Pulse Biosciences (NasdaqCM:PLSE) FY Conference Transcript

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]