Pulse Biosciences Receives FDA Approval for Cardiac Catheter Ablation Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 18 2025
0mins
Should l Buy PLSE?
Pulse Biosciences announced that the FDA has granted approval for the company's Investigational Device Exemption, allowing Pulse Biosciences to proceed with the initiation of its nPulse Cardiac Catheter Ablation System Study for the treatment of paroxysmal atrial fibrillation.
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Analyst Views on PLSE
Wall Street analysts forecast PLSE stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for PLSE is 22.00 USD with a low forecast of 22.00 USD and a high forecast of 22.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 14.040
Low
22.00
Averages
22.00
High
22.00
Current: 14.040
Low
22.00
Averages
22.00
High
22.00
About PLSE
Pulse Biosciences, Inc. is a bioelectric medicine company. The Company’s CellFX Nanosecond Pulsed-Field Ablation (nsPFA) technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. It is pursuing the development of its CellFX nsPFA technology for use in the treatment of atrial fibrillation (AF) 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. Its nsPFA Percutaneous Electrode System consists of a disposable, percutaneous, needle electrode for use with its CellFX Console. Its surgical cardiac ablation clamp is designed for use by cardiac surgeons during the surgical treatment of AF. The CellFX Console is a tunable, software-enabled, console-based platform, designed to accommodate the clinical workflow preferred by physicians. It is also developing a Nanosecond PFA 360-degree Cardiac Catheter System.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Pulse Biosciences to Present at 2026 J.P. Morgan Healthcare Conference
- 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.
See More
Pulse Biosciences (PLSE): Evaluating Valuation Following FDA IDE Approval for nPulse Cardiac Ablation Study
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.
See More
Pulse Biosciences Grants Equity Awards for 3,400 Shares to New Employees
- Equity Incentive Plan: On December 15, 2025, Pulse Biosciences granted equity awards totaling 3,400 shares to two new employees, aimed at attracting talent and enhancing the company's competitive edge in accordance with Nasdaq listing rules.
- Exercise Price Setting: The granted stock options have an exercise price of $14.13 per share, equal to the closing price on the grant date, a strategy that helps ensure alignment between employee interests and company performance.
- Long-term Incentive Mechanism: All stock options will vest over four years based on the employees' continued employment, with 1/4 vesting annually, designed to improve employee retention and incentivize long-term contributions.
- Technological Background: Pulse Biosciences focuses on its proprietary nPulse™ technology aimed at improving patient quality of life, and the implementation of equity incentives will help attract more talent to drive technology development and market expansion.
See More
Market Update: Health Care Stocks Show Varied Performance Ahead of Thursday's Opening Bell
Health Care Stocks Performance: Health care stocks showed mixed results before the market opened on Thursday.
State Street Health Care Select Sector: The State Street Health Care Select Sector SPDR was mentioned in relation to the performance of health care stocks.
See More
Pulse Biosciences Receives FDA Approval for Cardiac Ablation Study Using nPulse Technology
- FDA Approval: Pulse Biosciences has received FDA approval to initiate the nPulse Cardiac Catheter Ablation System study aimed at treating drug-resistant paroxysmal atrial fibrillation, marking a significant advancement in cardiac treatment.
- Study Scale: The study plans to enroll up to 145 patients across 30 centers, including three outside the U.S., demonstrating the company's potential for global expansion and confidence in its new technology.
- Technological Advantage: The nPulse technology utilizes nanosecond pulsed field ablation, significantly reducing energy requirements and minimizing damage to surrounding tissues, which could set a new standard for safety and effectiveness in atrial fibrillation ablation.
- Clinical Outlook: The ongoing feasibility study in Europe has enrolled 150 patients, with positive initial outcomes supporting a strong foundation for the global adoption of nsPFA treatments.
See More
Pulse Biosciences Partners with MD Anderson for Thyroid Cancer Clinical Study
- Clinical Research Collaboration: Pulse Biosciences has partnered with MD Anderson Cancer Center to initiate a clinical study for papillary thyroid microcarcinoma in early 2026, aiming to enroll 30 patients to evaluate the safety and efficacy of its nPulse technology, potentially offering new treatment options for hundreds of thousands of U.S. patients.
- FDA Approval: The company has received FDA approval for its first-in-human clinical feasibility study, marking a significant advancement for its nPulse Vybrance Electrode System in treating thyroid cancer, which could significantly enhance patient survival rates.
- Technological Advantage: The nPulse technology operates through a non-thermal mechanism, enabling precise removal of cellular tissue without damaging surrounding structures, positioning it as a potentially transformative treatment for both benign and malignant thyroid tumors, which may change existing treatment paradigms.
- Preclinical Studies: Under an existing material transfer agreement, Pulse Biosciences is conducting preclinical studies with MD Anderson researchers on anaplastic thyroid carcinoma, which has a five-year survival rate of less than 5%, highlighting the technology's potential in addressing deadly cancers.
See More
Pulse Biosciences to Present at 2026 J.P. Morgan Healthcare Conference
- 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.
See More
Pulse Biosciences (PLSE): Evaluating Valuation Following FDA IDE Approval for nPulse Cardiac Ablation Study
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.
See More
Pulse Biosciences Grants Equity Awards for 3,400 Shares to New Employees
- Equity Incentive Plan: On December 15, 2025, Pulse Biosciences granted equity awards totaling 3,400 shares to two new employees, aimed at attracting talent and enhancing the company's competitive edge in accordance with Nasdaq listing rules.
- Exercise Price Setting: The granted stock options have an exercise price of $14.13 per share, equal to the closing price on the grant date, a strategy that helps ensure alignment between employee interests and company performance.
- Long-term Incentive Mechanism: All stock options will vest over four years based on the employees' continued employment, with 1/4 vesting annually, designed to improve employee retention and incentivize long-term contributions.
- Technological Background: Pulse Biosciences focuses on its proprietary nPulse™ technology aimed at improving patient quality of life, and the implementation of equity incentives will help attract more talent to drive technology development and market expansion.
See More
Market Update: Health Care Stocks Show Varied Performance Ahead of Thursday's Opening Bell
Health Care Stocks Performance: Health care stocks showed mixed results before the market opened on Thursday.
State Street Health Care Select Sector: The State Street Health Care Select Sector SPDR was mentioned in relation to the performance of health care stocks.
See More
Pulse Biosciences Receives FDA Approval for Cardiac Ablation Study Using nPulse Technology
- FDA Approval: Pulse Biosciences has received FDA approval to initiate the nPulse Cardiac Catheter Ablation System study aimed at treating drug-resistant paroxysmal atrial fibrillation, marking a significant advancement in cardiac treatment.
- Study Scale: The study plans to enroll up to 145 patients across 30 centers, including three outside the U.S., demonstrating the company's potential for global expansion and confidence in its new technology.
- Technological Advantage: The nPulse technology utilizes nanosecond pulsed field ablation, significantly reducing energy requirements and minimizing damage to surrounding tissues, which could set a new standard for safety and effectiveness in atrial fibrillation ablation.
- Clinical Outlook: The ongoing feasibility study in Europe has enrolled 150 patients, with positive initial outcomes supporting a strong foundation for the global adoption of nsPFA treatments.
See More
Pulse Biosciences Partners with MD Anderson for Thyroid Cancer Clinical Study
- Clinical Research Collaboration: Pulse Biosciences has partnered with MD Anderson Cancer Center to initiate a clinical study for papillary thyroid microcarcinoma in early 2026, aiming to enroll 30 patients to evaluate the safety and efficacy of its nPulse technology, potentially offering new treatment options for hundreds of thousands of U.S. patients.
- FDA Approval: The company has received FDA approval for its first-in-human clinical feasibility study, marking a significant advancement for its nPulse Vybrance Electrode System in treating thyroid cancer, which could significantly enhance patient survival rates.
- Technological Advantage: The nPulse technology operates through a non-thermal mechanism, enabling precise removal of cellular tissue without damaging surrounding structures, positioning it as a potentially transformative treatment for both benign and malignant thyroid tumors, which may change existing treatment paradigms.
- Preclinical Studies: Under an existing material transfer agreement, Pulse Biosciences is conducting preclinical studies with MD Anderson researchers on anaplastic thyroid carcinoma, which has a five-year survival rate of less than 5%, highlighting the technology's potential in addressing deadly cancers.
See More
