PLSE Wins FDA IDE Approval to Launch nPulse AF Ablation Study Trial

Core Insights - Pulse Biosciences (PLSE) has received FDA Investigational Device Exemption (IDE) approval to initiate a study for its nPulse Cardiac Catheter Ablation System aimed at treating paroxysmal atrial fibrillation, marking a significant regulatory milestone for the company [1][4] Company Developments - The IDE approval allows PLSE to commence a multicenter clinical trial, the NANOPULSE-AF study, which will enroll up to 145 patients across 30 sites to evaluate the safety and effectiveness of its nsPFA technology [8][9] - PLSE's nsPFA technology is designed to use lower energy and create single-shot lesions, which could simplify workflows and reduce procedure times [10] - The company has a current market capitalization of $966.4 million [6] Clinical and Market Outlook - The FDA IDE approval strengthens PLSE's position in the fast-growing atrial fibrillation ablation market, which is projected to grow from $26.89 billion in 2024 to $65.33 billion by 2033, with a CAGR of 10.44% from 2025 to 2033 [12] - Encouraging clinical data from ongoing European studies, where 150 patients have been enrolled, supports the U.S. study and helps mitigate risks [11] Competitive Positioning - PLSE's differentiated nanosecond pulsed field ablation technology is expected to reduce collateral damage compared to traditional microsecond systems, potentially enhancing safety and procedural efficiency [10][11] - The successful execution of the study could lead to pivotal clinical data that supports regulatory approval and drives physician adoption, establishing PLSE as a next-generation ablation platform [4][11]