Pulse Biosciences, Inc. (NASDAQ:PLSE) Q4 2025 Earnings Call Transcript

Pulse Biosciences, Inc. (NASDAQ:PLSE) Q4 2025 Earnings Call Transcript February 20, 2026

Operator: Ladies and gentlemen, thank you for standing by. My name is Colby, and I will be your conference operator today. At this time, I would like to welcome you to the Pulse Biosciences Q4 and Full Year 2025 Earnings Call. [Operator Instructions] I will now turn the call over to Trip Taylor. You may begin.

Philip Taylor: Thank you, operator. Before we begin, I would like to inform you that comments and responses to your questions during today’s call reflect management’s views as of today, February 19, 2026, only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the U.S. Securities and Exchange Commission. Our SEC filings can be found on our website or on the SEC’s website. Investors are cautioned not to place undue reliance on forward-looking statements.

We disclaim any obligation to update or revise these forward-looking statements. We will also discuss certain non-GAAP financial measures. Disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable GAAP measures can be found in the press release. Please note that this conference call will be available for audio replay on our website at pulsebiosciences.com in the News and Events section on our Investor Relations page. With that, I would now like to turn the call over to Co-Chair of the Board and Chief Executive Officer, Paul LaViolette.

Paul LaViolette: Thank you, Trip. Good afternoon. Thank you, everyone, for joining us today. At Pulse Biosciences, we aren’t just making a better medical device, we are creating a pulsed field ablation platform to completely shift how physicians treat disease. We intend to transition the entire medical field away from using energies that apply extreme heat or cold to destroy tissue and toward our much more precise method, nanosecond pulsed field ablation or nsPFA. Our technology has potential to completely disrupt multiple soft tissue ablation markets. And here are the reasons why. First, it offers incredible precision. Our system directs ultra-short duration bursts of energy, lasting only a few billionths of a second to only the precise locations where therapy is needed.

Second, nsPFA creates a human body compatible healing advantage by initiating regulated cell death. Third, it operates with blisteringly fast speeds measured in billionths of a second. Precisely because of the speed and efficiency in ablating cells, we deliver less cumulative energy due to significantly shorter treatment cycles delivered in record fast procedure times. And finally, we have built an imposing legal fortress of intellectual property. We added 67 issued and 77 pending patents in 2025 alone, equivalent to adding a new piece of intellectual property every 2.5 days throughout the year to protect our novel developments. In total, 250 patents have been granted to Pulse Biosciences and an additional 180 patents are pending approval. Overall, we made progress in calendar year 2025.

Today, I will walk through those updates and our plans for 2026. After that, I’ll turn the call over to our CFO, Jon Skinner, to review the financial results, and we will conclude with a question-and-answer session joined by Bob Duggan, Co-Chair of the Board. At the start of 2025, we defined a focused set of objectives for the year. Our highest objective was and remains to advance our nanosecond PFA platform into late-stage clinical development to treat atrial fibrillation in both electrophysiology and cardiac surgery. In addition, we plan to explore launch feasibility of our soft tissue ablation system prior to gaining a specific therapeutic claim using Category II reimbursement. We are pleased to report we made progress across each of those goals in 2025, and that noteworthy progress continues into early 2026.

On the clinical front, we secured IDE approvals for both our electrophysiology catheter and our cardiac surgical clamp programs, positioning both to move into pivotal trial enrollment. In parallel, we significantly expanded treatment of patients in our European feasibility studies across both cardiac platforms, generating increasingly robust data sets to show superior workflow and procedural consistency. We also started publishing those data sets and through today have produced clinical performance of interest in each of our 3 clinical programs. On the commercial front, we continued the highly controlled launch of the Vybrance platform for soft tissue ablation in a targeted disciplined manner. We did so by focusing on supporting a few select institutions dedicated to procedural excellence in order to validate the clinical and economic model.

We fully appreciate the essential value of FDA indication clearance as well as reimbursement certainty. We anticipate this to be a worthwhile work in progress over the next 4 to 8 quarters. Operationally and financially, we executed well and maintained disciplined expense management, exiting the year with a strong balance sheet that will enable us to execute on our clinical priorities in 2026. As we look ahead to 2026, our focus is clinical and market development execution. In electrophysiology, we intend to commence and complete enrollment in the nPulse cardiac catheter IDE study while continuing to treat patients in Europe in support of expansive clinical data essential to our successful CE Mark submission. In cardiac surgery, we intend to expand and accelerate IDE site activation and complete patient enrollment in 2026, while continuing European feasibility activity and preparing for an additional CE Mark submission by the end of the year.

In soft tissue ablation, we are completing enrollment of the PRECISE benign thyroid nodule study, deepening commercial utilization in key accounts, driving the business model to our goal of financial viability and continuing to demonstrate the clinical advantages of the Vybrance nsPFA treatment. Each of these milestones advances our position as the disruptor in PFA therapies and first mover in nanosecond pulsed field ablation, a position that is reinforced by our significant intellectual property estate. Pulse Biosciences is advancing a platform that integrates advanced biophysics and precision engineering that will be changing for the better the standard of care for multiple disease states affecting patients worldwide. I will now start with our nPulse cardiac catheter system for AF ablation.

While our nsPFA technology is a versatile platform designed for multiple clinical applications across the body, our primary focus is transforming heart care for AFib patients. We have developed the world’s first one-shot ablation solution for atrial fibrillation. Our nPulse cardiac catheter can treat a targeted area of the heart with a 5-second single-shot burst, delivering circumferential pulmonary vein isolation or PVI. The nPulse cardiac catheter minimizes the need for the physician to reposition the catheter or overlap lesions. The nPulse cardiac catheter incorporates several differentiated design and performance features that set it apart from existing ablation technologies. We have previously presented data on acute procedural measures that validate workflow advantages and our recently presented outcomes data provide the first long-term clinical evidence of procedural success and are available on our website at pulsebiosciences.com.

Because nanosecond pulsed energy is delivered so rapidly, the system delivers minimal cumulative energy to tissue. This results in no measurable tissue temperature elevation and low neuromuscular stimulation, which contributes to shorter procedure times and may reduce required anesthesia levels. In addition, the catheter incorporates a patented proprietary flexible electrode design that enhances maneuverability and conformability within the left atrium, allowing physicians to deliberately move the catheter within the left atrium and rapidly achieve stable positioning, enabling seamless procedural efficiency. In comparison to the current standard of care, the clinical benefits we reported in February 2026 have been nothing short of outstanding.

In our European studies presented at the AF Symposium on February 5, the lead investigator of our feasibility study provided comprehensive as well as compelling data on procedural speed, workflow, safety and outcomes durability. Key study findings were outstanding and highlighted 100% procedural success or freedom from AFib at 6 months and 96% procedural success at 1 year for evaluable patients. Overall, freedom from atrial arrhythmia was 90% at 12 months as shown on a Kaplan-Meier curve and the data are available on our website. All 3 of these endpoints represent new standards of therapy effectiveness for nsPFA treatment of paroxysmal AF. Procedural efficiency remains remarkable. While still early on, we are routinely seeing physicians finish these ablations in just 6 to 8 minutes or faster, which could cut total procedure times by over 50%.

These results reflect the underlying advantages of nanosecond PFA, deeper lesion formation with fewer applications and lower cumulative energy to deliver durable isolation. Physicians continue to highlight the simplicity of a single-shot approach and the reduction in catheter manipulation and lesion stacking compared with legacy technologies. The nonthermal nature of nsPFA continues to show a favorable profile, allowing physicians to treat efficiently and proceed to additional targets without delays between dose deliveries, unlike microsecond PFA, which requires prolonged recharging times. The Pulse Biosciences system directly addresses limitations of current generation catheters, microsecond PFA or thermal modalities by enabling complete durable isolation in a single energy delivery with the potential to cut procedure times in half.

We expect to use the data from our European feasibility study to finalize our CE submission in the second half of 2026 with the potential for CE Mark approval in 2027. We are focused on accelerating our market entry strategy through strategic mapping partnerships. To bring this revolutionary nsPFA technology to the global market as swiftly as possible, we are actively pursuing strategic partnerships with world-class mapping providers and EP market leaders. Such a partnership should produce a tremendous win-win. By integrating our best-in-class nanosecond PFA solution with an existing best-in-class mapping ecosystem, our potential partner or partners can capture and solidify their market share with the most advanced energy solution available, while Pulse would benefit from nanosecond PFA worldwide commercial launch acceleration.

These synergies should ensure that physicians and patients gain rapid access to the fastest, most precise and durable nanosecond PFA solution in present time. Let’s now discuss our surgical ablation clamp. Our nPulse cardiac clamp is the first in the world FDA-approved IDE pivotal study, NANOCLAMP AF for a surgical device that delivers PFA. This represents a significant landmark in cardiac surgical innovation. Our system is designed to deliver fast, contiguous transmural ablation lines during open heart procedures for patients with atrial fibrillation. We believe the current treatment of preoperative AF with concomitant ablation is significantly underutilized and the speed and effectiveness of ablation delivered with nsPFA can transform this therapy and market.

Our IDE program is progressing and enrollment activity is underway and expected to conclude during 2026. As a reminder, NANOCLAMP AF is a prospective single-arm multicenter study designed to assess the primary safety and effectiveness of the nPulse cardiac surgical system in treating AF during concomitant cardiac surgeries. We intend to enroll 136 patients in approximately 20 sites, including 2 international locations. In Europe, we continue to generate excellent results. Data presented previously at EX highlighted what we consistently see with this system, very fast total ablation times, clean lesion sets and reproducible workflow in the surgical environment. Surgeons continue to emphasize the importance of speed and predictability in this setting, which aligns well with the intuitive workflow and short energy delivery times observed with our system.

These initial treatments keep us on track to file for CE Mark by the end of 2026. Beyond the significant clinical progress of our cardiac programs, the nPulse Vybrance percutaneous electrode system is validating in real-world use our technology in non-cardiac soft tissue applications. The nPulse Vybrance system is initially being used by physicians to treat symptomatic benign thyroid nodules, eliminating the need for traditional surgery. This is a very common and disabling condition associated with 250,000 new annual U.S. diagnoses. This annual incidence converts into 150,000 total or partial thyroid removal surgeries each year. And this is precisely the clinical practice opportunity we are exploring with our minimally invasive application of nsPFA to reduce nodule size and eliminate patient symptoms.

Our current nPulse Vybrance technology has the potential to shrink nodules while sparing vital nerves, blood vessels and sensitive structures in the neck. In the fourth quarter, the team generated $264,000 in revenue from Vybrance systems and electrodes, an increase in revenue versus the third quarter. We are taking an extremely disciplined approach as we closely monitor individual account procedural volumes, site-by-site patient outcomes, all local procedure reimbursement results, procedural efficiency and overall clinical and business success factors routinely considered by each hospital when adopting a new procedure. Our approach remains deliberate, evidence-based and focused, operating at an intentionally limited scale to demonstrate how meaningful this opportunity can be within key accounts at large hospital systems in selected geographies.

From a clinical perspective, the PRECISE benign thyroid nodule study remains on track to complete enrollment of 50 patients in the next few months. We plan to further expand the study to 100 patients over the ensuing 2 quarters. Broad adoption and viable long-term market expansion is our goal. It is important to note that scientific recognition of this work is on the rise. Data from Dr. Stefano Spiezia in Naples, Italy, have been accepted for a podium presentation at NAFID, the North American Society for Interventional Thyroidology in March. In parallel with the PRECISE-BTN study, we are expanding the clinical scope of the Vybrance platform. In the fourth quarter, we announced a research collaboration with the University of Texas MD Anderson Cancer Center, one of the world’s leading oncology institutions to evaluate the use of nanosecond PFA for the treatment of both benign and malignant thyroid tumors.

Under this collaboration, we are conducting an FDA-approved IDE study evaluating nsPFA for the treatment of papillary thyroid microarcinoma and expect to complete enrollment by year-end 2026. In addition, preclinical work is underway exploring the potential application of nsPFA in anaplastic thyroid carcinoma, a highly aggressive cancer with limited treatment options. We view this collaboration as strategically important for several reasons. First, it meaningfully expands the potential indication set for the percutaneous electrode beyond benign disease and into cancer, while remaining within the same core workflow of endocrine surgeons targeting thyroid disease. Second, it reflects external validation of the nonthermal mechanism of action of nanosecond PFA, particularly its ability to ablate cellular tissue and initiate regulated cell death while sparing surrounding critical structures, an attribute that is especially relevant in the neck because of the high density of critical nerves such as the recurrent laryngeal nerve, which controls the vocal cords, major blood vessels, the trachea and esophagus.

And third, partnering with a world-class institution such as MD Anderson reinforces institutional and physician belief that the Vybrance nsPFA platform has broad applicability and will expand over time beyond its initial commercial use case in benign thyroid nodules. While this work remains in the research and feasibility stage, it underscores the platform nature of nsPFA and its multi-decade potential to address a wide range of soft tissue applications as clinical evidence develops. Economically, the Vybrance system is driven by recurring disposable electrode utilization and minimal facility overhead. The opportunity and model align with the growing trend toward minimally invasive procedures performed in lower overhead settings. We look forward to continued adoption of the Vybrance system and additional data publication in the second half of 2026.

It is clear to us that multiple therapeutic FDA clearances beyond the soft tissue ablation clearance, while not yet achieved, will be essential to building a significant revenue growth business. Our commitment to generating clinical evidence, which will be highlighted later this quarter, will be the next critical step toward achieving FDA therapeutic clearances. With that, I will turn the call over to Jon to speak about our fourth quarter and full year financial updates. Jon?

Jon Skinner: Thank you, Paul. Now I will highlight our GAAP and non-GAAP financial results before providing commentary on future cash use. I encourage listeners to review today’s earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the fourth quarter, we generated nominal revenues comprised of both nPulse Capital and Vybrance disposable sales. Total revenue was $264,000, up from $86,000 in Q3. This sequential growth was driven by both capital and disposable devices. Cost of product revenue was $260,000 for the quarter, slightly lower on a sequential basis as compared to Q3 2025. Total GAAP costs and expenses decreased by $1.7 million to $18.5 million compared to $20.3 million in the prior year period.

The decrease in GAAP costs and expenses was primarily driven by a decrease in nonrecurring expenses. To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation and amortization as well as nonrecurring costs. Total non-GAAP costs and expenses in the fourth quarter of 2025 increased by $2 million to $13.3 million compared to $11.3 million in the prior year period. The expected increase was driven by increasing clinical trial and early commercial launch activity. GAAP net loss in the fourth quarter of 2025 was $17.4 million compared to $19.4 million in the prior year period. Non-GAAP net loss in the fourth quarter of 2025 was $12.2 million compared to $10.4 million in the prior year period. As of December 31, 2025, cash and cash equivalents totaled $80.7 million compared to $118 million as of December 31, 2024, and representing a decrease of $14.5 million versus Q3 of 2025.

Cash used in operating activities during the fourth quarter of 2025 was $14.8 million compared to $9.1 million used in the prior year period and $13 million in Q3 of 2025. We have also recently completed important corporate housekeeping filing a $200 million shelf registration. This provides the company with flexibility to support the balance sheet in an expeditious manner to ensure we have the resources required to achieve upcoming clinical milestones. Cash usage aligns with investment expenditures in pivotal trials, device scaling and initial commercialization. Expense growth remains deliberate and focused on long-term value creation. We continue to maintain ample liquidity to fund operations and clinical programs through major inflection points during 2026.

With that, I will now turn it back to Paul for closing remarks.

Paul LaViolette: Thank you, Jon. We are standing at the forefront of a medical transformation, leveraging Nanosecond PFA energy. Our Nanosecond PFA platform is no longer just a concept. It is scientifically validated, clinically proven in early use and its vast potential is slowly but certainly emerging across the fields of electrophysiology. We are moving forward with speed and purpose to establish Nanosecond PFA as the new global therapeutic standard. Our mission is steadfast, delivering significantly better outcomes for patients and creating robust long-term value via an emerging new era of patient and physician-friendly therapy for our shareholders. We are enthusiastic about the promising journey ahead, and thank you for your continued support. Now joining us for the question-and-answer session is Bob Duggan, Co-Chairman of the Board. Operator, please open the call for questions.

Q&A Session

Operator: [Operator Instructions] Your first question comes from Anthony Petrone with Mizuho Group.

Anthony Petrone: Congrats to a strong start to the year in 2026 to the team. Maybe Paul, I’ll start with Vybrance and then jump into nPulse for pulsed field ablation. Maybe looking at Vybrance here, we’re 2 quarters into the launch. The team is expanding in a limited launch release phase here. Maybe just as we think about the next couple of quarters, when do we transition from limited release to a broader release for Vybrance? And then maybe just a recap on the enrollment time lines for the post-market surveillance study for thyroid, and then I’ll have a follow-up on nPulse.

Paul LaViolette: Yes. Thank you very much, Anthony. I appreciate your comments. Vybrance is exactly where we want it to be right now. It is in a market development mode. We are at a limited number of centers, and we are evaluating exactly how it works and exactly what we need to really scale it. I would say that phase is going really well. You alluded to the fact that the team is stable. We’re focused on quality and as one would say, going deep rather than going broad. And we’re very focused on data, and I’ll talk about the benign — the BTN study in a second. We’re very focused on data. We’re very focused on repeating quality outcomes for patients in multiple centers, and we’re now at a number of centers. And we’re very focused on accelerating the reimbursement process.

So data will drive all of that and ultimately, data will drive a further therapeutic indication from FDA. We think those are the things that are required in our line of sight before we push on an accelerator to expand commercialization broadly. I’ve done a lot of market development work in my career in med tech, and it’s really important to get the foundation right. That’s what we are really focused on. We are very pleased to report increasing revenues. But we’re really focused on the qualitative build-out of the market development and market enabling factors that will underpin revenue growth going forward. And so our focus is on building that rock-solid foundation for the long term because we know given the size of this market, given the lack of alternatives to these patients, given the quality of the outcomes we’re seeing, given the, I’ll call it, exclusivity of nsPFA and its ability to treat benign thyroid nodules in comparison to other minimally invasive alternatives or surgery, we know that we have that right formula.

And so we’re really focused on ensuring that we build that foundation because growth in patient treatments, growth in activation of patients both in converting them from surgery to less invasive nsPFA and in recruiting patients off the watchful waiting list. We know those things will happen once we build the fundamentals. On the recap, if you will, of the enrollment, we had mentioned in our prepared remarks that we expect to finish enrollment in the next few months. We are right on track for that. We have already enrolled a majority of that patient target in the first few quarters, and we’re on track to finish it over the next 1 to 2 months ahead. So we feel very good about completing that enrollment on time. And then as I said earlier, our plan is to expand the study.

We think we have the likelihood for very favorable clinical outcomes. We think those clinical outcomes which are very focused on quality of life and qualitative performance of those patients symptom relief based on the ThyPRO-39 score. We think that data set in concert with the data set that we will present at the NAST conference, which will focus on long-term outcomes from our feasibility study in Europe. We think the combination of those two will really create a very strong data set for additional regulatory authorization. So that’s our focus with the current enrollment completed on time and the plan for expanded enrollment to increase the robustness of that data set.

Anthony Petrone: Very helpful. And then I’ll just squeeze one in on nPulse. So obviously, good showing at AF Symposium ’26. 96 procedural success rate at 1 year, 22-minute dwell time in the left atrial wall and 90% freedom for arrhythmia. So a quick 2-part question. One is we move away from that medical meeting a few weeks ago. What has been the reception from the community? There seems to be quite a bit of buzz at the conference. And then what are the updated time lines for the IDE study in terms of enrollment? Can it actually be accelerated just coming off a strong feasibility study?

Paul LaViolette: Yes. Thank you, Anthony. Receptivity to the data, I would say, has been exceptionally positive. The buzz in the meeting, which I appreciate your comment on, I think you read that accurately. The reason AFib is so exciting is because as a business, it treats the single most common arrhythmia in our population. And so it’s a very large market. We all know that over time, the retreatment rates for ablation generally fall in the real world in that 20% to 25% or 25% plus range. And so technology after technology, system after system have come along. We’ve seen the progression from RF to PFA. Most physicians would still say, in the real world, regardless of the system use, the recurrence rate requiring retreatment is still about 1/4 of the patients.

So when we report a 96% 1-year procedural success rate or a 90% rate for left atrial freedom from arrhythmia, that is an exceptionally differentiated outcome. It needs to be validated in a pivotal study. But it is, I would just call it noteworthy, and it has garnered a lot of attention. So we feel very good about how folks in all constituencies, if you will, physicians, patient populations, the corporate entities in the cardiovascular space, I think the reception to the data has been very, very positive. The time lines are, as we discussed, previously. We’re expecting to commence enrollment in our study in the next 1 to 2 months ahead. We would then expect to enroll relatively swiftly. Our plan is to complete — to start enrollment and complete enrollment in 2026.

And you asked about acceleration, and certainly, we’re prioritizing this program, and we’re looking at all ways feasible to accelerate. I think in my experience, I’ve run dozens of pivotal studies. There are many factors that contribute to enrollment velocity, nothing more important than physician embrace of the technology. It’s important to have a clean protocol, one that yields high patient flow through the screening process, one that fits well into the workflow of the clinical setting and physician interest in the technology because they believe it will treat their patients well and importantly, because it represents an improvement in workflow, in speed and ease of use. That is a very powerful combination. We’ve previously demonstrated with our data that our workflow is superior.

We hadn’t until the AF symposium put forth data that would imply an outcomes benefit. So those 2, we think, will accelerate physician interest and attention to the study. And when you look at that study hurdle of 155 patients in our protocol and look at the number of centers and the interest in participation in the study, we think it can move along quite swiftly.

Operator: Your next question comes from the line of Suraj Kalia with Oppenheimer.

Suraj Kalia: Gentlemen, I’d like to echo congrats on the exceptional data for nPULSE at the AF Symposium. Paul, if I could, just piggybacking on Anthony’s question, right? So we do expect or at least hope pace of enrollment would pick up. But one of the things that Dr. Reddy had said at the presentation, Paul, was the nPulse wasn’t really integrated effectively with mapping. I’m paraphrasing, but you get the point. For the IDE Pulse, are any steps being made to make the nPulse more effectively integrated with, let’s say, CARTO or EnSite? Just trying to analyze or assess if there could be some incremental benefit in the IDE from mapping integration. Paul, next question, if you could give us any update on the next-gen nPulse. And are you seeing any spillover on the NANOCLAMP side of the equation, just given the EFS with nPulse? I know I threw in a lot in there, Paul. Hopefully, you got all my questions.

Paul LaViolette: Thank you, Suraj. So I’ll try to get them all. The question really — the first question is about the potential benefit associated with a more completely or more effectively integrated catheter with mapping system. And so first of all, for those who may not have been at the AF Symposium, we did conduct a live case that morning from — that Saturday morning from Prague, which put on display a more completely integrated system between catheter and the mapping software. That is a good example of, I’ll call it, contemporary display of catheter rendering on a system. And it is precisely the quality of that rendering that had not been available for those first 150 cases. So that is what, Suraj, your point is alluding to.

And the answer to the question is yes, we do expect to have improved software integration in the IDE, number one. And it remains open to speculate — and I think Dr. Reddy commented on this in a couple of ways. It remains open to speculate how much better the results can be, and he somewhat jokingly implied that you can’t get much better than the results we’ve already achieved. On the other hand, he also said that through the dozens of cases that he had performed in the feasibility study, he couldn’t really tell exactly where the catheter was. And now having performed cases with a more integrated system, he could. And he felt that, that would improve the accuracy of his lesion creation and potentially reduce the number of lesions he might make.

Already at a record low for nPulse, but he could do even fewer lesions with high confidence that he was placing them precisely where he wanted. So I do think we could receive both acute procedural as well as outcomes benefits from improved integration, and we do expect to have improved integration available in the IDE. The next-generation nPulse system is a device that is still in the development phase. So we’re not providing time lines on that. Suffice it to say, it is intended to be a device that would integrate a regional footprint ablation system, which is what we have today with the current 360 as well as a, I’ll call it, a focal or a large footprint focal device integrated in the same product. What that would allow, of course, is pulmonary vein isolation and then left atrial ablation points or lines without having to exchange the device.

So that, we think, is a really breakthrough concept and will have significant procedural benefits, but is still in the development stage. And then lastly, your question about spillover benefit from nCLAMP. And I think the answer to that question is yes. And of course, those benefits are nsPFA derived. We’re now applying the same energy to cardiac tissue in different methods and for the same indication, but with different ablation line patterns. And as we previously reported, we’ve done comprehensive remapping of those open surgical cases, which builds our confidence in the, I’ll call it, the potency, the power of our ablation energy. We now have seen that 96% procedural success rate, that further reinforces the potency of our ablation energy.

We have outstanding safety being derived from both cohorts of data presented at ESC for surgery, at AFS for electrophysiology. You can imagine that those data sets are being submitted to the FDA. We feel we had an excellent process for IDE approval with FDA. I’m certain that the TAP program status and the breakthrough designation of the clamp device provided some tailwind, if you will, for the approval that we ultimately receive for the IDE for the EP catheter. So those, of course, will both be going through their data collection and ultimately, submission processes around similar times. And really, what that provides the FDA with is just more safety data, more clarity that we can deliver great lesions in either lesion set, interventional or surgical.

And I think it’s difficult to specify the benefits, but we know that there are real synergies as we generate great data in each application and both of those data sets go into the FDA to essentially comparable review teams on nearly overlapping time lines.

Operator: Your next question comes from the line of Josh Jennings with TD Cowen.

Joshua Jennings: It was great to see the stellar feasibility results for nPulse at AFib Symposium. During the data presentation, Dr. Reddy and others kind of discussed the clinical success rate that 90% freedom from atrial arrhythmia at 12 months, exceeding expectations and maybe even higher than what we expected just based on procedural success or lesion durability alone, suggesting the possibility of some other biologic impact or modulation beyond just the conduction block. You reviewed some of the hypotheses behind that at the Pulse event at the symposium. But maybe if you could just review those? And is there any way to confirm any of these hypotheses with either an animal model or anything on the preclinical side?

Paul LaViolette: Yes. Thank you, Josh, and very good question, and thank you for paying such close attention to everything that was reported at AFS. It’s great to see. I would echo exactly what you said. These are hypotheses. We don’t know that any incremental mechanism is actually required in order to achieve the results that we’ve seen. I think the first thing I would say is that the reason a hypothesis for incremental benefit might be pursued is because the original data that we presented were so strong in comparison to a history of delivering lesions with PFA that clearly maxed out at lower levels. It leaves one to question how it is that such a significant leap can be made. We have less wonder about why that leap can be made.

We’ve been making lesions in preclinical models for years. We have tremendous understanding about the power of nsPFA and that it is a differentiated energy. Yes, it’s a form of pulse electric field delivery, but we really do believe it is a different type of energy. It has a different mechanism of action already as we’ve defined than microsecond PFA and the consistency and depth and the transmurality of our lesion generation, we think is on its face, the explanation for superior results. That being said, we certainly can conduct preclinical experiments to assess whether other nerve targets that might be extra atrial could be effective. But while we will work with our clinical advisers to do that, I would say we are less inclined to search for a novel mechanism because we believe we understand the clinical results and why they are a direct result of the energy that we are delivering.

What’s unique about nsPFA, and we see this in multiple indications, is that it is hard to imagine how effective it can be while being so fast, while being so nonthermal and fitting into workflow as exists already in existing clinical practice. But that is what we’re seeing essentially time after time. So we believe the most important thing to replicate is not a novel mechanism that is the result of speculation, if you will, but rather to replicate these clinical trial results. They’ve been derived on a large n. We’re continuing to follow those patients. So I think the most important clinical discovery will be how does the next tranche of patients as you build up the full 150 now going to beyond that and follow those patients 6 and 12 months and continue to just reinforce the fantastic clinical results.

To us, that’s more important than looking at preclinical models for atrial ganglia ablation.

Joshua Jennings: Understood. And then just to follow up on the tail end of your answer, just how should we be thinking about the timing of future updates to the feasibility study results and particularly the final results that will be submitted, it sounds like for CE Mark approval.

Paul LaViolette: Thank you so much, Josh. Timing, really the next event will be at HRS. We plan to submit data for review at HRS. And that, of course, will be, I’ll call it, on a rolling time line. So as many patients as meet the endpoints by the various presentation cutoff deadlines, that’s what we’ll present. We think that will provide us a very nice increment in total number of patients over time. And so that will be the next event in addition to an update when we commence enrollment in the study, which we expect, as mentioned in the next few months. So very nice updates coming between the announcement of first patient enrollment as well as HRS by just a few months down the road.

Operator: Your next question comes from the line of [ Jesse Crawford ] with Luxury Lifestyle Design and Development.

Unknown Attendee: Thank you guys. Thanks for putting on these calls. These are actually really, really beneficial to everybody, especially all of the people who really believe in the technology. I’m one of those people. I evangelize for Pulse all the time. And when people ask me what it is, I kind of have to give them the dumbed down version of it, but I kind of equate it to the tricorder in Star Trek. People laugh at that analogy, but I really think this is the future of kind of the 2 holy grails of treatment for cancer and heart disease. So as an avid investor, I like to participate in the calls, but I also have AFib. So I would be very interested in participating in one of the clinical trials. I’m that big of a believer in it.

Paul LaViolette: Well, thank you, Jesse. And I appreciate your transparency about AFib. The fact of the matter is it is so common. We can’t go very far without finding a patient right in our midst. And AFib is so common. It’s growing in incidence. And what we’re faced with right now is, as you well know, a progression through early diagnosis and then most commonly drug therapy, which is often undesirable for the patient, some combination of anticoagulation therapy and antiarrhythmic medication. And I think the ultimate vision for a therapy is to pull forward the option that can be offered to a patient to allow for a very safe and highly effective intervention as first-line therapy so that a patient that is tolerating atrial fibrillation, which is obviously associated with higher risk factors that, that you would not have to tolerate AFib because the balancing act between first-time effectiveness and safety is so favorable that you can be offered the option of going straight to an intervention.

We know that with AFib, the earlier one intervenes, the likelihood is that the AFib is not advanced in its complexity. And if it resides still in the pulmonary veins, one is more likely to treat it definitively, which is to say an ablation can be a cure. And that’s not really the way patients are provided therapy opportunities today. That requires more data, more changes in guidelines. But I think the trend as supported by the kind of early results that we’ve seen so far could be supported by this kind of a breakthrough technology. So we really appreciate your support and your evangelizing. And I would say from what I’ve seen, if I had AFib, I would want the therapy, too. So we are like-minded. So thank you, Jesse.

Unknown Attendee: Thank you. I’m very — actually a very pharmaceutical treatment at averse. So this is very exciting to me and a lot of my friends as well. And I guess a follow-on question to that would be for Bob on what his strategy is for partnerships?

Robert Duggan: Jesse, good to hear your question. You sound — your viewpoint on the product and our efforts and the technology is really a duplicate of my own here and I’ll get to the money question that you just asked. The challenges have really been it’s a novel technology. This is not MicroPulse. It’s a nanoPulse. It’s different from, say, laparoscopy as robotic procedures where people recall robotic as it’s an extended form of laparoscopy, but it was quite a bit different, had a real significance. That had to be proved out, and we’ve had fortunately, the benefit of working with the world’s top-class surgeons, and we’re comfortable now. So we go into this final study on the CA side. It won’t be the final study, but it will be a study that we would expect we would go forward and get approval from.

So we’re very optimistic about that. When it comes to reimbursement in this business industry, which I’ve been in for a couple of decades, you — it’s really a high priority to have a label. But to get a label, you’ve got to have the top quality professionals using your product and really signing off on its ease of use and the duration of outcomes that they achieve because some of these are the best of the best and they can get almost anything to work. So you really have to democratize it for a bit. So we’re well into all of that now. On the — but importantly, we do not have a label from anything other than soft tissue ablation, which we cannot directly pinpoint and tell people. Here’s what you should do or train them for that and originate that.

And given the scarcity of people through a trial, we do not have reimbursement. Paul said on the call, and I think it’s accurate, that will come over the next 4 to 8 quarters. And so those that are potentially frustrated on the Vybrance, it’s just — we just have to live with that. I’ve seen many companies rush in without that. They get stalled out and you become a company that your revenues are not able to even match your expenses. So we will not be doing that. And it will take a little bit of time on the Vybrance side. We’re still working now to get a label on the CAF side and the clamp side, but we believe those are coming in 2027. But we think the probability of that is extraordinarily high. We are more than pleased with the outcomes. And just one touch more back on the Vybrance side.

We look forward to the readouts on that trial coming by midyear. So that news is all good. Now how do you turn around and fund that? That will require additional funding, but it could come in the nature of a partnership. It could come through distribution. There are any number of forms that, that could take place. We did a significant rights offering a year ago or so and you saw us participate in that. And we’re still living off of that. We have about $80 million in the bank closing the year out. We have another $2 million in warrants as the stock would trade over $22 a share for another few weeks. So that’s what we have in mind. We watch it carefully knowing that we’ve always got access to money. We haven’t had to go and get 2 years’ worth of equity dilution in order to have a couple of hundred million on account.

But we’re very pleased with our following now. We’re very pleased with the leadership. And I would say there’s a touch of frustration on the Vybrance side where the singular importance of being able to achieve a label has been long coming. But we’re now closing that gap, and we’ll get on that. And as much as — I wish I could say it was 2 to 4 months, but it’s really going to be about 4 to 8 quarters out before we have that lined up. And then it’s Katy bar the door. So I appreciate your enthusiasm. I think you called it correctly. I too have AFib. And as soon as this is labeled, I’ll be getting it, if not sooner. It’s — I’ve been in the operations, seeing the procedures, some without full anesthesia. — just really, it’s just warm my heart to know that I’ve participated in this and the benefits that will be accruing from it.

So I hope that addresses your questions, Jesse.

Operator: And with no further questions in queue, I’d like to turn the conference back over to Paul for any closing remarks.

Paul LaViolette: Well, first of all, thank you, Bob, for those comments and really for the great questions we received. On behalf of the team here at Pulse Biosciences, thank you all for your interest. We look forward to providing you with updates throughout the very busy 2026 we have ahead. So thank you all for joining, and good afternoon.

Operator: This concludes today’s conference call. You may now disconnect.