Pulse Biosciences, Inc. (PLSE) shares soared 40.91 percent, gaining $5.60, to $19.29 on Friday, possibly after yesterday company released late-breaking clinical data showing successful treatment of atrial fibrillation using its nPulse Cardiac Catheter.The stock was trading at $19.29, compared with a previous close of $13.69. Shares opened at $14.95 and traded between an intraday low of $14.72 and a high of $19.70 on the Nasdaq. Trading volume rose to about 0.65 million shares, well above the average daily ...

HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of the novel nPulseâ"¢ technology using proprietary Nanosecond Pulsed Field Ablationâ"¢ (nanosecond PFA or nsPFAâ"¢) energy, today announced late-breaking clinical data from the nPulse Cardiac Catheter first-in-human feasibility study. The study demonstrates successful treatment of atrial fibrillation in 150 patients with rapid procedure times and minimal adverse effects. The data were presented today at the 31st Annu. ...

Group 1 - The company is celebrating the one-year anniversary of its CEO, Paul LaViolette, who joined just before JPMorgan's event in 2025, reflecting on the past year's accomplishments and future outlook for 2026 [2] - The company's mission focuses on capitalizing on its exclusive control over nanosecond pulsed field ablation (PFA), which is recognized for its unique energy in pulsed electric fields, providing both technical and clinical advantages [3] Group 2 - The company aims to build a viable and thriving business, leveraging its unique technology in the PFA sector [4]

Summary of Pulse Biosciences FY Conference Call Company Overview - **Company**: Pulse Biosciences (NasdaqCM:PLSE) - **CEO**: Paul LaViolette - **Focus**: Nanosecond pulse field ablation (nsPFA) technology for medical applications Key Industry Insights - **Market Dynamics**: Pulse Biosciences is positioned to capitalize on the growing interest in pulsed field ablation (PFA) technology, which is gaining traction in various clinical markets [3][32] - **Addressable Market**: The initial addressable market for nsPFA is estimated at **$6 billion**, with potential for expansion as the technology is adopted internationally [9][32] Core Technology and Advantages - **nsPFA Technology**: nsPFA delivers energy in billionths of a second, offering a non-thermal method for tissue ablation, which reduces side effects compared to traditional thermal methods [11][12] - **Clinical and Technical Advantages**: nsPFA allows for regulated cell death without damaging surrounding tissues, leading to improved patient outcomes and workflow efficiencies for physicians [13][19] - **Intellectual Property**: The company has increased its IP portfolio by **144 patents**, enhancing its competitive edge and making replication of the technology difficult for competitors [14] Market Opportunities 1. **Electrophysiology (EP) Ablation Market**: - Atrial fibrillation (AF) is the most common arrhythmia, with low current ablation penetration rates [14][15] - nsPFA has shown rapid adoption in this market, with significant improvements in lesion quality and procedure speed [16][17] - The company has treated over **150 patients** and is preparing to present efficacy data at the Boston AF Symposium [20] 2. **Cardiac Surgery Market**: - nsPFA aims to improve AF treatment during cardiac surgeries, where current methods are underutilized due to reliability concerns [21][22] - The company has received breakthrough designation and IDE approval for this application, with ongoing patient enrollment [22] 3. **Benign Thyroid Market**: - Pulse Biosciences is creating a new market for interventional thyroid management, addressing the needs of **250,000 patients** diagnosed annually with benign thyroid nodules [24][25] - The procedure is minimally invasive, with significant patient benefits, including rapid symptom relief and preservation of thyroid function [26][27] Financial Snapshot - **Cash Position**: Ended 2025 with **$81 million** in cash, with a burn rate of approximately **$13 million** in Q3 and **$14 million** in Q4 [6][7] - **Revenue Generation**: Initiated revenue from the commercialization of the Vibrance platform for treating benign thyroid nodules [7] Strategic Goals for 2026 - **Clinical Trials**: Plans to enroll patients in IDE studies for cardiac surgery and EP ablation, with expected completion by the end of 2026 [31] - **Market Expansion**: Focus on building evidence and expanding into additional markets, including oncology-related applications [32] - **Commercialization**: Pilot commercialization of thyroid treatments is underway, with plans to convert pilot sites to commercial status by the end of January [28][29] Conclusion - Pulse Biosciences is positioned for significant growth in the medical device industry through its innovative nsPFA technology, with a strong focus on clinical evidence, market expansion, and strategic partnerships to enhance its competitive advantage [32]

This presentation and any documents incorporated by reference may contain market data that we obtain from industry sources. These sources do not guarantee the accuracy or completeness of the information. Although we believe that our industry sources are reliable, we do not independently verify the information. The market data may also include projections that are based on other projections. While we believe these assumptions and projections are reasonable and sound, as of the date hereof, actual results may ...

Group 1 - Pulse Biosciences, Inc. is set to present at the 44th Annual J.P. Morgan 2026 Healthcare Conference in San Francisco on January 14, 2026, at 3:45 PM PT [1][2] - The company utilizes its proprietary nPulse™ technology, which employs Nanosecond Pulsed Field Ablation (nsPFA) to deliver nanosecond pulses of electrical energy for non-thermal cell clearance while preserving adjacent noncellular tissue [3] - Pulse Biosciences aims to develop its nPulse technology for treating atrial fibrillation and other markets, potentially enhancing healthcare outcomes for patients and providers, particularly in surgical soft tissue ablation [3]

Core Insights - Pulse Biosciences (PLSE) has received FDA Investigational Device Exemption (IDE) approval to initiate a study for its nPulse Cardiac Catheter Ablation System aimed at treating paroxysmal atrial fibrillation, marking a significant regulatory milestone for the company [1][4] Company Developments - The IDE approval allows PLSE to commence a multicenter clinical trial, the NANOPULSE-AF study, which will enroll up to 145 patients across 30 sites to evaluate the safety and effectiveness of its nsPFA technology [8][9] - PLSE's nsPFA technology is designed to use lower energy and create single-shot lesions, which could simplify workflows and reduce procedure times [10] - The company has a current market capitalization of $966.4 million [6] Clinical and Market Outlook - The FDA IDE approval strengthens PLSE's position in the fast-growing atrial fibrillation ablation market, which is projected to grow from $26.89 billion in 2024 to $65.33 billion by 2033, with a CAGR of 10.44% from 2025 to 2033 [12] - Encouraging clinical data from ongoing European studies, where 150 patients have been enrolled, supports the U.S. study and helps mitigate risks [11] Competitive Positioning - PLSE's differentiated nanosecond pulsed field ablation technology is expected to reduce collateral damage compared to traditional microsecond systems, potentially enhancing safety and procedural efficiency [10][11] - The successful execution of the study could lead to pivotal clinical data that supports regulatory approval and drives physician adoption, establishing PLSE as a next-generation ablation platform [4][11]

Core Insights - Pulse Biosciences, Inc. (PLSE) has initiated a research collaboration with The University of Texas MD Anderson Cancer Center to test its nPulse technology, Vybrance, for treating malignant thyroid tumors, with FDA approval for human trials [1][5] Clinical Trial Details - The clinical trial is set to begin in early 2026, enrolling 30 patients across two sites to assess the safety of the nPulse Vybrance Percutaneous Electrode System for treating papillary thyroid microcarcinoma, a prevalent thyroid cancer in the U.S. [2] Pre-Clinical Studies - MD Anderson researchers are conducting pre-clinical studies on nsPFA energy as a potential treatment for anaplastic thyroid carcinoma, which has a five-year survival rate of less than 5% [3] Stock Performance - Following the announcement, PLSE shares increased by 1.4% during the last closing, but have declined 21.4% year-to-date, contrasting with a 3% rally in the industry and an 18.6% rise in the S&P 500 [4] Strategic Importance - The partnership with MD Anderson and FDA's IDE approval enhances PLSE's competitive position in the soft-tissue ablation market for thyroid cancer treatment, adding credibility to its nsPFA technology [5][9] Technology Overview - The nPulse Vybrance Percutaneous Electrode System utilizes a small needle electrode to deliver precise, non-thermal ablation of cancer tissue while protecting surrounding healthy tissues, positioning it as a potential breakthrough treatment for both benign and malignant thyroid tumors [10] Future Growth Potential - The collaboration with MD Anderson provides a solid clinical foundation for PLSE to build evidence and expand its technology into new medical areas, indicating long-term growth potential in the oncology market [11]

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]