Pulse Biosciences Unveils Promising First-in-Human Data for nPulse

Core Insights - Pulse Biosciences (PLSE) has reported promising late-breaking data from its nPulse Cardiac Surgical System, which utilizes Nanosecond Pulsed Field Ablation (nsPFA) technology for treating atrial fibrillation (AF) [1][3][8] - The feasibility study demonstrated a 94% success rate in pulmonary vein isolation and 100% in posterior box isolation, with no major complications reported [10][11] - The company plans to initiate an Investigational Device Exemption (IDE) study in the U.S. to advance toward regulatory approval and commercialization [4][9] Company Developments - The nPulse Cardiac Surgical System represents a novel approach to AF treatment, offering a nonthermal alternative that minimizes collateral damage compared to traditional thermal ablation methods [2][3] - The feasibility study involved 44 patients, with electroanatomical mapping showing significant safety and efficacy outcomes, reinforcing the system's potential as a disruptive technology in surgical AF treatment [10][11] - The average ablation time was recorded at 50 seconds, indicating a potential for faster surgical workflows [11] Market Context - The global atrial fibrillation market is projected to grow from $26.89 billion in 2024 to $65.33 billion by 2033, with a compound annual growth rate (CAGR) of 10.4% from 2025 to 2033 [12] - The increasing prevalence of AF, driven by aging populations and risk factors such as hypertension and diabetes, is creating a demand for advanced interventional procedures [12][13] - Pulse Biosciences aims to position itself in the market by addressing the limitations of existing radiofrequency and cryoablation methods, particularly in surgical settings [13]