Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $86,000, marking the company's initial revenue from N-Pulse Capital and Vibrance disposable sales [23] - Total GAAP costs and expenses increased by $6.8 million to $20.5 million compared to $13.7 million in the prior year period, primarily due to expanding organization expenses [23] - GAAP net loss for Q3 2025 was $19.4 million, compared to $12.7 million in the prior year period [24] Business Line Data and Key Metrics Changes - The M-Pulse Vibrance percutaneous electrode system has treated over 200 patients across pilot programs and initial commercial procedures, indicating strong product-market fit [9] - Procedure volumes grew sequentially, with one physician completing double-digit procedures in one month, suggesting scalability [9] - The M-Pulse cardiac surgical system for atrial fibrillation has initiated patient enrollment following FDA investigational device exemption approval [6][16] Market Data and Key Metrics Changes - The company is advancing its European feasibility studies for both cardiac devices, with initial positive outcomes reported [18] - The initial cohort of patients treated in Europe showed promising results, with ablation times as low as 50 seconds per patient [18] Company Strategy and Development Direction - The company is focused on early targeted adoption of its M-Pulse technology in soft tissue ablation and cardiac applications, aiming to address significant unmet clinical needs [5][6] - A strategic priority includes expanding accounts in large metropolitan areas while maintaining consistent commercial headcount [13][25] - The company is exploring potential collaborations with established leaders in electrophysiology to accelerate growth [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growing utilization of the Vibrance procedure and the positive trend in insurance claims being processed [12] - The company anticipates that disposables and N-Pulse system sales will grow alongside overall procedure acceptance [25] - Management emphasized the importance of generating consistent positive outcomes and driving account utilization before expanding the sales force [25][26] Other Important Information - The company has received FDA approval for its IDE pivotal study for the M-Pulse surgical ablation clamp, marking a significant step in clinical validation [16] - The PRECISE BTN study aims to generate robust clinical evidence for the safety and effectiveness of the Vibrance procedure, with over 40% enrollment to date [15] Q&A Session Summary Question: Clarification on the pre-op lesion work set for the Nanoclamp trial - The lesion set varies based on the severity of the AFib burden, allowing surgeons discretion in determining the lesion set [28] Question: Funding strategy for the NS360 pivotal trial - The company plans to fund the study unilaterally while remaining open to partnership strategies for support during commercialization [30] Question: Performance criteria for the PRECISE BTN study - The study will measure patient outcomes, quality of life, volume reduction, and symptom burden to establish a composite endpoint for treatment effectiveness [33]

Revenue - Product revenue for the three months ended September 30, 2025, was $0.1 million, with no revenue reported for the same period in 2024, attributed to the limited market release of the Vybrance Percutaneous Electrode System[128] - For the nine months ended September 30, 2025, product revenue was $0.1 million, with no revenue for the same period in 2024, linked to the limited market release of the Vybrance Percutaneous Electrode System[135] Expenses - Research and development expenses increased by $3.7 million to $11.4 million for the three months ended September 30, 2025, compared to $7.7 million in 2024, primarily due to increases in paid services, stock-based compensation, and employee-related expenses[131] - Selling, general and administrative expenses rose by $2.8 million to $8.8 million for the three months ended September 30, 2025, compared to $6.0 million in 2024, driven by increases in stock-based compensation and employee-related expenses[132] - Total cost and expenses for the three months ended September 30, 2025, were $20.5 million, up from $13.7 million in 2024, resulting in a loss from operations of $20.4 million[127] - Research and development expenses for the nine months ended September 30, 2025, increased by $12.1 million to $33.8 million compared to $21.7 million in 2024, mainly due to higher stock-based compensation and external research costs[138] - Selling, general and administrative expenses for the nine months ended September 30, 2025, increased by $10.4 million to $24.7 million from $14.3 million in 2024, primarily due to stock-based compensation and employee-related expenses[139] - Net loss for the nine months ended September 30, 2025, was $55.3 million, compared to a net loss of $34.2 million in 2024, reflecting a significant increase in operational costs[134] Cash Flow and Financing - Interest income for the nine months ended September 30, 2025, increased by $1.6 million to $3.4 million compared to $1.8 million in 2024, driven by higher cash balances[140] - The company completed a rights offering in June 2024, raising $60.0 million, with the majority of shares purchased by Robert Duggan, the majority stockholder[118] - The 2024 Rights Offering resulted in the sale of 6 million units at $10.00 per unit, generating gross proceeds of $60 million[142] - As of September 30, 2025, the company had cash and cash equivalents of $95.2 million, sufficient to fund projected operating requirements for at least the next twelve months[144] - During the nine months ended September 30, 2025, the company used $39.4 million in operating activities, compared to $27.2 million in the same period of 2024[146][147] - Cash provided by financing activities for the nine months ended September 30, 2025, was $16.8 million, primarily from $14.1 million in warrant exercises[149] - Cumulatively, as of September 30, 2025, the company received $63.5 million in gross proceeds from exercises of the 2024 Rights Offering Warrants[142] Future Outlook - The company incurred significant operating losses since inception and may continue to do so for several years[144] - The company plans to raise additional capital in the future, but there is no assurance that financing will be available on acceptable terms[145] - The ongoing global conflicts and increasing tariffs may negatively impact the company's ability to raise additional funds[145] Warrants - As of September 30, 2025, there were 411,907 outstanding 2024 Rights Offering Warrants subject to the 200% redemption feature[142] Investing Activities - The company used $0.2 million in investing activities during the nine months ended September 30, 2025, primarily for property and equipment purchases[148]

Financial Performance - Total revenue for Q3 2025 was $86 thousand, including sales from nPulse capital and Vybrance disposables[4] - GAAP net loss for Q3 2025 was ($19.4) million, compared to ($12.7) million for Q3 2024, representing a 52.6% increase in net loss year-over-year[6] - Non-GAAP net loss for Q3 2025 was ($13.5) million, compared to ($9.4) million for Q3 2024, indicating a 43.6% increase in net loss[6] - Net loss for Q3 2025 was $19,385 million, compared to a net loss of $12,680 million in Q3 2024, reflecting a 53% increase in losses[19] - Non-GAAP net loss for Q3 2025 was $13,512 million, compared to $9,404 million in Q3 2024, indicating a 43% increase[22] - Comprehensive loss for the nine months ended September 30, 2025, was $55,348 million, compared to $34,200 million for the same period in 2024, a 62% increase[19] Expenses and Costs - Total GAAP costs and expenses for Q3 2025 were $20.5 million, an increase of 49.5% from $13.7 million in the prior year period[5] - Total cost and expenses increased to $20,453 million in Q3 2025 from $13,655 million in Q3 2024, representing a 49% increase[19] - Research and development expenses rose to $11,393 million in Q3 2025, up from $7,703 million in Q3 2024, a 48% increase[19] - Stock-based compensation expense totaled $5,617 million in Q3 2025, up from $2,982 million in Q3 2024, a 88% increase[22] - Non-GAAP cost and expenses for Q3 2025 were $14,580 million, compared to $10,379 million in Q3 2024, a 40% increase[22] Cash and Liquidity - Cash and cash equivalents totaled $95.2 million as of September 30, 2025, up from $79.0 million a year earlier[8] - Cash used in operating activities in Q3 2025 was $13.0 million, compared to $9.0 million in the same period last year[8] Study and Approvals - The company treated over 200 patients across various studies and initial commercial procedures[7] - The nPulse Cardiac Surgery System Study received FDA IDE approval, marking it as the first PFA study approved for surgical cardiac ablation[7] - The company plans to commence an IDE study in Q1 2026 following the submission of the pivotal study protocol[7] Liabilities and Shares - Total liabilities as of September 30, 2025, were $16.1 million, a decrease from $17.6 million as of December 31, 2024[17] - The weighted average common shares outstanding increased to 67,385 million in Q3 2025 from 61,066 million in Q3 2024[19] Revenue Breakdown - Product revenue for Q3 2025 was $86 million, compared to $0 in Q3 2024[19] - Interest income for Q3 2025 was $1,001 million, slightly up from $976 million in Q3 2024[19]

Core Insights - Pulse Biosciences, Inc. has initiated the NANOCLAMP AF Study for treating atrial fibrillation, marking a significant step in its clinical research efforts [1] Company Developments - The first patient has been enrolled in the NANOCLAMP AF Study, with the procedure successfully completed at St. Helena Hospital in California [1] - The procedure utilized the nPulse™ Cardiac Surgical System, which is based on the company's proprietary Nanosecond Pulsed Field Ablation™ technology [1] - The company recently received FDA approval, which supports the advancement of its innovative treatment approach [1]

Core Insights - Pulse Biosciences (PLSE) has reported promising late-breaking data from its nPulse Cardiac Surgical System, which utilizes Nanosecond Pulsed Field Ablation (nsPFA) technology for treating atrial fibrillation (AF) [1][3][8] - The feasibility study demonstrated a 94% success rate in pulmonary vein isolation and 100% in posterior box isolation, with no major complications reported [10][11] - The company plans to initiate an Investigational Device Exemption (IDE) study in the U.S. to advance toward regulatory approval and commercialization [4][9] Company Developments - The nPulse Cardiac Surgical System represents a novel approach to AF treatment, offering a nonthermal alternative that minimizes collateral damage compared to traditional thermal ablation methods [2][3] - The feasibility study involved 44 patients, with electroanatomical mapping showing significant safety and efficacy outcomes, reinforcing the system's potential as a disruptive technology in surgical AF treatment [10][11] - The average ablation time was recorded at 50 seconds, indicating a potential for faster surgical workflows [11] Market Context - The global atrial fibrillation market is projected to grow from $26.89 billion in 2024 to $65.33 billion by 2033, with a compound annual growth rate (CAGR) of 10.4% from 2025 to 2033 [12] - The increasing prevalence of AF, driven by aging populations and risk factors such as hypertension and diabetes, is creating a demand for advanced interventional procedures [12][13] - Pulse Biosciences aims to position itself in the market by addressing the limitations of existing radiofrequency and cryoablation methods, particularly in surgical settings [13]

Core Insights - Pulse Biosciences, Inc. announced late-breaking clinical study results from its nPulse™ Cardiac Surgical System during the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark [1] Company Overview - Pulse Biosciences is leveraging its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) technology [1] Clinical Study Details - The feasibility study aims to assess the initial safety and effectiveness of the nPulse™ technology in a first-in-human context [1]

Core Insights - Pulse Biosciences Inc (PLSE) shares have crossed above their 200-day moving average of $17.14, reaching a high of $18.10 per share, indicating a positive trading day with an increase of approximately 11.2% [2] Price Performance - The 52-week low for PLSE shares is $13.7658, while the 52-week high is $25, with the last trade recorded at $18.01 [2]

Company Overview - Pulse Biosciences (PLSE) received FDA approval for its Investigational Device Exemption (IDE) to initiate the NANOCLAMP AF study, which evaluates its Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery System for atrial fibrillation (AF) [1][8] - The IDE approval is a significant growth catalyst for the company, validating its technology and enhancing its potential for broader clinical adoption in the cardiac ablation market [2][4] Market Position and Financials - PLSE currently has a market capitalization of $1.01 billion [6] - Following the announcement of the IDE approval, PLSE shares closed flat, with a year-to-date decline of 15.2%, compared to the industry's decline of 10.9% and the S&P 500's gain of 11.9% [3] Study Details - The NANOCLAMP AF study will involve up to 136 patients across 20 global sites, including two outside the United States, to evaluate the effectiveness of the nsPFA Cardiac Surgical System during concomitant cardiac surgeries [9][10] - Early clinical data from the EU indicate rapid and consistent ablation, with the device designed to minimize collateral tissue damage due to its nonthermal mechanism [10][11] Industry Prospects - The global atrial fibrillation market was estimated at $26.89 billion in 2024 and is projected to reach $65.33 billion by 2033, with a compound annual growth rate (CAGR) of 10.44% from 2025 to 2033 [12]

Summary of Pulse Biosciences (PLSE) FY Conference Call - August 13, 2025 Company Overview - **Company**: Pulse Biosciences - **CEO**: Paul Le Violette - **CFO**: John Skinner - **Industry**: Medical Technology, specifically focusing on pulsed electric field (PFA) therapies Core Points and Arguments - **Therapeutic Platform**: Pulse Biosciences is focused on a life-changing therapeutic platform utilizing nanosecond PFA technology to treat various diseases, including atrial fibrillation (AFib) and benign thyroid nodules [4][5][6] - **Market Potential**: The company targets multiple markets, including thyroid interventions, cardiac surgery, and electrophysiology (EP) ablation, with a total addressable market of approximately $6 billion, expected to double over time [19][20] - **PFA Technology**: The unique aspect of Pulse's PFA technology is its ability to deliver shorter pulse durations (in billionths of a second), which allows for non-thermal tissue ablation, reducing the risk of thermal damage and improving clinical outcomes [8][9][17] - **Clinical Applications**: The company has multiple FDA clearances and breakthrough designations for its technologies, indicating strong clinical validation and potential for market entry [10][11] Key Market Segments 1. **Thyroid Interventions**: - Targeting benign thyroid nodules, with 250,000 patients diagnosed annually in the U.S. and 150,000 leading to surgical removal [25][26] - Aims to convert surgical procedures into less invasive alternatives, preserving thyroid function and reducing recovery time [27][28] - Currently in a pilot program with plans for a limited launch across 10 centers [29][30] 2. **Cardiac Ablation**: - Focused on patients undergoing open-heart surgery who also have preoperative AFib, with only 25-30% currently receiving ablation therapy [32] - The technology aims to improve the efficiency and effectiveness of existing radiofrequency ablation methods [33] 3. **Electrophysiology (EP) Market**: - The largest market segment, with significant potential for NSPFA to enhance treatment speed and safety compared to first-generation PFA technologies [36][39] Financial Position - **Strong Balance Sheet**: The company reported over $100 million in cash at the end of the quarter, enabling execution of its strategic plans [14][40] Strategic Approach - **Hybrid Market Entry Strategy**: The company plans to pursue a combination of direct market entry and partnerships, focusing on capital-efficient approaches to maximize market penetration [20][21] Challenges and Considerations - **Clinical Data and Reimbursement**: The company acknowledges the importance of clinical data to drive adoption and is actively working on reimbursement strategies to facilitate market entry [43][47] - **Existing Codes**: There are existing codes for irreversible electroporation that could be leveraged for reimbursement, although thyroid is not currently an approved indication [47][48] Conclusion - **Future Outlook**: Pulse Biosciences is positioned for growth with its innovative PFA technology, targeting significant unmet needs in the medical market, and is optimistic about its potential to transform treatment paradigms in multiple therapeutic areas [39][41]

Financial Data and Key Metrics Changes - Total GAAP costs and expenses increased by $8.5 million to $20.3 million compared to $11.7 million in the prior year period [20] - GAAP net loss in 2025 was $19.2 million compared to $11.4 million in the prior year period [21] - Cash and cash equivalents totaled $106.3 million as of June 30, 2025, compared to $26.2 million as of June 30, 2024 [21] Business Line Data and Key Metrics Changes - The NSPFA Percutaneous Electrode System is FDA cleared for the ablation of soft tissue, with over 140 patients treated in the pilot program to date [9][12] - Surgeons are transitioning procedures to ambulatory surgery centers (ASC) or operating rooms (OR) for better patient and surgeon experience [10] - The company expects to generate initial revenue from the percutaneous electrode in the second half of the year [23] Market Data and Key Metrics Changes - The market potential for the NSPFA device in benign thyroid disease is significant, with hundreds of thousands of patients in the US alone [7] - The prevalence of thyroid nodules is estimated to be 50% or greater in the population, increasing with age [28] - Approximately 250,000 patients are diagnosed with thyroid issues annually, with 150,000 undergoing thyroidectomy [32] Company Strategy and Development Direction - The company is focused on advancing its NSPFA technology and expanding its market presence through pilot programs and clinical studies [5][19] - A strategic partnership in the electrophysiology space is being pursued to enhance market opportunities [19][39] - The company aims to demonstrate that NSPFA may be a better treatment than surgery for many patients suffering from benign thyroid disease [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical value proposition of NSPFA technology and its potential to transform treatment options [16] - The company anticipates increased cash usage as it invests in commercial infrastructure and clinical studies [22] - Management highlighted the importance of generating high-quality clinical data to support technology adoption and regulatory filings [17] Other Important Information - The company is engaged in a multicenter prospective clinical study to generate additional clinical data for the NSPFA technology [11] - The FDA awarded Breakthrough Device Designation for the Cardiac Surgical Clamp Ablation Device, which is under review for IDE submission [13][14] Q&A Session Summary Question: Can you share some patient baseline characteristics driving the pull through for NSPFA? - Management noted that symptomatic patients with benign nodules often seek therapy due to discomfort and the risks associated with thyroidectomy [28][30] Question: Is the expectation still for a single-arm study for catheter ablation? - Management confirmed it would be a single-arm study for electrophysiology [35] Question: Is Pulse collaborating with a market leader in cardiac ablation? - Management affirmed ongoing partnership discussions with a market leader in cardiac ablation [38][39] Question: How does the ASC opportunity position the NSPFA platform? - Management highlighted that the NSPFA system is well-suited for ASCs due to rapid procedure times and low neuromuscular stimulation [44][46] Question: Will the data collected overseas play into the PMA application for the clamp? - Management confirmed that human data collected will be included in IDE submissions, which is beneficial for FDA approval [53][55]