Pulse Biosciences Enrolls First Patients in NANOPULSE-AF IDE Pivotal Clinical Study Evaluating nPulse™ Cardiac Catheter System for Atrial Fibrillation

Key Terms

investigational device exemption regulatory

An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.

paroxysmal atrial fibrillation medical

A heart rhythm problem in which the heart’s upper chambers suddenly start beating fast and irregularly in episodes that begin and stop on their own, typically lasting minutes to days. Like a car that occasionally skids on a patch of ice before regaining control, these episodes raise risks of stroke, hospital visits and ongoing treatment needs, so they matter to investors because they shape demand for drugs, devices, clinical trials, regulatory decisions and healthcare costs tied to companies in this market.

nanosecond pulsed field ablation medical

Nanosecond pulsed field ablation is a medical technique that uses extremely short, high‑voltage electrical pulses—each lasting billionths of a second—to selectively disable small areas of tissue, most often to treat irregular heart rhythms. Like a precise, ultra‑brief electric zap that spares surrounding structures, it matters to investors because it can shorten procedure time, reduce complications and recovery, and therefore reshape demand, pricing and adoption for cardiac ablation devices and related services.

pulmonary vein isolation medical

Pulmonary vein isolation is a medical procedure that treats a common heart rhythm problem by using targeted energy to block abnormal electrical signals coming from the veins that return blood from the lungs to the heart. Think of it like disconnecting a shorted wire so the rest of the electrical system runs normally. Investors care because the procedure drives demand for specific medical devices, hospital services and follow-up care, and shifts potential revenue and regulatory risk in companies that make the tools and technologies used.

electroanatomical mapping medical

A medical technique that builds a detailed 3D picture of the heart’s shape and its electrical activity, used during procedures to find and treat abnormal heart rhythms. Think of it as a GPS for the heart that helps doctors target therapy more precisely, which matters to investors because better mapping can improve procedure success, shorten operating time, raise adoption of specialized equipment, and influence revenue, regulation and reimbursement trends in cardiac device and services markets.

catheter mapping medical

Catheter mapping is a medical procedure that uses thin, flexible tubes inserted into blood vessels to record the heart’s electrical signals and build a detailed, real-time map of where abnormal rhythms originate—think of it as a GPS for the heart’s electrical system. It matters to investors because advances or approvals in mapping technology can drive demand for related devices and procedures, affect clinical success rates, and influence regulatory and reimbursement outcomes for companies in cardiac care.

ep mapping medical

EP mapping is a medical technique that creates a detailed map of the heart’s electrical signals to locate abnormal pathways that cause irregular heartbeats. For investors, it matters because the tools and software used for EP mapping drive demand for medical devices, affect procedure success and patient outcomes, and influence regulatory approvals, reimbursement and hospital adoption—similar to how a high-precision GPS can make a delivery system faster and more reliable.

pivotal trial medical

A pivotal trial is a key test of a new medicine or treatment to see if it works and is safe enough to be approved by health authorities. It's like a final exam for a new product, and passing it is essential for bringing the treatment to the public.

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U.S. IDE Enrollment follows groundbreaking 96% procedural success at 12 months in European feasibility study

HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of nPulse™ technology using proprietary nanosecond pulsed field ablation (nsPFA™) energy, today announced enrollment of the first patients in its NANOPULSE-AF study, a prospective, multicenter, IDE pivotal clinical investigation currently evaluating the nPulse™ Cardiac Catheter System for treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF).

The first seven patients in this study were treated at St. Bernards Medical Center in Jonesboro, Arkansas, under the leadership of Devi Nair, MD, Principal Investigator of the Arrhythmia Research Group. "This is a promising technology, and our team is pleased to have enrolled and treated the first patients in this pivotal trial," said Dr. Nair. “The performance of the nPulse System, combined with integrated catheter mapping using the investigational EnSite X software from Abbott, provides a very user-friendly experience and supports an efficient, reproducible and streamlined workflow. This approach may potentially offer important advantages compared with existing technologies. I look forward to continued enrollment and further clinical evaluation of this strategy in atrial fibrillation ablation for the betterment of all involved.”

“Enrolling the first patients in this study marks an important milestone for the Company as we build on the encouraging results from our impressive feasibility experience,” said Darrin Uecker, CTO and Board Member. “With our nanosecond pulsed field ablation technology and the cardiac catheter’s novel design, we are advancing an entirely differentiated approach that we intend to significantly alter AF treatments. We’re thrilled by this strong start to the NANOPULSE-AF study and look forward to its rapid expansion.”

This milestone builds on Pulse Biosciences’ first-in-human feasibility study, which showed 96% procedural success at 12 months and 100% acute success, exceeding expectations in a field where 20-25% recurrence is typical. Outcomes were reproducible across operators and achieved without anti-arrhythmic drugs.

“I am excited to initiate our IDE study with Dr. Nair, a leader in the EP ablation space. This marks an important advancing next step in the clinical development of our nanosecond PFA platform,” said David Kenigsberg, MD, FACC, FHRS, Chief Medical Officer of Pulse Biosciences. “Building on encouraging first-in-human data demonstrating safety, procedural efficiency, durable pulmonary vein isolation, and ease of use, our catheter is now tightly integrated with the Abbott EnSite X 3D electroanatomical mapping system, enabling accurate catheter visualization, navigation and contact assessment to support optimal PFA delivery. We look forward to rigorously evaluating this technology in this larger, multicenter setting at up to 30 centers in the United States and Europe.”

Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY is the Principal Investigator of the NANOPULSE-AF Study. “From the initial clinical experience, the nPulse™ system demonstrated meaningful potential in the treatment of atrial fibrillation,” said Dr. Reddy. “The NANOPULSE‑AF pivotal trial represents an important step forward in evaluating this technology and its potential role in improving procedural outcomes for patients with atrial fibrillation.”

The nPulse Cardiac™ Catheter System delivers energy in billionths of a second — nanoseconds — compared with conventional, slower microsecond-based systems. This ultra-fast, non-thermal energy is designed to create precise, durable PVI while minimizing impact to surrounding cardiac structures.

Key design features of the System include:

• Precise Lesion Formation: Creates deep, circumferential lesions without stacking applications or rotating the catheter.
• Efficient Workflow: Isolates pulmonary veins with minimal applications and ultra-fast delivery (~5 seconds per application).
• Procedure Efficiency: Prior feasibility study showed median left atrial dwell time of 21 minutes and total procedure time of approximately 65 minutes.
• Enhanced Visualization: Integrated magnetic EP mapping with catheter-embedded sensors compatible with Abbott’s EnSite X system for real-time 3D electroanatomical visualization to provide a stable location reference, constructing anatomical shells, and standardizing electrophysiological maps to guide therapy.

About the NANOPULSE-AF Study

The NANOPULSE-AF Study is a prospective, multicenter, non-randomized IDE pivotal clinical investigation designed to evaluate the safety and effectiveness of the CellFX nsPFA Cardiac Catheter System in patients with drug-resistant, symptomatic, paroxysmal atrial fibrillation. The Study plans to enroll approximately 215 participants across multiple clinical sites, with the first patients treated at St. Bernards Medical Center in Jonesboro, Arkansas, under the leadership of Dr. Nair. Primary endpoints will be assessed at 6 and 12 months post-ablation to measure procedural success and safety outcomes, supporting the broader clinical development of the nPulse™ system.

About Pulse Biosciences®

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the intention as well as potential to improve the quality of life for patients. The Company’s proprietary nPulse™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue as well as initiating regulated cell death. The Company is actively pursuing the development of its nPulse technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers, such as surgical soft tissue ablation.

Pulse Biosciences, nPulse, Vybrance, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements concerning early clinical successes and whether they are predictive of the safety and effectiveness of any medical device such as the nPulse™ Cardiac Catheter System, Pulse Biosciences’ expectations, whether stated or implied, about whether the Company’s nsPFA technology will become either a disruptive treatment option or a superior option for treating atrial fibrillation or any other medical condition, statements about its expectations for the NANOPULSE-AF study such as any projections about enrollment, statements relating to the effectiveness of the Company’s nsPFA technology and nPulse System to non-thermally clear cells while sparing adjacent non-cellular tissue, statements concerning the Company’s expected product development efforts, such as advancement of its nPulse™ Cardiac Catheter to treat paroxysmal atrial fibrillation, statements concerning whether any clinical study will show that the Company’s novel nsPFA mechanism of action and catheter design will deliver durable pulmonary vein isolation or fast and precise ablations in cardiac tissue and streamline workflow, statements concerning market opportunities, customer adoption and future use of the nPulse System to address a range of conditions such as atrial fibrillation, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260407611763/en/

ICR Healthcare
Maggie Turano, Account Director
PulsebioPR@icrhealthcare.com

Investors:
Pulse Biosciences, Inc.
Jon Skinner, CFO
IR@pulsebiosciences.com

Or

Gilmartin Group
Philip Trip Taylor
415.937.5406
philip@gilmartinir.com

Source: Pulse Biosciences, Inc.