Pulse Biosciences (PLSE) Enrolls Its First Patients in a Pivotal Atrial Fibrillation Trial

Pulse Biosciences, Inc. (NASDAQ:PLSE) is one of the must-buy small cap stocks to buy. On April 7, Pulse Biosciences, Inc. (NASDAQ:PLSE) announced that it had enrolled the first patients in NANOPULSE-AF. This is the company’s US clinical trial testing the nPulse Cardiac Catheter System as a treatment for occasional episodes of irregular heart rhythm that doesn’t respond to drugs, or what the company describes as drug-resistant, symptomatic paroxysmal atrial fibrillation.

According to the press release, the first seven patients were treated at St. Bernards Medical Center in Jonesboro, Arkansas. Dr. Devi Nair of the Arrhythmia Research Group, led the exercise and Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at New York’s Mount Sinai Fuster Heart Hospital, was the overall principal investigator for the study. The trial plans to enroll about 215 patients across up to 30 centers in the U.S. and Europe, and the primary safety and effectiveness endpoints will be measured at 6 and 12 months post-procedure, the company said.

This trial builds on encouraging results from a prior European first-in-human feasibility study. Here, the company achieved 100% acute success and 96% sustained procedural success at 12 months across 75 evaluable patients. The study achieved these outcomes without anti-arrhythmic drugs. The new US-based study follows the FDA’s grant of an investigational device exemption to Pulse Biosciences in December 2025. This nod gave the company regulatory clearance to begin the study.

Pulse Biosciences, Inc. (NASDAQ:PLSE) is a medical technology company. It develops bioelectric therapies using its proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology. The company is advancing its nPulse platform across multiple applications, including cardiac ablation, tumor treatment, and soft tissue procedures.

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