Business
Pulse Biosciences Reports Business Updates and First Quarter 2025 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 first quarter ended March 31, 2025.\n\nRecent Business Highlights\n\nSoft Tissue Ablation\n\n\nExpanded direct commercial resources for the launch of the nsPFA Percutaneous Electrode expected in the second half of 2025.\n\n\nThe Company expects to commence a U.S. clinical trial in mid-2025 to expand evidence for the nsPFA Percutaneous Electrode System as a treatment for benign thyroid nodules.\n\n\nSurgical AF Ablation\n\n\nReceived EU approval to expand the clinical protocol for the nsPFA Cardiac Surgery System multi-center, first-in-human atrial fibrillation (AF) feasibility study enabling the treatment of additional patients beyond the initial 30.\n\n\nContinuing to advance an IDE and remaining on track to receive approval to commence a pivotal clinical trial in mid-2025 to support a premarket approval (PMA) application for FDA approval as a treatment for AF.\n\n\nEndocardial Catheter AF Ablation\n\n\nClinical data on the catheter-based treatment of AF with the nsPFA 360° catheter were presented at the Heart Rhythm Society 2025 Meeting, demonstrating excellent procedure efficiency and acute outcomes.\n\n\nTreated 100 total patients in Europe with the nsPFA 360° catheter in the first-in-human feasibility study for the treatment of AF.\n\n\nThe Company expects to commence a U.S. IDE pivotal clinical study sometime in the middle of 2025.\n\n\n“We are pleased to be generating mounting clinical evidence that confirms the tremendous benefits of our nsPFA technology across each of our three devices,” said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. “I am excited by the progress we have made early in 2025. Pulse Biosciences is positioned to expand our commercial efforts and launch the nsPFA Percutaneous Electrode System in the second half of the year and commence IDEs for the nsPFA Cardiac Surgery System and nsPFA 360 Cardiac Catheter System both in mid-2025.”\n\nFirst Quarter 2025 Financial Results\n\nTotal GAAP costs and expenses, representing research and development and general and administrative expenses, for the three months ended March 31, 2025, were $18.0 ...