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 AF ablation is designed to deliver nanosecond PFA technology, targeting a $3 billion annual U.S. market for ablation catheters [40] Market Data and Key Metrics Changes - The U.S. sees approximately 250,000 patients diagnosed with benign thyroid nodules annually, with about 150,000 opting for thyroidectomy [25] - The market for atrial fibrillation treatment is significant, with over 1.9 million patients diagnosed annually in the U.S. [40] - The company expects nanosecond PFA to capture a significant share of the AF treatment market, expanding from 20% in 2024 to 40%-50% in 2025 [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 its differentiated technology across multiple clinical programs while maintaining operational excellence [53][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the unique nanosecond PFA technology's potential to disrupt multiple clinical applications and improve patient outcomes [11][12] - The company is optimistic about its growth trajectory, with a strong balance sheet and a commitment to advancing its clinical programs [10][21] - Management highlighted the importance of robust clinical evidence to drive adoption and validate the technology's effectiveness [45] Other Important Information - The company has received seven FDA clearances and has treated 6,000 patients, indicating a mature platform for future growth [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 strategies [50][53] Q&A Session Summary Question: What are the company's expectations for the commercialization of its products? - The company is focused on advancing the commercialization of its soft tissue ablation device and initiating pivotal studies for its cardiac catheter and surgical clamp [22] Question: How does the company plan to address the competitive landscape? - The company will implement a hybrid business model to efficiently enter markets, either through direct sales or partnerships with established companies [48][49] Question: What is the outlook for the nanosecond PFA technology? - Management expressed confidence in the technology's potential to disrupt multiple clinical applications and improve patient outcomes [11][12]