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Pulse Biosciences(PLSE) - 2022 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Non-GAAP net loss for Q4 2022 was $8.1 million, an improvement from $11.5 million in Q4 2021 [24] - Cash, cash equivalents, and investments totaled $61.1 million as of December 31, 2022, compared to $28.6 million a year earlier and $69.2 million as of September 30, 2022 [25] - Cash used in Q4 2022 was $8 million, reduced from $13.4 million in the same period last year and $10.6 million in Q3 2022 [25] Business Line Data and Key Metrics Changes - The company has shifted focus to the treatment of atrial fibrillation (AF), a high-growth market valued at $8 billion, which is seen as a path for long-term value creation [9][10] - The development of two main devices, a cardiac clamp and a catheter, is underway, both utilizing the proprietary nsPFA technology [19][47] Market Data and Key Metrics Changes - The AF intervention market is projected to grow by more than 10% annually due to factors such as an aging population and increased clinical evidence [37] - Over 1.2 million catheter-based surgical ablations are performed annually, indicating a significant market opportunity [37] Company Strategy and Development Direction - The company aims to advance its nsPFA technology for AF treatment by developing a cardiac clamp and completing regulatory milestones for a catheter [38] - The strategy includes meeting with the FDA to discuss regulatory requirements for the cardiac clamp and preparing for human clinical use [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the technology's potential to disrupt the current treatment landscape for AF, emphasizing the safety and efficacy of nsPFA compared to thermal modalities [34][43] - The company is focused on long-term success and building a foundation for a viable business, with a clear understanding of the time and expertise required for execution [38] Other Important Information - The company has a strong patent portfolio with over 100 patents granted and another 100 filed, ensuring a competitive edge in the market [84] - The company plans to increase awareness of its technology through presentations at key industry events, such as the Heart Rhythm Society Meeting [22] Q&A Session Summary Question: Why pivot to cardiac? - Management indicated that the pivot was driven by physician feedback and promising preclinical outcomes, highlighting the significant market opportunity in cardiac applications [29][30] Question: How should success be viewed for Pulse Biosciences in 2023? - Success will be measured by advancing the cardiac clamp through the FDA regulatory path and completing catheter product milestones [31] Question: What was the significance of the AF Symposium poster? - The acceptance of the poster at the AF Symposium validated the technology and demonstrated interest from leading electrophysiologists [61]