Transcription of The Stock Network Interview with EBR Systems (ASX:EBR), President & CEO, John McCutcheon
Lel Smits: EBR Systems is the developer of the world’s only wireless cardiac pacing technology, the WISE System, designed to revolutionize treatment for heart failure patients who require cardiac resynchronization therapy, also known as CRT. With the WISE Up study now underway, EBR Systems is generating long-term real-world performance data to further validate the benefits of left ventricular endocardial pacing and strengthen adoption of the WISE System globally. Joining me today is John McCutcheon, President and CEO of EBR Systems, to share how this major milestone positions the company for future commercial acceleration.
John, welcome to the Stock Network.
John McCutcheon: Hey, Lel, thanks so much for having me.
Lel Smits: Now, John, EBR has just announced the first two patients enrolled in the WISE Up study.
This is a landmark moment in advancing wireless CRT. John, just how significant is this milestone for EBR Systems and also for the clinicians treating heart failure patients?
John McCutcheon: Well, the implications are several. One is that we have an FDA obligation to start enrolling in the post-approval study within a certain window after approval.
And actually, the goal was to have the first patients enrolled by early December. So we exceeded that. We’ve over-delivered there for FDA, so that’s great.
And that gets us further down the goal of meeting that obligation of fulfilling the 300 patients over the next couple of years.
Lel Smits: Wonderful. Now, WISE Up will follow more than 300 patients across 50 U.S. centers over the five years ahead, capturing real-world outcomes using the FDA-approved WISE System.
What insights do you expect this study to deliver? And also, why is real-world data so important for driving adoption of new cardiac technologies?
John McCutcheon: Yeah, it’s a great opportunity. So some people see it as an obligation from the FDA, but it’s really an opportunity where we can validate what we saw in the formal SOLVE study, the pivotal trial. So the data should reflect that.
And then the other thing in the real-world study is that physicians are allowed to use our device off-label. Now, WISE Company cannot promote off-label use, but the FDA does want us to gather any off-label usage in this real-world study. That’s often used for getting label expansion with real-world data.
So that would be the best outcome is if we do see that physicians are using it in ways that we hadn’t really thought of before or that weren’t on-label, that we eventually do get that, and that would potentially expand our TAM.
Lel Smits: Great. And John, clinicians leading the study have already described the WISE System as a step change in cardiac resynchronization therapy.
How does the WISE System improve on traditional CRT devices? And also, what patient groups stand to benefit the most from wireless endocardial pacing?
John McCutcheon: Yeah. Well, the cardiac resynchronization therapy or CRT is the gold standard. It’s the standard of care with patients with this type of heart failure that we’re treating.
Now, many of them can’t get conventional CRT because the leads or wires that are used just don’t work in their anatomy. And so it’s a game changer because we can actually deliver the gold standard to patients that wouldn’t otherwise get it. And heart failure is a debilitating disease.
It’s progressive. And so without intervention, these people really have poor quality of life and often limited lifespan. And so the ability to finally get that with our wireless technology is a real game changer for those patients.
Lel Smits: It certainly is. And now with FDA approval and U.S. commercial rollout underway, the WISE Up study will provide clinical evidence to support broader adoption. How will this study support your commercial strategy? And also, what are the next steps as ABR expands across the U.S. and internationally?
John McCutcheon: Yeah. Well, in terms of the commercial importance, first of all, it’s a commercial study. So we’re actually selling devices as part of the enrollment. So it’s not a sponsored study whereby we might give away devices.
These are all commercial. They’re paid for. So it’s part of our market adoption.
It also shows the physicians what they can do. So it gives them incentive to be part of that study and to treat more patients and get their own experience. And then the best marketing for medtech devices in general is publications.
So the more data you have, the more podium presence, the more studies that you’ve published, the better for adoption. The physicians enrolling in the study will be talking to their peers at meetings and one-on-one and through publications. And that will get the word out and really help us accelerate our adoption.
Lel Smits: And John, I see you’ve just released your quarterly earnings. How are you feeling about the results and what were the highlights?
John McCutcheon: Yeah, we’re really excited to talk about our pilot launch. So people may remember that our limited mark release really doesn’t start or didn’t start until October 1 of this year, the fourth quarter.
So these earnings precede that, and it shows that we treated three patients in the second quarter. That increased to nine patients in the third quarter, so cumulatively 12. We posted Q3 revenue of just over $500,000 U.S., again, a significant increase over the prior quarter.
And really, you should see this as this early adoption, this excitement that the physicians are bringing forward in advance of getting their reimbursement in place. So these are really the early adopters, the doctors that are excited to get it as early as possible. The other thing is we’re seeing a lot of usage with leadless pacemakers, which has been part of our TAM.
So we’re sort of verifying or validating our TAM buildup with these early data. So investors should be really excited about the results that we’re seeing.
Lel Smits: Excellent. Well, thank you for the update and look forward to hearing more from EBR Systems as those developments come through.
John McCutcheon: Great. Thank you, Lel.
Ends