Q1 2026 Pulse Biosciences Inc Earnings Call

May 7, 2026

Operator: Hello, and thank you for standing by. My name is Mel, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Pulse Biosciences Q1 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. Thank you. I would now like to turn the call over to Trip Taylor of Investor Relations. Please go ahead.

Speaker #2: All lines have been placed on mute to prevent any background noise. After the speakers' 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 1 on your telephone keypad.

Speaker #2: If you would like to rejoin your question, press star 1 again. Thank you. I will now like to turn the call over to Trip Taylor of Investor Relations.

Speaker #2: Please go ahead. Thank you, operator. Before we begin, I'd like to inform you that comments and responses to your questions during today's call reflect management's views as of today.

Tripp 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, 7 May 2026 only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations, and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued on Monday and in our filings with the US 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.

Trip 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, 7 May 2026 only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations, and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued on Monday and in our filings with the US 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.

Speaker #2: May 7th, 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.

Speaker #2: These risks and uncertainties are more fully described in our press release issued on Monday and in our filings with the US Securities and Exchange Commission.

Speaker #2: 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.

Speaker #2: 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.

Trip Taylor: 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 & 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.

Tripp Taylor: 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 & 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.

Speaker #2: 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.

Speaker #2: With that, I would now like to turn the call over to co-chair of the board and chief executive officer, Paul LaViolette.

Speaker #3: 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.

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

Paul LaViolette: Good afternoon. Thank you for joining us. For those of you that are new to the Pulse Biosciences story, let me start with a brief overview of the technology at the core of everything we do. Pulse Biosciences is the pioneer of Nanosecond Pulsed Field Ablation, or nsPFA, a fundamentally new category of energy that we believe will change the way soft tissues in the human body are treated across multiple disease states. Conventional ablation modalities, whether radiofrequency, cryoablation, microwave, or even today's 1st-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.

Speaker #3: PULSE BIOSCIENCES is the pioneer of nanosecond pulse 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.

Speaker #3: Conventional ablation modalities—whether radiofrequency, cryoablation, microwave, or even today's first-generation microsecond pulse 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.

Speaker #3: Our NSPFA platform creates an entirely different and proprietary approach and experience. We deliver pulses measured in billions of a second. At that timescale, with each pulse, the duration of a few billions of a second, the energy interacts with cells through a non-thermal mechanism that initiates regulated cell death in target tissue while leaving collagen, blood vessels, nerves, and other non-cellular structures intact.

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

Speaker #3: 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.

Speaker #3: Surrounding this core technology, we have built a substantial and growing intellectual property estate that positions Pulse Biosciences as the clear first mover and the long-term leader in nanosecond PFA.

Speaker #3: 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.

Speaker #3: 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.

Paul LaViolette: Against this backdrop, Q1 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 System for atrial fibrillation. Have rapidly reorganized our focus and operations to allocate an increased portion of our overall company resources to this program. Third, in just the past several weeks, we commenced enrollment in our IDE US pivotal study, NANOPULSE-AF, treating our first patients with the nsPFA catheter system in early April.

Speaker #3: 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 pulse field ablation therapy.

Speaker #3: Second, leveraging this unprecedented clinical dataset, 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 and increase portion of our overall company resources to this program.

Speaker #3: 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.

Speaker #3: 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.

Paul LaViolette: We also released updated follow-up data from the European feasibility study, further validating strong positive outcomes. Each one of these milestones represents a meaningful achievement. Together, they reflect a clinical development program of great importance, moving at impressive speed. Today, I will provide updates on our nsPFA system in more detail and will then turn the call over to our Chief Financial Officer, Jon Skinner, to review the Q1 financial results. We will conclude with a question-and-answer session joined by Bob Duggan, Co-Chairman of the Board, and Liane Teplitsky, Chief Operating Officer. I will now begin with our nPulse Cardiac Catheter System for AF ablation. Our nPulse Cardiac Catheter System is purpose-built to address atrial fibrillation with a 360 degrees circular design.

Speaker #3: Together, they reflect a clinical development program of great importance moving at impressive speed. Today, I will provide updates on our NSPFA system in more detail and will then turn the call over to our chief financial officer, John Skinner, to review the first quarter financial results.

Speaker #3: We will then conclude with a question-and-answer session joined by Bob Duggan, co-chair of the board, and Leanne Teplisky, chief operating officer. I will now begin with our NPULSE cardiac catheter system for AF ablation.

Speaker #3: 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.

Paul LaViolette: The clinical goal of ablation in the treatment of paroxysmal AF is straightforward: electrically isolate the pulmonary veins from the left atrium to prevent abnormal electrical signals from triggering arrhythmias. Achieving that goal durably, efficiently, and safely has been the ongoing challenge in the field, and the ability to advance improvements in AF care will set our catheter apart from existing technology in this rapidly growing market. The nPulse nsPFA system represents what we believe is the world's first true single-shot pulmonary vein ablation treatment platform for AF. Early data suggest a physician can now rapidly position the circular catheter, deliver a single 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.

Speaker #3: 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.

Speaker #3: The NPULSE NSPFA system represents what we believe is the world's first true single-shot pulmonary vein ablation treatment platform for AF. Early data suggest a physician can now rapidly position the circular catheter deliver a single five-second application of nanosecond pulse energy per target location and achieve a complete circumferential and transmural ablation without repositioning, without rotating, and without the need to stack multiple overlapping lesions.

Speaker #3: That workflow advantage stems directly from the underlying ultra-short duration and high energy pulse parameters unique to NSPFA energy and PULSE's unique catheter design, which is possible in part because of the unique properties of the energy.

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

Speaker #3: Because the energy is delivered in billions of a second, the total cumulative energy transferred to tissue is dramatically lower. Which means no measurable temperature rise and minimal neuromuscular stimulation.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Paul LaViolette: 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: As part of the strategic realignment, we continue to expand our EP leadership team. Most notably, Dr. David Kenningsburg has transitioned to a full-time chief medical officer.

Speaker #3: Dr. Kenningsburg will lead our clinical strategy investigator engagement, medical affairs, and study execution as we enroll the pivotal IDE study and expand our clinical dataset.

Speaker #3: In addition, we welcomed Leanne Teplisky to the Pulse Biosciences executive team as Chief Operating Officer, a newly created role on our executive leadership team.

Paul LaViolette: 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.

Speaker #3: Leanne is a seasoned medtech executive with 20 years of experience and an exceptional track record of building and scaling innovative medtech businesses particularly in electrophysiology.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: Collectively, the additions of David and Leanne 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.

Speaker #3: At the heart rhythm, 2026 meeting for 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.

Paul LaViolette: 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 63 subjects within the 5-second ablation cohort. The results were simply outstanding and reinforced the differentiated clinical profile we have observed since the earliest cases. Key findings included: sustained 100% procedure success by 24-hour Holter of evaluable patients at 6 months, with 95 of 95 patients meeting the endpoint. Sustained 96% procedural success by 24-hour Holter of evaluable patients at 1 year. Sustained 90% Kaplan-Meier estimated freedom from recurrent AF, atrial flutter, or atrial tachycardia, also at 1 year.

Speaker #3: Building upon the very positive data presented at the AF symposium in February, this newly expanded dataset included six-month follow-up on 95 subjects and 12-month follow-up on 53 subjects within the five-second ablation cohort.

Speaker #3: The results were simply outstanding and reinforced the differentiated clinical profile we have observed since the earliest cases. Key findings included sustained 100% procedure success by 24-hour Holter of evaluable patients at six months.

Speaker #3: With 95 of 95 patients meeting the endpoint, sustained 96% procedural success by 24-hour Holter of evaluable patients at one year, and sustained 90% Kaplan-Meier estimated freedom from recurrent AF atrial flutter or atrial tachycardia also at one year.

Speaker #3: Procedural performance data at HRS improved from the already impressive readout at the AF Symposium, with lower atrial dwell time, lower average number of applications, and lower procedure and fluoroscopy times.

Paul LaViolette: Procedural performance data at HRS improved from the already impressive readout at AF Symposium, with lower atrial dwell time, lower average number of applications, and lower procedure and fluoroscopy times. The safety profile also remained excellent, with a primary safety endpoint serious adverse event rate of just 1.7% across 177 treated subjects. These outcomes are remarkable in a field where reported 20% 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.

Speaker #3: 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 percent AF recurrence rates are typical.

Speaker #3: It is particularly notable that our results were achieved without anti-arrhythmic 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.

Speaker #3: 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.

Speaker #3: These results reflect the underlying advantages of nanosecond PSA and our innovative catheter design. Deeper lesion formation with fewer applications, lower cumulative energy, and durable pulmonary vein isolation in a fast reproducible workflow.

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

Speaker #3: 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 times significantly.

Speaker #3: This time-saving advantage represents a meaningful potential capacity expansion for EP procedures and would likely drive rapid adoption of NSPSA as the preferred next-generation energy in the market.

Speaker #3: 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 for the ASC, we expect all the benefits of the NPULSE cardiac catheter to align directly with the needs of the ASC and the overall expansion of treating the growing population of patients with atrial fibrillation.

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

Speaker #3: 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 US IDE pivotal trial.

Speaker #3: In early April, we announced that the first patients had been enrolled in our nanopulse AF study, a prospective multi-center IDE pivotal clinical investigation evaluating the NPULSE cardiac catheter system for the treatment of recurrent drug-resistant symptomatic paroxysmal atrial fibrillation.

Speaker #3: The first seven patients were treated at St. Bernard's Medical Center in Jonesboro, Arkansas, in just one day under the leadership of Dr. Debbie Nair, principal investigator of the arrhythmia research group.

Paul LaViolette: The first seven patients were treated at St. Bernards Medical Center in Jonesboro, Arkansas, in just one day under the leadership of Dr. Devi Nair, principal investigator of the Arrhythmia Research Group. Dr. Nair had not previously used the nPulse catheter, 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 timeline to reflect the likely faster pace of our study execution.

Speaker #3: Dr. Nair had 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.

Speaker #3: 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.

Speaker #3: 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 timeline to reflect the likely faster pace of our study execution.

Speaker #3: 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.

Paul LaViolette: 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 timelines to optimize the planned filing date for the clinical PMA module.

Speaker #3: Using a blend of follow-up durations, we'll shorten overall follow-up time for the study. This method allows determination of success earlier than traditional statistical methods used in other studies.

Speaker #3: Overall, we are accelerating both enrollment and follow-up timelines to optimize the planned filing date for the clinical PNA 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.

Paul LaViolette: On the regulatory front in Europe, we expect to use the data from our European feasibility study to finalize our CE submission in H2 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.

Speaker #3: 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.

Speaker #3: This creates a compelling synergy in which our partner or partners may gain access to the most advanced nanosecond PSA energy solution available. These partnership conversations are active and we will share details of partnership prospects when the time is appropriate.

Speaker #3: Let's now discuss our surgical ablation clamp. Our NPULSE cardiac clamp pivotal study nano clamp AF is the first and only clinical study of a surgical device delivering PSA to receive FDA IDE approval.

Paul LaViolette: 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.

Speaker #3: The NPULSE cardiac clamp applies nanosecond PSA energy to create durable transmural lesion sets during concomitant procedures where the surgeon has direct cardiac tissue access and atrial fibrillation is present.

Speaker #3: 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.

Speaker #3: Concerns that nanosecond PSA 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 NSPSA energy can transform this therapy and market.

Speaker #3: Enrollment in nano clamp AF continued to progress during the first quarter. As a reminder, the trial is a prospective single-arm multi-center study designed to assess the primary safety and effectiveness of the NPULSE cardiac surgical system in treating AF during concomitant cardiac surgeries.

Paul LaViolette: Enrollment in NANOCLAMP AF continued to progress during Q1. 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 H1 2027. We have moderated near-term development in cardiac surgery while maintaining trial execution and regulatory preparation, and clinical site activations continued to expand during Q1. In Europe, we continue to generate excellent results in our cardiac surgery feasibility study.

Speaker #3: We plan to enroll a target of 136 patients at approximately 20 sites, including two international locations. Reflecting our strategic prioritization of the EP catheter ablation program, including some resource shifts we now expect to complete enrollment of this IDE study by the end of the first half of 2027.

Speaker #3: We have moderated near-term development in cardiac surgery while maintaining trial execution and regulatory preparation. Clinical site activations continue to expand during Q1. In Europe, we continue to generate excellent results in our cardiac surgery feasibility study.

Speaker #3: To date, investigators have treated over 60 patients and we have expanded the study to now include six clinical sites. Within this 60-patient cohort, 34 patients underwent electroanatomical mapping approximately three months after their ablation procedures to assess the effectiveness and durability of the treatment.

Paul LaViolette: 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 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.

Speaker #3: 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.

Speaker #3: Notably, as patient numbers have increased, the PVI success rate of 94% at approximately three months has remained consistent, with the clinical outcomes we reported in our initial data readout in October of 2025.

Speaker #3: 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.

Speaker #3: Feedback from the surgical community and predictability matter as much as efficacy in the operating room, and the early signal is that nanosecond PSA delivers very favorably on both.

Paul LaViolette: 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 nsPFA delivers very favorably on both. We remain on track to submit for CE mark by the end of 2026 using the European clinical dataset. Turning to our nPulse Vybrance Percutaneous Electrode System. The nPulse Vybrance system applies nanosecond nsPFA technology to ablate soft tissue in surgical procedures through a percutaneous approach, offering, for example, an alternative to surgical removal for patients with symptomatic benign thyroid nodules. Vybrance is designed to address this patient population through a minimally invasive outpatient procedure that reduces nodule volume, alleviates symptoms, and preserves surrounding anatomy and normal thyroid function. Outcomes that cannot be achieved with traditional surgical excision.

Speaker #3: We remain on track to submit for CE mark by the end of 2026 using the European clinical data set. Turning to our NPULSE VIBRANCE percutaneous electrode system.

Speaker #3: The NPULSE VIBRANCE system applies nanosecond PSA 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.

Speaker #3: VIBRANCE is designed to address this patient population through a minimally invasive outpatient procedure that reduces nodule volume, alleviates symptoms, and preserves surrounding anatomy and normal thyroid function.

Speaker #3: Outcomes that cannot be achieved with traditional surgical excision. In the first quarter, the team generated approximately 400,000 dollars in revenue from NPULSE VIBRANCE systems and electrodes.

Paul LaViolette: In Q1, the team generated approximately $400,000 in revenue from nPulse Vybrance systems and electrodes. Our approach continues to be extremely disciplined and remains focused on core market development objectives. We continue to operate at an intentionally limited scale to demonstrate how meaningful over the long term, and how well we can service the initial Vybrance customers in exploring along with them the potential of the nPulse Vybrance system. Our work is focused on ensuring we generate robust clinical data to support a treatment indication while formalizing patient reimbursement to expand patient access in partnership with key accounts at large hospital systems in select geographies. On the clinical front, the PRECISE-BTN, or benign thyroid nodule study, reached an important milestone with enrollment of the first 50 patients now completed.

Speaker #3: 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 VIBRANCE customers in exploring a long with them the potential of the NPULSE VIBRANCE system.

Speaker #3: 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.

Speaker #3: 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.

Paul LaViolette: 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 Spiazzi of Naples, Italy, were presented in a podium session at the North American Society for Interventional Thyroidology, or NASIT, in March, which demonstrated remarkable results. Data presented from durable 15 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.

Speaker #3: It is also notable that scientific recognition of this work continues to build. Data from Dr. Stefano Spiazza of Naples, Italy, were presented in a podium session at the North American Society of Interventional Thyroidology or NASIT.

Speaker #3: 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.

Speaker #3: Continued volume reduction improvements were seen from one 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 VIBRANCE platform through our research collaboration with the University of Texas MD Anderson Cancer Center.

Speaker #3: Under this collaboration, we are conducting a first-in-human feasibility study evaluating NSPFA for the treatment of papillary thyroid microcarcinoma PTMC on up to 30 patients at two sites and we are happy to announce that first patient enrollments were completed in Q1.

Paul LaViolette: 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. 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?

Speaker #3: We continue to expect to complete enrollment by year-end 2026. With that, I will turn the call over to John to speak about our first quarter financial results.

Speaker #3: John?

Speaker #2: Thanks, Paul. Now I will highlight our gaps and non-gap financial results. I encourage listeners to review Monday's earnings release for a detailed reconciliation of non-gap measures to the most comparable gap measures.

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 Q1, we generated revenues comprised of both nPulse capital and Vybrance disposable sales. Total revenue was $401,000, and cost of product revenue was $370,000 for the quarter. Total GAAP costs and expenses for the quarter increased by $1.6 million to $19.6 million, compared to $18 million in the prior year period. The increase in GAAP costs and expenses was primarily driven by increased investment in our clinical programs, partially offset by lower stock-based compensation expense. To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation, and amortization, as well as non-recurring costs.

Speaker #2: In the first quarter, we generated revenues comprised of both NPULSE capital and VIBRANCE disposable sales. Total revenue was 401,000 dollars and cost of product revenue was 370,000 for the quarter.

Speaker #2: Total gap costs and expenses for the quarter increased by 1.6 million dollars to 19.6 million. Compared to 18 million in the prior year period.

Speaker #2: The increase in gap 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-gap costs and expenses exclude stock-based compensation depreciation and amortization as well as non-repairing costs.

Speaker #2: Total non-gap costs and expenses in the first quarter of 2026 increased by 4.7 million dollars to 17.4 million. Compared to 12.7 million in the prior year period.

Jon Skinner: Total non-GAAP costs and expenses in Q1 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 Q1 2026 was $18.6 million, compared to $16.8 million in the prior year period. Non-GAAP net loss in Q1 2026 was $16.4 million, compared to $11.4 million in the prior year period. As of 31 March 2026, cash and cash equivalents totaled $68.3 million compared to $80.7 million as of 31 December 2025, representing a decrease of $12.4 million versus the prior quarter.

Speaker #2: The expected increase was driven by increasing clinical trial product development and market development activity. Gap net loss in the first quarter of 2026 was 18.6 million compared to 16.8 million in the prior year period.

Speaker #2: 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.

Speaker #2: 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.

Jon Skinner: Cash used in operating activities during Q1 2026 was $14.6 million, compared to $13.5 million used in the prior year period and $14.8 million in Q4 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 31 March 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.

Speaker #2: As we discussed last quarter, we completed important corporate housekeeping by filing a 200 million dollar shelf registration all of which is available. In addition, the company has an ATM program in effect with approximately 60 million dollars of availability as of March 31, 2026.

Speaker #2: 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.

Speaker #2: Cash usage aligns with investment expenditures and 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.

Jon Skinner: We continue to maintain ample liquidity to fund operations and clinical programs through major inflection points during 2026.

Speaker #2: With that, I will now turn it back over to Paul for his closing remarks.

Jon Skinner: With that, I will now turn it back over to Paul for his closing remarks.

Speaker #1: Thank you, John. This was a defining quarter for PULSE BIOSCIENCES. We sharpened our strategic focus on electrophysiology, delivered landmark clinical outcomes at heart rhythm 2026 and AS Symposium, that reinforced the durability and efficiency of our technology and commenced enrollment in our US IDE pivotal trial for our cardiac catheter program.

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 US IDE pivotal trial for our cardiac catheter program. Today, resulting from those efforts, we announced a tightened timeline for anticipated completion of enrollment in our paroxysmal AF pivotal study. We've strengthened the team supporting this mission, and we continue to advance our surgical and percutaneous programs in a disciplined manner aligned with our priorities. Our path forward is clear. Enroll and complete our pivotal trials, finalize our CE mark submissions, and continue to advance our partnership pipeline, all while maintaining the financial discipline to fund the company through the milestones that will define its future.

Speaker #1: Today, resulting from those efforts, we announced a tightened timeline 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.

Speaker #1: 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.

Speaker #1: 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.

Paul LaViolette: This disruptive nsPFA technology we are advancing has the potential to change how ablation is performed across multiple disease states. 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.

Speaker #1: 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, Leanne Teplitzky, operator, please open the call for questions.

Speaker #3: Thank you. At this time, I would like to remind everyone in order to ask a question, press start and the number one on your telephone keypad.

Operator: Thank you. At this time, I would like to remind everyone, in order to ask a question, press star then the number 1 on your telephone keypad. Again, that will be star 1 on your telephone keypad. We kindly ask each participant to limit their question to 1 question and 1 follow-up. We have the first question comes from the line of Suraj Kalia of Oppenheimer. Your line is now open. You may now ask your question.

Speaker #3: Again, that will be star one on your telephone keypad. We kindly ask each participant to limit their question to one question and one follow-up.

Speaker #3: We have the first question comes from the line of Suraj Kalaya of Oppenheimer. Your line is now open. You may now ask your question.

Speaker #4: Hi, Paul, John, can you hear me all right?

Suraj Kalia: Hi, Paul, Jon, can you hear me all right?

Speaker #5: Yes, Suraj.

Paul LaViolette: Yes, Suraj.

Speaker #4: Perfect. Gentlemen, congrats on all the progress and the excitement at HRS. Paul, many calls going on, so please forgive me. I'll ask all my questions together.

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

Speaker #4: 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.

Speaker #4: And finally, if these patients are consciously sedated or general anesthesia. Gentlemen, thank you.

Speaker #5: 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.

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

Speaker #5: And that's important in part because it determines how many total roll-in patients can be advanced in the study. And that affects the total number of patients that we can enroll, bringing that number up to 215.

Speaker #5: 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.

Speaker #5: And as a result of that, we're likely to involve active sites less than the number that we're allowed in our protocol of 30. As it relates to the limits per site, you're right.

Paul LaViolette: As a result of that, we're likely to involve active sites less than the number that we're allowed in our protocol of 30. As it relates to the limits per site, you're right. Every protocol limits the number of sites based on a % of total so that there's not an unbalanced skew toward too few enrolling locations. That number is typical in this study as it is with many others. Usually, it's around 15% 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.

Speaker #5: 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.

Speaker #5: And that number is typical in this study as it is with many others. Usually, it's around 15 to 20 percent of total enrollment is the cap for an individual site.

Speaker #5: 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.

Paul LaViolette: 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 US market and migrate patient therapies to the ambulatory surgery setting. That being said, the protocol in the pivotal study calls for general anesthesia.

Speaker #5: We've seen that in Europe. And we are quite enthusiastic about the potential for lower sedation long-term particularly as we enter the US market and migrate patient therapies to the ambulatory surgery setting.

Speaker #5: That being said, the protocol in the pivotal study calls for general anesthesia.

Speaker #3: Thank you. Again, if anyone would like to ask a question, you may press star one on the telephone keypad. That will be star one on the telephone keypad.

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

Speaker #3: Okay. We have the next question comes from the line of Anthony Petron. From Mizuo, your line is now open. You may ask your question.

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

Speaker #4: Thanks. And good afternoon, everyone. Congrats here on a strong start to the year. And the two 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.

Speaker #4: 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.

Speaker #4: 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.

Anthony Petrone: 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.

Speaker #4: And any risks that there may be just from the differences in patient populations. And I'll have one quick follow-up.

Speaker #5: Thanks, Anthony. Very good question. We're very pleased with the data set so far. It has been extremely strong. And obviously, just to remind folks, at six months, 100% efficacy against our primary endpoint of rhythm control as measured by Holter monitor at that 180-day point.

Paul LaViolette: Thanks, Anthony. A very good question. We're very pleased with the data. The data set so far has been extremely strong and obviously just to remind folks, at 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%. Of course, not a primary endpoint per se, but a broader measure of efficacy would be the data that we represent in our Kaplan-Meier curve of 90% success with respect to freedom from atrial fibrillation, AFl, and atrial tachycardia. Those are the numbers that we're starting with. As it relates to the comparison of patient severity between the European feasibility study and the pivotal study, for the most part, there is no difference.

Speaker #5: 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 represent in our Kaplan-Meier curve of 90% success with respective freedom from atrial fibrillation.

Speaker #5: 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.

Speaker #5: 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.

Paul LaViolette: 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. That's not a significant risk factor. The CHA₂DS₂-VASc score, which is an important cardiovascular measure, was relatively low.

Speaker #5: 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 US, you will see minor changes in factors such as BMI, right?

Speaker #5: 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 US.

Speaker #5: But that's not a significant risk factor. The CHAD score which is an important cardiovascular measure was relatively low. That will be consistent in the US based on a paroxysmal population.

Paul LaViolette: That will be consistent in the U.S., based on a paroxysmal population. Other factors in the medical history, whether it's hypertension or heart failure, we expect to have a relatively generic paroxysmal patient population, most notably with a relatively near-term onset of atrial fibrillation, typically in the 1 to 2 year timeframe. I think overall, the patient population, while representing the U.S. population, and maybe a little bit less healthy, is not representing a, I'll call it a higher risk factor than the U.S. Therefore, degradation is not to be expected. This is a pulmonary vein isolation strategy using a highly effective novel energy, which we've now seen evidence that produces a really impressive ablation and impressive electrical isolation.

Speaker #5: 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 one- to two-year timeframe.

Speaker #5: So I think overall, the patient population while representing the US population and maybe a little bit less healthy is not representing I'll call it a higher risk factor than the US.

Speaker #5: 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 an impressive electrical isolation we've treated more patients in Europe actually than will enroll in the United States.

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

Speaker #5: The endpoints that were using in this case of freedom from AF as measured by Holter are the same so same endpoints. And I would also say the sites that were moving to while we will have more sites in the United States, we used multiple sites, multiple operators.

Speaker #5: In Europe. And the sites that were 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.

Speaker #5: 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 US based on how we observe those cases performed in our European sites.

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

Speaker #5: Lastly, I think you make a great point about mapping. Mapping is now tightly integrated, as we mentioned, with the Abbott NSYTE system. That mapping—I'll call it refinement—that fidelity provides our US 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 US is managed well by all of these consistencies between Europe and the US, and that we don't see the introduction of a meaningful new risk that would dilute expected clinical performance.

Paul LaViolette: is managed well by all of these consistencies between Europe and the US, 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 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 number 1 most common arrhythmia in medicine.

Speaker #5: My last comment there would be success is not defined in our case explicitly by a specific number that is 96% or 95%. We have the potential here to redefine the way atrial fibrillation is treated.

Speaker #5: 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.

Speaker #5: This is a significant disruptive technology in the hands of physicians going against the number one most common arrhythmia in medicine. And I do believe we have something that's very significant here and is going to be a combination of both acute and long-term outcomes that will reinforce that for us coming out of the US trial.

Paul LaViolette: I do believe we have something that's very significant here, and is gonna be a combination of both acute and long-term outcomes that will reinforce that for us coming out of the US trial.

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

Speaker #1: Thank you. And maybe just throw the follow-ups in here real quick. Would be just to confirm in the pivotal study here IDE study well, NSYTE be the only mapper or will you bring an additional mapping technologies?

Speaker #1: 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.

Speaker #1: On the carcinoma side of the equation. For the thyroid. Thanks. Congratulations again.

Speaker #4: Thank you very much, Anthony. Yes. On NSYTE—based on the speed of enrollment and the availability of NSYTE—it would appear today that NSYTE will be the most common, predominant, and likely the only system used in our IDE.

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 dataset is a compilation of patients treated using 3 different mapping systems. We would integrate with not only different systems over time, but because of the number, we have 12 sensors built into our device. We have now a magnet for electroanatomical connectivity, if you will, to the mapping system.

Speaker #4: That is against the backdrop that our technology really will work with multiple mapping systems. We have used different mapping systems. In fact, the European feasibility data set is a compilation of patients treated using three different mapping systems.

Speaker #4: 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.

Speaker #4: So, our system is capable now of higher fidelity mapping and navigation than we saw in our European data set. But principally, we expect NSYTE to be the system used.

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

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: 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.

Paul LaViolette: 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. Because this is a slow-growing non-metastasizing cancer, which makes it very amenable to our therapy, we believe, there is also a very large prevalence pool of papillary microcarcinoma patients who are living with cancer and who would want that cancer treated if a minimally invasive approach proved effective. The way we think about the addressable market there is that you have those 25,000 new diagnoses. You have a large prevalence pool seeking treatment. You're likely to yield perhaps 50,000 incremental procedures.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: 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 to 200,000 based on annual incidence and conversion of patients from a watchful waiting pool add a number that might be an incremental 25 to 35 percent of that population based on the addition of a papillary microcarcinoma indication in the future.

Paul LaViolette: 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.

Speaker #5: 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.

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.

Speaker #5: Sir, for closing remarks.

Speaker #4: 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.

Paul LaViolette: Well, thank you, operator, and thank you all for joining us on our Q1 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.

Speaker #4: Thank you all very much.

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