Pulse Biosciences announced that the U.S. Food and Drug Administration granted an Investigational Device Exemption for its nPulse Cardiac Catheter Ablation System, enabling the company to launch the NANOPULSE‑AF study targeting paroxysmal atrial fibrillation. The single‑arm, multicenter trial will enroll up to 145 patients at 30 sites, including three international locations, and will evaluate the safety and effectiveness of the company’s nanosecond pulsed‑field ablation (nsPFA) technology for durable pulmonary vein isolation.
The approval marks a critical regulatory milestone for Pulse Biosciences, positioning the nsPFA platform closer to commercialization in the $3 billion U.S. atrial fibrillation catheter ablation market that is currently dominated by Boston Scientific and Medtronic. By demonstrating a non‑thermal ablation approach that delivers lower total energy and potentially reduces collateral injury, the company aims to offer electrophysiology laboratories a simpler, clinician‑friendly procedure that could improve safety and efficacy.
Management emphasized the significance of the milestone. Chief Medical Officer Dr. David Kenigsberg said the IDE approval “represents a critical next step—evaluating nanosecond pulsed field ablation across leading U.S. centers and select European sites to further improve safety and durable freedom from atrial arrhythmias.” CEO Paul LaViolette added that the approval “is a major milestone that validates our preclinical and early clinical data and signals confidence from the regulatory community in the potential of nsPFA to transform AF ablation.”
While the regulatory approval is a positive development, Pulse Biosciences’ financial profile remains challenging. In the third quarter of 2025, the company generated $86 thousand in revenue from a limited market release of its disposable products but posted a GAAP net loss of $19.4 million, driven by rising administrative expenses and stock‑based compensation. The company’s cash burn continues to accelerate, underscoring the need for additional capital to fund the clinical program and future commercialization.
The NANOPULSE‑AF study will provide the first prospective data on nsPFA safety and efficacy in a large, diverse patient population. Successful outcomes could accelerate the company’s path to pre‑market approval and open a new revenue stream in a highly competitive market. However, the company must navigate the substantial investment required to bring the technology to market while managing ongoing operating losses.
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