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Hello, thank you for standing by. My name is Mel, I will be your conference operator for today. At this time, I would like to welcome everyone to the Pulse Biosciences Quarter One 2026 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Tripp Taylor of Investor Relations. Please go ahead.

Thank you, operator. Before we begin, I'd like to inform you that comments and responses to your questions during today's call reflect management's views as of today, May 7, 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 on Monday 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'll 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-Chairman of the Board and Chief Executive Officer, Paul LaViolette.

Good afternoon, and thank you for joining us. For those of you that are new to the Pulse Biosciences story, let me start with a brief overview of the technology at the core of everything we do. Pulse Biosciences is the pioneer of nanosecond pulsed field ablation, or nsPFA, a fundamentally new category of energy that we believe will change the way soft tissues in the human body are treated across multiple disease states. Conventional ablation modalities, whether radiofrequency, cryoablation, microwave, or even today's first generation microsecond pulsed field systems, share common limitations. They rely on relatively long-duration energy delivery windows. They deliver current or temperature changes through tissue inefficiently. They cover small treatment areas, create shallow lesions, and often require repeated applications. Our nsPFA platform creates an entirely different and proprietary approach and experience. We deliver pulses measured in billionths of a second.

At that time scale, with each pulse, the duration of a few billionths of a second, the energy interacts with cells through a non-thermal mechanism that initiates regulated cell death in target tissue while leaving collagen, blood vessels, nerves, and other non-cellular structures intact. The practical effect of nsPFA delivery is meaningful. nsPFA creates deeper and more durable lesions delivered in dramatically less time while providing a margin of safety that has been a core challenge for legacy energy sources. Surrounding this core technology, we have built a substantial and growing intellectual property estate that positions Pulse Biosciences as the clear first mover and the long-term leader in nanosecond PFA. We are developing this platform to treat atrial fibrillation, where the unmet need is enormous and where our differentiation seems to be pronounced. We are advancing additional applications that leverage these remarkable underlying therapeutic advantages of nsPFA energy.

Against this backdrop, the first quarter of 2026 produced a true inflection point for Pulse Biosciences. Three milestones defined the quarter and recent progress produced by our team. First, we presented landmark late-breaking data from our large European feasibility study at the AF Symposium, which set a new bar for what physicians and patients should expect from a pulsed field ablation therapy. Second, leveraging this unprecedented clinical data set, we made the decision to strategically reshape Pulse Biosciences to focus on our highest value opportunity, our nPulse cardiac catheter for atrial fibrillation, have rapidly reorganized our focus and operations to allocate an increased portion of our overall company resources to this program. Third, in just the past several weeks, we commenced enrollment in our IDE U.S. pivotal study, NANOPULSE-AF, treating our first patients with the nsPFA catheter system in early April.

We also released updated follow-up data from the European feasibility study, further validating strong positive outcomes. Each one of these milestones represents a meaningful achievement. Together, they reflect a clinical development program of great importance moving at impressive speed. Today, I will provide updates on our nsPFA system in more detail, and will then turn the call over to our Chief Financial Officer, Jon Skinner, to review the first quarter financial results. We will then conclude with a question-and-answer session joined by Bob Duggan, Co-Chairman of the Board, and Liane Teplitsky, Chief Operating Officer. I will now begin with our nPulse cardiac catheter system for AF ablation. Our nPulse cardiac catheter system is purpose-built to address atrial fibrillation with a 360 degrees circular design.

The clinical goal of ablation in the treatment of paroxysmal AF is straightforward: electrically isolate the pulmonary veins from the left atrium to prevent abnormal electrical signals from triggering arrhythmias. Achieving that goal durably, efficiently, and safely has been the ongoing challenge in the field, and the ability to advance improvements in AF care will set our catheter apart from existing technology in this rapidly growing market. The nPulse nsPFA system represents what we believe is the world's first true single-shot pulmonary vein ablation treatment platform for AF. Early data suggest a physician can now rapidly position the circular catheter, deliver a single five-second application of nanosecond pulse energy per target location, and achieve a complete circumferential and transmural ablation without repositioning, without rotating, and without the need to stack multiple overlapping lesions.

That workflow advantage stems directly from the underlying ultra-short duration and high-energy pulse parameters unique to nsPFA energy and Pulse's unique catheter design, which is possible in part because of the unique properties of the energy. Because the energy is delivered in billionths of a second, the total cumulative energy transferred to tissue is dramatically lower, which means no measurable temperature rise and minimal neuromuscular stimulation. The result is a system designed for speed, reproducibility, and durability, qualities that make the procedure more streamlined and efficient for operators as we redefine the standard of care in electrophysiology. Since our last call, we announced a meaningful strategic alignment to prioritize and accelerate the development and future commercialization of our nPulse cardiac catheter ablation system. The European feasibility study results from 177 patients send a powerful message.

The nPulse cardiac catheter system has the potential to improve clinical practice for millions of patients living with atrial fibrillation. In response, we are increasingly prioritizing the program by allocating additional resources to our clinical and R&D teams to accelerate time to market for this catheter system. This investment in resources and focus will accelerate the pivotal IDE study, the introduction of additional clinical studies, and the development of our next-generation catheters. As part of the strategic realignment, we continue to expand our EP leadership team. Most notably, Dr. David Kenigsberg has transitioned to a full-time Chief Medical Officer. Dr. Kenigsberg will lead our clinical strategy, investigator engagement, medical affairs, and study execution as we enroll the pivotal IDE study and expand our clinical data set.

In addition, we welcomed Liane Teplitsky to the Pulse Biosciences executive team as Chief Operating Officer, a newly created role on our executive leadership team. Liane is a seasoned med tech executive with 20 years of experience and an exceptional track record of building and scaling innovative med tech businesses, particularly in electrophysiology. She held senior marketing and commercial leadership roles at Abbott Laboratories and St. Jude Medical, contributing to the development, clinical validation, and global commercialization of electrophysiology therapies. She will oversee our clinical, regulatory, quality, and commercial functions and will be focused on accelerating our strategic priorities with emphasis on the cardiac catheter development program. Collectively, the additions of David and Liane strengthen our ability to execute a successful pivotal IDE study and advance toward regulatory approvals. On the clinical data front, we had a landmark quarter.

At the Heart Rhythm 2026 meeting, or HRS, Dr. Vivek Reddy, the national principal investigator of our pivotal study, presented late-breaking updated data from our nPulse cardiac catheter system first-in-human feasibility study. Building upon the very positive data presented at the AF Symposium in February, this newly expanded data set included six-month follow-up on 95 subjects and 12-month follow-up on 63 subjects within the five-second ablation cohort. The results were simply outstanding and reinforced the differentiated clinical profile we have observed since the earliest cases. Key findings included sustained 100% procedure success by 24-hour Holter of evaluable patients at six months. With 95 of 95 patients meeting the endpoint, sustained 96% procedural success by 24-hour Holter of evaluable patients at one year, and sustained 90% Kaplan-Meier estimated freedom from recurrent AF, atrial flutter, or atrial tachycardia, also at one year.

Procedural performance data at HRS improved from the already impressive readout at AF Symposium, with lower atrial dwell time, lower average number of applications, and lower procedure and fluoroscopy times. The safety profile also remained excellent, with a primary safety endpoint serious adverse event rate of just 1.7% across 177 treated subjects. These outcomes are remarkable in a field where reported 20%-25% AF recurrence rates are typical. It is particularly notable that our results were achieved without antiarrhythmic drugs and with a high degree of consistency across operators and sites, which is typically difficult to achieve at an early stage of clinical development. As Dr. Reddy noted, the durability of pulmonary vein isolation, plus the procedural efficiency we are observing, is a positive combination, not typically expected at this point in the clinical program.

These results reflect the underlying advantages of nanosecond PFA and our innovative catheter design. Deeper lesion formation with fewer applications, lower cumulative energy, and durable pulmonary vein isolation in a fast, reproducible workflow. We believe our system directly addresses the limitations of current-generation microsecond ablation catheters by enabling complete durable isolation in a single energy delivery with the potential to reduce procedure time significantly. This time-saving advantage represents a meaningful potential capacity expansion for EP procedures and would likely drive rapid adoption of the nsPFA as the preferred next-generation energy in the market, especially in light of the potential benefits of the efficacy improvements observed to date.

As we look ahead toward the migration of AF ablation procedures to ambulatory surgery centers or the ASC, we expect all the benefits of the nPulse cardiac catheter to align directly with the needs of the ASC and the overall expansion of treating the growing population of patients with atrial fibrillation. The compelling body of clinical evidence from our European feasibility study provided a strong foundation for the most important operational milestone of the quarter, the commencement of our U.S. IDE pivotal trial. In early April, we announced that the first patients had been enrolled in our NANOPULSE-AF study, a prospective multi-center IDE pivotal clinical investigation evaluating the nPulse cardiac catheter system for the treatment of recurrent drug-resistant symptomatic paroxysmal atrial fibrillation.

The first seven patients were treated at St. Bernards Medical Center in Jonesboro, Arkansas, in just one day under the leadership of Dr. Devi Nair, principal investigator of the Arrhythmia Research Group. Dr. Nair had not previously used the nPulse catheter, the efficiency with which the procedures were completed speaks volumes about the short learning curve and usability benefits we can expect from our system. Early feedback from physician investigators reinforces the user-friendly nature of the system and the efficient, reproducible, streamlined workflow it supports. This positive feedback has helped create significant enthusiasm for study participation. Site activation is accelerating; we are encouraged by the current and planned enrollment momentum we are seeing. Based on the excitement and momentum coming out of HRS, along with the benefit of our strategic realignment, we are tightening our enrollment timeline to reflect the likely faster pace of our study execution.

We now anticipate enrollment to be completed in early Q4 2026, compared to prior guidance that planned enrollment completion by the end of 2026. Regarding study follow-up, the final proportion of participants with primary effectiveness success or freedom from treatment failure through 12 months will be estimated using a Bayesian analysis that includes outcomes at 12 months for a subset of patients and at six months for the remainder. Using a blend of follow-up durations will shorten overall follow-up time for the study. This method allows determination of success earlier than traditional statistical methods used in other studies. Overall, we are accelerating both enrollment and follow-up timelines to optimize the planned filing date for the clinical PMA module.

On the regulatory front in Europe, 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 mid-2027. We are also continuing discussions with potential strategic partner candidates. Potential partners include the world-class mapping providers and EP market leaders. A key advantage of the nPulse cardiac catheter is its ability to be integrated with all mapping systems. This creates a compelling synergy in which our partner or partners may gain access to the most advanced nanosecond PFA energy solution available. These partnership conversations are active, and we will share details of partnership prospects when the time is appropriate. Let's now discuss our surgical ablation clamp.

Our nPulse cardiac clamp pivotal study, NANOCLAMP AF, is the first and only clinical study of a surgical device delivering PFA to receive FDA IDE approval. The nPulse cardiac clamp applies nanosecond PFA energy to create durable transmural lesion sets during concomitant procedures where the surgeon has direct cardiac tissue access and atrial fibrillation is present. The clinical opportunity is substantial. However, despite strong guideline support for concomitant AF treatment during cardiac surgery, adoption of currently available devices remains low. We believe the primary adoption barriers have been procedural complexity, unreliable outcomes, and too much time added to the surgery, concerns that nanosecond PFA may directly address through a combination of rapid energy delivery, reproducible lesion formation, and a straightforward surgical workflow. We continue to believe that concomitant ablation for preoperative AF is significantly underutilized, and that the speed and effectiveness of nsPFA energy can transform this therapy and market.

Enrollment in NANOCLAMP AF continued to progress during the first quarter. As a reminder, the trial 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 plan to enroll a target of 136 patients at approximately 20 sites, including two international locations. Reflecting our strategic prioritization of the EP catheter ablation program, including some resource shifts, we now expect to complete enrollment of this IDE study by the end of the first half of 2027. We have moderated near-term development in cardiac surgery while maintaining trial execution and regulatory preparation. Clinical site activations continued to expand during Q one. In Europe, we continue to generate excellent results in our cardiac surgery feasibility study.

To date, investigators have treated over 60 patients, and we have expanded the study to now include six clinical sites. Within this 60-patient cohort, 34 patients underwent electroanatomical mapping approximately three months after their ablation procedures to assess the effectiveness and durability of the treatment. These data were presented at the European Heart Rhythm Association 2026 meeting and are very promising, with individual ablation times averaging a very rapid 41 seconds total per patient. Notably, as patient numbers have increased, the PVI success rate of 94% at approximately three months has remained consistent with the clinical outcomes we reported in our initial data readout in October of 2025. Surgeons using the system have reported favorable procedural characteristics, rapid ablation delivery, consistent lesion quality, and smooth integration into existing surgical workflows without meaningful time or complexity added to the underlying surgery.

Feedback from the surgical community emphasizes that workflow efficiency and predictability matter as much as efficacy in the operating room. The early signal is that nanosecond PFA delivers very favorably on both. We remain on track to submit for CE mark by the end of 2026 using the European clinical data set. Turning to our nPulse Vybrance percutaneous electrode system. The nPulse Vybrance system applies nanosecond PFA technology to ablate soft tissue in surgical procedures through a percutaneous approach, offering, for example, an alternative to surgical removal for patients with symptomatic benign thyroid nodules. Vybrance is designed to address this patient population through a minimally invasive outpatient procedure that reduces nodule volume, alleviates symptoms, and preserves surrounding anatomy and normal thyroid function, outcomes that cannot be achieved with traditional surgical excision.

In the first quarter, the team generated approximately $400,000 in revenue from nPulse Vybrance systems and electrodes. Our approach continues to be extremely disciplined and remains focused on core market development objectives. We continue to operate at an intentionally limited scale to demonstrate how meaningful over the long term and how well we can service the initial Vybrance customers in exploring along with them the potential of the nPulse Vybrance system. Our work is focused on ensuring we generate robust clinical data to support a treatment indication while formalizing patient reimbursement to expand patient access in partnership with key accounts at large hospital systems in select geographies. On the clinical front, the PRECISE-BTN, or benign thyroid nodule study, reached an important milestone with enrollment of the first 50 patients now completed.

We have further expanded the study to 100 patients to broaden the data set supporting adoption and long-term market expansion. It is also notable that scientific recognition of this work continues to build. Data from Dr. Stefano Spiezia of Naples, Italy, were presented in a podium session at the North American Society for Interventional Thyroidology, or NASIT, in March, which demonstrated remarkable results. Data presented from durable 15 month-22 month results showed 74% volume reduction of treated benign thyroid nodules with overwhelming patient satisfaction reported. Continued volume reduction improvements were seen from one month through 22 months with no regrowth of nodules at 15 month-22 months. In parallel with the PRECISE-BTN study, we are continuing to expand the clinical scope of the Vybrance platform through our research collaboration with the University of Texas MD Anderson Cancer Center.

Under this collaboration, we are conducting a first-in-human feasibility study evaluating nsPFA for the treatment of papillary thyroid microcarcinoma, PTMC, on up to 30 patients at two sites, and we are happy to announce that first patient enrollments were completed in Q1. We continue to expect to complete enrollment by year-end 2026. With that, I will turn the call over to Jon to speak about our first quarter financial results. Jon?

Thanks, Paul. Now I will highlight our GAAP and non-GAAP financial results. I encourage listeners to review Monday's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the first quarter, we generated revenues comprised of both nPulse capital and Vybrance disposable sales. Total revenue was $401,000, and cost of product revenue was $370,000 for the quarter. Total GAAP costs and expenses for the quarter increased by $1.6 million to $19.6 million, compared to $18 million in the prior year period. The increase in GAAP costs and expenses was primarily driven by increased investment in our clinical programs, partially offset by lower stock-based compensation expense. To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation, and amortization, as well as non-recurring costs.

Total non-GAAP costs and expenses in the first quarter of 2026 increased by $4.7 million to $17.4 million, compared to $12.7 million in the prior year period. The expected increase was driven by increasing clinical trial, product development, and market development activity. GAAP net loss in the first quarter of 2026 was $18.6 million, compared to $16.8 million in the prior year period. Non-GAAP net loss in the first quarter of 2026 was $16.4 million, compared to $11.4 million in the prior year period. As of March 31, 2026, cash and cash equivalents totaled $68.3 million compared to $80.7 million as of December 31, 2025, representing a decrease of $12.4 million versus the prior quarter.

Cash used in operating activities during the first quarter of 2026 was $14.6 million, compared to $13.5 million used in the prior year period and $14.8 million in Q4 of 2025. As we discussed last quarter, we completed important corporate housekeeping by filing a $200 million shelf registration, all of which is available. In addition, the company has an ATM program in effect with approximately $60 million of availability as of March 31, 2026. We have received Board of Directors approval for interested executives and board members to participate in our ATM program. Our Co-Chairman of the Board and our CEO and Co-Chairman have both indicated they are likely to purchase shares in the near term. Cash usage aligns with investment expenditures in pivotal trials, device scaling, and market development. 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 over to Paul for his closing remarks.

Thank you, Jon. This was a defining quarter for Pulse Biosciences. We sharpened our strategic focus on electrophysiology, delivered landmark clinical outcomes at Heart Rhythm 2026 and AF Symposium that reinforced the durability and efficiency of our technology, and commenced enrollment in our U.S. IDE pivotal trial for our cardiac catheter program. Today, resulting from those efforts, we announced a tightened timeline for anticipated completion of enrollment in our paroxysmal AF pivotal study. We've strengthened the team supporting this mission, and we continue to advance our surgical and percutaneous programs in a disciplined manner aligned with our priorities. Our path forward is clear. Enroll and complete our pivotal trials, finalize our CE mark submissions, and continue to advance our partnership pipeline, all while maintaining the financial discipline to fund the company through the milestones that will define its future.

This disruptive nsPFA technology we are advancing has the potential to change how ablation is performed across multiple disease states, and we believe that executing toward those near-term milestones will unlock that potential for patients, physicians, and shareholders alike. Thank you for your continued support. Now, joining us for the question and answer session are Bob Duggan, Co-Chairman of the Board, and for her first earnings call with Pulse Biosciences, our Chief Operating Officer, Liane Teplitsky. Operator, please open the call for questions.

Thank you. At this time, I would like to remind everyone, in order to ask a question, press star, then the one on your telephone keypad. Again, that will be star one on your telephone keypad. We kindly ask each participant to limit their question to one question and one follow-up. We have the first question. Comes from the line of Suraj Kalia of Oppenheimer. Your line is now open. You may now ask your question.

Hi, Paul, Jon, can you hear me all right?

Yes, Suraj.

Perfect. Gentlemen, congrats on all the progress and the excitement at HRS. Paul, many calls going on, so please forgive me, I'll ask all my questions together. First, did you highlight the number of sites that are as part of the clinical trial? The limits to each site, you know, because you don't want too much concentration. Finally, if these patients are consciously sedated or general anesthesia. Gentlemen, thank you.

Thank you, Suraj. Yes, we are happy to take all your questions at once. Regarding the number of sites, we have approval for up to 30 sites, and that's important in part because it determines how many total roll-in patients can be advanced in the study, and that affects the total number of patients that we can enroll, bringing that number up to 215. Total number of sites is 30. We do not anticipate reaching that many sites, just based on the total size of the study enrollment, the likelihood that a number of sites entering early in the protocol will, as you allude to in your second question, enroll at or close to the limit of their total enrollee allocation.

As a result of that, we're likely to involve active sites less than the number that we're allowed in our protocol of 30. As it relates to the limits per site, you're right. Every protocol limits the number of sites based on a percent of total so that there's not an unbalanced skew toward too few enrolling locations. That number is typical in this study as it is with many others. Usually, it's around 15%-20% of total enrollment is the cap for an individual site, and that is the case here, which limits our sites to between, let's just say the low 20s of patients per site maximum.

As it relates to our anesthesia protocol, you raised a really good question because conscious sedation is a likely viable sedation protocol for these patients. We've seen that in Europe, we're quite enthusiastic about the potential for lower sedation long term, particularly as we enter the U.S. market and migrate patient therapies to the ambulatory surgery setting. That being said, the protocol in the pivotal study calls for general anesthesia.

Thank you. Again, if anyone would like to ask a question, you may press star one on the telephone keypad. That will be star one on your telephone keypad. Okay, we have the next question, comes from the line of Anthony Petrone from Mizuho. Your line is now open. You may ask your question.

Thanks, good afternoon, everyone. Congrats, you're on a strong start to the year, and the two good medical meetings, AF Symposium, HRS. Maybe you've taken it from HRS, the podium presentation, Dr. Reddy, maybe a little bit of noise that crept into the dialogue there at HRS relative to AF Symposium. You know, sort of the idea that as we expand to more sites in the U.S., we potentially enroll a somewhat sicker patient population in the U.S. that we can see at least some degradation to the durability statistics that we saw out of the early feasibility study.

Maybe just walk through the expectations for the capability to maintain durability, how continuous mapping can potentially help to improve that, and any risk that there may be just from the differences in patient populations. I'll have one quick follow-up.

Thanks, Anthony. A very good question. We're very pleased with the data. The data set so far has been extremely strong and obviously just to remind folks, at six months, 100% efficacy against our primary endpoint of rhythm control, as measured by Holter monitor at that 180-day point. Same thing at 12 months, 96%. Of course, not a primary endpoint per se, but a broader measure of efficacy would be the data that we represent in our Kaplan-Meier curve of 90% success with respect of freedom from atrial fibrillation, Aflutter and atrial tachycardia. Those are the numbers that we're starting with. As it relates to the comparison of patient severity between the European feasibility study and the pivotal study, for the most part, there is no difference.

These are both principally paroxysmal patients. A patient enrolled in the European feasibility study was, by definition, per his or her medical record, a paroxysmal patient. The same severity measure will be applied in the United States. As it relates to some changes, let's say, in the population background, you will see, just based on moving to the United States and enrolling the vast majority of patients in the U.S., you will see minor changes in factors such as BMI, right? The United States patient population is slightly heavier, we would expect the BMI, which was 28 in Europe, to go up in the U.S. That's not a significant risk factor. The CHA2DS2-VASc score, which is an important cardiovascular measure, was relatively low.

That will be consistent in the U.S., based on a paroxysmal population. Other factors in the medical history, whether it's hypertension or heart failure, we expect to have a relatively generic paroxysmal patient population, most notably with a relatively near-term onset of atrial fibrillation, typically in the one-to-two-year timeframe. I think overall, the patient population, while representing the U.S. population, and maybe a little bit less healthy, is not representing a, I'll call it, a higher risk factor than the U.S. Therefore, degradation is not to be expected. This is a pulmonary vein isolation strategy using a highly effective novel energy, which we've now seen evidence that produces a really impressive ablation and impressive electrical isolation.

We've treated more patients in Europe actually than we'll enroll in the United States. The endpoints that we're using in this case, of freedom from AF as measured by Holter are the same, so same endpoints. I would also say the sites that we're moving to, while we will have more sites in the United States, we use multiple sites, multiple operators in Europe. The sites that we're going to in the United States represent the best in the world. We believe that, and we've seen this, I think, early on in our enrollment experience, we believe that we are going to see outstanding clinical results.

Physicians are, I'd say, rapidly assimilating our technology into their workflow, and it's performing the way we expected it to in the U.S. based on how we observed those cases performed in our European sites. Lastly, I think you make a great point about mapping. Mapping is now tightly integrated, as we've mentioned, with the Abbott EnSite system. That mapping, I'll call it refinement, that fidelity provides our U.S. pivotal trial operators with a very high degree of precision location of the catheter, enabling them to localize catheter placement and ablation placement very rapidly in our procedures and very accurately.

We think the risk of experiencing a meaningfully different outcome in the U.S. is managed well by all of these consistencies between Europe and the U.S. We don't see the introduction of a meaningful new risk that would dilute expected clinical performance. My last comment there would be success is not defined in our case explicitly by a specific number that is 96% or 95%. We have the potential here to redefine the way atrial fibrillation is treated. The workflow, the efficiency associated with this technology, which we see, of course, in an acute way, we don't need follow-up data for that is a dramatic change.

This is a significant disruptive technology in the hands of physicians going against the number one most common arrhythmia in medicine. I do believe we have something that's very significant here, and is gonna be a combination of both acute and long-term outcomes that will reinforce that for us coming out of the U.S. trial.

Thank you. Maybe just throw the follow-ups in here real quick, just to confirm in the pivotal study here, IDE study, you know, will EnSite be the only mapper or will you bring in additional mapping technologies? A quick one just on soft tissue ablation, you know, papillary thyroid microcarcinoma, new collaboration with MD Anderson, maybe just a high level on the underlying TAM opportunity on the carcinoma side of the equation for the thyroid. Thanks. Congratulations again.

Thank you very much, Anthony. Yes. On EnSite, based on the speed of enrollment and the availability of EnSite, it would appear today that EnSite will be the most common predominant and likely the only system used in our IDE. That is against the backdrop that our technology really will work with multiple mapping systems. We have used different mapping systems. In fact, the European feasibility data set is a compilation of patients treated using three different mapping systems. We would integrate with not only different systems over time, but because of the number We have 12 sensors built into our device. We have now a magnet for electro-anatomical connectivity, if you will, to the mapping system.

Our system is capable now of higher fidelity mapping and navigation than we saw in our European data set. Principally, we expect EnSite to be the system used. As it relates to the PTMC opportunity or papillary thyroid microcarcinoma, that is the single most commonly diagnosed thyroid cancer. If we think about the TAM to your question, the TAM for soft tissue ablation focused on benign thyroid nodules begins with the annual diagnosis of about 250,000 patients with benign nodules. Converting from that, approximately 150,000 thyroidectomies are performed, and we believe the benign indication goes after some combination of surgical conversion and treatment of patients avoiding surgery now and going into active surveillance.

If you think about 250,000 as the annual diagnostic volume in benign nodules, if we flip over then to papillary microcarcinoma, that number is lower. That number is about 25,000. If we then take, because this is a slow-growing non-metastasizing cancer, which makes it very amenable to our therapy, we believe, there is also a very large prevalence pool of papillary microcarcinoma patients who are living with cancer and who would want that cancer treated if a minimally invasive approach proved effective. The way we think about the addressable market there is that you have those 25,000 new diagnoses. You have a large prevalence pool seeking treatment. You're likely to yield perhaps 50,000 incremental procedures.

If we think about the TAM, driven by the benign indications, that could be 100,000-200,000, based on annual incidence and conversion of patients from a watchful waiting pool, add a number that might be an incremental 25%-35% of that population based on the addition of a papillary microcarcinoma indication in the future.

Thank you. That will conclude our question-and-answer session. I will now turn the call back over to Mr. Paul LaViolette, CEO and Co-Chairman. Sir, for closing remarks.

Well, thank you, operator, thank you all for joining us on our first quarter earnings call. We look forward to providing updates on our very active operating plans in upcoming financial conferences in Q2 and on our Q2 earnings call later this summer. Thank you all very much.

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

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.

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.

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?

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.

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.

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

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.

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.

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?

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.

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

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.

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.

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

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?

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.

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.

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.

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

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.

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.

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?

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.

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

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.

This concludes today's conference call. You may now disconnect.