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Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Investor Relations - Philip Taylor Co-Chair of the Board and Chief Executive Officer - Paul LaViolette Chief Financial Officer - Jon Skinner Co-Chair of the Board - Bob Duggan Need a quote from a Motley Fool analyst? Email [email protected] Operator: Thank you for standing by. My name is Tina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Pulse Biosciences Q2 2026 earnings call. [Operator Instructions] It is now my pleasure to turn the call over to Philip Taylor, Investor Relations. Please go ahead. Philip Taylor: 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, August 6, 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 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, and good afternoon, and thank you everyone for joining us today to discuss the results of our very active second quarter of 2026. I would like to begin with a discussion of the amazing and novel technology that sits at the core of everything we do at Pulse Biosciences, our proprietary nanosecond pulsed field ablation, or nsPFA technology. By delivering electric pulses in only billionths of a second durations paired with high energy, we are able to treat tissue non-thermally and with exceptional effectiveness. This translates into tangible and measurable advantages across a range of different diseases and tissues in the human body. nsPFA produces targeted energy, non-thermal ablations, durable lesions, quicker ablation times, and faster procedure times, all complementing the natural body function of regulated cell death. This mechanism is uniquely stimulated by nsPFA and is unmatched by existing ablation energies, including all prior art and the broad category of microsecond PFA alternatives. Underpinning the platform are a uniquely experienced technology development team, which has produced the highly novel nsPFA system and a deep patent estate of more than 250 issued patents worldwide. Together, this team, a number of whom have worked together for over a decade, and patent moat, are fundamental to protecting and amplifying our long-term leadership in this field. Last quarter, we announced a strategic alignment to prioritize, accelerate, and broaden the development of our nPulse Cardiac Catheter Ablation System. Our focus remains concentrated on the treatment of atrial fibrillation and the development of our nPulse Cardiac Catheter Systems while we continue to advance our surgical clamp and thyroid programs with discipline and optimism. As part of our strategic alignment, we focused on two key pillars in our program, generating compelling clinical data and executing rapid trial enrollment across a growing base of studies. During the second quarter, with this shift in focus, we have delivered positive and important achievements in our Cardiac Catheter Program. We enrolled the first patient in our pivotal catheter IDE study, including 7 cases on day 1. We activated multiple sites, presented outstanding feasibility data at the Heart Rhythm Society meeting in April, and further strengthened our leadership team with the additions of Liane Teplitsky as Chief Operating Officer and Dr. David Kenigsberg as full-time Chief Medical Officer. These two leaders have strengthened our ability to execute a successful pivotal IDE study and advance toward regulatory approvals. We also meaningfully bolstered our balance sheet now with over $100 million on hand, expanding our runway to fund development and clinical milestones ahead. Our financing progress was an important marker of external confidence in Pulse Biosciences. Through our at-the-market, or ATM, program, we raised a total of $57.5 million in net proceeds to date, initiated with continued insider support of approximately $13 million, and the remaining portion coming from outside institutional investors. This strengthened our balance sheet during the quarter and reflects growing and expanding conviction in the nsPFA platform and the growth opportunities in front of us. This is a complex environment for raising capital, and we are proud that investors who took a close look at our technical and clinical progress were able to appreciate the value creation story we are building at Pulse Biosciences. Additionally, we recently announced that we have surpassed the halfway point of enrollment in our U.S. pivotal catheter study ahead of our original schedule, and on the strength of that pace, we are confident in completing enrollment on our accelerated timeline of early Q4. Reaching this point so quickly in a pivotal AFib study is extraordinary, and we attribute it partly to a straightforward dynamic. Physicians are thrilled by their personal nsPFA clinical experience when using this catheter and are highly enthusiastic to both expand their use and share their positive experiences with their peers. This response is universal across operators. Today I will focus most of my remarks on the catheter and then we'll provide updates on our two other nsPFA devices. We will then turn the call over to our Chief Financial Officer, Jon Skinner, to review the second quarter financial results in detail. We will then conclude with a question and answer session joined by Bob Duggan, Co-Chair of the Board. I will now discuss the nPulse Cardiac Catheter System for AF ablation. Earlier in July, we shared that the NANOPULSE-AF study crossed its enrollment midpoint with more than 82 evaluable patients, net of roll-ins, treated in the IDE since the study began enrolling in April. The pace exceeds all expectations and reflects investigational site enthusiasm for what nsPFA technology offers. Durable pulmonary vein isolation, familiar and rapid workflow, intuitive user experience, an efficient procedure, and consistently positive outcomes for patients in need of AFib resolution. We are proud of current results and, rest assured, we are persistent in striving to do even better. Given our enrollment cadence thus far and expectations for site performance in the second half of the study, we are confirming our target completion date of early October, 3 months earlier than our original timeline. This enrollment velocity reflects the quality of our investigational sites, along with their lab and clinical research staffs, and the compelling clinical attributes of our catheter and energy system. Physicians comment that the system is extremely intuitive, with a straightforward learning curve, as well as seamless workflow integration, translating directly to rapid, efficient procedure and ablation times. We have seen multiple sites perform 5 and up to 7 cases in a day, and multiple physicians have completed their initial cases with 7 to 8 minutes or faster ablation times. With other ablation catheters currently available, EP labs generally do not schedule more than 2 to 3 cases per day. This early on meaningful expansion of daily case capacity is the best evidence of the workflow and procedure speed advantages as well as potential hospital economies that will follow as they utilize the nPulse system. Catheters that change practice patterns for the better, and dramatically so in our view, will become a compelling and welcomed option for electrophysiologists and hospitals. Upon the basis of workflow efficiencies, patient outcomes, and more, our nsPFA console and catheters continue to demonstrate unprecedented potential to transform the treatment landscape for atrial fibrillation. We chose to amend our NANOPULSE-AF pivotal study protocol to increase the total enrollment target by 19 patients from a target of 145 to a new target of 164. This is being done in concert with reducing prior enrollment restrictions on the types of antiarrhythmic drugs, or AADs, a patient must fail in order to qualify for inclusion. Now, patients that have failed any 1 of the 4 classes of AADs may qualify for the study. We believe this protocol modification better reflects contemporary clinical practice and real-world patient management. This protocol change also expands the pool of qualifying patients. We are pleased to confirm that full study enrollment is still expected to be completed by our revised date of early October, even with the increase in study size. Site activation continues to proceed well, and the momentum across our investigational network is being maintained as we expanded the base of active study sites to 12, and this number is expanding in real time. While the study protocol allows for enrollment at up to 30 sites, we do not anticipate activating all 30 due to the physician enthusiasm and enrollment velocity we have already experienced in the current base as sites and investigators are activated. Diving further into our study protocol, our efficacy endpoint, freedom from treatment failure through 12 months, incorporates a mix of both 12-month and 6-month patient follow-up data. The blended endpoint optimizes overall follow-up time for the study while supporting statistical rigor. As a reminder of our data presented at Heart Rhythm Society, or HRS, Dr. Vivek Reddy, the National Principal Investigator for our pivotal study, shared expanded results from our European nPulse Cardiac Catheter feasibility study, including 6-month follow-up on 95 patients and 12-month follow-up on 53 patients within the 5-second ablation cohort. These data were outstanding. 100% freedom from AF measured by 24-hour Holter monitor at 6 months and 96% as measured by 24-hour Holter monitor at 1 year, along with 90% Kaplan-Meier estimated freedom from recurrent AF, flutter, or tachycardia at 1 year, alongside a serious adverse event rate of just 1.7% across 177 patients. Those numbers compare quite favorably to the meaningfully lower success rates typically seen with other ablation technologies and were achieved without antiarrhythmic drugs and with consistent performance across operators and sites. The EU feasibility data continue to support our path toward a CE Mark submission in the second half of this year, and we see a potential CE approval around the middle of 2027, roughly 6 months post-submission. Supporting our go-to-market strategy with the EP catheter, we are continuing to pursue a partnership strategy. Our dialogue with prospective partners is ongoing, centered around the established players in electrophysiology with available mapping technologies. Those conversations are underway and we'll provide details when appropriate. Let's now move to our surgical clamp program, where treatments in our pivotal IDE clinical study continue to perform well. Concomitant ablation for pre-existing AF is, in our view, significantly underpenetrated, and we believe nanosecond PFA can support increased surgeon adoption and drive meaningful market penetration over time. Currently available tools provide inconsistent results with involved and time-consuming procedure protocols. Our clamp was designed to address these needs efficiently and to deliver the speed and effectiveness of nsPFA technology, which is capable of delivering reproducible transmural lesions nearly instantaneously, producing a more reliable and trusted ablation procedure, all for the purpose of improved patient outcomes. In addition to our IDE enrollment, our EU feasibility study has now treated more than 70 patients across 6 sites. Three-month post-procedure electroanatomical mapping results were presented at the European Heart Rhythm Association 2026 meeting and demonstrated excellent lesion durability and procedural efficacy on 34 patients. Total ablation time averaged just 41 seconds per patient. And pulmonary vein isolation success held steady at an extremely high rate of 94% at the 3-month follow-up, unchanged from the initial readout we provided in October of 2025. Just as telling is the qualitative feedback. Surgeons consistently praised the speed, lesion quality, and ease of use provided by the Pulse nsPFA clamps. Given this encouraging progress, we remain on schedule to file for CE Mark before the end of 2026. In the U.S., our pivotal study, NANOCLAMP AF, continues to enroll. As a reminder, it remains the only trial of a PFA surgical device to have secured FDA IDE approval. The IDE is a prospective single-arm study spanning 20 centers, 3 of them international, with a target of 136 patients designed to establish the safety and effectiveness of the nPulse Cardiac Catheter System in treating AF during concomitant cardiac surgery. Enrollment and site activation is progressing, and we expect to complete enrollment by the end of the first half of 2027. Turning to our nPulse Vybrance Percutaneous Electrode System, the nPulse Vybrance System uses our nanosecond PFA technology to ablate soft tissue percutaneously. Vybrance can be used to ablate symptomatic benign thyroid nodules as an alternative to full thyroidectomy surgery. Rather than removing tissue unnecessarily, Vybrance treats the thyroid through a minimally invasive approach in the outpatient setting. The procedure shrinks the nodule and relieves symptoms while sparing the surrounding anatomy and preserving thyroid function, a highly desirable outcome that is not possible with traditional surgical excision of the thyroid. In the second quarter, Vybrance's disposable sales were $434,000, a sequential increase from $400,000 in the first quarter. We remain focused on core market development goals, including generating clinical data for both expanding reimbursement coverage and achieving specific regulatory label claims. We are proud to announce a new partnership with the Clayman Thyroid Center in Tampa, Florida, the largest thyroid surgery center in the United States. This unique partnership is focused on supporting our core strategy of demonstrating the viability of the Vybrance system therapy for patients with symptomatic benign thyroid nodules. Key elements of this partnership will include registry data generation and unique study protocols for interventional therapy in thyroid disease. Bringing on a center of this caliber is an important step toward our goal of establishing nsPFA as a minimally invasive standard of care for benign thyroid nodules. Over the past several weeks, the Clayman Center has onboarded the Vybrance system and performed its first cases, and we look forward to reporting on progress toward our partnership objectives in future quarters. Additionally, our PRECISE-BTN, benign thyroid nodule study, continues to proceed quickly, and we expect the study to be fully enrolled this month. We broadened the study from its original 50-patient design to 100 patients to deepen the data set in support of adoption and long-term market expansion. Scientific recognition of this work continues to grow. Data from Dr. Stefano Spiezia in Naples, Italy, was recently presented in a podium session at the North American Society of Interventional Thyroidology, or NASIT. The data showed durable results out to 15 to 22 months, a 74% reduction in treated nodule volume as per our expectations, alongside overwhelming patient satisfaction, featuring very rapid symptoms relief post-treatment. Volume reduction continued to improve from 1 month all the way through 22 months with no nodule regrowth observed in the 15 to 22-month time frame. Beyond PRECISE-BTN, we are also widening the clinical scope of our Vybrance platform. Through our research collaboration with the University of Texas MD Anderson Cancer Center, researchers at 2 study centers are conducting a multi-center, first-in-human feasibility study of nsPFA for papillary thyroid microcarcinoma, or PTMC. This study is designed to enroll up to 30 patients across 2 sites. I'm pleased to announce that this study is approximately half enrolled, and we expect to complete enrollment by year-end 2026. And looking ahead, we've begun planning additional clinical trials with the aim of extending the Vybrance platform into new thyroid indications as we support our plans to bring this revolutionary therapy to a broader patient population. With that, I'll turn the call over to Jon to walk through our second quarter financial results. Jon Skinner: Thank you, Paul. Now, I will highlight our GAAP and non-GAAP financial results. 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 second quarter, we generated revenue of $434,000 and cost of product revenue was $273,000 for the quarter. We remain in a disciplined launch focused on clinical and market development. Based on strong clinical results, we remain focused on growing procedural utilization within a limited customer base. Total GAAP costs and expenses for the quarter increased by $5.4 million to $25.7 million, compared to $20.3 million in the prior year period. The increase in GAAP costs and expenses was primarily driven by increased investment in our clinical programs and compensation and employee-related spend supporting our growth in clinical and product development. Compensation and employee-related expenses, including stock-based compensation, increased approximately $2.7 million versus the prior year period. 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 second quarter of 2026 increased by $5.7 million to $20.5 million, compared to $14.8 million in the prior year period. The expected increase was driven by increasing clinical trial expenses and $2.9 million of compensation and employee-related expenses. Looking ahead, we expect quarterly operating expenses to remain in this range on a non-GAAP basis as we continue to invest in our clinical programs. GAAP net loss in the second quarter of 2026 was $24.7 million compared to $19.2 million in the prior year period. Non-GAAP net loss in the second quarter of 2026 was $19.4 million compared to $13.7 million in the prior year period. As of June 30, 2026, cash and cash equivalents totaled $101.6 million compared to $68.3 million as of March 31, 2026, representing an increase of $33.3 million versus the prior quarter. Cash used in operating activities during the second quarter of 2026 was $18.7 million compared to $12.8 million used in the prior year period and $14.6 million in Q1 of 2026. Through our ATM program, $57.5 million in net proceeds was raised since May. Bob Duggan and the Pulse team partnered with a sales agent to manage daily participation and run a successful program, raising approximately $44.5 million from outside investors. During Q2, insiders announced intent to purchase shares through the ATM program 3 trading days prior to the insider transaction, and management provided this update during our Q1 earnings call. This continued insider support contributed approximately $13 million through the ATM. Of the $57.5 million in net proceeds, $46.8 million was raised during the second quarter, with an additional $10.7 million raised subsequent to the close of Q2 and thus not included in our reported cash balances. As a result, we strengthened our balance sheet, ending with a stronger cash position than we began and extending our runway to the key clinical and regulatory milestones ahead. Additionally, we put a new $75 million ATM facility in place to preserve our financing flexibility going forward, along with our shelf that was put in place in February. We also received gross proceeds of $1.8 million related to exercises of the second tranche of 2024 rights offering warrants in July. Following this redemption, there are no remaining warrants outstanding. We remain disciplined on expense growth while continuing to fund our clinical programs, prioritizing financing through key milestones ahead. With that, I will now turn it back to Paul for closing remarks. Paul LaViolette: Thank you, Jon. Our strategic focus remains the treatment of atrial fibrillation, and with each new data readout, each new site activation, and each new investigator experience, the clinical strength and disruptive market potential of nsPFA becomes clearer to all. Enrollment in our pivotal IDE study is progressing ahead of our original timeline, driven by strong physician demand and site motivation. Looking ahead, our priorities remain clear. Continuing enrollment of our IDEs, progressing towards CE Mark approvals for our cardiology devices, advancing our catheter partnership discussions, and new this quarter, developing Vybrance market value through our partnership with Clayman Center, all while maintaining the operating discipline required to effectively execute and complete these critical milestones that will define Pulse Biosciences' future. nsPFA technology continues to demonstrate remarkable clinical differentiation, and our work going forward is to transform that platform potential into durable, scaled businesses capable of generating multiple billion dollars of recurring revenue. Thank you for your continued support, and we look forward to updating you again next quarter. 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: [Operator Instructions] Our first question comes from the line of Bill Plovanic with Canaccord Genuity. Bill Plovanic: Congratulations on successfully the enrollment rates. My first question pertains to that. You've talked about the combination of the 6 and 12-month data and the final module submission. Given that this enrollment is so fast, I don't think I've seen anything quite this fast, does it even benefit you to have it be a combination of 6 and 12-month data, or is this something where you might end up waiting till you have full 12-month data for the final module submission of the PMA for the NANOPULSE-AF? Paul LaViolette: Thank you, Bill. Good question, and you're right. So just to be, let's say, level-setting, the 6 and 12-month combination presumes that patients early in enrollment will be followed 12 months, and patients later in enrollment will be followed 6 months. Then the question becomes, what's the long pole, right? And if you enroll the second half of the study and follow those patients for 6 months, they might reach their 6-month endpoint before the earlier patients reach 12 months. So I think the real way to focus, that the -- I'll call it on the absolute timeline, is to think about 12-month follow-up on the patient cohort. And frankly, at that point, if enrollment continues to go so swiftly, whether you set that bar and say, "Let's do 12-month follow-up on the 80th patient or the 100th patient or the 130th patient, the absolute time differential between those is relatively short." So we're focused less on that than we are on quality and expedited enrollment. We're very pleased by how enrollment is going. I would say we're very pleased by the uptake of second and third wave sites, and the fact that there's really no distinction between how a new user establishes clinical comfort with our catheter today versus how that was established a few months ago when the IDE commenced or last year when our first in human experience was commenced. So, very good question. 12 months from the earlier patient group is the long pole in the tent. And despite that, we'll certainly, we're going to be using all tools available to us to manage timelines effectively, including enrollment, including follow-up, and then, of course, submitting very clean data to provide FDA the opportunity to minimize their review time once submitted. Bill Plovanic: Just a follow-up on that, Paul, is -- given that, I mean, 80 patients out of, you probably had only 6 or 7 accounts that did all of those, I would imagine it's gone so quickly. Do any of these accounts stop out just because they've had too many, you don't want them to get to be too many patients or too big a piece of the study? And so that's maybe why the pacing that you're providing kind of maintaining, even though you expand the number, but maintaining the timeline on this is because some of those earlier sites are going to cap out. Paul LaViolette: That also is a great observation. And the typical of all FDA-approved protocols, the FDA is worried about and focused on generating a representative patient pool of data. And in a multi-center study, they want to assure that there is not excessive skew toward 1 or 2 centers. And so we do have a cap that represents 15% of patient enrollment at a given site, no more. And I will say in response specifically to your observation, yes, several sites already have met their cap. Now, of course, the next sites being opened are equally interested in enrolling as many patients as they can. But as is always the case with clinical trial management, one, the sponsor, in this case, Pulse Biosciences, can't specifically predict which next site will be the next site to enroll very rapidly and to reach its cap. So, our job is to continue to activate sites, which we're doing. We have more in the queue, and we'll activate more sites over the next 1 and 2 months, and we'll continue to do that up to the point where we are nearing final enrollment. But, yes, some of the measured momentum throughout now and the next several months toward our expected completion date is regulated, if you will, by the turnover of high-performing sites as we cap out on some and as new ones emerge to become the next high-volume enrollers. Bill Plovanic: And then last one, I promise, is just, you expanded the study. So my question was any major learnings, you've enrolled 80 patients, but any major learnings from those 80 patients, and it sounds like one of them is just, hey, let's make sure we have all the AADs and get a real-world patient population, but I don't want to put words in your mouth. Paul LaViolette: Thank you, Bill. Well, I won't comment on any form of results, but as we've indicated in our message about both the rapidity of enrollment and all the way back to our first announcement of first patient in. This is a -- it's an exciting trial. Physicians are extremely enthusiastic about this technology. As you know, I've been doing clinical trials for 40 years, cardiovascular breakthrough clinical trials for probably 35 years. I've never seen trial enthusiasm any stronger than what we have here. And so we're just amazed by -- and I actually had this conversation with several members of our team, that as we focus on the extraordinary data, the outcomes, the data set that we announced at HRS, unprecedented data, it's important for us not to take for granted the acute experience in the lab. If we think about the AFib market, if we think about the dynamic change, the disruptive change that new technologies have brought in the last year, the shifts in market share, how those shifts in market share have translated to really fundamental shifts in market leadership positions, that has all been principally driven without outcomes data differences and mostly based on acute experience in the lab. And so the acute experience in the lab we have been clear about, we have been transparent about. That acute experience in the lab is unbelievable. Rapid learning curve. Almost no required time to become facile with our catheter. Extremely rapid procedure times based principally on a limited number of ablations required because of the clarity and power of our lesions, and extremely short lesion delivery times of 5 seconds. So when you piece those together, the physicians who are the crème de la crème are telling us that this is an experience they've never had before. And I think while it's not data, it's observation and it's anecdotal, but I think the biggest learning is the validation of the fact that the Pulse Biosciences catheter experience in the lab is something unlike they've ever experienced before. That is a telling marker for how this technology is likely to be adopted when it becomes available. Robert Duggan: Paul, this is Bob. If I just might add something to Bill here. Paul LaViolette: Please, Bob. Robert Duggan: Thank you. The faster enrollment is really a very positive product function feature as it's easy to use, as we found out. The quantity of patients treated is a very positive product economic feature for the OR. It is OR ROI that is significant. So we're really pleased about both of them, both the economics, which ultimately are the adjudicator of hospital take-up if in fact the product is giving you superior results on the patient side. So we look forward to the patient side, we're very confident, but we're very pleased about the quantity of patients being treated, and it wasn't something that we pushed or promoted. It was just the doctors went "Look, I've got more time here. I'm done with the 3 in a few hours, and I did stack up some patients, and we'll just bring them all through." So it's a double positive. We're really pleased with that. Operator: Your next question comes from the line of Anthony Petrone with Mizuho Group. Anthony Petrone: And congrats here on the progress on the IDE study. Maybe, Paul and/or Bob, just one on just mapping integration. In the last, at HRS, we talked about nPulse magnet being compatible with Abbott's EnSite. I think the messaging there was that CARTO was going to be brought into the study. So in the IDE, are we still only using EnSite? Have you brought in CARTO at this point? And maybe can you recap, what do you think continuous mapping can do, you know, ultimately for results when you compare it just to the IDE or the EFS study where we just used fluoro? And I'll have one quick follow-up. Paul LaViolette: Thank you, Anthony. Yes, so the study has been enrolled to date with EnSite. We've been clear about that. You're commenting on physician commentary coming out of, I think, HRS where in some of those panel discussions, physicians, I would say, speculated about the potential for results to potentially even improve with higher quality integration of how our catheter is represented on the mapping system. And so I would say we expect to see that manifested. And I will say, if you think about more sites picking up the technology for the first time, treating patients, and you measure, I think, your question by the efficiency of the procedure. How many ablations were needed? And you can't compare specifically the IDE to feasibility because the feasibility study contained a little bit more patient heterogeneity, some additional ablation strategies were deployed. But if you look at the IDE, the number of ablations per case is quite limited, quite efficient. And that's a measure of physician confidence in their specific placement of the catheter in the anatomy. And of course, they deliver that limited lesion set, and then they do a post-anatomical map, and they can record specifically the effectiveness in the lab of that lesion set. And so the ability to have tight integration translates to limited lesion numbers while achieving acute isolation, and that's the goal. So I do think we see a clear result of tighter integration. And we won't comment further on any changes in the mapping systems being used, but I will confirm that through today, and while we have the ability to use other mapping systems, all of the cases have been done with the EnSite system. Anthony Petrone: No, it's helpful. And the follow-up here would be on capitalization. You brought some more capital in. The cost of the trials here is going higher. But we are getting to a point it is enrolling faster. You're looking into 2027. Almost presumably, you could be on a footing for a launch. Today as well, you announced on track for CE Mark submission. So does the capital also contemplate building up the infrastructure, you know, perhaps even on the direct sales side, where does the capital bring you? Is it just through clinical trial development, or will you actually start market development as well? Paul LaViolette: Thank you, Anthony. Go ahead, Bob. Robert Duggan: Yes. Yes. I've had my finger on the pulse of that. Away from the pre-announcement that Paul and I made and gave other investors 3 days to jump in front of us if they desired to, the balance of the money was raised in the 27-28 area, which is about where we closed out the quarter. So we were pleased with our patience and how that went. The valuation has now gone up. So taking a measured pace on this was the right thing to do. We think it will continue to be the right thing to do. We will comfortably stay out there with at least 5 quarters of cash on hand relative to our forward spend. And as you get a label or close to a label, that spend will accelerate. I will say we already have calls from some of the best of sales and the best of marketing say, "As and if you get a label, don't lose my number, and here it is for the first time." That's the easiest area to add to and to complement what you have because you're getting calls from people that are competing with you now that well know how you stand. So that would be very difficult to go out and find a batch of engineers that could match or beat what we do. That's nigh near impossible. There's other administrative duties, regulatory, et cetera, that are difficult to come by. So we will be prepared for that. And whatever that case may be, we do recognize this is a business that has entrenched sales and marketing, but we do note that Boston Scientific from out of nowhere took market share like they were the Goliath, and until it was viewed as a commodity, I mean, they had like a $40 billion market cap jump when it looked like a monopoly. So valuation will not be a problem, if you look at that, and attracting the right people will not be a problem. Time is on our side. We look for the continuation of the trial and the very popular trial status will in a sense provide some early benchmark. You get physicians that are doing 7 a day, that's like 35 a week. There will be a classic number of EPs that go after this. And we have dealt with all the KOLs, so, to really get to the number, you can check in with them as to what they see, how competitive this will be. But we're pretty optimistic and we're very aware. In my former Pharmacyclics company, remember, we've not been in the drug business priorly, and my team, other people that are on board here, we did $1 billion of revenue in the second year from out of nowhere. So we're not unfamiliar with what it takes to do that. I hope that helps to respond to the question and our preparedness for it. Operator: Thank you, Anthony. Your next question comes from Suraj Kalia with Oppenheimer. Suraj Kalia: Congrats on all the progress. So Paul, Bob, two questions. The first is a multi-part question, and just trying to get my arms around this. Paul, the fourth AAD added, I presume it's a calcium channel blocker. And maybe you could help us understand the average age of the patients now, is it going to end up being similar to the EFS? And maybe if you could just kind of help us on the math of 19 additional patients. Paul LaViolette: Sure. So, yes. So, let's just level set for everybody. There are 4 classes of AADs. Two of which are calcium channel blockers, 1 sodium and then 1 beta blocker. And the history of the field has generally driven patients to be non-responders at least in the class 1 and class 3. Current practice, though, if you think about what's going on in the marketplace today is that patients are in higher demand for earlier ablation. And that earlier ablation implies, yes, that patient still needs to be a non-responder to an AAD, but they don't want to go through the escalation of more severe drugs with greater toxicity and adverse effect profiles. So in order to keep the protocol contemporary with current clinical practice, we felt it was important to add the other 2 AAD classes so that they could fail any 1 of the classes. Now, first question on patient age. I don't believe this will alter patient age. What this will potentially do, and the way we thought about the stats, the change in the enrollment number was to basically accept a question from FDA regarding the possibility that if you skewed more patients to being non-responders to a lower efficacy drug, it's possible that their AF burden could be slightly lower. So that leads to a potential question about performance goals, statistical rigor, and in order to bring equilibrium to all of those moving parts, we added patients. I think the important part of our thought process there was that there's very little price for us to pay by adding 19 patients because our enrollment velocity is so high, that in order to keep all the stats balanced with the slight theoretical change in, call it, background risk of the phenotype of the enrollee, we'll add a few patients and it won't cost us anything because the time to enrollment would be essentially the same. So that's how we thought about it. I don't believe it will change the age. And when you consider that we're not implementing this change until midway through the study. You then have the first half already having gone through the class 1 and class 3 non-response. The second half potentially being a mix of 1 through 4, the larger patient population is going to be quite comparable. And we just bolstered our statistical assurance, if you will, by adding those 19 patients. Suraj Kalia: Perfect. Paul, 1 quick question, and I'll hop back in queue. The rest of the patients to be enrolled in Nano-Pulse. Maybe I missed your commentary. I know everything has been done on EnSite so far. Should we glean from that the rest of the patients also will be on EnSite just for statistical purity here, and maybe if you could also share -- give us an idea of the 80-plus patients enrolled, what percent would be on the AADs and what are now on four AADs? Paul LaViolette: Thank you, Suraj. You may have missed it. I did make the comment that all the patients so far have been enrolled using our system mapped with EnSite. We are not going to comment on any expected change in that. So I think staying the course, the safest assumption should be that the remaining patients also will be enrolled on EnSite. That would not, by the way, change anything in the statistics. To your question, our IDE actually allows us to use any available commercial mapping system. So there is no anticipated outcome difference. It really comes down to the -- really the quality of the feel and the representation of our catheter on those systems in the lab. So that's point number 1. And then point number 2, we are not going to comment on the specific AAD, I'd say, regimen of the first half of the population, the second half of the population. I would say physicians generally feel they can enroll with greater ease by using a more liberal definition of AAD class non-responder. But we don't expect it to translate through to any difference in the first half and second half of the study population. Given that, again, our principal goal here is to really make it easier for the clinical community to address patients who are now in the real world moving faster from diagnosis to ablation than they would have prior to the availability of PFA in the marketplace. Operator: And your next question comes from the line of Josh Jennings with TD Cowen. Joshua Jennings: I wanted to just ask about the procedural efficiency you're seeing in the IDE study. The protocol, I think, is just general anesthesia for each patient. So it sounds like from your download, and I would imagine that physicians are having aha moments as they're doing 6, 7 cases in 1 day. And have any of them, kind of, forecast how many procedures using nPulse AFib ablation procedures they could do in an ASC, when, like, conscious sedation is used? I imagine some may be thinking about double-digit days, but I wanted to ask that, and I've got a follow-up. Paul LaViolette: Thanks, Josh. You're right. The protocol does call for general anesthesia. So one of the, I think, key observations that we have is that the relative time efficiency that we can deliver is technically impaired, right, by the protocol and by the way we're treating these patients. And that in the real world, that you would have higher throughput when a lab is thinking purely commercial cases, morning, midday and afternoon, multiple rooms, and patient throughput and efficiency. When you enter a patient in a protocol, you're more focused on great results, capturing data, and if it takes 10, 20 more minutes, you don't really think about that on a given day. Now, one of the dynamics we've emphasized, and this is key to Bob's point, and I'm sure he'd be interested in commenting as well, this is about the translation of efficiency through to hospital economics. And we are actually asking our sites to try, if it's within their management approach, to stack some cases. Let's try to do back-to-back cases. That does a couple of things. It's more efficient for the completion of the IDE, but it really forces them to experience what a day in the life would be like in the real world when this technology is available and when you can do 3 and 4 or 5 or 7 cases back-to-back and experience what that is like, you get both the acute benefit in that case, hey, my ablation time was only 6 or 8 minutes in total. But then you also get the sense when that patient has turned over to the next, to the next, to the next, and now you've done 4 or 5 cases and it's only 1 o'clock, this is what is creating such a positive enthusiasm and expectation for this technology going forward. You could then take that, yes, into the ASC. And we have done patients, of course, not in an ASC in the U.S., but we have done patients with sedation protocols in Europe. And so we believe that's going to be quite feasible. And of course, that is an unlock for ASC conversion in the future. So we do think multiple cases per day will be feasible. We do think labs will be thinking about how to make the downtime, right? It's less about now the time that Pulse consumes. It's about the non-ablative time in the case, and then it's about the movement of patients in and out of the lab and the turnover of that lab because the physician is not strained by these cases. And as a result, the physician can do multiple cases, and then it becomes more about, to use the analogy, the pit crew and the ability to turn over the room. And labs will be thinking about that because they know if they can do that low-value time more efficiently, they can bring higher throughput and do more cases, and that will translate directly to the ASC. And Bob, do you want to make any further comments about hospital economics? Robert Duggan: Yes, just the number of procedures that I've been fortunate enough to be in that the doctors walk away at, and I've seen 2 of them at the 7 level just fresh, ready to do more. We're going to come back the next morning. This is huge for not only the doctor and their sanity, but for the hospital and its return. You really look at 7 cases exceeds the revenue, the cost of capital of the generator. So the economics are superb here. And we want a label, we want this done efficiently and we want smiles on everybody's faces, including the patient. Patients, by and large, if they have something less than full anesthesia, would rather do it if they knew for sure the outcome was the match and nothing less than full anesthesia. So I believe that is chapter 2. Some have been done. They look good, but we won't be doing that in the trial. Let's get through the trial, get the approval, and that's an uplift to be looked at as we get through regulatory approval and commercialization. But it's very practical and very doable. And yes, so I think, Josh, you're looking at it the right way. And it's really another differentiator. I think it's very, very difficult to pull that off with any pulse other than a pulse that stimulates regulated cell death, which other pulses have a very difficult time if they can do it at all; we do it consistently. Remember, the nsPulse is a 1,000-fold faster than the micropulse. You penetrate into the cell at a pace that the cell does not interbulate the inner cell working. So we're -- it's a powerful technology. We'll take it 1 step at a time, but it looks really, really good. Highly, highly differentiated. All in the direction of better for the physician, better for the OR owner, and better for the patient. Joshua Jennings: Thanks for sharing those answers and just one follow-up on them. I mean, just looking at the first in-human data and AFib symposium at the HRS, nPulse seems to have the potential to deliver a differentiated efficacy profile, maybe even a record kind of freedom from atrial arrhythmia rate in the IDE study, but in a scenario where, you know, it comes closer or even in line to the efficacy rates of competing AFib ablation technology or pulsed field ablation technologies and what you're talking about in terms of the economic value proposition that's coming into play. I mean, that would potentially still be a home run for Pulse Biosciences and the platform just in terms of the adoption trajectory. Have you had discussions like that with any investigators or any KOLs in terms of where they're thinking about the efficacy bar needs to be? And clearly, I'm not suggesting that it will be lower. Very strong preliminary signals in play already. Paul LaViolette: Thanks, Josh. I think... Robert Duggan: Paul, you're the best one to answer that. But just on the top of this, Josh, an nsPulse delivered as we deliver it kills the cells. A dead cell, unless they are cousin of Lazarus, does not come back. A stunned cell, which can be otherwise the appearance of a dead cell, can come back. So I look at it that the reason that you report and you're on the OR table is AF tachycardia, bradycardia. There are many ways to accrue brady and tachycardia. But the way that you came into that OR, that means in that mechanism, you're not coming back when you're treated with nsPFA. Now, you may come up with -- you may marry someone else or lose money in the stock market or do whatever you do and have your heart go wild on it, and you could be back. We can't prevent other forms. But the reason that you reported in, that one's handled -- irreversibly handled. Dead cells don't come back, and we maintain that any other form of ablation can kill and can stun and have the appearance of dead cells, but somehow they seem to have recurrences. We're not going to be in that class. So that puts us in a good position, but it doesn't mean that you will never have another. You may have tachycardia today and 2 years later have bradycardia. That's just the human physiology. Paul LaViolette: And yes, I agree with Bob 100%. I think the way I would add further to that, Josh, is that let's assume that our data are exactly replicated from Europe and that we post a 90% Kaplan-Meier outcome across all atrial arrhythmias. That's going to be questioned, right? Competition in the marketplace will say, "Well, that was a single study, it's not head-to-head." And they will say, "That was still a relatively small data set, we've done 100,000 cases." So I think the market will accept that if we post that feasibility data, and by the way the feasibility cohort will be double, right, in terms of 1-year follow-up by then. Then we have the IDE data followed a year. That will be compelling. You put those 2 data sets together. It's going to be, I think, very impressive. But I yield to the scientific community to say, "Until we've seen 10,000 patients, until we've seen this or that, we're not entirely convinced." But at that point they say, "You know, actually, the acute performance is so good, and I'm predisposed to believe in better outcomes, even if it's not definitive head-to-head across a 5,000-patient study." The market is going to switch. The market has switched heretofore, based on acute performance, where there's been 0 differentiation across outcomes. And so to add another leap in acute performance and complement that with a likely superior outcome still to be added to with more and more studies and more real-world evidence, I think that physicians are looking at that saying, "You know what, I don't need any more than that to switch." Operator: And with no further questions in queue, I'll now return the call back to Paul for closing remarks. Paul LaViolette: Thank you, Operator, and thank you for those questions. Thank you all for your interest in Pulse Biosciences. We look forward to providing further updates on our progress, and I just want to wish everyone a good day, and thank you all for joining. Operator: Thank you again for joining us today. This does conclude today's conference call. You may now disconnect. Before you buy stock in Pulse Biosciences, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Pulse Biosciences wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Pulse Biosciences (PLSE) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the accelerated enrollment in the NANOPULSE-AF pivotal study to the 'unprecedented' acute experience in the lab, where physicians are performing up to 7 cases per day compared to the standard 2-3. The proprietary nanosecond Pulsed Field Ablation (nsPFA) technology is positioned as a disruptive mechanism that stimulates regulated cell death, which management claims is unmatched by existing thermal or microsecond PFA alternatives. Strategic alignment has prioritized the nPulse Cardiac Catheter System for atrial fibrillation while maintaining disciplined advancement of the surgical clamp and thyroid programs. The company bolstered its balance sheet with over $100 million in cash, primarily through an ATM program supported by both institutional investors and $13 million in insider participation. Management highlighted that the system's intuitive workflow and 5-second ablation times are driving a rapid learning curve and significant hospital ROI through expanded daily case capacity. The surgical clamp program is targeting the underpenetrated concomitant ablation market, with feasibility data showing 94% pulmonary vein isolation success at 3 months. The Vybrance thyroid program is shifting toward market development through a partnership with the Clayman Thyroid Center to establish nsPFA as a minimally invasive standard of care for benign nodules. Full enrollment for the NANOPULSE-AF pivotal study is now expected by early October 2026, three months ahead of the original schedule despite an increase in the target patient count. Pulse Biosciences plans to submit for a CE Mark for the nPulse Cardiac Catheter in the second half of 2026, with potential approval anticipated around mid-2027. The surgical clamp program remains on track for a CE Mark filing before the end of 2026, with U.S. pivotal enrollment expected to conclude by the end of the first half of 2027. Management is actively pursuing a partnership strategy for the EP catheter, focusing on established players with existing mapping technologies to support global commercialization. Quarterly non-GAAP operating expenses are expected to remain in the current range as the company continues to fund its multiple clinical programs through key regulatory milestones. The NANOPULSE-AF study protocol was amended to increase enrollment from 145 to 164 patients to maintain statistical rigor while broadening inclusion criteria to reflect real-world patient management. A new $75 million ATM facility was established to preserve financing flexibility and ensure at least five quarters of cash runway relative to forward spend. The company successfully redeemed all remaining 2024 rights offering warrants, resulting in no warrants outstanding as of July 2026. Management noted the complex capital-raising environment but emphasized that technical and clinical progress helped secure institutional confidence. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that the 12-month follow-up on the earlier patient cohort remains the 'long pole in the tent' for the final PMA submission. The company will use all available tools to manage timelines effectively, but the absolute time differential between 6-month and 12-month data cohorts is narrowing due to rapid enrollment. The addition of 19 patients was a proactive measure to address potential FDA questions regarding patient heterogeneity after allowing failures of all four classes of antiarrhythmic drugs (AADs). Management believes this change better reflects contemporary clinical practice where patients seek ablation earlier without failing multiple toxic drug classes. All IDE cases to date have utilized the Abbott EnSite system, though the protocol allows for any commercial mapping technology. Tighter integration is expected to translate to fewer required ablations and higher physician confidence in catheter placement within the anatomy. Management indicated they are already receiving interest from top-tier sales and marketing talent from competitors. The company intends to be prepared for a rapid commercial launch upon regulatory approval, citing past experience scaling revenue to $1 billion in two years at previous ventures.

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Pulse Biosciences Inc (NASDAQ:PLSE) reported exceptional enrollment progress in its pivotal NanoPulse-AF IDE study, surpassing the halfway point with over 82 patients and confirming an accelerated completion timeline of early Q4 2026, three months ahead of schedule. The company presented outstanding feasibility data at HRS, showing 100% freedom from AF at six months and 96% at one year, with a 90% Kaplan-Meier estimated freedom from recurrent atrial arrhythmias and a low 1.7% serious adverse event rate. Physician enthusiasm is high, with multiple sites performing five to seven cases per day and initial ablation times of seven to eight minutes, demonstrating significant workflow and procedure speed advantages over existing technologies. Pulse Biosciences Inc (NASDAQ:PLSE) strengthened its balance sheet, raising $57.5 million in net proceeds through its ATM program, ending Q2 with over $100 million in cash and extending its runway through key clinical and regulatory milestones. The company is advancing multiple programs, including the surgical clamp (with 94% pulmonary vein isolation success at three months) and the Vibrance thyroid system (with a new partnership with the Clayman Thyroid Center and a 74% reduction in nodule volume), while progressing toward CE mark submissions. Management confirmed ongoing partnership discussions with established electrophysiology players, which could support a robust go-to-market strategy for the EP catheter upon approval. Pulse Biosciences Inc (NASDAQ:PLSE) continues to incur significant operating losses, with GAAP net loss widening to $24.7 million in Q2 2026, up from $19.2 million in the prior year period, driven by increased clinical and employee-related expenses. The company amended its pivotal study protocol to increase the enrollment target by 19 patients (from 145 to 164) and broaden AAD inclusion criteria, which could introduce additional statistical complexity and potentially dilute the efficacy signal. The company's reliance on a limited number of high-performing clinical sites, which are subject to a 15% enrollment cap, creates a risk of enrollment slowdown as these sites reach their limits and new sites need to ramp up. The timeline for regulatory approval remains lengthy, with CE mark approval for the cardiac catheter not expected until mid-2027 and US PMA approval likely dependent on 12-month follow-up data, which could extend the path to commercialization. The company's revenue generation remains minimal, with Vibrance disposable sales of only $434,000 in Q2, indicating that the commercial launch is still in very early stages and far from achieving meaningful scale. The company's strategy of raising capital through ATM programs, while successful, has resulted in significant dilution for existing shareholders, and the need for continued financing could pressure the stock price. Warning! GuruFocus has detected 3 Warning Sign with PLSE. Is PLSE fairly valued? Test your thesis with our free DCF calculator. Q: Given the rapid enrollment in the NanoPulse-AF pivotal study, does it still benefit you to use a combination of six- and 12-month data for the final PMA module submission, or might you wait for full 12-month data? A: Paul LaViolette, CEO: The six- and 12-month combination presumes early patients are followed for 12 months and later patients for six. The "long pole in the tent" is the 12-month follow-up on the earlier patient cohort. Since enrollment is so swift, the absolute time difference between following the 80th, 100th, or 130th patient for 12 months is relatively short. We are focused on quality and expedited enrollment, and we will use all tools to manage timelines, including submitting clean data to minimize FDA review time. Q: Do any of the high-enrolling sites stop out because they hit a cap on patient numbers, and is that why you are maintaining the timeline despite expanding the study? A: Paul LaViolette, CEO: Yes, FDA protocols require a representative patient pool, so we have a cap of 15% of patient enrollment per site. Several sites have already met their cap. Our job is to continue activating new sites, which we are doing, and the measured momentum is regulated by the turnover of high-performing sites as they cap out and new ones emerge as high-volume enrollers. Q: What are the major learnings from the first 80 patients enrolled in the IDE study? A: Paul LaViolette, CEO: The biggest learning is the validation of the acute lab experience. Physicians are extremely enthusiastic, and I have never seen stronger trial enthusiasm in my 40 years of clinical trials. The catheter has a rapid learning curve, extremely rapid procedure times, and short lesion delivery times of five seconds. While this is anecdotal, the acute experience is unlike anything physicians have experienced before, which is a telling marker for future adoption. Q: In the IDE study, are you still only using Abbott's EnSite mapping system, or have you brought in Carto? What can continuous mapping do for results? A: Paul LaViolette, CEO: All cases to date have been done with the EnSite system. We won't comment on any expected changes, but the safest assumption is that remaining patients will also be enrolled on EnSite. The number of ablations per case in the IDE is quite limited and efficient, which is a measure of physician confidence in catheter placement. Tighter integration translates to limited lesion numbers while achieving acute isolation, which is the goal. Q: Does the capital raised contemplate building out infrastructure, such as a direct sales force, or is it just for clinical trial development? A: Bob Duggan, Co-Chairman: We will comfortably stay out there with at least five quarters of cash relative to forward spend. As we get closer to a label, spend will accelerate. We already receive calls from top sales and marketing talent saying, "don't lose my number" if we get a label. Attracting the right people will not be a problem. We recognize this is a business with entrenched sales and marketing, but we are prepared for that, and time is on our side. Q: Can you help us understand the math behind adding 19 patients to the study and the change in AAD (antiarrhythmic drug) classes? Will it change the average age of patients? A: Paul LaViolette, CEO: There are four classes of AADs. We added the other two classes so patients can fail any one of the four classes, which reflects contemporary clinical practice. This change won't alter patient age. We added 19 patients to bring equilibrium to statistical rigor, as there is a theoretical possibility that patients failing lower-efficacy drugs could have slightly lower AF burden. There is little price to pay for adding 19 patients given our enrollment velocity, and it won't cost us time. Q: Given the procedural efficiency seen in the IDE, have physicians forecast how many procedures they could do in an ASC (Ambulatory Surgery Center) with conscious sedation? A: Paul LaViolette, CEO: The protocol calls for general anesthesia, which impairs relative time efficiency. In the real world, labs would have higher throughput. We are asking sites to stack cases back-to-back to experience a real-world day. We have done patients with sedation protocols in Europe, so we believe ASC conversion is feasible. The physician is not strained by these cases, so labs will focus on turnover time, which will translate directly to ASCs. Q: If the efficacy rates in the IDE come in line with competing technologies, would the economic value proposition still be a home run for adoption? A: Bob Duggan, Co-Chairman: An NSPFA pulse kills cells, and dead cells don't come back. Other ablation forms can stun cells, which can recover. The reason you came into the OR is handled irreversibly with NSPFA. While you could have other arrhythmias later, the original mechanism is permanently addressed. This puts us in a good position. Paul LaViolette, CEO: Even if our data replicates Europe's 90% Kaplan-Meier outcome, competition will question it. However, the market has historically switched based on acute performance, and adding a leap in acute performance with likely superior outcomes will drive physicians to switch. Q: What is the status of the surgical clamp program and the CE mark timeline? A: Paul LaViolette, CEO: The EU feasibility study has treated more than 70 patients across six sites. Three-month mapping results presented at EHRA 2026 showed excellent lesion durability with total ablation time averaging just 41 seconds per patient and 94% pulmonary vein isolation success. Surgeons praise the speed, lesion quality, and ease of use. We remain on schedule to file for CE mark before the end of 2026. In the U.S., the NanoClamp AF pivotal study continues to enroll, with completion expected by the end of the first half of 2027. Q: Can you provide an update on the Vibrance thyroid program and the partnership with the Clayman Thyroid Center? A: Paul LaViolette, CEO: Vibrance disposable sales were $434,000 in Q2, up sequentially from $400,000 in Q1. We announced a new partnership with the Clayman Thyroid Center in Tampa, the largest thyroid surgery center in the U.S., to support registry data generation and unique study protocols. The PR For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Pulse Biosciences, Inc? Here are five stocks we like better. Pulse Biosciences accelerated its atrial fibrillation program: The U.S. NANOPULSE-AF pivotal trial surpassed 82 evaluable patients across 12 sites and is now expected to complete enrollment in early October, ahead of schedule. The enrollment target was increased to 164 patients, with broader eligibility criteria. European feasibility data for the nPulse cardiac catheter showed 96% freedom from atrial fibrillation at one year among 53 patients and a 1.7% serious adverse-event rate across 177 patients. Pulse plans to pursue a CE mark submission in the second half of 2026, potentially leading to approval around mid-2027. Higher clinical spending widened losses: Second-quarter revenue was $434,000, while the GAAP net loss increased to $24.7 million from $19.2 million a year earlier. The company ended June with $101.6 million in cash after raising $57.5 million through its at-the-market program, extending its runway for planned clinical and regulatory milestones. Pulse Biosciences (NASDAQ:PLSE) reported second-quarter revenue of $434,000 as it accelerated clinical development of its nanosecond pulsed field ablation, or nsPFA, technology, particularly for atrial fibrillation treatment. Chief Executive Officer and Co-Chairman Paul LaViolette said the company’s strategic focus remains its nPulse Cardiac Catheter System for atrial fibrillation, while it continues development of its surgical clamp and thyroid-focused Vybrance system. The company added that it has more than 250 issued patents worldwide supporting its nsPFA technology. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Pulse said its U.S. NANOPULSE-AF pivotal investigational device exemption, or IDE, study had enrolled more than 82 evaluable patients, excluding roll-in patients, since enrollment began in April. The company has activated 12 investigational sites and expects to complete enrollment in early October, three months earlier than its original target. The company increased the study’s enrollment target to 164 patients from 145 patients. The protocol change also broadens eligibility to include patients who have failed any one of four antiarrhythmic drug classes, rather than maintaining prior restrictions. LaViolette said the change was intended to better reflect contemporary clinical practice and expand the pool of qualifying patients. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Management said some sites have reached enrollment caps, which limit a single site to no more than 15% of total study enrollment. The company expects to continue activating additional sites while it works toward completing enrollment. LaViolette said physicians using the system have reported rapid learning curves and efficient workflows. Multiple sites have performed five to seven cases in a day, while some physicians completed initial cases with ablation times of seven to eight minutes or less, according to the company. He said the study has used Abbott’s EnSite mapping system for all cases to date, though the protocol permits use of other commercial mapping systems. → Ulta's Growth Is Real, But So Are the Risks During the question-and-answer session, LaViolette said the pivotal study’s efficacy endpoint combines six- and 12-month patient follow-up data. He described 12-month follow-up among earlier-enrolled patients as the longer timeline consideration for the program. Pulse reiterated results from its European nPulse Cardiac Catheter feasibility study presented at the Heart Rhythm Society meeting. In the five-second ablation cohort, the company reported 100% freedom from atrial fibrillation at six months by 24-hour Holter monitoring among 95 patients, and 96% at one year among 53 patients. The company also reported 90% Kaplan-Meier estimated freedom from recurrent atrial fibrillation, flutter or tachycardia at one year, with a serious adverse-event rate of 1.7% across 177 patients. LaViolette said the results support a planned CE mark submission in the second half of 2026, with potential approval around the middle of 2027. Pulse said it continues discussions with potential commercial partners, focusing on established electrophysiology companies with mapping technologies. The company did not identify prospective partners or provide a timetable for a partnership announcement. Pulse’s surgical clamp program also remains in clinical development. Its European feasibility study has treated more than 70 patients at six sites. The company said three-month electroanatomical mapping results in 34 patients showed 94% pulmonary vein isolation success, unchanged from an October 2025 readout, and average total ablation time of 41 seconds per patient. The company expects to submit the surgical clamp for CE mark review before the end of 2026. Its U.S. NANOCLAMP AF pivotal study is targeting 136 patients across 20 centers, including three international centers, with enrollment expected to conclude by the end of the first half of 2027. For its Vybrance percutaneous electrode system for symptomatic benign thyroid nodules, disposable sales rose sequentially to $434,000 in the second quarter from $400,000 in the first quarter. Pulse said it entered a partnership with the Clayman Thyroid Center in Tampa, Florida, to generate registry data and conduct thyroid-disease study protocols. The company expects its PRECISE-BTN benign thyroid nodule study to complete enrollment in August after expanding the trial to 100 patients from 50. Pulse also said a first-in-human feasibility study of nsPFA for papillary thyroid microcarcinoma, conducted through a research collaboration with The University of Texas MD Anderson Cancer Center, is approximately half enrolled and is expected to complete enrollment by year-end. Chief Financial Officer Jon Skinner said second-quarter GAAP costs and expenses increased $5.4 million year over year to $25.7 million, primarily due to higher clinical-program spending and compensation-related expenses. Non-GAAP costs and expenses rose to $20.5 million from $14.8 million a year earlier. Pulse reported a GAAP net loss of $24.7 million for the second quarter, compared with a $19.2 million loss in the prior-year period. Its non-GAAP net loss was $19.4 million, compared with $13.7 million a year earlier. Skinner said the company expects quarterly non-GAAP operating expenses to remain in a similar range as it funds clinical programs. Cash and cash equivalents totaled $101.6 million as of June 30, up from $68.3 million at March 31. Cash used in operating activities was $18.7 million during the quarter, compared with $14.6 million in the first quarter. The company raised $57.5 million in net proceeds through its at-the-market program since May, including $46.8 million raised during the second quarter. Pulse established a new $75 million at-the-market facility and received $1.8 million in gross proceeds from warrant exercises in July. Management said the financing extends its operating runway through planned clinical and regulatory milestones, while the company continues to prioritize investment in its cardiac catheter program. Pulse Biosciences, Inc is a clinical-stage bioelectric medicine company that develops and commercializes medical devices based on its proprietary Tissue NanoPoration (TNP) platform. The company’s core technology, NanoPulse Stimulation (NPS), delivers ultrashort, high-voltage electric pulses to targeted tissue, triggering cellular responses without the thermal damage associated with traditional energy-based devices. Pulse Biosciences focuses on applications in dermatology and aesthetic medicine, where controlled ablation of unwanted lesions is critical. The company’s flagship product, the CellFX® System, is designed to treat a range of benign and malignant skin lesions, including seborrheic keratosis, non-melanoma skin cancers, and various epidermal and dermal lesions. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Pulse Biosciences Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

HAYWARD, Calif., August 06, 2026--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nano-PFA or nsPFA™) technology, today announced business updates and financial results for the second quarter ended June 30, 2026. Recent Business Highlights Cash and cash equivalents totaled $101.6 million as of June 30, 2026. During Q2 the Company raised $46.8 million in net proceeds through an at-the-market (ATM) program, raising approximately $13 million from insiders and the remaining $33.8 million in net proceeds from outside investors. Subsequent to the close of Q2, the Company raised an additional $10.7 million in net proceeds through the ATM and $1.8 million in gross proceeds from the exercise of warrants. Endocardial Catheter AF Ablation Surpassed the halfway point of enrollment in NANOPULSE-AF, exceeding 82 evaluable patients, the U.S. IDE pivotal clinical study of the nPulse Cardiac Catheter System. The Company reiterates its enrollment completion target of early Q4, three months earlier than the original timeline. Amended the NANOPULSE-AF protocol to reduce prior restrictions on the class of anti-arrhythmic drug (AAD) failure required for qualification, such that patients on all four classes of AADs now qualify, reflecting real-world patient management. The amendment increases the total evaluable patient target by 19 patients to 164, and expands the pool of qualifying patients, supporting the early Q4 enrollment completion expectation. Continued to open investigational sites, now totaling 12 active sites. Observed rapid, efficient procedures across operators, with multiple sites performing five or more cases in a single day and multiple physicians completing cases with ablation times of 7–8 minutes or faster within their first several cases. Continued to progress toward a CE Mark submission in the second half of 2026, supported by European feasibility data at six months of follow-up, with potential approval anticipated by the middle of 2027. Surgical AF Ablation Continued to enroll NANOCLAMP-AF, the U.S. IDE pivotal study for concomitant surgical AF ablation, with enrollment expected to be completed by the end of the first half of 2027. Treated over 70 patients to date across six sites in the first-in-human European feasibility study. The Company remains on schedule to file for CE Mark for the nPulse Cardiac Surgical System before the end of 2026, with potential approval anticipated by the middle of 2027. Soft Tissue Ablation Announced a partnership with the Clayman Thyroid Center in Tampa, Florida to demonstrate the viability of Vybrance system therapy for patients with symptomatic benign thyroid nodules. We look forward to reporting on progress toward our partnership objectives in Q4. Generated $434 thousand of second quarter revenue, representing sequential growth over the first quarter. Advanced the PRECISE-Benign Thyroid Nodule (PRECISE-BTN) study, which is expected to complete enrollment within the month, following expansion from its original 50-patient design to 100 patients. We are pleased to project trial completion across three sites in under one year. First-in-human feasibility study of nsPFA for papillary thyroid microcarcinoma (PTMC) is approximately half-enrolled, conducted in collaboration with The University of Texas MD Anderson Cancer Center. The study is designed to enroll up to 30 patients across two sites, with enrollment expected to be completed by year-end 2026. While still early in the study, physicians remain highly enthusiastic about this first nsPFA cancer indication. "This was a highly productive quarter for Pulse Biosciences, defined by exceptional momentum in our cardiac catheter program," said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. "We have recently surpassed the halfway point of enrollment in our U.S. pivotal NANOPULSE-AF study, and even after expanding the enrollment target by 19 patients, we continue to anticipate completing enrollment by early Q4. The catheter’s ease of use, seamless workflow integration and its demonstrated safety and durability outcomes are driving rapid progress in the study. Together with a meaningfully strengthened balance sheet, we are well positioned to advance the clinical and regulatory milestones that will bring the transformative potential of nanosecond PFA technology to patients and physicians globally." Second Quarter 2026 Financial Results Total revenue for the three months ended June 30, 2026 was $0.4 million and the Company remains in a controlled commercial launch while it focuses its efforts on market development. Based on strong clinical results, the Company is focused on growing procedural utilization within a limited customer base. Total GAAP costs and expenses, representing cost of product revenue, research and development, and selling, general and administrative expenses, for the three months ended June 30, 2026, were $25.7 million, an increase of $5.4 million compared to $20.3 million in the prior year period. The increase was primarily driven by increased investment in clinical programs and compensation related spend supporting our clinical and product development programs. Non-GAAP costs and expenses for the three months ended June 30, 2026, were $20.5 million, an increase of $5.7 million compared to $14.8 million in the prior year period, driven by increased clinical trial and compensation expenses. GAAP net loss for the three months ended June 30, 2026 was ($24.7) million compared to ($19.2) million for the three months ended June 30, 2025. Non-GAAP net loss for the three months ended June 30, 2026 was ($19.4) million compared to ($13.7) million for the three months ended June 30, 2025. Cash and cash equivalents totaled $101.6 million as of June 30, 2026, compared to $106.3 million as of June 30, 2025 and $68.3 million as of March 31, 2026. The sequential increase of $33.3 million reflects net proceeds raised under the Company’s ATM program during the quarter. Cash used in operating activities in the second quarter of 2026 totaled $18.7 million, compared to $12.8 million used in the same period in the prior year, and $14.6 million used in the first quarter of 2026. During the quarter, the Company raised $46.8 million in net proceeds under its ATM program and an additional $10.7 million in net proceeds subsequent to the end of the quarter. $44.5 million in net proceeds came from outside investors, and approximately $13 million reflected continued insider support. The Company has since put a new $75 million ATM facility in place and continues to maintain an effective shelf registration statement for up to an additional $125 million, providing continued financing flexibility through the key clinical and regulatory milestones ahead. Reconciliations of GAAP to Non-GAAP costs and expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures." Webcast and Conference Call Information Pulse Biosciences’ management will host a conference call Thursday, August 6, 2026, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-800-715-9871 from the U.S. or 1-646-307-1963 internationally and providing Conference ID 3486060. A live and recorded webcast of the event will be available at https://investors.pulsebiosciences.com/. About Pulse Biosciences® Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the intention as well as potential to improve the quality of life for patients. The Company’s proprietary nPulse™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue as well as initiating regulated cell death. The Company is actively pursuing the development of its nPulse technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Pulse Biosciences, nPulse, Vybrance, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries. Non-GAAP Financial Measures In this press release, in order to supplement the Company’s condensed consolidated financial statements presented in accordance with Generally Accepted Accounting Principles, or GAAP, management has disclosed certain non-GAAP financial measures for the statement of operations. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results in order to supplement investors’ and other readers’ understanding and assessment of the Company’s financial performance. Company management uses these measurements as aids in monitoring the Company’s ongoing financial performance from quarter to quarter, and year to year, on a regular basis and for financial and operational decision-making. Non-GAAP adjustments include stock-based compensation, depreciation and amortization, and a legal settlement. From time to time in the future, there may be other items that the Company may exclude if the Company believes that doing so is consistent with the goal of providing useful information to management and investors. The Company has provided a reconciliation of each non-GAAP financial measure used in this earnings release to the most directly comparable GAAP financial measure. Investors are cautioned that there are a number of limitations associated with the use of non-GAAP financial measures as analytical tools. Investors are encouraged to review these reconciliations, and not to rely on any single financial measure to evaluate the Company’s business. Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies, which could reduce the usefulness of the Company’s non-GAAP financial measures as tools for comparison. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Non-GAAP financial measures in this earnings release exclude non-cash expenses for stock-based compensation, depreciation and amortization and legal settlement expenses. Forward-Looking Statements All statements in this press release that are not historical are forward-looking statements, including, among other things, statements concerning early clinical successes and whether they are predictive of the safety and effectiveness of any medical device such as the nPulse Cardiac Catheter System, statements concerning the anticipated timing of enrollment completion and possible outcomes in any of the Company’s clinical trials, statements concerning any of the Company’s regulatory submissions, including CE Mark submissions and the potential regulatory approval of any Company product, Pulse Biosciences’ expectations, whether stated or implied, about whether the Company’s nsPFA technology will become either a disruptive treatment option or a superior option for treating atrial fibrillation or any other medical condition, statements relating to the effectiveness of the Company’s nsPFA technology and nPulse System to non-thermally clear cells while sparing adjacent non-cellular tissue, statements concerning the Company’s expected product development efforts, such as advancement of its nPulse Cardiac Catheter to treat atrial fibrillation, statements concerning whether any clinical study will show that the Company’s novel nsPFA mechanism of action and catheter design will deliver fast, precise ablations in cardiac tissue and streamline workflow, statements concerning market opportunities, customer adoption and future use of the nPulse System to address a range of conditions such as atrial fibrillation, statements concerning the Company’s partnership and financing activities, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as "may," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expects," "intends," "plans," "projects," "believes," "estimates," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806008388/en/ Contacts Investors: Pulse Biosciences, Inc.Jon Skinner, [email protected] Or Gilmartin GroupPhilip Trip [email protected]

Interested in Pulse Biosciences, Inc? Here are five stocks we like better. Pulse Biosciences is shifting priority to its nPulse cardiac catheter for atrial fibrillation, calling the quarter an “inflection point” and reallocating more clinical and R&D resources to accelerate its pivotal IDE study and next-generation development. Updated feasibility data from the first-in-human European study were strong, including 100% procedure success at six months, 96% at one year, and a 1.7% serious adverse event rate across 177 treated subjects. The company has started U.S. pivotal trial enrollment in NANOPULSE-AF and now expects enrollment to finish in early Q4 2026, while ending the quarter with $68.3 million in cash and saying it has enough liquidity to reach major 2026 milestones. Pulse Biosciences (NASDAQ:PLSE) said it is sharpening its focus on its nanosecond pulsed field ablation platform for atrial fibrillation after reporting first-quarter 2026 results and highlighting new clinical data from its cardiac catheter program. On the company’s earnings call, Co-Chairman and Chief Executive Officer Paul LaViolette described the quarter as an “inflection point,” citing updated feasibility data, a strategic shift toward the company’s nPulse cardiac catheter for atrial fibrillation, and the start of enrollment in its U.S. pivotal study. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% The company’s technology is based on nanosecond pulsed field ablation, or nsPFA, which LaViolette said delivers energy in billionths of a second. He said the approach is designed to create deeper and more durable lesions while avoiding measurable temperature rise and minimizing neuromuscular stimulation. Pulse Biosciences is prioritizing its nPulse cardiac catheter system, which is being developed for ablation of paroxysmal atrial fibrillation. LaViolette said the device is designed as a 360-degree circular catheter intended to provide “single-shot” pulmonary vein ablation with a five-second energy application per target location. → Light Speed Returns: Corning Cashes In on NVIDIA Growth The company said it is shifting more resources to the catheter program, including clinical and research and development support. LaViolette said the realignment is intended to accelerate the company’s pivotal IDE study, additional clinical studies and next-generation catheter development. As part of that effort, Dr. David Kenigsberg has moved into a full-time chief medical officer role, while Liane Teplitsky has joined as chief operating officer. LaViolette said Teplitsky will oversee clinical, regulatory, quality and commercial functions, with an emphasis on the cardiac catheter program. → Years in the Making, AMD’s Upside Movement Has Just Begun LaViolette highlighted updated data presented by Dr. Vivek Reddy at the Heart Rhythm 2026 meeting. The data came from the company’s first-in-human European feasibility study of the nPulse cardiac catheter system and included six-month follow-up on 95 subjects and 12-month follow-up on 63 subjects in the five-second ablation cohort. According to the company, key findings included: 100% procedure success by 24-hour Holter among evaluable patients at six months, with 95 of 95 patients meeting the endpoint. 96% procedure success by 24-hour Holter among evaluable patients at one year. 90% Kaplan-Meier estimated freedom from recurrent atrial fibrillation, atrial flutter or atrial tachycardia at one year. A primary safety endpoint serious adverse event rate of 1.7% across 177 treated subjects. LaViolette said the results were achieved without antiarrhythmic drugs and showed consistency across operators and sites. He also said procedural data improved from an earlier presentation at the AF Symposium, including lower atrial dwell time, fewer average applications, and lower procedure and fluoroscopy times. Pulse Biosciences has begun enrolling patients in its NANOPULSE-AF study, a prospective, multicenter IDE pivotal clinical trial evaluating the nPulse cardiac catheter system for recurrent, drug-resistant symptomatic paroxysmal atrial fibrillation. The company said the first seven patients were treated in one day at St. Bernards Medical Center in Jonesboro, Arkansas, under Dr. Devi Nair, principal investigator of the Arrhythmia Research Group. LaViolette said Dr. Nair had not previously used the nPulse catheter, and he pointed to the initial cases as evidence of the system’s usability and learning curve. Pulse Biosciences now expects to complete enrollment in the study in early fourth-quarter 2026, tightening its prior guidance from completion by the end of 2026. LaViolette said the company is also using a Bayesian analysis that will incorporate 12-month outcomes for a subset of patients and six-month outcomes for the remainder, which he said should shorten follow-up time compared with traditional methods. In Europe, the company expects to use its feasibility study data to finalize a CE mark submission in the second half of 2026, with potential CE mark approval in mid-2027. LaViolette also said discussions with potential strategic partners are ongoing, including mapping providers and electrophysiology market leaders. During the question-and-answer session, LaViolette said the U.S. pivotal protocol allows up to 30 sites, though the company does not expect to use all of them. He said individual sites are generally capped at about 15% to 20% of total enrollment, or in the low 20s of patients per site. He also said the study protocol calls for general anesthesia, though conscious sedation could be viable over the longer term. Pulse Biosciences is continuing its NANOCLAMP AF pivotal study for the nPulse cardiac clamp, though LaViolette said the company has moderated near-term development in cardiac surgery as it prioritizes the catheter program. The company now expects to complete enrollment in the surgical clamp IDE study by the end of the first half of 2027. The surgical clamp study is designed to enroll 136 patients at approximately 20 sites, including two international locations. In Europe, investigators have treated more than 60 patients in a cardiac surgery feasibility study, now expanded to six clinical sites. The company said 34 patients underwent electroanatomical mapping about three months after ablation, with a 94% pulmonary vein isolation success rate and average ablation times of 41 seconds per patient. For the nPulse Vybrance percutaneous electrode system, which is being evaluated for soft tissue ablation including benign thyroid nodules, the company reported about $400,000 in first-quarter revenue from systems and electrodes. LaViolette said the company is operating the program at an intentionally limited scale while focusing on clinical data, reimbursement and selected hospital accounts. The PRECISE-BTN benign thyroid nodule study has completed enrollment of its first 50 patients and has been expanded to 100 patients. LaViolette also said the company’s collaboration with the University of Texas MD Anderson Cancer Center has begun first-patient enrollment in a feasibility study for papillary thyroid microcarcinoma, with enrollment expected to complete by the end of 2026. Chief Financial Officer Jon Skinner said first-quarter revenue totaled $401,000, while cost of product revenue was $370,000. Total GAAP costs and expenses were $19.6 million, up from $18 million in the prior-year period, with the increase primarily driven by investment in clinical programs and partly offset by lower stock-based compensation expense. Non-GAAP costs and expenses rose to $17.4 million from $12.7 million a year earlier, reflecting increased clinical trial, product development and market development activity. GAAP net loss was $18.6 million, compared with $16.8 million in the prior-year period. Non-GAAP net loss was $16.4 million, compared with $11.4 million a year earlier. Pulse Biosciences ended the quarter with $68.3 million in cash and cash equivalents, down from $80.7 million at the end of 2025. Cash used in operating activities was $14.6 million. Skinner said the company has a $200 million shelf registration available and an at-the-market program with about $60 million of availability as of March 31, 2026. Skinner said cash usage is aligned with spending on pivotal trials, device scaling and market development, and that the company believes it has sufficient liquidity to fund operations and clinical programs through major 2026 milestones. Pulse Biosciences, Inc is a clinical-stage bioelectric medicine company that develops and commercializes medical devices based on its proprietary Tissue NanoPoration (TNP) platform. The company’s core technology, NanoPulse Stimulation (NPS), delivers ultrashort, high-voltage electric pulses to targeted tissue, triggering cellular responses without the thermal damage associated with traditional energy-based devices. Pulse Biosciences focuses on applications in dermatology and aesthetic medicine, where controlled ablation of unwanted lesions is critical. The company’s flagship product, the CellFX® System, is designed to treat a range of benign and malignant skin lesions, including seborrheic keratosis, non-melanoma skin cancers, and various epidermal and dermal lesions. The article "Pulse Biosciences Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Image source: The Motley Fool. Thursday, May 7, 2026 at 4:30 p.m. ET Co-Chairman — Paul LaViolette Chief Financial Officer — Jon Skinner Co-Chairman of the Board — Bob Duggan Chief Operating Officer — Liane Teplitsky Need a quote from a Motley Fool analyst? Email [email protected] 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 radio frequency, 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 nonthermal mechanism that initiates regulated cell death in target tissue while leaving collagen, blood vessels, nerves and other noncellular 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 state 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. And 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. 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 and have rapidly reorganized our focus and operations to allocate an increased portion of our overall company resources to this program. And 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 we'll 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-Chair 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-degree 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 suggests a physician can now rapidly position the circular catheter, deliver a single 5-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 ultrashort 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 billionth 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 6-month follow-up on 95 subjects and 12-month follow-up on 53 subjects within the 5-second ablation cohort. The results were simply outstanding and reinforce 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 6 months with 95 of 95 patients meeting the endpoint. Sustained 96% procedural success by 24-hour Holter of evaluable patients at 1 year and sustained 90% Kaplan-Meier estimated freedom from recurrent AF, atrial flutter or atrial tachycardia also at 1 year. Procedural performance data at HRS improved from the already impressive readout at AS 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% to 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 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 ASCs, 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 multicenter IDE pivotal clinical investigation evaluating the nPulse Cardiac Catheter System for the treatment of recurrent drug-resistant symptomatic paroxysmal atrial fibrillation. The first 7 patients were treated at St. Bernards Medical Center in Jonesboro, Arkansas in just 1 day under the leadership of Dr. Devi Nair, principal investigator of the Arrhythmia Research Group. Dr. Nair has not previously used the nPulse catheter. And 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, and 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 time line 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 6 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 time lines 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 2 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 and clinical site activations continue to expand during Q1. 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 6 clinical sites. Within this 60-patient cohort, 34 patients underwent electroanatomical mapping approximately 3 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 3 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. And 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, alleviate symptoms and preserve 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 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 of Interventional Thyroidology, or NASIT, in March, which demonstrated remarkable results. Data presented from durable 15- to 22-month results showed 74% volume reduction of treated benign thyroid nodules with overwhelming patient satisfaction reported. Continued volume reduction improvements were seen from 1 month through 22 months with no regrowth of nodules at 15 to 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 2 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? Jon Skinner: 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 Catheter 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 nonrecurring 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. Paul LaViolette: 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 time line for anticipated completion of enrollment in our paroxysmal AF pivotal study. We 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. Operator: [Operator Instructions] We have the first question comes from the line of Suraj Kalia of Oppenheimer. Suraj Kalia: 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 because you don't want too much concentration. And finally, if these patients are consciously sedated or general anesthesia. Paul LaViolette: Thank you, Suraj. And 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 rolling 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. So 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. And as a result of that, we're likely to involve active sites less than the number that we were 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. And that number is typical in this study as it is with many others. Usually, it's around 15% to 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. And then 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, and 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. Operator: [Operator Instructions] We have the next question comes from the line of Anthony Petrone from Mizuho. Anthony Petrone: Congrats on a strong start to the year and the 2 good medical meetings, AF Symposium, HRS. Maybe taking 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, 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. So 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. And I'll have one quick follow-up. Paul LaViolette: Thanks, Anthony. 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 6 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%, and of course not a primary endpoint per se, but a broader measure of efficacy would be the data that we represented in our Kaplan-Meier curve of 90% success with respect to freedom from atrial fibrillation, a flutter and atrial tachycardia. So 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, and so we would expect the BMI which was 28 in Europe to go up in the U.S., but that's not a significant risk factor. The CHADS score, which is an important cardiovascular measure was relatively low. That will be consistent in the U.S. based on a paroxysmal population. And 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 1- to 2-year time frame. So I think overall, the patient population, while representing the U.S. population and maybe a little bit less healthy is not representing, I'll call it, a higher risk factor than the U.S. And 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 the same endpoints. And 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. And the sites that we're going to in the United States represent the best in the world. So 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 observe 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. And so 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. and that 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 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. That is a dramatic change. This is a significant disruptive technology in the hands of physicians going against the #1 most common arrhythmia in medicine. And I do believe we have something that's very significant here. And it's going to be a combination of both acute and long-term outcomes that will reinforce that for us coming out of the U.S. trial. Anthony Petrone: And just the follow-ups in here real quick would be just to confirm in the pivotal study here, IDE study, will EnSite be the only mapper, or will you bring in additional mapping technologies? And then a quick one just on soft tissue ablation, 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. Congratulations again. Paul LaViolette: 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 3 different mapping systems, and 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 electroanatomical connectivity, if you will, to the mapping system. So our system is capable now of higher fidelity mapping and navigation than we saw in our European data set. But 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. And so 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. So 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. So 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. And 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. And so 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. So if we think about the TAM driven by the benign indications, that could be 100,000 to 200,000 based on annual incidents and conversion of patients from a watchful waiting pool, add a number that might be an incremental 25% to 35% of that population based on the addition of a papillary microcarcinoma indication in the future. Operator: 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. Paul LaViolette: Well, thank you, operator, and 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. Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect. Before you buy stock in Pulse Biosciences, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Pulse Biosciences wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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Image source: The Motley Fool. Thursday, Feb. 19, 2026, at 4:30 p.m. ET Chairman of the Board — Robert Duggan Co-Chairman of the Board — Paul LaViolette Chief Financial Officer — Jon Skinner Need a quote from a Motley Fool analyst? Email [email protected] 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. 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. Before you buy stock in Pulse Biosciences, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Pulse Biosciences wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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