Pulse Biosciences Unveils Promising First-in-Human Data for nPulse

Pulse Biosciences PLSE recently reported encouraging late-breaking data from the first-in-human feasibility study of its nPulse Cardiac Surgical System. The study data were unveiled at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen. The device, which leverages Nanosecond Pulsed Field Ablation (nsPFA) energy, represents the first epicardial pulsed field ablation (PFA) surgical technology aimed at treating atrial fibrillation (AF).

AF remains one of the most common and challenging cardiac arrhythmias to treat, with limitations in current thermal ablation methods. The nsPFA approach offers a nonthermal alternative designed to minimize collateral damage while enabling more efficient procedures.

The early data sets a promising foundation for Pulse Biosciences’ cardiac ambitions. With its unique nanosecond PFA platform demonstrating safety, durability, and speed, the nPulse Cardiac Surgical System may provide a viable alternative to conventional ablation methods and broaden treatment options for AF patients worldwide.

The company also highlighted plans to initiate an Investigational Device Exemption (“IDE”) study in the United States later this year, marking a pivotal step toward regulatory approval and eventual commercialization. If subsequent trials confirm safety and efficacy, Pulse Biosciences could emerge as a first mover in surgical PFA, potentially reshaping the treatment landscape for atrial fibrillation.

Likely Market Impact

Shares of Pulse Biosceinces have gained 1.1% so far this year against the industry’s decline of 10.3%. The S&P 500 Index has gained 12.2% in the period.

The strong feasibility data are likely to generate investor optimism around Pulse Biosciences, as it marks a significant step toward clinical validation of its proprietary nPulse platform. Given the unmet need in atrial fibrillation treatment and the market’s appetite for disruptive technologies, shares of PLSE could see near-term upward momentum. Longer-term valuation support will depend on the initiation and success of the planned IDE study and the company’s ability to navigate regulatory pathways and scale commercialization.

Strong Early Clinical Outcomes

The feasibility study has so far treated 44 patients across leading Dutch centers, with electroanatomical mapping performed in 24 patients at the three-month follow-up mark. Results show a 94% pulmonary vein isolation success rate and 100% posterior box isolation success in the high-dose group. Importantly, no patients experienced esophageal or phrenic nerve damage, or other severe ablation-related complications — issues that have historically limited wider adoption of thermal ablation technologies.

The average ablation time was 50 seconds, requiring only 13 applications per patient, underscoring the potential for faster surgical workflows. These findings reinforce the system’s ability to deliver durable outcomes with a favorable safety profile, attributes that could position the nPulse system as a disruptive technology in surgical AF treatment.

Strategic Implications for Pulse Biosciences

Per a Grand View Research report, the global atrial fibrillation market size was estimated at $26.89 billion in 2024 and is projected to reach $65.33 billion by 2033, at a CAGR of 10.4% from 2025 to 2033. Atrial fibrillation is a major contributor to stroke and heart failure, making its early detection and effective management a key priority for healthcare systems. Its prevalence continues to rise, fueled by aging populations and the growing incidence of risk factors such as hypertension, diabetes and obesity. This expanding patient base is driving demand not only for pharmacological therapies but also for advanced interventional procedures.

For Pulse Biosciences, the study results validate its broader ambition of expanding nPulse technology into multiple clinical domains. While radiofrequency and cryoablation dominate current AF treatment paradigms, both approaches face limitations in safety and procedure times. By introducing a novel epicardial PFA solution, the company is positioning itself to carve out a niche, particularly in surgical settings where ablation adoption has been comparatively limited.

Pulse Biosciences, Inc Price

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PLSE’s Zacks Rank and Key Picks

Pulse Biosciences currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the broader medical space are Masimo MASI, ENDRA Life Sciences NDRA and Edwards Lifesciences EW, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Masimo shares have declined 12.5% so far this year. Estimates for the company’s 2025 earnings per share have increased 1.3% to $5.30 in the past 30 days. MASI’s earnings beat estimates in each of the trailing four quarters, the average surprise being 13.8%. In the last reported quarter, it posted an earnings surprise of 8.1%.

Estimates for ENDRA Life Sciences’ 2025 loss per share have narrowed 22.1% to $7.48 in the past 30 days. Shares of the company have gained 3.5% so far this year. NDRA’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 4.94%. In the last reported quarter, it delivered an earnings surprise of 24.67%.

Estimates for Edwards Lifesciences’ 2025 earnings per share have increased 0.8% to $2.51 in the past 30 days. Shares of the company have lost 0.1% so far this year. EW’s earnings yield of 3.39% also outpaces the industry’s -4.53%. Its earnings beat estimates in three of the trailing four quarters and met once, the average surprise being 5.50%.

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