Pulse Biosciences, Inc

Hello and thank you for standing by. My name is Mark and I will be your conference operator today. At this time, I would like to welcome everyone to the Pulse Biosciences Q3 2025 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, see the press star followed by the number one on your telephone keypad. And to withdraw your question, press star one again. Thank you. Now I would like to turn the call over to Tripp Taylor, Investor Relations. Please go ahead.

Thank you, Operator. Before we begin, I would like to inform you that comments and responses to your questions during today's call reflect management's views as of today, November 5, 2025 only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations, and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the U.S. Securities and Exchange Commission. Our SEC filings can be found on our website or 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 also discussed certain non-GAAP financial measures. Disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable GAAP measures, can be found in the press release. Please note that this conference call will be available for audio replay on our website at pulsebiosciences.com in the news and events section on our investor relations page. With that, I would now like to turn the call over to co-chair of the board and chief executive officer, Paul LaViolette.

Thank you, Tripp. Good afternoon and thank you for joining. I'm very pleased by the progress Pulse Biosciences has made in Q3 towards advancing our goals in each of our three market development programs. I'm pleased to share these updates with you today. I will then turn the call over to our CFO, John Skinner, who will review the third quarter 2025 financial results and we will conclude with a question and answer session joined by Bob Duggan, co-chair of the board. At our core, Pulse Biosciences creates, markets, and services a medical technology platform that delivers proprietary nanosecond pulse electric fields generated by our NPulse technology to ablate tissue in various parts of the anatomy. We are developing a portfolio of specialized devices for multiple clinical applications with a goal of creating great procedures. Nanosecond PFA is clinically differentiated from thermal ablation energies and microsecond PFA as it delivers higher, shorter bursts and lower cumulative energy levels into tissue, preventing tissue temperature rise or the spread of thermal injury. Our extensive preclinical and clinical experiences suggest nanosecond PFA should advance the speed safety, efficacy, and workflow efficiency of prior generation energy modalities in multiple clinical specialties and has already shown the potential to be a truly disruptive technology. As the next generation leader in pulse field ablation, Pulse Biosciences is committed to advancing transformative therapies in large and growing markets with significant unmet clinical needs, consistently improving patient outcomes, procedural efficiency, and patient access to minimally invasive therapies. With this scientific foundation in place, we are now dedicated to executing our strategic priorities outlined at the start of the year. We are driving early targeted adoption of the MPulse Vibrance percutaneous electrode system for soft tissue ablation with benign thyroid nodule treatment as the first use case. This includes our pilot program, new commercialization accounts, and the initiation of the precise BTN, or precise benign thyroid nodule clinical study, all of which contribute to growing procedural utilization. We have received FDA investigational device exemption approval to study the impulse cardiac surgery system for atrial fibrillation, or AF, including the start of patient enrollment. We continue to advance our IDE submission for our NPulse 360 catheter for the treatment of atrial fibrillation. Simultaneously, we are advancing our European feasibility studies for both of our cardiac devices, with additional patients being treated with the surgical clamp and the electrophysiology catheter. Early therapy outcomes suggest market-disrupting potential. and we will continue to share new data as available in the quarters ahead. We are proud of these recent accomplishments and pleased to see the excitement grow and a bright future emerge for nanosecond PFA in the medical community. Our patient results speak volumes. Regulatory progress is essential and we are pleased to be thoroughly engaged in that regulatory process. I will now provide more detailed updates on each of our individual market programs. Starting with our soft tissue ablation device, the NPulse Vibrance Percutaneous Electrode System. We are excited to announce our new product and technology naming. Our proprietary nanosecond PFA platform is now called NPulse Technology. Our percutaneous electrode is now the Vibrance Percutaneous Electrode. This new naming was rolled out and well received by physicians at the recent American Thyroid Association annual meeting in Scottsdale, Arizona. Physicians are currently using the Vibrance device for the ablation of symptomatic benign thyroid nodules along with toxic and cystic thyroid nodules. Through our pilot launch, we are proving very strong product market fit for the application of NSPFA to these conditions. Over 200 patients have now been treated across the pilot program, the precise BGN study, and our first commercial procedures. Procedure volumes in the quarter grew on a sequential basis as positive and consistent outcomes are being reported across a growing number of providers. We are pleased to observe growing utilization, with one physician completing double-digit procedures in one month, indicating scale potential for this procedure. Our commercial team's primary focus is on driving procedure count to the point of clear economic viability for our customers within a limited array of accounts and geographies. We are intensely focused during this early phase, ensuring we identify proper patients, develop and train physicians and staff on consistent techniques across multiple conditions, confirm market access for commercial reimbursement, and provide clinical support to generate consistently positive outcomes. The NPulse Vibrant System is a first-in-class treatment, and we are very pleased with early results. Given that physicians are already caring for many patients with symptomatic benign thyroid nodules, patient flow has been positive or accelerating at all pilot sites. Patients who do not want or are not candidates for surgeries the watchful waiters, including those patients under active surveillance and those who are newly diagnosed, are all strong candidates for the VIBRANCE procedure. We continue to take steps to validate the potential of the NPulse VIBRANCE system to both convert current thyroidectomy volume and expand this overall interventional market by addressing the active surveillance pool of patients. Doctors have reported the procedure being straightforward to learn. They are able to leverage the skillset used to perform other ultrasound-guided procedures, enabling them to gain proficiency after performing just a few cases. The perceived safety benefits of the inherently non-thermal energy delivery of the NPulse system are of high importance to physicians treating benign thyroid nodules with this minimally invasive alternative to thyroidectomy. Dr. Richard Harding of the Thyroid Nodule Treatment Center recently said, quote, I have treated 15 symptomatic thyroid nodule patients, and it is the safest intervention I perform for my patients on a weekly basis. We are seeing early and significant symptomatic relief in all patients, and they are very excited and satisfied with to feel like themselves again without requiring invasive surgical procedure, end quote. We are hearing very similar feedback across our expanding group of new users. We are encouraged to see a positive trend in insurance claims being processed and paid, which supports the clinical value of these procedures. There is a compelling economic reality to be presented for the minimally invasive organ sparing vibrance procedure versus the more expensive and invasive thyroidectomy that typically requires hormone replacement therapy and continual lifelong medical monitoring. We believe this economic argument will be a growing consideration for payers as we expand market access for patients and providers. We are early in our launch and focused on quality therapy development and are proud to recognize initial revenues this quarter as we initiated our limited market release during the third quarter. We have launched new accounts outside of our pilot program and completed initial commercial procedures during Q3 and expect to see procedures grow in Q4. As we progress through the rest of the year, we will maintain consistent commercial headcount in Q4 as we concentrate on expanding accounts in the existing large metropolitan geographies covered by our current commercial team. Once these initial accounts achieve the desired utilization levels, we will expand headcount and launch into new geographies. As the pilot program continues to progress, we simultaneously initiated the precise BTN study with the first successful procedures of the study completed in multiple sites during the quarter. This prospective single arm multicenter clinical study aims to generate robust clinical evidence to demonstrate the safety and effectiveness of this less invasive thyroid preserving procedure. Benign thyroid nodule soft tissue ablation procedures will be performed on up to 50 patients at up to four sites. Study endpoints evaluated during the follow-up time points will include safety, symptoms reduction, improvements in quality of life, targeted nodule volume reduction, and cosmesis over various follow-up periods. The study is progressing according to plan with more than 40% enrollment to date with multiple sites up and running. We expect to complete enrollment in Q1 and will report on results at our next quarterly update. Positive data from our pilot program showcasing the safety, effectiveness, and workflow efficiency of the impulse vibrance percutaneous electrode system was recently presented by Dr. Ralph Tufano at the prestigious American Thyroid Association annual meeting in September, and we look forward to sharing continued updates as patient follow-ups progress and long-term follow-up data are published in the future. Long-term follow-up evaluations of patients in our recently published Italian feasibility study are underway to further demonstrate the durability of Vibrant's thyroid treatments. Additional data and publications will play an important role in driving adoption and utilization of this novel procedure as our commercial efforts scale. Let's now discuss our surgical ablation clamp. We are pleased to announce that the FDA has granted approval of our IDE pivotal study, allowing us to proceed with the initiation of the end-pulse surgical ablation clamp study, NanoClamp AF, for the treatment of atrial fibrillation. This is the first PFA study approved by FDA for a surgical cardiac ablation device in concomitant surgical procedures. The first patient has successfully been enrolled and treated in the IBE study, marking an important step in clinically validating the NPulse cardiac surgical system. Based on active discussions and preparations, we intend to expand into additional sites by the end of the year, as well as into Q1. This prospective single-arm, multicenter study is designed to assess the primary effectiveness of the NPulse cardiac surgical system in treating AF during concomitant surgical surgeries. I'm sorry, concomitant cardiac surgeries. Up to 136 patients will be enrolled across approximately 20 sites, including two international locations. The NPulse cardiac clamp is engineered to deliver precise, continuous, and transmural linear lesions during concomitant cardiac surgeries. Due to its non-thermal mechanism, NSPFA significantly reduces the risk of unintentional damage to surrounding tissues. This bipolar system utilizes Pulse Bioscience's proprietary nanosecond pulse field ablation, NSPFA, energy, to achieve full thickness, contiguous, durable lesions with reduced ablation times compared to traditional thermal ablation methods like radiofrequency. The NPulse cardiac surgical system was granted FDA breakthrough device designation in July 2024 and is currently part of the FDA's Total Product Life Cycle Advisory, or TAP, program. The company's feasibility study continues to enroll patients in the EU and aims to evaluate the initial safety and effectiveness of the impulse cardiac surgical system for the treatment of atrial fibrillation. To date, 44 patients have been treated by investigators in Europe, including Dr. Bart Van Poot at St. Antonia's Hospital in Newigan, Dr. Bart Mason at Maastricht University, Medical Center, and Dr. Antoine Driessen at Amsterdam Medical Center. Within this initial cohort, 27 patients have undergone electroanatomical mapping approximately three months after their ablation procedures to assess the effectiveness and durability of the treatment. Initial data are incredibly promising, with individual ablation times as low as 50 seconds total per patient. Late-breaking clinical results from the feasibility study were recently presented at the renowned annual European Association for Cardiothoracic Surgery meeting, or EACS, held October 8 to 11 in Copenhagen, Denmark. As the first clinical use of an NSPFA cardiac surgical technology, the study demonstrated that the NPulse cardiac surgical clamp enables a fast, safe, and efficient workflow, highlighting its potential to significantly broaden the adoption of surgical ablation in the treatment of atrial fibrillation. We are excited to advance the IDE study while we continue to generate and publish positive patient outcomes with our feasibility study in Europe. Now, moving on to our NPulse360 catheter for AF ablations. The NPulse 360 catheter is designed to deliver a complete circumferential lesion in a single, brief energy application, eliminating the need to stop, rotate, and reposition the catheter. We believe the system offers key advantages, including lower cumulative energy delivery, potentially reduced neuromuscular stimulation, as well as the valuable ability to create deeper, more uniform lesions. The NPulse 360 catheter system's flexible design also enhances maneuverability within the left atrium, making it intuitive and user-friendly for physicians. Encouraging initial clinical outcomes from Europe confirm our belief that the benefits of nanosecond PFA delivered by the 360 catheter will significantly advance the treatment of AF for patients worldwide. Regarding current status with our IDE submission with this device, we are making positive progress. We are engaged with the FDA on our proposed IDE study protocol and expect to resolve several remaining open items over the next couple of months and will be in position to commence the study in Q1. In Europe, our ongoing feasibility study with the 360 catheter has now enrolled 150 patients by leading investigators and follow-up on early results continue to be collected. Importantly, in what we believe will be a significant development for the AF clinical community and positive catalyst for PULSE, we are anticipating sharing new safety and efficacy data, including one-year follow-up data from the initial cohort of patients at an upcoming scientific meeting in Q1. The EP ablation market presents a significant opportunity where a strategic partnership could accelerate Pulse's growth and quickly achieve significant market penetration. We continue to explore potential collaborations with established leaders in electrophysiology and will share updates on any partnership progress as and when appropriate. With that, I will turn the call over to John to speak about our third quarter financial updates. John?