Pulse Biosciences(US:PLSE)2025-03-27 23:46Financial 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]