Pulse Biosciences Inc. (PLSE) has taken a major step forward in its atrial fibrillation program, enrolling the first patients in its pivotal U.S. Investigational Device Exemption (IDE) study, NANOPULSE-AF.
The milestone follows groundbreaking 96% procedural success at 12 months in the company's European first-in-human feasibility study, where the nPulse Cardiac Catheter System delivered durable pulmonary vein isolation without the need for anti-arrhythmic drugs.
Atrial fibrillation, one of the most common heart rhythm disorders, often requires catheter ablation when medications fail. Traditional thermal ablation methods can be time-consuming and may affect surrounding heart tissue. Pulse Biosciences aims to change that with its nanosecond pulsed field ablation (nsPFA) technology- a non-thermal, ultra-fast energy approach designed to precisely target cardiac tissue while minimizing collateral damage.
The first seven patients in the pivotal study were treated at St. Bernards Medical Center in Jonesboro, Arkansas, under the direction of Dr. Devi Nair, Principal Investigator of the Arrhythmia Research Group. Dr. Nair noted that the system's performance, combined with integrated mapping using Abbott's investigational EnSite X software, created a streamlined and user-friendly workflow that may offer advantages over existing ablation technologies.
The NANOPULSE-AF study is a prospective, multicenter pivotal investigation evaluating the safety and effectiveness of the nPulse Cardiac Catheter System in adults with drug-resistant, symptomatic paroxysmal atrial fibrillation. The trial plans to enroll approximately 215 participants across up to 30 centers in the United States and Europe. Primary endpoints will be assessed at six and twelve months to measure procedural success and safety outcomes.
Pulse Biosciences' Chief Technology Officer, Darrin Uecker, said the first patient enrollment marks an important step as the company builds on its early feasibility results. Those initial findings showed 100% acute success, reproducible outcomes across operators, and durable pulmonary vein isolation- performance that exceeded expectations in a field where recurrence rates of 20-25% are typical.
The company's nPulse system delivers energy in billionths of a second- far faster than conventional microsecond-based pulsed field ablation systems. According to the company, this design enables precise, circumferential lesion creation without the need for catheter rotation or stacked applications. In the feasibility study, the system achieved a median left atrial dwell time of 21 minutes and a total procedure time of about 65 minutes. The catheter is also integrated with Abbott's EnSite X 3D mapping platform, allowing real-time visualization and navigation to support consistent therapy delivery.
Dr.Vivek Reddy of the Mount Sinai Fuster Heart Hospital, who serves as the global Principal Investigator for the pivotal trial, said the early clinical experience suggests meaningful potential for the technology in treating atrial fibrillation. Pulse Biosciences' Chief Medical Officer, Dr. David Kenigsberg, added that the pivotal study represents a critical next step in evaluating the platform in a larger, multicentre setting.
Pulse Biosciences continues to position its nsPFA technology as a differentiated, non-thermal approach that could streamline workflow and improve outcomes in cardiac ablation. The company is also exploring additional applications for its nPulse platform in other soft-tissue ablation markets.
PLSE has traded between $12.56 and $26.30 over the past year. The stock closed Tuesday's trading at $19.96, down 12.99%. In pre-market trading the stock is trading at $21.20, up 6.21%.
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