Pulse Biosciences Releases Cardiac Catheter Clinical Data
Pulse Biosciences announced late-breaking clinical data from the nPulse Cardiac Catheter first-in-human feasibility study. The study demonstrates successful treatment of atrial fibrillation in 150 patients with rapid procedure times and minimal adverse effects. The data were presented today at the 31st Annual AF Symposium 2026 meeting, taking place February 5-7, 2026, in Boston, MA. "These 6- and 12-month data demonstrate a strong safety profile with highly effective and durable PVI achieved with the nPulse Cardiac Catheter Ablation System, suggesting that this system has the ability to considerably advance the treatment of atrial fibrillation (AF)," said Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY. "The conformable catheter design, differentiated energy, and zero rotation workflow have produced highly efficient and effective results when compared to other AF feasibility studies in my experience, highlighting the nPulse Cardiac Catheter's simple and effective workflow for PVI." The ongoing feasibility study is assessing the initial safety and efficacy of the nPulse Cardiac Catheter System for the treatment of AF. To date, a total of 165 patients have been treated by nine investigators in Europe, including the Na Homolce Hospital in Prague led by Dr. Vivek Reddy and Prof. Petr Neuzil, Jessa Hospital in Hasselt led by Dr. Johan Vijgen, and Tor Vergata Hospital in Rome, led by Dr. Andrea Natale. The initial cohort of treated patients has been evaluated by remapping at ~3 months and for rhythm control completed at 6 and 12 months post ablation procedure.
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- Clinical Data Release: Pulse Biosciences presented clinical data for its nPulse cardiac catheter at the 2026 AF Symposium, successfully treating 150 patients with atrial fibrillation, showcasing rapid procedure times and minimal adverse effects, highlighting the technology's potential in atrial fibrillation treatment.
- Study Results Validation: The results from a study of 165 patients validated the safety and efficacy of the nPulse catheter system, with CEO Paul LaViolette noting its clear advantages in lesion quality and speed, potentially establishing it as a first-in-class system.
- Optimistic Treatment Outlook: The data suggest that the nPulse catheter could reduce atrial fibrillation recurrence rates, typically ranging from 20-25%, as Pulse Biosciences prepares to treat additional patients in the U.S. and Europe, initiating a pivotal IDE study.
- Strong Stock Performance: Pulse Biosciences saw trading volume surge to 1.68 million shares, significantly above the average of 183,000 shares, with the stock price rising 38.02% to $14.95, indicating a strong bullish setup and potential breakout above the $20 resistance level.
- Dow Jones Performance: The Dow Jones index rose over 700 points on Friday, indicating a strong market rebound that reflects investor optimism about economic recovery, which could further drive consumer spending and investment.
- Strategic Shares Surge: Strategy shares jumped 14.1% to $122.56 on Friday, signaling a positive market outlook for the company and potentially attracting more investor interest in its future growth prospects.
- Overall Market Trend: The overall rise in U.S. stocks suggests a restoration of investor confidence, which may lead to increased capital inflows into the stock market, thereby promoting economic growth and corporate earnings.
- Market Data Source: This market update is provided by Benzinga APIs, highlighting improved market information transparency that aids investors in making more informed decisions.
- Clinical Study Results: Pulse Biosciences successfully treated 150 patients with atrial fibrillation in its first-in-human feasibility study of the nPulse cardiac catheter, demonstrating rapid procedure times and minimal adverse effects, indicating significant potential for this technology in cardiac treatment.
- Safety and Efficacy: The findings reveal a strong safety profile and durable pulmonary vein isolation at 6 and 12 months, exceeding expectations for atrial fibrillation treatment and suggesting a potential shift in treatment standards within the field.
- International Collaboration: A total of 165 patients have been treated under the guidance of nine investigators across Europe, showcasing the technology's potential for international application and furthering Pulse Biosciences' expansion in the global market.
- Future Development Plans: The company aims to initiate pivotal IDE studies in the U.S. and Europe, intending to revolutionize atrial fibrillation treatment through nanosecond pulsed field ablation technology, ultimately enhancing patient quality of life.
- Clinical Success Rate: The nPulse cardiac catheter achieved a 100% procedural success rate at 6 months and 96% at 12 months among 150 patients, demonstrating the technology's effectiveness and durability in treating atrial fibrillation.
- Efficiency Improvement: The average number of applications per procedure was 16.1, with total procedure times averaging 65 minutes and fluoroscopy times at 9.8 minutes, indicating significant efficiency gains over traditional methods.
- Strong Safety Profile: Only 1.3% of the 150 subjects experienced serious adverse events related to the primary safety endpoint, underscoring the system's safety and enhancing confidence in its clinical application.
- Broad Market Potential: The Chief Medical Officer of Pulse Biosciences noted that the nPulse technology has the potential to revolutionize atrial fibrillation treatment, with plans to expand patient treatment in Europe and the U.S., thereby increasing market adoption.
- Conference Participation: Pulse Biosciences is scheduled to present on January 14, 2026, at the J.P. Morgan Healthcare Conference in San Francisco, showcasing its innovative nPulse™ technology, which is expected to attract attention from investors and the healthcare industry, thereby enhancing the company's visibility in the bioelectric medicine sector.
- Technology Introduction: The company leverages its proprietary Nanosecond Pulsed Field Ablation (nsPFA™) technology to non-thermally clear cells while sparing adjacent noncellular tissue, demonstrating its potential in treating atrial fibrillation and possibly improving patients' quality of life significantly.
- Market Prospects: Pulse Biosciences is actively pursuing the development of its nPulse technology for use in atrial fibrillation and other markets, which, if successful, could lead to substantial health improvements for both healthcare providers and patients, further driving the company's strategic growth in medical innovation.
- Investor Relations: The company will provide a live and recorded webcast of the presentation on its investor website, enhancing interaction with investors and increasing transparency, which may attract more investor interest and trust.

Regulatory Approval: Pulse Biosciences received FDA approval for its nPulse Cardiac Catheter Ablation System, which has positively impacted its stock price, showing a 17.29% return over the past month.
Valuation Concerns: Despite a strong three-year total shareholder return of over 500%, Pulse Biosciences is considered overvalued with a price-to-book ratio of 11.2, significantly higher than industry peers.
Market Sentiment: The current high valuation reflects market optimism about future growth potential, but ongoing losses and potential setbacks could reverse this positive sentiment.
Investment Opportunities: The article suggests exploring other healthcare stocks and highlights various investment themes, including penny stocks and dividend stocks, for potential growth and income strategies.









