Summary of Pulse Biosciences FY Conference Call Company Overview - **Company**: Pulse Biosciences (NasdaqCM:PLSE) - **Industry**: Medical Technology (Med Tech) - **Technology**: Nanosecond Pulsed Field Ablation (nsPFA) Core Points and Arguments - **Technology Significance**: Nanosecond PFA produces extremely short pulses at high amplitudes, delivering less overall energy while addressing large unmet clinical needs in med tech [2][3] - **Market Potential**: The company targets three primary markets: thyroid treatment, cardiac surgery, and electrophysiology (EP), with a current market value of $6 billion expected to grow to over $16 billion [11][12] - **Unique Mechanism of Action**: nsPFA initiates non-thermal cell death, allowing for repeated ablation without damaging surrounding tissues, which is a significant advantage over traditional thermal methods [8][10] - **Clinical Evidence and FDA Approvals**: Pulse Biosciences has seven FDA clearances and a breakthrough device designation, with ongoing clinical studies to support its technology [4][19] Financial Position - **Cash Reserves**: The company ended Q3 with $95 million in cash, with a projected burn rate of $36 million for 2024, which will increase due to funding two Investigational Device Exemptions (IDEs) and a commercial launch in 2025 [6][7] - **Revenue Generation**: The company has just begun posting revenue, indicating growth potential moving forward [7] Market Strategies - **Direct vs. Partnership Approach**: The company plans to directly pursue markets with low competition (e.g., thyroid) while partnering in heavily resourced markets (e.g., EP) to optimize capital efficiency [12][13] - **Thyroid Market Opportunity**: There are 250,000 newly diagnosed benign thyroid patients annually, with a billion-dollar opportunity due to the lack of competition and the potential for thyroid-sparing procedures [13][14] Competitive Landscape - **Comparison with Competitors**: The CEO compared Pulse's technology favorably against Cardium, highlighting that Cardium's focus on mapping may not align with the anatomical-driven nature of pulmonary vein isolation, which is crucial for AFib treatment [20][21] Additional Insights - **Clinical Applications**: The technology allows for outpatient procedures without general anesthesia, enhancing patient comfort and procedural efficiency [10] - **Future Outlook**: The company anticipates significant milestones in clinical, regulatory, and commercial aspects over the next year, with a strong focus on expanding its market presence [19]

Summary of Pulse Biosciences Conference Call Company Overview - **Company Name**: Pulse Biosciences - **Ticker**: NasdaqCM:PLSE - **Industry**: Bioelectric medicine - **Technology**: Proprietary nanopulse stimulation technology (nanosecond pulsed field ablation, nsPFA) for tissue ablation in clinical settings [1][4] Core Points and Arguments Technology and Innovation - Pulse Biosciences is pioneering a new class of medical technology platforms powered by M-Pulse technology, which delivers ultra-precise nanosecond pulsed electric fields [5] - The nsPFA technology offers significant advantages over traditional microsecond PFA, including higher amplitude, shorter duration pulses that enable faster and deeper ablations [3][6] - The company has invested approximately $400 million in the development of M-Pulse technology and has multiple FDA clearances and breakthrough device designations [5][6] Market Opportunities - Pulse Biosciences targets three initial markets: 1. **Thyroid Intervention Market**: Represents a $1 billion annual opportunity with approximately 250,000 patients diagnosed annually in the U.S. with benign thyroid nodules [11][14] 2. **Cardiac Surgery**: Focuses on surgical ablation for atrial fibrillation (AFib), which is significantly underpenetrated, with only about 30% of patients receiving concomitant procedures during cardiac surgeries [18] 3. **Electrophysiology Market**: The AFib ablation market alone is valued at $3 billion and is expected to grow, with combined market opportunities exceeding $6 billion [12] Clinical Evidence and Studies - The company is conducting a clinical study (Precise BTN) for benign thyroid nodule treatment, aiming to demonstrate safety and effectiveness with over 40% enrollment to date [17] - The M-Pulse Cardiac Clamp study (NanoClamp AF) has received FDA approval, with the first patient treated recently, focusing on AFib during concomitant cardiac surgeries [19][20] Competitive Advantages - nsPFA technology allows for non-thermal energy delivery, reducing the risk of thermal damage to surrounding tissues and enabling procedures with lower sedation requirements [10][11] - The M-Pulse Cardiac Catheter is designed for rapid ablation cycles, significantly reducing total ablation times compared to existing devices [21][22] - The company holds over 215 issued patents and more than 100 pending applications, indicating a strong intellectual property position [6] Financial Position - Pulse Biosciences reported $95.2 million in cash at the end of Q3, providing a solid foundation to execute its plans through 2026 [7][24] - Initial revenue of $86,000 was generated during the quarter from the limited market release of the M-Pulse Vibrance system [8] Additional Insights - The company is focused on building a strong foundation in specific geographies and expanding its commercial activities as initial accounts achieve desired utilization levels [16][34] - There is potential for partnerships in markets with established competitors, while pursuing direct opportunities in less competitive areas [12][26] - The technology has broader applications beyond the current focus, with potential future indications being explored [30][31] Conclusion Pulse Biosciences is positioned as a novel platform company with proprietary technology that addresses significant market needs in the healthcare landscape. The company is actively pursuing clinical studies and market opportunities while maintaining a strong financial position to support its growth strategy [24][36]

Group 1 - The article does not provide any specific content or key points related to a company or industry [1]

Core Insights - Pulse Biosciences reported a quarterly loss of $0.29 per share, which was better than the Zacks Consensus Estimate of a loss of $0.31, but worse than a loss of $0.16 per share a year ago, indicating an earnings surprise of +6.45% [1] - The company generated revenues of $0.09 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 82.8%, compared to zero revenues a year ago [2] - The stock has underperformed, losing about 7.8% since the beginning of the year, while the S&P 500 gained 15.1% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.33 on revenues of $0.75 million, and for the current fiscal year, it is -$1.17 on revenues of $1.25 million [7] - The estimate revisions trend for Pulse Biosciences was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical - Instruments industry, to which Pulse Biosciences belongs, is currently in the top 37% of over 250 Zacks industries, suggesting that stocks in the top 50% outperform those in the bottom 50% by more than 2 to 1 [8] - Another company in the same industry, Teleflex, is expected to report quarterly earnings of $3.38 per share, reflecting a year-over-year change of -3.2%, with revenues expected to be $893.51 million, up 16.9% from the previous year [9][10]

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]