Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the intention as well as potential to improve the quality of life for patients. The Company's proprietary nPulse™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The Company is actively pursuing the development of its nPulse technology for use in the treatment of atrial fibrillation and in a select few other markets where it coul ...

Key Takeaways PLSE won FDA IDE approval to begin a U.S. multicenter trial of its nPulse system for paroxysmal AFib.The NANOPULSE-AF study will enroll up to 145 patients across 30 sites to assess safety and effectiveness.PLSE's nsPFA technology uses lower energy and single-shot lesions to simplify workflows.Pulse Biosciences (PLSE) recently announced that the FDA has granted Investigational Device Exemption (“IDE”) approval to initiate its nPulse Cardiac Catheter Ablation System study for the treatment of pa ...

Key Takeaways PLSE partners to start a clinical study using the nPulse technology for papillary thyroid microcarcinoma.The FDA grants the IDE application for an early trial, enrolling 30 patients in 2026.The alliance expands the PLSE's clinical breakthrough in non-thermal soft-tissue ablation.Pulse Biosciences, Inc. (PLSE)  announced that it initiated a research collaboration with The University of Texas MD Anderson Cancer Center to test its nPulse technology — Vybrance — for treating malignant thyroid tumo ...

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]

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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]