 21:35
  Speaker 1: And then how does that strategy for enrollment going to
• 21:37
  Speaker 1: play out? Because, you know, once again, aortic stenosis, aortic
• 21:42
  Speaker 1: regurgitation type of analogy, it is a different procedure. And
• 21:47
  Speaker 1: so you have a number of physicians that have already
• 21:49
  Speaker 1: been in the VCAS trial. Are you going to focus
• 21:53
  Speaker 1: on those surgeons first? Or do you think this is
• 21:56
  Speaker 1: a technology that could be able to be replicated by
• 22:00
  Speaker 1: surgeons who are new to the technology as well?
• 22:03
  Speaker 4: So certainly, you know, early on, especially as we kick
• 22:07
  Speaker 4: off the trial, we will go to those VT centers
• 22:10
  Speaker 4: that are very high enrolling and experienced sites. But then
• 22:15
  Speaker 4: we're going to hopefully, you know, have upwards of 30
• 22:19
  Speaker 4: to 35 centers within our trial. And that'll be a
• 22:23
  Speaker 4: global trial, global meaning that we'll be in the United States, we'll.
• 22:27
  Speaker 2: Be in Canada.
• 22:29
  Speaker 4: Will be in the Netherlands, Europe, Czech Republic, et cetera,
• 22:33
  Speaker 4: the usual places. And we're going to be moving as
• 22:39
  Speaker 4: we move to those second tier sites, so to speak,
• 22:43
  Speaker 4: to basically show that we can democratize this field with
• 22:48
  Speaker 4: a workflow and an ease of use component that not
• 22:52
  Speaker 4: just the big, big academic centers that are treating high
• 22:57
  Speaker 4: volume VT, can treat, that this can be really more democratized.
• 23:02
  Speaker 1: Yeah, actually, that's interesting because one of the things I
• 23:04
  Speaker 1: thought of previously and I forgot to ask, when you
• 23:07
  Speaker 1: talk about the democratizing it and ease of flow and everything,
• 23:10
  Speaker 1: is how is the catheter connected to some of the
• 23:14
  Speaker 1: mapping systems that are currently in the market? Is it agnostic?
• 23:17
  Speaker 1: Is it linked to a certain mapping system? Are you
• 23:21
  Speaker 1: guys developing your own mapping system? How is that being developed?
• 23:25
  Speaker 4: So we are a generator and a catheter company, and
• 23:29
  Speaker 4: we span software, firmware, and hardware. We are not a
• 23:33
  Speaker 4: mapping company, so we currently use and work with the
• 23:37
  Speaker 4: commercial mapping devices.
• 23:40
  Speaker 2: Abbott and.
• 23:42
  Speaker 4: J & J have some of the bigger mapping systems,
• 23:47
  Speaker 4: and we work very well with those mapping technologies, but
• 23:53
  Speaker 4: we do not have our own mapping system.
• 23:55
  Speaker 1: Interesting. Yeah. And so, I mean, I'm actually curious though,
• 23:58
  Speaker 1: because there is a big, yeah, let's just take a
• 24:00
  Speaker 1: step back. Cause there's, there's a huge transition that's going on.
• 24:04
  Speaker 1: It used to be, you had the huge mapping systems,
• 24:08
  Speaker 1: Abbott and J & J, you would have the catheters
• 24:11
  Speaker 1: and then it turned that, you know, kind of turned
• 24:12
  Speaker 1: to that competition of like, if I was Abbott or
• 24:15
  Speaker 1: J & J, I'd be like, Hey, if you're using
• 24:17
  Speaker 1: my mapping, why don't you use my catheters? And so
• 24:19
  Speaker 1: then you saw Boston and Medtronic trying to come out
• 24:21
  Speaker 1: with their mapping. You're seeing other private companies that are
• 24:25
  Speaker 1: coming out with a, you know, a sphere that has
• 24:28
  Speaker 1: mapping and catheter. You're starting to see those combinations. I'd
• 24:32
  Speaker 1: love to just see what your thoughts are, that transition,
• 24:35
  Speaker 1: because it seems like there's a lot of different options
• 24:37
  Speaker 1: going out there. And just kind of for someone like me,
• 24:41
  Speaker 1: who's not in the space, I'm curious what you guys
• 24:43
  Speaker 1: are seeing being developed in the path of that, you know,
• 24:48
  Speaker 1: just that path of how these surgeons are utilizing all
• 24:51
  Speaker 1: this technology.
• 24:52
  Speaker 4: Yeah, I'll start and then I'd be interested actually to
• 24:55
  Speaker 4: hear Stephen's comments on this because we debate a little
• 24:58
  Speaker 4: bit back and forth about this.
• 25:00
  Speaker 2: You're right, Matt.
• 25:00
  Speaker 4: I mean, some of the field, if you look at
• 25:02
  Speaker 4: what Medtronic has done with their success with Afera, it's
• 25:06
  Speaker 4: a mapping and ablation system all built in one. The
• 25:11
  Speaker 4: way I look at it, though, from my perch is
• 25:13
  Speaker 4: that we want a system or a catheter that's going
• 25:18
  Speaker 4: to give us the safest and most effective outcome patients.
• 25:24
  Speaker 4: And whether we have a best-in-class and purpose-built catheter that's
• 25:29
  Speaker 4: going to treat the particular pathophysiology and then work with
• 25:33
  Speaker 4: someone else's mapping system, that to me is fine. And
• 25:37
  Speaker 4: I believe that's how also the key strategics out there
• 25:42
  Speaker 4: are looking at that is how can they integrate maybe
• 25:46
  Speaker 4: a purpose-built catheter into their workflow and into their mapping
• 25:51
  Speaker 4: systems to create really a best-in-class overall product.
• 25:57
  Speaker 2: Stephen, would you agree or thoughts?
• 25:59
  Speaker 3: Yeah, I mean, when you combine two of the most complex,
• 26:03
  Speaker 3: difficult things into one catheter, you may or may not
• 26:06
  Speaker 3: get the best of both worlds. I think as a workhorse,
• 26:11
  Speaker 3: it's an attractive strategy, and I fully recognize that. In
• 26:18
  Speaker 3: order to go after complex arrhythmias, getting the best-in-class mapping
• 26:21
  Speaker 3: tool linked with the best in class ablation tool, I
• 26:24
  Speaker 3: think will remain, you know, the go-to for complex stuff.
• 26:29
  Speaker 3: For bread and butter, especially anatomic stuff, having a combo
• 26:32
  Speaker 3: map and ablate is great. It's important to note though, however,
• 26:36
  Speaker 3: that there's, it's not about a combo catheter per se.
• 26:41
  Speaker 3: I mean, our catheter can map, by the way, so
• 26:44
  Speaker 3: can a ring catheter and even the, even the you know,
• 26:49
  Speaker 3: the fair wave can map. It's a question of the
• 26:52
  Speaker 3: fidelity of the map and what you're, and, and, you know,
• 26:57
  Speaker 3: if there's a cost savings, if there is a, you know,
• 27:01
  Speaker 3: a procedural savings, the safety savings that you can see,
• 27:04
  Speaker 3: you know, the difference between exchanging one catheter through a
• 27:08
  Speaker 3: sheath versus just using the same catheter the whole time,
• 27:12
  Speaker 3: you know, the, the real value proposition there, I think
• 27:16
  Speaker 3: as we see the evolution of the field, will become evident.
• 27:20
  Speaker 3: And Farah has done great stuff. It has taken market
• 27:23
  Speaker 3: share from the fair wave. Now, of course, everybody's taking
• 27:27
  Speaker 3: market share from the fair wave because they had a
• 27:29
  Speaker 3: monopoly for a while.
• 27:31
  Speaker 1: I mean, that's the thing. When you're at 100% of
• 27:32
  Speaker 1: the market share, new markets come in. Yeah, naturally. Walk
• 27:36
  Speaker 1: me through that fidelity of mapping. Is that just simply
• 27:38
  Speaker 1: the accuracy of the mapping? And it makes sense. If
• 27:42
  Speaker 1: you're combining two products into one catheter, there's got to
• 27:46
  Speaker 1: be some sacrifices that have to be made and accuracy
• 27:49
  Speaker 1: and power and things like that. So, but, and I also,
• 27:53
  Speaker 1: what you made, you highlighted so well is that there's
• 27:55
  Speaker 1: some cases that don't need that level of accuracy.
• 27:58
  Speaker 3: It's good enough.
• 27:59
  Speaker 1: It's good enough. Especially when we're talking about the atrium, the,
• 28:03
  Speaker 1: where the walls are thinner and everything. And so for
• 28:05
  Speaker 1: those more complex cases like VT, then that's where you're
• 28:08
  Speaker 1: able to be able to say, okay, I will be
• 28:11
  Speaker 1: willing to take out the mapping catheter to put in
• 28:13
  Speaker 1: then the ablation catheter because I need to have that accuracy.
• 28:19
  Speaker 1: I need to have that power to be able to
• 28:21
  Speaker 1: treat it. Yeah.
• 28:23
  Speaker 3: I mean, if you look at the software that's integrated
• 28:25
  Speaker 3: with things like the octa ray or the HD grid,
• 28:27
  Speaker 3: you know, those, those are, you know, you know, people
• 28:30
  Speaker 3: who are leading the charge in high density, um, you know, and,
• 28:34
  Speaker 3: you know, and in advanced mapping concepts that I'll point
• 28:37
  Speaker 3: the doctors to targets that are, were, are otherwise very
• 28:41
  Speaker 3: hard to find. You know, those will kind of lead
• 28:45
  Speaker 3: the way, you know, and all the companies are exploring
• 28:49
  Speaker 3: dual-use type ablation map platforms. But in the ventricle, it
• 28:56
  Speaker 3: becomes a harder problem because ultimately, you know, those sacrifices
• 29:01
  Speaker 3: will potentially interfere with your ability to get to the
• 29:04
  Speaker 3: places you need to get to. It's a moving opportunity. structure,
• 29:08
  Speaker 3: it's a very complex, rugated, you know, muscle bands and,
• 29:12
  Speaker 3: you know, mitral apparatus and stuff that are in your way.
• 29:15
  Speaker 3: And so having a big tip is a problem sometimes.
• 29:19
  Speaker 3: You know, and so we'll see how that all plays out.
• 29:21
  Speaker 3: I think, you know, my bet is on, you know,
• 29:24
  Speaker 3: the best in class map, best in class obliques, a
• 29:28
  Speaker 3: combo wins for the complex stuff.
• 29:31
  Speaker 1: And then just, you know, let's take one step back again, because,
• 29:34
  Speaker 1: you know, you talked about anatomical which, you know, you're
• 29:36
  Speaker 1: talking about that, the isolation in the pulmonary vein. And
• 29:39
  Speaker 1: now you're talking about this complex. Just so I understand,
• 29:44
  Speaker 1: is it just because anatomical, it's the same spot to
• 29:48
  Speaker 1: be treated with every patient, complex, every patient has a
• 29:53
  Speaker 1: unique need and And is that why you need to
• 29:56
  Speaker 1: have that extra mapping power, extra ablation power?
• 30:00
  Speaker 3: Yeah, I've categorized the two. You know, there's a Venn
• 30:03
  Speaker 3: diagram overlap somewhere, right? But the reality is that, you know,
• 30:07
  Speaker 3: pulmonary vein isolation is the therapy for paroxysmal AFib. That's
• 30:12
  Speaker 3: the gold standard. Everyone has pulmonary veins. And if you
• 30:15
  Speaker 3: isolate them, your chances of going into AFib are less.
• 30:19
  Speaker 3: And so... You know, that's an anatomic approach in the end.
• 30:23
  Speaker 3: We have a couple of other places in the heart
• 30:24
  Speaker 3: that we know if you're going to have typical flutter,
• 30:27
  Speaker 3: it's always going to be dependent on this little bridge
• 30:31
  Speaker 3: of muscle between the inferior vena cava and the tricuspid valve.
• 30:36
  Speaker 3: And so those are anatomic approaches. Whereas with complex arrhythmias,
• 30:40
  Speaker 3: and not all of them are complex, i.e. hard arrhythmias,
• 30:43
  Speaker 3: But complex in the sense that they're not always, the
• 30:46
  Speaker 3: diagnosis of the exact location of the target is unknown
• 30:49
  Speaker 3: until you're in the heart. And that's where the mapping shines.
• 30:53
  Speaker 2: Yeah.
• 30:54
  Speaker 1: Very interesting. And then just then to kind of summarize
• 30:57
  Speaker 1: the Veritas, we talked about it as a single arm.
• 30:59
  Speaker 1: If I heard correctly, six-month follow-up for these patients. So
• 31:04
  Speaker 1: if we start that enrollment end of calendar year, I'm
• 31:06
  Speaker 1: starting to now do my, you know, the analyst type
• 31:09
  Speaker 1: of countdown and everything, six months follow-up. probably gets you
• 31:14
  Speaker 1: to the end of 2027. Looks like then potentially data
• 31:18
  Speaker 1: readout 2028 and potentially even submission and approval by then.
• 31:22
  Speaker 1: These are my words, by the way. How do you
• 31:28
  Speaker 1: start that process? Because we're end of 2026, we're thinking
• 31:31
  Speaker 1: about end of 2028. Just what are the steps that
• 31:35
  Speaker 1: are needed to be able to say, okay, We've got
• 31:38
  Speaker 1: this done. What's next on the checklist? How do you
• 31:40
  Speaker 1: stay organized during those two plus years to be able
• 31:43
  Speaker 1: to get it from the enrollment to getting that product
• 31:46
  Speaker 1: out to the market?
• 31:47
  Speaker 2: Yeah, Matt, it's a good question.
• 31:49
  Speaker 4: And I think your timeline actually as a back of
• 31:52
  Speaker 4: envelope is pretty close to where we're kind of looking
• 31:55
  Speaker 4: at this.
• 31:57
  Speaker 2: You know, it is a continuum.
• 31:58
  Speaker 4: It's not like you submit your IDE for your pivotal
• 32:02
  Speaker 4: trial and then work stops and then you get to
• 32:05
  Speaker 4: the next phase. It's a continuum. You continue to work
• 32:08
  Speaker 4: because ultimately when you're submitting with the FDA with your
• 32:11
  Speaker 4: PMA module for ultimate commercialization, that's a modular submission and
• 32:17
  Speaker 4: you have to go through manufacturing modules, you go through
• 32:20
  Speaker 4: your clinical modules, et cetera. One of the situations that
• 32:27
  Speaker 4: we're in right now is that we're pretty much oversubscribed
• 32:31
  Speaker 4: for our Veritas trial because There is such an unmet
• 32:35
  Speaker 4: need out there for patients being treated with ventricular tachycardia.
• 32:40
  Speaker 4: And we have more sites that are calling us and
• 32:43
  Speaker 4: wanting to be part of the trial. We do think
• 32:46
  Speaker 4: that we will be able to enroll this trial fairly quickly.
• 32:50
  Speaker 4: And that ultimately will drive the timeline because that's from
• 32:54
  Speaker 4: when we can lock our data and then submit our
• 32:57
  Speaker 4: data to the FDA and then the time it takes
• 33:00
  Speaker 4: ultimately to for the FDA to give that PMA approval.
• 33:03
  Speaker 4: But your timeline that you laid out is pretty much,
• 33:06
  Speaker 4: you know, an accurate timeline here. The team now is
• 33:10
  Speaker 4: working on getting the trial up and running, as we've spoken,
• 33:14
  Speaker 4: that we'll have, you know, hopefully first patient enrolled by
• 33:17
  Speaker 4: the end of this calendar year.
• 33:18
  Speaker 2: And then, you know, we'll have.
• 33:21
  Speaker 4: A trial that enrolls pretty quickly, I think, and then
• 33:24
  Speaker 4: we'll move forward with submission of our PMA modules.
• 33:28
  Speaker 1: That's always a good problem to be oversubscribed. I mean,
• 33:30
  Speaker 1: is that something where you're able to then work with
• 33:33
  Speaker 1: the FDA to expand that out further? Could this potentially
• 33:36
  Speaker 1: be like a passionate patient care setting? Because, you know,
• 33:40
  Speaker 1: you talked earlier about, you know, sudden cardiac death being,
• 33:43
  Speaker 1: you know, ventriculopathy is a major cause of that. Are
• 33:47
  Speaker 1: you able to speak with the FDA potentially and say,
• 33:49
  Speaker 1: let me go, hey, you know, look at all these
• 33:52
  Speaker 1: patients that could be at risk of this, you know,
• 33:55
  Speaker 1: sudden cardiac arrest? are we able to expand this out
• 34:00
  Speaker 1: to treat those patients as well so they don't have
• 34:02
  Speaker 1: to wait until 2028 to get this treatment potential?
• 34:05
  Speaker 4: Yeah, I think, let me give a big shout out
• 34:08
  Speaker 4: quickly to the FDA. You know, sometimes they take a
• 34:13
  Speaker 4: lot of grief, but my experience over my years with
• 34:17
  Speaker 4: CDRH in particular, which is the medical device division of
• 34:21
  Speaker 4: the FDA, they have been incredibly helpful. We're part of
• 34:25
  Speaker 4: a new pilot program that the FDA has in store
• 34:29
  Speaker 4: called the TAP program, which allows us to have some
• 34:33
  Speaker 4: quicker reviews and to meet with our review teams.
• 34:37
  Speaker 2: We have already.
• 34:38
  Speaker 4: Done and have, you know, since the time of our
• 34:42
  Speaker 4: feasibility work, compassionate use cases. We will continue now as
• 34:47
  Speaker 4: we over the next couple months to actually do some
• 34:52
  Speaker 4: additional compassionate use cases. And the FDA is open to
• 34:55
  Speaker 4: that as long as we're not doing compassionate use as
• 34:59
  Speaker 4: our clinical strategy, as long as we're moving forward.
• 35:02
  Speaker 2: With our pivotal trial.
• 35:04
  Speaker 4: They're okay and understand that there are patients out there
• 35:08
  Speaker 4: that need therapies that the market just currently can't provide.
• 35:14
  Speaker 4: And so, you know, we'll be working with investigators in
• 35:17
  Speaker 4: some you know, key sites to do some compassionate use cases.
• 35:22
  Speaker 4: And some of those cases, it's important to understand are
• 35:25
  Speaker 4: patients that have recurrence of VT. They've been treated with
• 35:29
  Speaker 4: either thermal ablation or other ablative catheters that basically have recurrences.
• 35:37
  Speaker 4: And that is not a good situation for a patient
• 35:40
  Speaker 4: because from a quality of life standpoint and a risk
• 35:43
  Speaker 4: of sudden death and other things, These patients really are
• 35:47
  Speaker 4: in need of therapy. And, you know, to be able
• 35:50
  Speaker 4: to go and help a patient that has had two
• 35:52
  Speaker 4: or three recurrences and get them back to a really
• 35:57
  Speaker 4: good quality of life, that's what this field is about
• 36:00
  Speaker 4: and what we're excited about bringing to market.
• 36:03
  Speaker 1: Yeah, no, and that's kind of interesting, the recurrence, because
• 36:06
  Speaker 1: that kind of then, you know, I'm thinking about beyond Veritas,
• 36:11
  Speaker 1: beyond VT, And I believe I saw somewhere where you
• 36:15
  Speaker 1: talked about, you know, well, you actually even said support
• 36:20
  Speaker 1: future indications in cardiology and beyond. And so I would
• 36:24
  Speaker 1: love to get into that beyond first. But I also
• 36:25
  Speaker 1: know immediately in cardiac, you can expand this VT indication
• 36:31
  Speaker 1: to AFib as well. And especially, you know, AFib can
• 36:35
  Speaker 1: be split between persistent and proximal. So you guys started
• 36:40
  Speaker 1: with the field pulse first in human study. Kind of
• 36:44
  Speaker 1: a similar vein of when I was talking about the VCAS,
• 36:47
  Speaker 1: what was that study designed for and kind of what
• 36:49
  Speaker 1: did the data show, especially regarding PVI durability?
• 36:54
  Speaker 3: Field pulse, which is our AFib trial. So you have
• 36:57
  Speaker 3: to realize that the catheter that we have, it was
• 36:59
  Speaker 3: designed to be basically a tool that every doctor already
• 37:02
  Speaker 3: knows how to use. And what we've done is empower
• 37:06
  Speaker 3: that tool to have a larger range of capabilities and
• 37:12
  Speaker 3: And so the VT is our focus, and we know
• 37:15
  Speaker 3: that's the big unmet need. That's the growth opportunity. But
• 37:18
  Speaker 3: to have a universal tool that treats all arrhythmias was
• 37:22
  Speaker 3: part of the vision. And so we demonstrated that. That
• 37:27
  Speaker 3: one was also a feasibility study where we tested a
• 37:30
  Speaker 3: number of much lower energy pulse results.
• 37:35
  Speaker 2: Waveforms.
• 37:36
  Speaker 3: So we're talking about 1 20th the amount of energy
• 37:39
  Speaker 3: is being used for the HRL applications. And looking at
• 37:42
  Speaker 3: that workflow and the efficacy. And so what we saw
• 37:45
  Speaker 3: was with one of the waveforms that we had a
• 37:51
  Speaker 3: very high durability, which is on par with what you
• 37:54
  Speaker 3: would expect in an early feasibility study in that 80%
• 37:57
  Speaker 3: range and very good safety profile of the technology. So
• 38:01
  Speaker 3: quite encouraging preliminary results for an investigational tool again. And
• 38:07
  Speaker 3: what we're working on now is further optimization of that technology.
• 38:11
  Speaker 3: We think we know where the need is in the
• 38:15
  Speaker 3: AFib focal, you know, that versatility of the catheter. And
• 38:20
  Speaker 3: that's going to be complex versions of AFib, the persistent AFib,
• 38:24
  Speaker 3: which is a massive part of the AFib market that, again,
• 38:27
  Speaker 3: doesn't have great tools. Almost every tool that's been designed
• 38:30
  Speaker 3: right now is a mimic of the foresight fair wave
• 38:33
  Speaker 3: single shot kind of continuum. And, and we want to
• 38:38
  Speaker 3: kind of bring that into the other targets of AFib.
• 38:41
  Speaker 3: And I think, you know, what we're working on right
• 38:44
  Speaker 3: now internally is quite exciting.
• 38:47
  Speaker 1: Is it the same kind of message that we were
• 38:49
  Speaker 1: talking about VT with how the field medical is able
• 38:53
  Speaker 1: to get that width and depth and that fraction of
• 38:57
  Speaker 1: a second type of treatment? Is that kind of, you know,
• 39:00
  Speaker 1: I don't want to say copy and paste, but is
• 39:01
  Speaker 1: that the similar vein going into for those persistent AF patients?
• 39:06
  Speaker 3: Well, I think so. I think there's a lot of
• 39:09
  Speaker 3: similarity there. The depth has been a big challenge for
• 39:12
  Speaker 3: the doctors for a long time. I've done my fair
• 39:15
  Speaker 3: share of VT ablation, but for the AFib application, the
• 39:21
  Speaker 3: nuances are a little more challenging to talk about, which
• 39:27
  Speaker 3: is precision of energy delivery, to allow you to have
• 39:31
  Speaker 3: reproducible results. And so that's additional. So large area ablation
• 39:38
  Speaker 3: for a scar-related VT, I think we have a great
• 39:41
  Speaker 3: tool for that. But when you get into the atria
• 39:44
  Speaker 3: and you want to reduce kind of, you know, you
• 39:46
  Speaker 3: want to only ablate the tissue that's abnormal near the
• 39:50
  Speaker 3: catheter in a very small areas, right? These are thin structures.
• 39:54
  Speaker 3: So that's what, so that added precision is what we're
• 39:58
  Speaker 3: refining right now.
• 39:59
  Speaker 4: Yeah. And I think one other piece that I think
• 40:01
  Speaker 4: we can add here is, is that, and we've spoken
• 40:04
  Speaker 4: a bit about this, you know, PFA, first generation Farrapulse,
• 40:08
  Speaker 4: we're now in that world where we're moving towards, second-generation PFA.
• 40:13
  Speaker 4: And we've talked about how that works on the ventricle.
• 40:17
  Speaker 4: Stephen's just alluded to some of the workflow advantages. But
• 40:22
  Speaker 4: in addition, I think one of the areas that the
• 40:25
  Speaker 4: field is looking to move on the atrial side is,
• 40:28
  Speaker 4: how can we take patients now that are treated with
• 40:31
  Speaker 4: a therapeutic modality like PFA that require general anesthesia and
• 40:38
  Speaker 4: And then take those patients and possibly move them to
• 40:41
  Speaker 4: more conscious sedation and then bring that therapy possibly to
• 40:45
  Speaker 4: the ambulatory care center. And once you are able to
• 40:49
  Speaker 4: obviously move patients to the ambulatory care center, that really
• 40:52
  Speaker 4: can expand the marketplace as well. And there are therapeutic
• 40:58
  Speaker 4: ways that we're working and others are working to try
• 41:02
  Speaker 4: to evaluate how we can make that a tolerable treatment.
• 41:06
  Speaker 2: For patients.
• 41:07
  Speaker 4: So general anesthesia is not required.
• 41:10
  Speaker 1: And more broadly thinking, just longer term, I'd love to
• 41:15
  Speaker 1: hear more about this transition to the ASC because the
• 41:18
  Speaker 1: general anesthesia, and, you know, I'm thinking of what made
• 41:22
  Speaker 1: Ferripulse so successful. It was a very quick and a
• 41:25
  Speaker 1: very safe procedure. And, you know, now the new second
• 41:29
  Speaker 1: generations of PFA technology is trying to also increase the
• 41:32
  Speaker 1: effectiveness of the technology as well. When I think of that, though,
• 41:37
  Speaker 1: and I think of more power and, you know, focusing
• 41:40
  Speaker 1: on that effectiveness, I would have the kind of my
• 41:43
  Speaker 1: mind I'm thinking of, OK, that might mean, you know,
• 41:47
  Speaker 1: more patients need general anesthesia. So I feel like I'm
• 41:50
  Speaker 1: wrong in that assumption, but I'm just curious about what
• 41:53
  Speaker 1: are the barriers to transition from a general anesthesia procedure
• 42:00
  Speaker 1: to that ASC procedure within EPP? cases?
• 42:03
  Speaker 2: I'll start at a high level and then I'm going
• 42:05
  Speaker 2: to turn over to.
• 42:06
  Speaker 4: Stephen maybe to talk a bit, but it's around developing out.
• 42:10
  Speaker 2: What we would call a tolerable therapy. Okay.
• 42:14
  Speaker 4: A therapy that basically is going, that a patient, when
• 42:18
  Speaker 4: we hit that button and ablate, is going to feel
• 42:22
  Speaker 4: comfortable receiving without being under general anesthesia. And There's a
• 42:28
  Speaker 4: lot that goes into developing out that tolerable waveform.
• 42:33
  Speaker 2: But Stephen, do you want to add anything?
• 42:35
  Speaker 4: Yeah.
• 42:35
  Speaker 3: I mean, so one of the big kind of takeaways
• 42:37
  Speaker 3: from the field pulse trial was the speed at which
• 42:39
  Speaker 3: we were able to do what is considered standard pulmonary
• 42:43
  Speaker 3: vein isolation. I mean, the average times was 12 minutes
• 42:46
  Speaker 3: for all four pulmonary veins with equal equivalence. I mean,
• 42:52
  Speaker 3: our energy is delivered in less than 200 milliseconds and
• 42:54
  Speaker 3: you can move the catheter very quickly. skilled hands. The
• 43:00
  Speaker 3: one thing we didn't attempt to do at the time
• 43:02
  Speaker 3: was that tolerability. And that ends up being the brass
• 43:06
  Speaker 3: ring here, right? How do you expand it into ASCs? Well,
• 43:09
  Speaker 3: you don't want to have people under general anesthesia. You
• 43:11
  Speaker 3: can avoid it. And it's because general anesthesia adds time
• 43:15
  Speaker 3: and some risk to the patient. And cost.
• 43:17
  Speaker 1: And cost, yeah.
• 43:18
  Speaker 3: And to expand that market, make AFib ablation much more
• 43:25
  Speaker 3: available and ablation in general available to more people, you know,
• 43:29
  Speaker 3: then the next thing is that tolerability arm. General anesthesia
• 43:34
  Speaker 3: in Europe is not as widely used. And those single
• 43:37
  Speaker 3: shot tools allow you to kind of get some, you know,
• 43:40
  Speaker 3: progress there. We think the versatility and the speed of
• 43:44
  Speaker 3: a catheter like this will also be able to do
• 43:47
  Speaker 3: that as well.
• 43:48
  Speaker 2: Interesting.
• 43:48
  Speaker 1: Because, yeah, I was just thinking, you know, one of the, Yeah,
• 43:51
  Speaker 1: that's interesting in Europe as well about the fact that
• 43:53
  Speaker 1: they don't have as much general anesthesia that we have
• 43:55
  Speaker 1: in the U.S. And that kind of makes you realize
• 43:58
  Speaker 1: some of the market share shifts that are going on
• 44:02
  Speaker 1: seem to be more relevant here in the U.S. where
• 44:05
  Speaker 1: you can have those cases that can go under general anesthesia. Well,
• 44:09
  Speaker 1: in Europe, you're not seeing it as much because you
• 44:11
  Speaker 1: still want the quickest and safest procedure done. With that said,
• 44:15
  Speaker 1: you know, we have the field pulse trial that that
• 44:20
  Speaker 1: those results done. What is the next steps for an
• 44:25
  Speaker 1: IDE study? And then for you, Mark, this is kind
• 44:29
  Speaker 1: of where breadth and depth come in again, because we
• 44:32
  Speaker 1: have Veritas, we're looking at a commercialization sometime at 2028.
• 44:40
  Speaker 1: How do you allocate that capital? Are you are you
• 44:44
  Speaker 1: guys just solely focused on the Veritas to make sure
• 44:46
  Speaker 1: that gets out as seamlessly as possible? Or do you
• 44:50
  Speaker 1: have enough of the capacity to be able to say, oh,
• 44:52
  Speaker 1: we can have these dual programs running at the same time?
• 44:56
  Speaker 2: Yeah, and it's an excellent question, Matt.
• 44:58
  Speaker 4: And obviously as a private company and as a smaller company,
• 45:03
  Speaker 4: you know, we're still only about 40 employees overall for
• 45:06
  Speaker 4: the whole company. You have to do well what you
• 45:10
  Speaker 4: can do. And basically right now, you know, our main
• 45:14
  Speaker 4: push is to get through our VERITAS trial and lead
• 45:19
  Speaker 4: with our VT indication. That said, we have some excellent
• 45:24
  Speaker 4: R & D work that's going on in the background,
• 45:27
  Speaker 4: looking at how we can advance the atrial fibrillation space,
• 45:31
  Speaker 4: similar to some of the things that we've spoken about,
• 45:34
  Speaker 4: and how we can work to bring a next-generation tolerable
• 45:38
  Speaker 4: waveform to the market. So we have allotment of You know,
• 45:43
  Speaker 4: some resources going to our R & D programs and
• 45:46
  Speaker 4: on the big R side, while our key development and
• 45:50
  Speaker 4: clinical programs that are ultimately going to lead to commercialization
• 45:55
  Speaker 4: are going to be on the ventricular side. Yeah.
• 45:59
  Speaker 3: The company literally ran both those trials almost simultaneously. Eight
• 46:04
  Speaker 3: weeks after we enrolled our first patient in VCAS, we
• 46:07
  Speaker 3: enrolled in FieldPulse. We just didn't talk about FieldPulse very
• 46:10
  Speaker 3: much because what we knew is that we wanted a
• 46:13
  Speaker 3: universal tool, but, you know, the nuance in the AFib
• 46:17
  Speaker 3: market is kind of, it's, you know, it's a different beast.
• 46:21
  Speaker 3: The true and met need isn't that ventricle. And so,
• 46:23
  Speaker 3: and that's where we're going to focus our efforts.
• 46:26
  Speaker 4: Yeah.
• 46:26
  Speaker 1: And then it kind of, Similar topic, when we think
• 46:29
  Speaker 1: about the commercial launch for VT, how do you strategize
• 46:36
  Speaker 1: that width and depth within the PFA market? We talked
• 46:41
  Speaker 1: about the trial being oversubscribed by hospitals wanting to be
• 46:45
  Speaker 1: a part of it. Does that make you consider more
• 46:49
  Speaker 1: of the breadth of a commercial launch, or do you
• 46:52
  Speaker 1: still want to make sure that the first hospitals, the
• 46:56
  Speaker 1: first surgical centers that are using this technology are using
• 47:00
  Speaker 1: it the right way and they develop that program to
• 47:03
  Speaker 1: be able to use field medical technology.
• 47:05
  Speaker 4: I think whenever you think about a launch and, you know,
• 47:09
  Speaker 4: I've had the opportunity to be at both the big
• 47:12
  Speaker 4: companies and smaller companies here, you know, the key is
• 47:18
  Speaker 4: always to make sure that commercial launch is done in
• 47:22
  Speaker 4: a way that provides the highest safety and the most
• 47:27
  Speaker 4: effective outcome. Interventionalists and whether they're electrophysiologists or interventional cardiologists
• 47:33
  Speaker 4: have very short memories. So if you launch a technology
• 47:37
  Speaker 4: that don't produce good outcomes, ultimately they may not give
• 47:40
  Speaker 4: you a second or third chance. So I do like
• 47:43
  Speaker 4: the idea when ultimately you move to a commercialization, you do,
• 47:48
  Speaker 4: you know, small selected, you know, centers, high volume centers
• 47:52
  Speaker 4: that are going to give you good early results and
• 47:55
  Speaker 4: you follow those results, you know, also, you know, those
• 47:59
  Speaker 4: early results can allow for further CMS, you know, help
• 48:06
  Speaker 4: from a reimbursement standpoint to your programs. But you're preparing
• 48:12
  Speaker 4: at the same time for, you know, kind of a
• 48:15
  Speaker 4: larger market opportunity once you get those regular regulatory approvals, both.
• 48:22
  Speaker 2: In the EU and, And elsewhere, and obviously in North America.
• 48:27
  Speaker 1: And it's interesting that you say that, like how the
• 48:30
  Speaker 1: short memory span for some of these surgeons, because there's
• 48:34
  Speaker 1: so much new technology coming in, the market is so
• 48:36
  Speaker 1: competitive that if you kind of do one and then
• 48:38
  Speaker 1: you move on, there's going to be three or four
• 48:41
  Speaker 1: other companies that come in with their technology to trial.
• 48:43
  Speaker 1: So that aspect does make sense.
• 48:46
  Speaker 3: Yeah. And the early launch, I had another company, Atroverse.
• 48:51
  Speaker 3: We were very cautious about the early launch of the technology,
• 48:54
  Speaker 3: primarily because that's an opportunity for learning as well. So
• 48:59
  Speaker 3: as you move something into commercial, the doctors use it differently.
• 49:05
  Speaker 3: And because of that, you know, they can start using
• 49:09
  Speaker 3: stuff off-label and things like that. And you learn, you know,
• 49:12
  Speaker 3: how are they actually going to utilize it before you
• 49:15
  Speaker 3: you you give it to everybody you know that's a
• 49:18
  Speaker 3: feedback loop that's a closed loop kind of opportunity for
• 49:21
  Speaker 3: you to refine how you market it how you bring
• 49:24
  Speaker 3: it out and i fully agree with mark 100 you
• 49:27
  Speaker 3: know that is that that has to be highly curated
• 49:30
  Speaker 3: yeah well.
• 49:33
  Speaker 1: Kind of now we're closing out we're talking about all
• 49:34
  Speaker 1: this great technology that's you know starting to come out
• 49:38
  Speaker 1: if on schedule, 2028. But let's talk about even further out.
• 49:41
  Speaker 1: I mean, what got my attention again is a flexible
• 49:45
  Speaker 1: platform built to support future indications in cardiology and beyond.
• 49:51
  Speaker 1: What is the beyond? And then over the next five
• 49:55
  Speaker 1: to 10 years, how do you see ablation catheter technology
• 49:59
  Speaker 1: being part of the mainstream of the healthcare system?
• 50:03
  Speaker 4: Yeah, maybe I'll take a start and then Stephen, I'm sure,
• 50:07
  Speaker 4: can chime in. here because he's got that great innovator mind.
• 50:13
  Speaker 4: But Matt, it gets back to where we started this conversation.
• 50:17
  Speaker 4: The mechanism of action of PFA, that it can be
• 50:22
  Speaker 4: very focused therapy that is very different than thermal types
• 50:27
  Speaker 4: of ablations. We're not the first to think about other
• 50:31
  Speaker 4: indications for PFA outside of what we're working on in
• 50:35
  Speaker 4: the complex arrhythmia space. but even outside the cardiac realm.
• 50:40
  Speaker 4: And there are people that are working on PFA for
• 50:44
  Speaker 4: areas outside, whether ultimately PFA can be used in areas
• 50:49
  Speaker 4: of neuromodulation, other areas of cancer therapy, like liver ablation
• 50:55
  Speaker 4: and that sort of thing. I'm excited, especially as a
• 50:59
  Speaker 4: background coming out of the structural heart spaces.
• 51:02
  Speaker 2: Can we use PFA, for example, and.
• 51:06
  Speaker 4: The specificity of PFA and the workflow of PFA to treat,
• 51:10
  Speaker 4: for example, hypertrophic cardiomyopathy, which is sometimes treated by thermal
• 51:15
  Speaker 4: ablation today? Or can we help improve and treat patients
• 51:21
  Speaker 4: that may have outflow tract obstruction after putting in a
• 51:26
  Speaker 4: mitral prosthesis and by ablating that outflow tract to allow
• 51:32
  Speaker 4: more patients to be candidates for mitral prostheses. There's a
• 51:37
  Speaker 4: lot of areas that PFA can be used and, and
• 51:40
  Speaker 4: currently be investigated by many folks. Um, uh, it's an
• 51:45
  Speaker 4: exciting field and that's one of the reasons why I was, uh,
• 51:48
  Speaker 4: tremendously excited to, to join this space.
• 51:51
  Speaker 2: But Stephen, your thoughts? Yeah.
• 51:53
  Speaker 3: Um, you know, there's active research and clinical trials ongoing
• 51:57
  Speaker 3: in other areas. Um, you know, um, you know, like
• 52:01
  Speaker 3: Alan Zingler's company, um, Alpha is working on the prostate.
• 52:05
  Speaker 3: There are a number of other companies out there. I
• 52:07
  Speaker 3: think Pulse Biosciences did a thyroid trial. You got the
• 52:12
  Speaker 3: guys at Galvanize who did the pulmonary.
• 52:16
  Speaker 1: Applications.
• 52:18
  Speaker 3: Cancer is an exciting area for Pulse Field primarily because
• 52:23
  Speaker 3: even though people have been working on a nanonife from
• 52:26
  Speaker 3: Angin and Amish, all those guys, You know, they haven't
• 52:31
  Speaker 3: really funded the types of trials needed to drive that
• 52:34
  Speaker 3: innovation and and an adoption. What we see is, you know,
• 52:40
  Speaker 3: you know, like activation of the immune system in those applications.
• 52:44
  Speaker 3: And there are, I would think, four or five really
• 52:47
  Speaker 3: exciting places where this is the right energy. to treat
• 52:52
  Speaker 3: some very persistent and challenging things. And when we were
• 52:56
  Speaker 3: doing our, you know, a lot of our pilot work,
• 53:00
  Speaker 3: we started realizing that there could be some great applications
• 53:03
  Speaker 3: for this particular generator, given the versatility of the generator.
• 53:08
  Speaker 3: And that's why we say Beyond.
• 53:09
  Speaker 2: Yeah.
• 53:10
  Speaker 1: Well, I'm very excited to see how the next two
• 53:13
  Speaker 1: years and Beyond plays out as well. But Mark and Stephen,
• 53:17
  Speaker 1: thanks so much for joining us today.
• 53:19
  Speaker 2: Thank you for having us, Matt.
• 53:20
  Speaker 3: It's been great, Matt.
• 53:20
  Speaker 1: Yeah. And thank you to our producers at Didya Simani
• 53:23
  Speaker 1: and Mariam Thawele for all the behind the scene work.
• 53:26
  Speaker 1: And thank you to our listeners for tuning in today.
• 53:28
  Speaker 1: We hope you join us for future episodes. And if
• 53:30
  Speaker 1: you'd like to stay up to date, you can click
• 53:32
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• 53:35
  Speaker 1: Take care. Thank you.