Pulse Biosciences Q3 2026 Earnings Call Transcript

Pulse Biosciences (NASDAQ:PLSE) reported third-quarter financial results on Thursday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

Pulse Biosciences reported a strong third quarter with significant clinical and financial achievements, including completing enrollment for the NanoPulse AF study ahead of schedule.

The company ended the quarter with $189 million in cash and marketable securities, providing a two-year runway, supported by $150 million raised through ATM programs.

Pulse Biosciences is focused on pre-commercial readiness for its NPULSE cardiac catheter system, planning for manufacturing scale-up and strategic partnerships to support a potential 2028 launch.

The NSPFA technology demonstrated superior procedural efficiency and safety in trials, with promising data expected to bolster market penetration and support regulatory submissions.

Management emphasized strong execution, strategic investments, and the potential for significant market share gains upon FDA and CE Mark approvals, highlighting the unique differentiation of their nanosecond technology.

Full Transcript

OPERATOR

Today, at this time, I would like to welcome everyone to the Pulse Biosciences third quarter 2026 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker’s remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. I would now like to turn the call over to Tripp Taylor, Investor Relations.

Please go ahead.

Tripp Taylor (Investor Relations)

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, November 5, 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 (Chief Executive Officer)

Thank you, Tripp. Good afternoon, and thank you, everyone, for joining us today to discuss our third quarter 2026 results and business progress. The team at Pulse Biosciences delivered a strong quarter, and we are looking forward to creating continued momentum in Q4 and into 2027. I will begin by describing the technology at the core of everything we do at Pulse Biosciences: our proprietary Nanosecond Pulse Field Ablation energy, or NSPFA, technology. NSPFA produces a fundamentally unique form of non-thermal ablation energy with a differentiated mechanism of action to treat cells. Because our pulses last only billionths of a second, there is virtually no energy deposition that converts to heat and almost no rise in the temperature of the tissue being treated or to adjacent areas.

The unique NSPFA energy acts on the membranes of the structures inside the cell, causing the cell to undergo regulated cell death without unwanted inflammatory responses. In addition, this energy is delivered very efficiently. High-efficiency energy delivery allows our catheter system to produce cardiac ablation lesions in tissue that are larger, deeper, and more consistent than lesions created with early-generation PFA systems. The combination of highly efficient lesion production and a very effective ablation mechanism of action results in a non-thermal ablation with exceptional procedural workflow efficiency, very reliable lesion formation, and minimized risk of collateral tissue injury. This mechanism is unique to NSPFA and is substantially different from that produced by thermal energies or by the broad category of first-generation microsecond PFA alternatives.

As the pioneer in this field, we are the developmental source of this energy technology as well as the delivery systems that enable its wide array of clinical applications, and we protect this platform with over 285 owned patents. This patent moat, together with more than a decade amassing dedicated technical know-how, protects our long-term leadership in this field. We are the first, we are the best, and at this point in time we are the only source of NSPFA for the foreseeable future.

The third quarter was a period of strong execution in both our clinical and financial capital formation programs. On the clinical front, we announced in early October that NanoPulse AF, our U.S. pivotal IDE study of the NPULSE cardiac catheter, reached its enrollment target of evaluable patients, completing this critically important phase of the study. We completed enrollment in less than six months, nicely exceeding the forecasted pace of our original enrollment timeline of nine months.

We believe this pace was the result of exceptional physician enthusiasm stemming from the demonstrated safety, efficacy, and workflow differentiation of the technology. We are extremely proud of the Pulse Biosciences team and this accomplishment. On the financial front, we ended the quarter with cash and marketable securities of $189 million, comfortably supporting our operating goals with approximately two years of cash runway. Our ATM program has raised more than $150 million in net proceeds since May, and we are proud to have raised this capital at low cost and with increasing equity value. With cumulative dilution of under 6%, we view the strength of our balance sheet as a strategic asset.

It positions us to fund our programs through key clinical and regulatory milestones and to make strategic operational investments that will strengthen our catheter launch readiness. Clearly, we continue to have favorable access to capital, and John will discuss our remaining ATM capacity later on in this call. Now we will discuss our cardiac catheter program in greater detail. Then I will provide updates on our surgical clamp and Vibrance programs. We will then turn the call over to our Chief Financial Officer, Jon Skinner, to review the third quarter financial results in detail. We will 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 designed to fundamentally improve current catheter-based treatments for atrial fibrillation. In early October, we shared that the NanoPulse AF study completed enrollment for evaluable patients, net of roll-ins, which occurred across 15 clinical sites with 36 investigators. We concluded study enrollment with 169 evaluable patients and 189 total patients, including 20 roll-ins. Our study enrolled with rapid velocity and finished three months ahead of the originally communicated timeline, and we could not be more pleased with the collaboration established between our Pulse Biosciences team and the clinical investigators and site teams that enabled us to achieve this extraordinary enrollment accomplishment.

As expected, what we have observed in the study has reinforced our procedural observations in the European feasibility study. Physicians commented, and our team members observed directly in every case, that the NPULSE cardiac catheter system was extremely intuitive to use with minimal learning curve and offered seamless workflow integration. This was observable in site after site as dozens of electrophysiologists used the NPULSE system for the first time in the pivotal study.

The NPULSE cardiac catheter is designed to complete isolation with a single 5-second delivery per location, with no need to reposition the catheter or overlap lesions. Our patented flexible electrodes conform to the anatomy, providing physicians the ease of maneuverability to place the catheter accurately and quickly and to hold it stably while delivering therapy. Because NSPFA is so efficient, total energy delivery is low, nerve and muscle stimulation is very limited, tissue is not heated, and there is no waiting time between deliveries.

These factors combine to allow physicians to move quickly and confidently from one vein to the next without delay as they complete pulmonary vein isolation with unmatched expediency as well as confidence in its outcomes, safety, and precision. This technique differentiation translates into clinical efficiency, and in several cases we observed physicians perform their first case with ablation times in under seven minutes, which is unusually efficient when compared to any available ablation system.

Our Chief Medical Officer, Dr. David Koenigsberg, described the pattern at our sites well: once operators did one case, they were amazed and eager to treat more patients. Dr. Vivek Reddy from Mount Sinai Fuster Heart Hospital and National PI on the trial noted that NanoPulse AF was one of the fastest enrolling trials he has seen or participated in, and Dr. Sheppard Doshi of Pacific Heart Institute described his early experience with the NPULSE system as potentially transformative, pointing to the catheter design and its one-shot approach.

With enrollment completed, all patients are now in follow-up. As a reminder, our efficacy endpoint, freedom from treatment failure through 12 months, incorporates a mix of 12-month and 6-month follow-up data. Based on that follow-up plan, we expect to receive final patient data based on the blended 6-month and 12-month follow-up in Q3 2027 and to convert that data into the final clinical module for PMA submission. We are actively working on our FDA and CE regulatory submissions processes and have commenced modular submissions.

We also anticipate CE Mark approval occurring in Q4 of 2027. Our European feasibility results have made a powerful statement about the clinical efficacy potential of NSPFA, and we believe the growing data set from Europe will be informative of future IDE results. The EU dataset features the same catheter, the same energy settings, the same paroxysmal AF enrollment criteria, and even some of the same operators as in the IDE. EU feasibility enrollment has now reached more than 190 patients in total and over 155 patients in the 5-second cohort.

We intend to submit these data for presentation at the AF Symposium in early 2027, which will include more than 100 patients with 12-month follow-up. As a reminder, at Heart Rhythm Society, or HRS, in April of this year, Dr. Vivek Reddy, National Principal Investigator of our pivotal study, presented expanded results from our European NPULSE cardiac catheter feasibility study. The data reported on the 5-second ablation cohort with 12-month follow-up on 53 patients.

The results were outstanding: freedom from AF measured by 24-hour Holter monitor was 96% at one year. Kaplan-Meier estimated freedom from recurrent atrial fibrillation, flutter, or tachycardia was 90% at one year. Given the breakthrough level of efficacy reported to date and the volume of patient data to be reported—over 100 patients followed 12 months during Q1 2027—we believe those data will be very informative of the NPULSE system’s potential to establish significant share penetration of the AF ablation market upon commercial launch.

I want to spend a moment on our strategic outlook for 2026 and beyond. With the NPULSE catheter IDE fully enrolled, our focus now shifts to pre-commercial readiness. In addition to regulatory submissions, we intend to build a strong foundation to support commercial launches and broad market adoption. These initiatives include supply chain planning, market access planning, marketing, and customer segmentation. Planning will support virtually any form of launch or partnership and accelerate our preparedness to support a launch beginning in early 2028.

With the capital we have raised, a portion of our cash and marketable securities balance of $189 million will be invested in both total production capacity and production process efficiency to create high product output potential and margin expansion potential. We continue to build out our market and procedure segmentation strategy. We will continuously expand our planning and prelaunch capabilities throughout this year and 2027 to prepare Pulse Biosciences to support a world-class product launch that amplifies the clinical potential of our product platform.

In parallel, we are advancing our pipeline of AF catheter clinical studies with focus on extending the same innovative platform technology into larger and more complex patient populations. The first of these will be persistent AF. We intend to submit our IDE application for a persistent AF study, and in the fourth quarter of 2026 we will provide details on the protocol, timing of first patient enrollment, our enrollment expectations, and other important elements of the study, once approved.

I also want to highlight planned additions to our European feasibility program to supplement ongoing evidence development. We will begin to evaluate the uniqueness of our NSPFA technology in both concomitant procedures with left atrial appendage closure devices and in the mechanism of action of NSPFA and its differentiation as compared to microsecond PFA. Our next-generation NPULSE cardiac catheter continues to progress through its developmental stages. As a reminder, this device includes the circumferential ablation zone in our current NPULSE cardiac catheter, with the addition of a focal electrode and the ability to switch between each of these ablation types. This enables all benefits of our current catheter with added functionality of a focal electrode for ablation lines on the mitral isthmus or the cavo-tricuspid isthmus, or the CTI.

We are pleased with our progress in development and preclinical evaluation of this next-generation catheter, and we expect to conduct first-in-human evaluations in 2027. Beyond AF, we are exploring the potential of NSPFA in other arrhythmias, including ventricular tachycardia, also known as VT, and premature ventricular contractions, abbreviated to PVCs. At the International VT Symposium in New York last month, Dr. Jacob Carruth of Mount Sinai presented preclinical applications of two NPULSE prototype endocardial and endovascular catheters designed to demonstrate the potential for treatment of non-AF arrhythmias.

This work is an example of the versatility of our novel first-in-kind generator and lesion-making capacity in delivering NSPFA energy and the innovativeness of our engineering and product development teams. This work is still in the research phase and not necessarily predictive of results in humans. We do believe the advanced research and development progress we are making is a strong indicator of the broad versatility and differentiated capabilities of the NSPFA platform, which we plan to pursue to unlock the ultimate potential of our NSPFA technology in cardiac applications.

Let me now move to our surgical clamp and Vibrance programs. We continue to enroll NanoClamp AF and are seeing, as expected, acceleration in enrollment with site expansion and study experience. We are also now opening additional clinical trial sites over the remainder of 2026 to increase enrollment velocity and increase the breadth of physician exposure, physician experience, and patient access. Based on our expected trajectory, we remain on track to complete enrollment by the end of 1H 2027.

In parallel, we are using our European data to finalize our CE Mark submission through a modular process and anticipate CE Mark approval occurring in Q4 of 2027. We have also successfully completed our first-in-human evaluation of a cardiac surgery pen to create ablation lines complementary to the clamp to potentially enable surgeons to perform a broader array of lesion sets when treating AF. Early results are encouraging, and regulatory and clinical plans are in development.

We will provide updates as they progress. Our strategy for Vibrance, the percutaneous electrode with FDA clearance, has focused on the initial use case in benign thyroid disease and has been centered around market development and data creation, which we expect will drive adoption as high-quality data continues to be generated and published. Our partnership with the Clayman Thyroid Center in Tampa, the largest thyroid surgery center in the United States, is progressing well. We plan to commence a real-world registry of patients treated in routine clinical care.

We also plan to initiate a formal controlled study of select benign thyroid nodule patients intended to evaluate Vibrance and other treatment alternatives. This partnership with the Clayman Center enables expanded access to our Vibrance technology and the collection of first-in-class and best-in-class outcomes data, and we look forward to reporting on the progress toward our substantive partnership objectives in the quarters ahead. In September, we announced completion of enrollment in our PRECISE-BTN study for the treatment of symptomatic benign thyroid nodules. The study enrolled 100 patients, double its original 50-patient design, in approximately 12 months. The first patient enrolled has completed 12-month follow-up. Preliminary data were presented at the American Thyroid Association today, with the primary endpoint of a single non-thermal NSPFA treatment reducing nodule volume by greater than 50% being achieved in 86% of patients.

The study also produced an average 78% improvement to the overall quality-of-life score at 6 months and no serious adverse events. Additional data readouts are expected once all patients complete 6-month and 12-month follow-up during 2027. Data derived from this trial will support a 510(k) submission to include an on-label indication for the treatment of benign thyroid nodules. We are very pleased with the progress being achieved by this clinical initiative.

Beyond PRECISE-BTN, we continue to widen the scope of our Vibrance platform into other indications, including our new study in parathyroid disease. This is a first-in-human feasibility study of the Vibrance percutaneous electrode for the treatment of primary hyperparathyroidism and will include 15 patients to assess initial safety and efficacy of NSPFA energy for this patient population. Primary hyperparathyroidism is one of the most common hormonal disorders in the United States, with an estimated annual incidence of approximately 100,000 patients, often leading to a surgical intervention.

The Vibrance procedure could offer a minimally invasive treatment option for these patients. Simultaneously, we continue to enroll our first-in-human feasibility study of NSPFA for papillary thyroid microcarcinoma, or PTMC, conducted through our research collaboration with The University of Texas MD Anderson Cancer Center. The study is designed to enroll up to 30 patients across two sites. We are continuing with enrollment and expect to complete the study in the months ahead.

With that, I’ll turn the call over to Jon to walk through our third quarter financial results.

Jon Skinner (Chief Financial Officer)

Thanks, Paul. To begin today, I want to highlight the significant progress we have made strengthening our balance sheet through our ATM programs. We have raised more than $150 million in net proceeds since May, including 95.8 million during the third quarter. We have approximately $64 million remaining capacity on our ATM which preserves our Financing flexibility going forward. Share dilution has been less than 6% for the cumulative ATM activity during 2026. 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 third quarter we generated revenue of 395,000, an increase versus the prior year period of 86,000. Importantly, we grew commercial case volume on a sequential basis and remained focused on clinical and market development within a limited customer base. Cost of product revenue was 191,000 for the quarter, and at scale we anticipate the gross margins on our disposables to exceed 70%. Total GAAP costs and expenses for the quarter were 24.7 million, an increase of 4.2 million compared to 20.5 million in the prior year period. The increase in GAAP costs and expenses was primarily driven by increased clinical investments along with compensation and employee-related spend supporting the company’s clinical and product development. 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 third quarter of 2026 increased by 4.5 million to 19.1 million compared to 14.6 million in the prior year period. The expected increase was again driven by increasing clinical trial expenses and compensation and employee-related expenses. GAAP net loss in the third quarter of 2026 was 23.1 million compared to 19.4 million in the prior year period. Non-GAAP net loss in the third quarter of 2026 was 17.5 million compared to 13.5 million in the prior year period. As of September 30, 2026, cash and marketable securities totaled 189.2 million compared to 101.6 million as of June 30, 2026, representing an increase of 87.6 million versus the prior quarter. Cash used in operating activities during the third quarter of 2026 was 15.3 million compared to 13 million used in the prior year period and 18.7 million in Q2 of 2026.

Cash burn was lighter than the second quarter primarily due to the timing of payments related to clinical studies. Looking ahead, we expect spending to increase as we move into the persistent AF IDE along with additional clinical studies to further our evidence generation, build out manufacturing capabilities for partnership readiness, and other pre-commercial readiness efforts for the Impulse cardiac catheter. In the coming quarters we expect quarterly non-GAAP costs and expenses to increase by 15% to 25% above our average levels in Q2 and Q3 of approximately 20 million.

Consistent with our business focus, we expect the majority of the increases invested in EP catheter-related activities. We will continue to share more on future earnings calls. We will remain disciplined on expense growth with spend tracking the priorities we have established. We aim every dollar at creating lasting value as we continue to fund our clinical programs with financing prioritized to carry us through the key milestones ahead. With that, I will now turn it back to Paul for closing remarks.

Paul LaViolette (Chief Executive Officer)

Thank you, Jon. Completing enrollment in Nanopulse AF in six months, three months ahead of our original plan, is more than an operational milestone for Pulse Biosciences. It is a clear signal of how electrophysiologists respond to NSPFA once they have it in their hands, and it moves us meaningfully closer to our final goal of FDA clearance. As I described earlier, we are leaning in on investments into commercial readiness programs. That begins with adding competencies in manufacturing and process engineering consistent with our goal of being able to supply the market to support high market share achievement through a partnership of various forms. We are continuing to advance our clinical programs to generate further evidence and have plans for additional data releases of results which to date have been viewed as unprecedented and potentially enable significant share penetration.

With cash and marketable securities of 189 million, our balance sheet supports this work and we are well capitalized for the milestones ahead. Going forward we will remain judicious as well as opportunistic, comfortable with our cash balance and the remaining ATM balance of 64 million over the coming quarters. Our priorities are clear: following our Nanopulse AF patients through to data readout, submitting the cardiac catheter for CE mark and submitting our persistent AF IDE by year end, completing enrollment in Nanoclamp AF for concomitant use in surgery, and continuing to build the evidence base for Vibrants.

Each of these milestones brings us closer to our goal of turning the clinical differentiation of NSPFA into durable scaled businesses. Our platform is grounded in science, supported by encouraging early clinical experience and now getting closer and closer to reaching the market. We are moving deliberately to make NSPFA a worldwide treatment standard with meaningfully improved results for patients and growing value for those who invest in us. Thank you to our investigators, clinical teams, patients and employees, and to our stakeholders for your continued support. We look forward to updating you again next quarter.

Now, joining us for the question and answer session is Bob Duggan, co-chair of the board. Operator, please open the call for questions.

OPERATOR

Thank you. At this time I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. We ask to please limit to one question and one follow-up. We will pause for just a moment to compile the Q&A roster. And your first question comes from the line of Marie Thiebault with BTIG. Your line is open, ma’am.

Marie Thiebault (Analyst at BTIG)

Hi, good evening. Thanks for taking the questions, and congrats on all the execution this quarter. I think you started to touch on it a little bit here, but I wanted to go in a little bit more detail about what you at the company are doing on your end for launch readiness. I know it’s not immediate, obviously, but what are you doing, I guess, on manufacturing? Any of the things that you can control? If you can give us an update on kind of what’s happening behind the scenes there.

Paul LaViolette (Chief Executive Officer)

Thanks, Marie, and thanks for your comments. Yes, think about it this way. We’re about five quarters away from planned FDA approval timeline. That’s really valuable time for us to get ready to support a launch. And so the first thing that comes in planning launch, I would say, is scale. We are very enthusiastic about the data that support this program and we anticipate that there will be high demand for this catheter. And as a result, we want to be prepared with volume availability and we are thinking about meaningful market share for demand of both the catheter and our systems.

We are thinking about the quantity of sites that will want access to the console and we’re thinking about supplying that from where we are today, which is obviously supplying only IDE volumes. And so we have a fair amount of scale-up to do over the next number of quarters. We’ve previously described that we’re using contract manufacturers, more than one, for our catheter supply, and that we, as a team, Pulse Biosciences, vertically integrated, will supply console volumes. And so we’re really focused on preparing to scale up console manufacturing internally and preparing our contract manufacturers with both the ability to produce production lines to be provided with process-engineered efficiency in our catheter and essentially all of the things necessary to go from literally one manufacturing line to two, and two to four, in more than one location.

We’ve a head start on that by initiating production in our first contract manufacturer and then transferring that capability to a second manufacturer. So we know we have reliability in our processes, we have transferability of the overall production, and we’re working from that point forward in making every step more reliable so that we ultimately land on a launch that is supported by high yields, high-efficiency manufacturing, translating of course to favorable gross margins and ultimately scale that supports meaningful market share.

So that’s on the supply side. On the remaining side of non-manufacturing, we’re very focused on planning for launch. And this planning, of course, is consistent with our partnership strategy, but it supports our business no matter what direction we go. And so everything I’m talking about is what a company would do if it were planning to launch for itself as a strategic, or for Pulse to be positioning itself to support a partner in launch or a direct launch.

And so everything that we’re doing can support a strategy and strategic flexibility. And on the non-operations planning, we’re very focused on how this catheter would be launched, how you train for this, how you integrate it with mapping systems, how you ultimately segment the market and identify sites that would be the first and second and third tiers of launches. All things that an upstream marketing function would do in a strategic, as an example.

So all of those things require, I would say, targeted competencies that we’re adding to the company now. We’ll be adding senior management under our Chief Operating Officer, Leanne Teplitsky, and under our Chief Technology Officer, Darrin, who many of you know, and Darrin and Leanne and I have done this before. We’ve launched significant products before, as you know, and we’re planning to add some of those capabilities to Pulse in preparation for launch, again across the spectrum of how our launch may ultimately take shape.

Marie Thiebault (Analyst at BTIG)

That’s very detailed and thorough. Thank you for that, Paul. As a brief follow-up, I heard you mention the EU dataset that we’ll get an update on the results at AF Symposium here coming up in a few months. Excited to see that. Can you tell us a little bit about what that means for kind of read-throughs for the U.S. pivotal trial as well as any impacts to sort of the tone, the tenor, the timeline for some of the partnership discussions you’re having?

And thanks again for taking the questions.

Paul LaViolette (Chief Executive Officer)

Thanks, Marie. So I’ll let Bob comment on partnership activity, but I do think the data, if we take a look at where we’ve been with data to date, it’s moving quickly and we have to remind ourselves that our first data readout didn’t occur until February at the AF Symposium and was validated with a slight increase in follow-up at HRS. So really, if you think about data maturation, that data set has been in the market for a relatively short amount of time, only about six months.

And so there’s no question that physicians have been extremely impressed and the anticipation for this platform has grown exponentially. But we also believe we have to add to that data set in the form of a higher number of patients followed and followed for a more definitive period out to 12 months. And so the most important comment would be that our plan for AF Symposium is to submit data for presentation. Of course, our data would be relatively high profile, so we feel good about the likelihood that will be presented and, at a minimum, have one-year follow-up for 100 patients. We think that’s a very substantial increase in a very substantive data set. Number one, as it relates to reading on both the IDE and, let’s say, the market receptivity for this data, we think that 100 patients followed a year starts to create an impression that becomes relatively solid, relatively concrete.

If we are capable of maintaining the same levels of endpoint success, which is to say freedom from AF as measured by a Holter, at a year consistent with the IDE endpoint at 100 patients, it becomes harder and harder to imagine that the data will begin to waver thereafter. We’ve seen very solid, consistent results, very reliable ablation performance. We think there’s a reason behind our superior data. And as that data set grows, it becomes more likely to be predictive of, I think, the permanent outlook for how this catheter performs clinically. Obviously, physicians and others, including strategics, are paying close attention to that data set. It, of course, is up to them as to exactly what specific amount of data they’ll be looking for.

But I think it really sends an important message that we have a very substantial data set in Europe. As mentioned in my prepared remarks, the total population treated now with the five-second cohort within the five-second cohort is in excess of 150. So that data set will continuously read out in 2027 as we complete follow-up from the 169 evaluable patients in the IDE. We think those two data sets combined throughout the course of 2027 will produce a very substantial view of what pulse is capable of producing in AF and would be indicative of how the IDE will likely read out in our hands in Q3 of 2027 as we follow up patients throughout the clinical module and submit data to the FDA in the second half of next year. And with that, Bob, I don’t know if you’d like to make any further comments on that, and if not, we’ll just go ahead and move on to the next questioner.

Bob Duggan (Co-Chair of the Board)

Yeah, Paul. Marie asked to give a little color on partnership. This is really important because it’s a significant business. There are some clear world-class, multibillion-dollar organizations that have owned it. They’ve seen market share shift here recently in the last year and a half. That’s a good indicator because it shows that a newbie with something entirely relevant and distinguished can come in and take share. Having said that, the way to assume immediate share would be via partnership with one of the bigger players.

They are evidence-based, as is usually the case. I’ve dealt with most of them on the drug side as well as early on in the days in robotics. So I know where they’re coming from and why they’re coming from that space. So you have IDE, you have FDA, you have CE Mark, you have labels per histology. All these things add real value. The really good news, Marie, here is that we are in the business of replacing MS as the dominant procedural efficacy. It’s really a combination of RF and MS PFA. NS is entirely different. I told one of the leading doctors the other day, it’s like sherbet versus ice cream. There’s a little similarity, but they’re really different. Ask your kids if you don’t agree. We are on the NS side. NS has the potential, a few years out, to really become the mechanism that cures the disease, especially for the specific causes for which the disease is reported and has occurred.

That’s impossible with RF, impossible with MS. There are certain cells there that are stunned, and stunned cells can, as they are wont to do, recover and come back. And all of a sudden you have either redo, a touch-up, or the disease come back. We ablate cells that do not come back. We joke, unless their name is Lazarus. When they’re done, they’re done. So we feel the outcomes that we’re generating in the 90th percentile here are really powerful and we fully expect that to continue.

So what’s my point here? My point is when we get clearances, this product is going to assume share rapidly, provided that you can service the accounts. We need to be in a manufacturing position either to do it ourselves if the valuations are not adequate or the compensation is not adequate to partner with someone, or we need to have the inventory so that if we do partner it can be made, because no one else is going to be able to make these. This is not just a normal MS PFA and one looks similar to the other.

So that’s what we’re gearing up to do. We’ll be hiring a very senior manufacturing—15 years of catheter experience, well experienced in this. We’re very excited about it. It’s necessary that it be done specifically and appropriately and with knowledge. But that knowledge is all available. We manufacture a product with procedures and have had a very good throughput, very good efficiency, and really no problems. Now we just have to order it up by 200 or 300-fold to get to the scale that’s going to be necessary.

Scaling does have its challenges, but those that have been through it before can handle it well. So I hope that gives you a little bit of color. There’s no lack of interest in this, but having invested in NS Pulse at under a billion dollars for the console and the catheter, thinking that that was a monopoly, turned out to be a cul-de-sac. It was not a freeway. We are different. I don’t blame them for saying, look, prove it before, you know, we pay the kind of prices that you all are looking for. So that’s the situation we’re in, ready to go as far as we need to to demonstrate the viability so that a partner taking it on is—it’s a two-way street.

They’re happy to get into it as we are to partner with them. And those terms and conditions will be ironed out later on as they become appropriate to disclose to our investor base.

Marie Thiebault (Analyst at BTIG)

Well, very good. Thank you so much, Bob and Paul.

Paul LaViolette (Chief Executive Officer)

Okay, thank you, Marie.

OPERATOR

And your next question comes from the line of Mike Matzin with Needham. Your line is open.

Joseph (Analyst at Needham)

Gentlemen, thank you very much for taking our questions. This is Joseph on for Mike. Paul, appreciate all the color you gave on the commercialization strategy. I guess just to start, I’m wondering, just looking at how much PFA share has shifted between competitors in recent quarters, did this change your view or strategy in terms of marketing, commercialization, or the details you provided today? Was that kind of the plan from day one? And then just kind of separately, in conversations with physicians involved in your ongoing trials, how much has maybe Medicare’s MPPR policy come into the conversation?

Obviously a negative for concomitant, but, you know, with the procedural efficiency of NS PFA, you gotta imagine that maybe Pulse Biosciences would be the winner in that challenge. Thanks.

Paul LaViolette (Chief Executive Officer)

Thanks, Joseph. Well, let’s just break it down. Share shifting, I would say, has become part of the landscape in AFib ablation in particular. And that is relatively new. And I say that because if you think about what has really defined the market, it’s principally been mapping share that has been established and remained relatively stable over time. And then, of course, ablation energies followed that with a high degree of stability and, not surprisingly, new to the game.

When PFA was launched with great effect by Boston Scientific just a few years ago, shares began to change very rapidly, and we’ve seen that continue through the last year with the launch of Medtronic’s products. So share shifting, to your point, is relatively new, but it’s entirely, I guess, consistent with our expectation in the market and a driver, a positive driver for us. We have seen now repeatedly in the last couple of years that improved technologies that can drive, for the most part to date, only workflow gains with some perceived safety benefits over RF, those have really driven major shifts in market share, which have translated to obviously dramatic changes in revenue per player and significant shifts in market capitalization in this space. So it has reinforced that this is a very high-value market and that ablation has taken over for the installed capital base of mapping to be really the driver of utilization and of aggregate share for AFib.

So I would say that is absolutely the premise upon which we’re pursuing. That’s why Bob made the comments that he made about strategics and about how we’re perceived and the relative value that is being applied to our story. It’s because of that perceived ability to lead with data, to provide workflow drop-in, to provide efficiency gains in the lab, and then that ultimately is expected to produce meaningful revenue share changes. I think the one important element to bring up, and this has not been the case between the current PFA players, is that those technologies have not been differentiated in their energy. They have followed one another and enabled quite low barriers, if you will, in share shifting because overall results haven’t been differentiated, and the shares have shifted rapidly based principally on form factor changes in the catheter systems. I think what will change with Pulse Biosciences is that we will drop into workflow with seamless integration.

We will be substantially more efficient in procedural timing. We are looking at the data set that we’ve commented on already that, for the first time, could create definitive differentiation between the clinical outcomes that one catheter—our catheter system—can produce versus others. And our sense is that that allows for two things to happen which are extremely favorable for us. One is that we expect shares to shift and to shift rapidly because of the lack of learning curve requirement, the lack of really any kind of change management, because of the drop-in nature of the technology, and because nsPFA produces differentiated performance. And because we have, obviously as described, we’re the only nsPFA play, and we have a dramatic experiential moat and patent moat protecting that, unlike the recent share shifts that we’ve seen between microsecond plays, we believe that shares that shift to our platform can be preserved and produce significant and protracted revenue gains that are stably preserved over time.

And so we are definitely thinking about the share shifting. We think shares can shift rapidly again. But in follow-up to the potential for our share gains, we would not expect share losses because there is no follow-on nsPFA program coming from anybody else. As for your comments about reimbursement, about concomitant procedures, basically everything that you see favors the elements provided or to be provided by Pulse Biosciences: the speed of energy delivery, the efficiency of workflow, the ability to shift whether it’s done in a hospital or done in an ASC, all of the cost-effectiveness associated with reduced time, faster patient turnover, the ability to do concomitant procedures more effectively. We think all of those favor our platform.

And one of the things I alluded to briefly, which I’ll comment just a little bit more on now specifically with concomitant—and I mentioned that one of the things we’ll be investing in for a second-generation clinical protocol in Europe will be use of our system in concomitant procedures—we want to explore that, we want to validate that, and we want to be able to show upon commercialization that we have generated data that validates the performance of ablation and left atrial occlusion in the same procedure.

So that’s something that we’re working on; that’s something that we think we’ll excel at. As will be the case, as I mentioned, our next study up will be the persistent IDE in the United States. And to the extent we have demonstrated workflow superiority in, I’ll call it more straightforward PVI ablation strategies for paroxysmal AF, we expect that our workflow efficiency will be accentuated as we move outside the veins into persistent ablation strategy. And that same story is going to be extended into more complex patients done with concomitant occlusion.

So we think we’re set up extremely well for that based principally on the workflow gains that we’ve already demonstrated.

Bob Duggan (Co-Chair of the Board)

Joseph, from an exterior position, when you look at it from the hospital side and treating the patient and the physician and the patient himself, a number of things are important. The first is how safe is the procedure. The second is how long does the procedure take. The third is how easy is the procedure. And those we feel we are, if not marginally, decently the winner in those categories at this point in time. With paroxysmal we don’t see that we’ll lose that as we go forward, but that does have to be proved out.

But the most important is the fourth factor. That’s the recurrence. A recurrence—just the day you come back in—can cost the hospital $10,000. It’s not inexpensive, it’s not free, it’s not given, it’s disruptive for the patient. And a redo is expensive. So in that area we are substantially. We do not expect to leave any doubt or reservation about our leadership there. So that has to be fully proven out and get all the way through the approvals, which is what we’re working on now.

But that’s why we think the share will shift. Then it just gets a question of can you cover the sites and cover the doctors? They will, through the demonstrations that we go to, the trade shows. We do live demos. Most people do video, previously taped demos. We do live. We’re right there fully exposed to what’s going on. They’ve gone over very, very well. So we have a lot of confidence in what we do and how we do it. And then we look to spread this out not only from cardiac as we move into other soft tissue areas of the human body.

And this is a factor of NS. NS is what precludes the recurrent site, and other factors in delivering that, of course, allow us to get the workflow, the ease of use, the safety. So that’s what we’re driving. That’s what I think we’re found to be exciting. That’s why the doctors are coming to us, knocking on the doors to be a part of the trials, happy once they are that they have been. But this has taken 10 years to get here. This was not a journey without getting through the desert and seeing a few lakes that turned out to be mirages.

But we are on it now. We’re in it now. We’ve got great people, others will join, and we’re pretty excited and appreciate your coverage and that of others, Joseph.

Joseph (Analyst at Needham)

Yeah, absolutely. Really appreciate all that detail. It was very thorough. If I could just do one quick follow-up, and apologies if you guys have discussed this before, but just in terms of the trial that Paul detailed, the mechanism of action trial, I’m just trying to understand what’s involved in here. Is this, you know, a trial to show the difference between micro and nano in terms of like histological or, you know, mechanistic data showing, I guess, different lesion characteristics, you know, on the cellular level?

I’m just trying to understand a little more detail on that.

Paul LaViolette (Chief Executive Officer)

Thanks, Joseph. Yeah, we haven’t disclosed it in detail, so I’ll be careful with what I describe here. But it won’t be histological because we’re not going to take tissue samples from patients. But it will be using other biomarkers that are indicative of ablation depth and ablation completeness. We know that we produce lesions that are deeper and that are more contiguous than anything produced by multiple lesions from a microsecond PFA device. And so our focus is on showing that that difference is real by more, I’d say, comprehensive metrics, but doing so in the clinical setting, so not histological.

We’ve already done that, by the way, on the preclinical level repeatedly. And so what we’re really trying to do now is take that into the clinic and demonstrate absolute differentiation in lesion quality between microsecond and nanosecond PFA.

Joseph (Analyst at Needham)

Perfect. Thanks so much.

OPERATOR

Your next question comes from the line of Anthony Petrone with Mizuho. Your line is open.

Anthony Petrone (Analyst at Mizuho)

Thanks, and good afternoon, everyone. Hope everyone’s doing well. Maybe I’ll start with catheter and then go to nanoclamp. On the catheter side, just looking for an update on EP mapping configuration. I think there’s certainly one partner out there where, in the IDE study, nPULSE has been configured with a specific mapper. There are other mapping players out there. So just an update on how do you think configuration with the mapping landscape is going to play out through the remainder of the clinical phase, but potentially into commercialization.

And then I’ll have a couple of follow-ups on clamp.

Paul LaViolette (Chief Executive Officer)

Thanks, Anthony. Yes. So just for everyone to be on the same level, of course, the IDE was supported by the Abbott EnSite system. Abbott provided fantastic collaboration for us in our study and did so with a customized integration and rendered our system quite nicely. And as you also know, we have demonstrated that at least through live case demonstrations earlier this year, we’ve shown comparable preliminary integration with the CARTO system. And so, going forward, we would expect to do the same.

We would expect to add to our work with Abbott and potentially initiate work with other mapping systems. We do think, although there are now nearly half a dozen mapping systems available, that the market tends to configure around the top several. And we recognize the potential value of having our system integrated with not only more than one player, but with certainly the top several selections of mapping systems, and those are well known. So our plan is to continue to expand the versatility of the mapping integration that we can offer with our ablation system.

Anthony Petrone (Analyst at Mizuho)

That’s helpful. And then on nanoclamp, maybe to spend a moment there, prospective multicenter. You have first patient in, and this seems to match up well with a competitor trial out there looking at postoperative AFib and really to, I guess, control clinical AFib as well. Maybe just, if you kind of level set and compare and contrast those two studies and sort of bring in the experience of NPulse on the catheter side of the equation, do you think it’s possible that we see a similar experience in terms of durability of outcomes?

But even on this, you know, the 30-day outcome measure here, this is a pretty complex population you’re looking at. The primary safety endpoint is, I believe, all-cause mortality, stroke, excessive bleeding. Maybe just to level set that study on expectations and how to compare and contrast it to some of the studies that are out there already. And if I can just to sneak one in, there’s also a larger opportunity here, which is the prophylactic population, and that may be a few years ahead. But what are your thoughts on the prophylactic population as well in this space? Thanks.

Paul LaViolette (Chief Executive Officer)

Thanks, Anthony. Great question. And so I think there are a lot of similarities. It’s not coincidental that we’re running parallel IDEs between catheter-based EP and surgical concomitant AFib therapy with our clamp. And so we do believe the clamp has the potential to do in concomitant ablation precisely what we’ve seen the catheter do in EP ablation, which is to rewrite the efficiency of the procedure and potentially deliver superior outcomes. I think to your point about prophylaxis, you’re really alluding to the fact that a very large population of patients do not currently receive ablation today because they don’t have preoperative AFib, but they are likely to acquire AFib as a result of the cardiac damage done during the surgery. And so they’ll end up with AFib after the procedure. And I think it’s extremely important to comment that the current studies seeking to demonstrate effectiveness in reducing AFib postoperatively, they’re using RF.

And to the extent such an endpoint is demonstrated successfully with RF, one could imagine that by using NSPFA instead and producing a lesion set much faster, much more efficiently, with single ablations delivered per location, that the overall risk-benefit ratio for patients who are generally not receiving this therapy now would be tilted in favor of receiving the therapy based upon the likely benefits delivered by nanosecond PFA instead of RF. So we think the market in cardiac surgical ablation has several step-ups in value. One would be to increase penetration today based on the availability of an energy that simply treats patients faster. And these patients are, to your point, more frail, they’re older, they have complex cardiovascular disease. That’s why they’re undergoing open-heart surgery. And today they have atrial fibrillation, but two-thirds of them are not being treated for it while they’re on the table.

So that’s opportunity number one. And then opportunity number two of course would be to extend that to the prophylactic therapy for postoperative-acquired AFib. That’s a very large population. And a superior ablation technology would be more likely to support market expansion than one that requires multiple long-duration heat-based ablations, which is the only thing that would be available today. So we think our learnings with the catheter read directly on cardiac surgery and that our technology has the potential to accelerate penetration in the existing preoperative market and enable expansion over time of the postoperative AFib market.

Anthony Petrone (Analyst at Mizuho)

Excellent. Thank you so much.

OPERATOR

And our next question comes from the line of Keith Hinton with Freedom Capital Markets. Your line is open.

Keith Hinton (Analyst at Freedom Capital Markets)

Great. Thank you for taking the questions, and apologize if either of these were addressed in prepared remarks. I’m hopping around a little bit. But, you know, something we’ve heard from some investors about, you know, I believe there was a case of hemolysis leading to AKI in the feasibility study. My understanding is there are somewhat simple mitigation steps that can be taken, things like post-procedure hydration, limiting the number of applications, things like that, to try to prevent hemolysis from becoming a serious issue.

So I wanted to ask, you know, are any of those protocols built into the nanopulse design, maybe that weren’t in the feasibility study? And has the IDMC alerted you to any kind of hemolysis-related SAEs so far?

Paul LaViolette (Chief Executive Officer)

Thanks, Keith. Very insightful question. I won’t comment on the specific data readout of our pivotal. We of course are not releasing data yet. I will say we are extremely confident in the safety profile of our NSPFA Epicenter system. And so let’s break that down a little bit. We treated, of course, as you know, over 150, now closer to 175 patients. In our European study we’ve reported out on a large data set for efficacy but on the full data set for safety from that study and, as you cite, there was a single instance of elevated kidney markers, which obviously correlate to hemolysis.

I think let’s step back. Number one, hemolysis can be related to PFA energy delivery and is generally correlated with total dosing. And so as dosing increases relatively significantly, and I would say to the extent, let’s say, of about two to three times normal dosing, then there is the possibility of introducing some hemolytic factor into the procedure, number one. Number two, exactly to your point, as dosing increases, so too can the mitigation of hemolysis, which can be managed extremely readily with real-time fluid delivery that essentially flushes the kidneys in real time.

And so if one were to anticipate higher-than-normal dosing in a procedure, it would be common to increase fluids pre-procedure and during the procedure. And then third, to your specific question about the IDE, yes, patients in the IDE received pre-procedure infusion of fluids as a mitigating step. And of course, per the physician’s judgment, if they felt based on either protracted time or energy delivery that any elevation in hemolytic risk would be incurred, they would readily add additional fluids during the procedure.

And given that, I’d say clarity of risk, the low level of risk, and the simplicity of mitigation, one can assume that our performance on that factor is likely to be very, very positive and strong. But I won’t go into any specific data readouts in respect of the confidentiality of the data.

Keith Hinton (Analyst at Freedom Capital Markets)

Understood. Thanks so much. So, second question, and again, apologies if you’ve talked about this, but now that you’ve hit full enrollment for nanopulse, do you plan to present any kind of trial-in-progress poster that talks about the design in a little more detail or the baseline characteristics of the patients enrolled? And is there anything you can tell us now about the enrolled population and how it looks compared to some of the other IDE trials for microsecond catheters?

Paul LaViolette (Chief Executive Officer)

Thank you, Keith. The answer is essentially no. We don’t have any interim readouts or sneak peeks. We think this is a seminal pivotal study. We think this will be a kind of matinee, late-breaking data set when it’s ready for release. And in respect to the magnitude of the study, we certainly intend to present it in full safety and efficacy readout at a time when we have completed the data analysis. So that isn’t relatively near term. I do think it’s really important to draw a parallel between the IDE and the European feasibility study. Again, with the EU enrollment now at 155 patients in the 5-second cohort. If you compare that 155 number to the 169 number in the IDE, you’re looking at essentially comparable study size with the same follow-up, the same patient enrollment criteria, all paroxysmal, some of the same operators actually, and of course they’ve been enrolled contemporaneously.

So we will continue to highlight our European feasibility data as the best proxy for the likely outcome of the IDE. But we’re going to preserve the IDE intact and we’ll present it in a future clinical setting. And we have not yet released our specific publication plans for that study, just based on its early timing and the fact that it won’t be ready for presentation until sometime mid-’27.

Keith Hinton (Analyst at Freedom Capital Markets)

Okay, understood. Yeah. Just to be clear, I wasn’t referring to any kind of interim look at actual efficacy. I was talking about whether you were going to just put out anything on sort of the baseline characteristics of the patients that were enrolled. And the reason I bring it up is because I think one concern that some investors have had is that a patient population that’s mostly in the U.S. could look very different in terms of some underlying baseline characteristics, higher levels of hypertension, other risk factors, versus an EU feasibility study.

So, you know, I don’t know. Yeah, I don’t know if you have any comments on that.

Paul LaViolette (Chief Executive Officer)

Well, I won’t comment on the actual patient data, but I will just reinforce that while the U.S. population overall might be less healthy, these are first-onset paroxysmal patients, so they tend to be certainly younger. They tend not necessarily to have advanced cardiovascular comorbidities. Obviously, hypertension can be a predisposing factor for AFib and would likely be present in both populations. So we have commented that we think there is comparability of the two studies because, importantly, they’re restricted to paroxysmal AF and really to a treatment-naive population or interventional-naive population.

Both of those patient populations are on the same essential drug regimens, so there shouldn’t be dramatic differences. But obviously until we release the final data set, we won’t be able to compare and contrast it at a detailed level.

Keith Hinton (Analyst at Freedom Capital Markets)

Great. Thanks for taking the questions.

Paul LaViolette (Chief Executive Officer)

Thank you, Keith.

OPERATOR

And your next question comes from the line of Siraj Khalia with Oppenheimer. Your line is open.

Siraj Khalia (Analyst at Oppenheimer)

Paul, it’s been a long call and I’ll just keep it to one. Your comparative trial, Paul, versus microsecond. I guess I’m just curious, have you picked this up in your strategic discussions where it is necessary to do a side by side with microsecond versus nanosecond? Any additional insights would be great. Gentlemen, thank you.

Paul LaViolette (Chief Executive Officer)

Thank you, Siraj. Very good question. Our purpose, our motivation for comparative study is really driven by the underlying mechanistic differentiation between microsecond and nanosecond PFA. And so it’s entirely about, I would say, it’s more than scientific curiosity. Of course, we really do want to show how this compares, but it’s more on a mechanistic level. And, no, I would say if I were trying to sell as many microsecond catheters as possible, I would not be anxious for Pulse Biosciences to compare against me because there may not be many ways for me to win in that if I’m a competitor.

So this is not about proving anything to the marketplace. This is about validating the underlying clinical science of nanosecond pulse energy and of really helping to fill in the blanks to explain why our outcomes appear to be so much better. They can’t be better by accident. And Bob talked about killing cells with high efficiency. There’s clearly something there. And is it a function of, I’ll say, simple targeting? Is it a function of leaving no gaps? Is it a function of a broader regional catheter footprint that’s enabled by the low energy requirements to ablate cells? Is it a function of the depth of the lesion? All of those things are… they’re points about which we have evidence in the preclinical setting, and we want to bring that into the clinic and further demonstrate the rock-solid foundation of this mechanistic differentiation.

And that’s really what we’re doing it for. Thank you. Thank you, Siraj.

OPERATOR

Thank you. I’m not showing any further question in the queue. I will now turn back over to Paul LaViolette for closing remarks.

Paul LaViolette (Chief Executive Officer)

Thank you, operator. And thank you all for participating today. We sincerely appreciate the high engagement we’re getting from the investment community. Thank you all for participating. We know this is an extremely busy time of year for you all and we look forward to providing updates later in the quarter on our continued progress with Pulse Biosciences. Thank you all.

OPERATOR

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

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