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Pulse Biosciences (PLSE) FY Conference Transcript
2025-08-13 16:00
Summary of Pulse Biosciences (PLSE) FY Conference Call - August 13, 2025 Company Overview - **Company**: Pulse Biosciences - **CEO**: Paul Le Violette - **CFO**: John Skinner - **Industry**: Medical Technology, specifically focusing on pulsed electric field (PFA) therapies Core Points and Arguments - **Therapeutic Platform**: Pulse Biosciences is focused on a life-changing therapeutic platform utilizing nanosecond PFA technology to treat various diseases, including atrial fibrillation (AFib) and benign thyroid nodules [4][5][6] - **Market Potential**: The company targets multiple markets, including thyroid interventions, cardiac surgery, and electrophysiology (EP) ablation, with a total addressable market of approximately $6 billion, expected to double over time [19][20] - **PFA Technology**: The unique aspect of Pulse's PFA technology is its ability to deliver shorter pulse durations (in billionths of a second), which allows for non-thermal tissue ablation, reducing the risk of thermal damage and improving clinical outcomes [8][9][17] - **Clinical Applications**: The company has multiple FDA clearances and breakthrough designations for its technologies, indicating strong clinical validation and potential for market entry [10][11] Key Market Segments 1. **Thyroid Interventions**: - Targeting benign thyroid nodules, with 250,000 patients diagnosed annually in the U.S. and 150,000 leading to surgical removal [25][26] - Aims to convert surgical procedures into less invasive alternatives, preserving thyroid function and reducing recovery time [27][28] - Currently in a pilot program with plans for a limited launch across 10 centers [29][30] 2. **Cardiac Ablation**: - Focused on patients undergoing open-heart surgery who also have preoperative AFib, with only 25-30% currently receiving ablation therapy [32] - The technology aims to improve the efficiency and effectiveness of existing radiofrequency ablation methods [33] 3. **Electrophysiology (EP) Market**: - The largest market segment, with significant potential for NSPFA to enhance treatment speed and safety compared to first-generation PFA technologies [36][39] Financial Position - **Strong Balance Sheet**: The company reported over $100 million in cash at the end of the quarter, enabling execution of its strategic plans [14][40] Strategic Approach - **Hybrid Market Entry Strategy**: The company plans to pursue a combination of direct market entry and partnerships, focusing on capital-efficient approaches to maximize market penetration [20][21] Challenges and Considerations - **Clinical Data and Reimbursement**: The company acknowledges the importance of clinical data to drive adoption and is actively working on reimbursement strategies to facilitate market entry [43][47] - **Existing Codes**: There are existing codes for irreversible electroporation that could be leveraged for reimbursement, although thyroid is not currently an approved indication [47][48] Conclusion - **Future Outlook**: Pulse Biosciences is positioned for growth with its innovative PFA technology, targeting significant unmet needs in the medical market, and is optimistic about its potential to transform treatment paradigms in multiple therapeutic areas [39][41]