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]

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]

Financial Data and Key Metrics Changes - In Q4 2024, total GAAP costs and expenses increased by $7.7 million to $20.3 million compared to $12.5 million in the prior year period, primarily driven by an increase in non-cash stock-based compensation [55] - GAAP net loss in Q4 2024 was $19.4 million compared to $11.9 million in the prior year period, while non-GAAP net loss was $10.4 million compared to $8.3 million in the prior year period [56] - Cash and cash equivalents totaled $118 million as of December 31, 2024, compared to $44.4 million as of December 31, 2023 [57] Business Line Data and Key Metrics Changes - The company is advancing commercialization of its soft tissue ablation device, the Percutaneous Electrode, which has broad market clearance for the ablation of soft tissue, particularly for benign thyroid disease [23][27] - The surgical cardiac clamp for treating atrial fibrillation is undergoing a feasibility study in Europe, with 30 patients treated so far [36] - The 360 Catheter system for atrial fibrillation ablation is designed to deliver nanosecond PFA technology, with an estimated $3 billion annual U.S. market for ablation catheters [40] Market Data and Key Metrics Changes - The U.S. market sees approximately 250,000 patients diagnosed with benign thyroid nodules annually, with about 150,000 opting for thyroidectomy [25] - The company estimates a prevalence of approximately 2 million patients in the watchful waiting category for benign thyroid disease, indicating a significant market opportunity [26] - The annual U.S. market for atrial fibrillation ablation is estimated at $3 billion, with PFA expected to be used in 20% of global AF cases in 2024, expanding to 40% to 50% in 2025 [40][41] Company Strategy and Development Direction - The company aims to advance commercialization of its soft tissue ablation device and initiate pivotal studies for its cardiac catheter and surgical clamp [22] - A hybrid business model will be implemented to efficiently enter markets, either through direct sales or partnerships with established companies [48][49] - The focus is on leveraging differentiated technologies backed by strong clinical evidence to disrupt existing treatment paradigms [47] Management's Comments on Operating Environment and Future Outlook - The CEO expressed confidence in the company's unique nanosecond PFA technology and its potential to improve patient outcomes across various medical conditions [11][15] - Management highlighted the importance of clinical data in validating the technology and driving adoption [45] - The company is optimistic about its growth prospects in 2025, with several important milestones set to be achieved [19][22] Other Important Information - The company has received seven FDA clearances and has treated 6,000 patients, indicating a mature platform for its technologies [17] - The company has a portfolio of over 180 issued patents covering various systems and methods for nanosecond pulse therapies [18] - The new CFO, Jon Skinner, has joined the company and is expected to contribute significantly to its growth and operational excellence [50][53] Q&A Session Summary - No questions were raised during the Q&A session, and the call concluded with closing remarks from the CEO [58][60]