Business
Pulse Biosciences Reports Business Updates and Fourth Quarter & Full Year 2024 Financial Results
HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™
About this update from Pulse Biosciences, Inc
[{"type":"text","content":" HAYWARD, Calif.--(BUSINESS WIRE)--\nPulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) technology, today announced business updates and financial results for the fourth quarter and full year ended December 31, 2024.\n\nRecent Business Highlights\n\nSoft Tissue Ablation\n\n\nAnnounced positive preliminary results from its first-in-human feasibility study using Nanosecond Pulsed Field Ablation technology for the treatment of benign thyroid nodules at the North American Society for Interventional Thyroidology Annual Meeting.\n\n\nAdvanced pilot program optimizing therapy delivery with 8 centers in the U.S. that are expected to begin commercial use of the system over the next several months.\n\n\nThe Company expects to commence a U.S. clinical trial in mid-2025, informed by the ongoing U.S. pilot program, and evaluate the Percutaneous Electrode System as a treatment for benign thyroid nodules.\n\n\nSurgical AF Ablation\n\n\nPublished a preclinical study in the Journal of Thoracic and Cardiovascular Surgery demonstrating the advantages of the nsPFA Cardiac Surgery System over radiofrequency technology for the ablation of cardiac tissue.\n\n\nTreated 30 patients and opened a second study site as part of the multi-center, first-in-human atrial fibrillation (AF) feasibility study underway in Europe.\n\n\nThe Company expects to submit an IDE, enabling it to commence its pivotal clinical trial in mid-2025 to support a premarket approval (PMA) application for FDA approval to commercialize the nsPFA Cardiac Surgery System in the United States, specifically as a treatment for AF.\n\n\nEndocardial Catheter AF Ablation\n\n\nPositive late-breaking clinical data was released from the Nanosecond PFA 360° Cardiac Catheter System first-in-human feasibility study, at the 30th Annual AF Symposium 2025 meeting.\n\n\nTreated over 80 patients with the Nanosecond PFA 360° Cardiac Catheter System from the first-in-human feasibility study for the treatment of AF being conducted in Europe.\n\n\nAppointed David Kenigsberg, M.D. as Chief Medical Officer of Electrophysiology\n\n\nThe Company expects to commence a U.S. IDE pivotal clinical study sometime in the middle of 2025.\n\n\nFinancial & Corporate Updates\n\n\nStrengthened the balance sheet raising $47.9 mill...