Pulse Biosciences, Inc. is a bioelectric medicine company specializing in health innovation through its patented Nano-Pulse Stimulation (NPS) technology. The company develops advanced medical devices that deliver nanosecond-duration electrical pulses to non-thermally ablate targeted cells while preserving surrounding tissue. Its primary focus is on leveraging this technology for applications in atrial fibrillation treatment and surgical soft tissue ablation.
- Nano-Pulse Stimulation (NPS) Technology - Delivers nanosecond-duration electrical pulses to ablate targeted cells non-thermally while sparing adjacent tissue, addressing unmet medical needs in healthcare.
- CellFX System - A proprietary nsPFA delivery platform initially commercialized for treating benign skin lesions, now focused on broader medical applications such as cardiology and surgical procedures.
- nsPFA Percutaneous Electrode System - A disposable needle electrode designed for precise nonthermal removal of cellular tissue, suitable for soft tissue ablation in surgical settings.
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| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Darrin R. Uecker ExecutiveBoard | Chief Technology Officer | Darrin R. Uecker has served as the Chief Technology Officer of Pulse Biosciences since September 2022. He has been a Director on the Board since September 2015 and previously served as CEO for seven years until September 2022. | ||
Paul A. LaViolette ExecutiveBoard | Chief Executive Officer and President | Managing Partner at SV Health Investors ; Director at Edwards Lifesciences ; Chairman of the Innovation Advisory Board at Mass General Brigham | Paul A. LaViolette has served as the CEO of Pulse Biosciences, Inc. since January 9, 2025 and as Co-Chairman of the Board since August 9, 2024, bringing over 40 years of global medical technology experience to the company. | |
Robert W. Duggan ExecutiveBoard | Executive Chairman of the Board of Directors | Co-Chief Executive Officer and Executive Chairman of Summit Therapeutics Inc. since February 2020; Chief Executive Officer of Duggan Investments, Inc. since 2016 | Robert W. Duggan has served as the Executive Chairman of the Board at PLSE since September 2022, following his initial appointment as Chairman in November 2017, and he is also the majority stockholder. | |
Jon Skinner Executive | Chief Financial Officer (CFO) | Jon Skinner was appointed as the Chief Financial Officer (CFO) of PLSE effective February 3, 2025, serving as the company’s principal financial officer with extensive experience in financial leadership roles at companies such as Copeland, Imperative Care, and Teleflex. | ||
Kevin P. Danahy Executive | Chief Executive Officer | Kevin P. Danahy has served as the Chief Executive Officer of Pulse Biosciences since September 20, 2022, after previously serving as the Chief Commercial Officer from February 9, 2022. He is known for his strategic leadership in advancing the company's commercial objectives. | ||
Mahkam Zanganeh Board | Director | Co-Chief Executive Officer of Summit Therapeutics Inc.; Founder/CEO of Maky Zanganeh and Associates | Mahkam Zanganeh, D.D.S., has served as a Director at PLSE since February 2017 and was appointed to the Strategic Advisory Committee in August 2024. | |
Manmeet S. Soni Board | Lead Independent Director | Chief Operating Officer of Summit Therapeutics, Inc. ; Member of the Board of Directors of Summit Therapeutics Inc. | Manmeet S. Soni has been a board member at PLSE since November 2017 and was appointed Lead Independent Director in March 2023. He also chairs the Audit Committee and serves on the Compensation Committee at PLSE. | |
Richard A. van den Broek Board | director | Managing Partner at HSMR Advisors, LLC; Director at Cogstate Ltd | Richard A. van den Broek has served as a director at PLSE since August 2020, bringing extensive biotechnology and global pharmaceutical market experience to the board. |
- How will management address the $7.7 million GAAP cost increase in Q4 2024, particularly the noncash stock-based compensation jump, while ensuring sustainable cost control as you scale your commercialization efforts?
- With the pilot program for the percutaneous electrode in benign thyroid nodules underway, what key metrics and timeline will you use to gauge market adoption and transition these accounts into consistent revenue streams?
- Given your dual strategy of direct commercialization for less complex markets and partnering for more competitive ones, how do you plan to allocate resources effectively while mitigating operational risks across these differing market approaches?
- As multiple clinical trials progress for both atrial fibrillation devices and soft tissue ablation, what measures will management take to balance clinical development with commercial ramp-up without diluting focus on either area?
- Considering the strong early data from your nanosecond PFA studies, what strategies do you have in place to ensure that these clinical outcomes translate into a competitive market advantage, especially against established technologies in both the electrophysiology and soft tissue segments?
Research analysts who have asked questions during PULSE BIOSCIENCES earnings calls.
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
The company sells ablation-based surgical and catheter-based medical devices for the treatment of heart arrhythmias, including atrial fibrillation (AF), and is actively developing or already has PFA products for the treatment of AF. These companies have greater financial, technical, research, and other resources, as well as larger and more established manufacturing capabilities and marketing, sales, and support functions. | |
The company offers ablation-based surgical and catheter-based medical devices for treating heart arrhythmias, including AF, and is actively developing or already has PFA products for AF treatment. They possess competitive advantages such as established relationships with healthcare professionals and distribution networks. | |
The company provides ablation-based surgical and catheter-based medical devices for heart arrhythmias, including AF, and is actively developing or already has PFA products for AF treatment. They have competitive products with greater efficacy or better safety profiles. | |
The company sells ablation-based surgical and catheter-based medical devices for heart arrhythmias, including AF, and is actively developing or already has PFA products for AF treatment. They have greater experience in obtaining patents and regulatory approvals for product candidates. | |
The company offers ablation-based surgical and catheter-based medical devices for heart arrhythmias, including AF, and is actively developing or already has PFA products for AF treatment. They have larger financial and human resources for product development, sales, and marketing. |
Recent press releases and 8-K filings for PLSE.
- Pulse Biosciences is commercializing its proprietary nanosecond pulsed field ablation (nsPFA) technology, which delivers ultra-precise nanosecond pulsed electric fields and offers significant advantages over microsecond PFA, including non-thermal, faster, and deeper ablations.
- The company reported a strong balance sheet with $95.2 million in cash at the end of Q3 and generated $86,000 in revenue during the quarter from the limited market release of its M-Pulse Vibrance percutaneous electrode system.
- Pulse Biosciences is targeting three initial market opportunities with its M-Pulse technology: benign thyroid nodules (a $1 billion annual market), surgical cardiac ablation, and AFib ablation in electrophysiology (a $3 billion opportunity), totaling a $6 billion opportunity today.
- Key clinical developments include the initiation of the PRECISE-BTN study for thyroid nodules (with over 40% enrollment to date) , the NANOCLAMP AF study for surgical cardiac ablation (with the first patient treated last month) , and plans to commence a pivotal trial for the M-Pulse Cardiac Catheter in EP in Q1 2026.
- The company plans a hybrid commercialization strategy, pursuing direct entry for markets like thyroid and seeking partnerships for larger, established markets such as electrophysiology.
- Pulse Biosciences reported a strong balance sheet with $95.2 million in cash at the end of Q3 2025 and generated $86,000 in revenue during the quarter from the limited market release of its FDA-cleared M-Pulse Vibrance percutaneous electrode system for soft tissue ablation.
- The company is commercializing its proprietary nanosecond pulsed field ablation (nsPFA) technology, which delivers higher amplitude, shorter duration pulses (nanoseconds) compared to microsecond PFA, enabling non-thermal, faster, and deeper ablations with remarkable clinical benefits.
- Pulse Biosciences is targeting three initial markets: the $1 billion annual thyroid intervention market, the underpenetrated surgical cardiac ablation market, and the $3 billion electrophysiology (AFib) market, with a combined potential of $6 billion today.
- Clinical studies are progressing, with the Precise BTN study for benign thyroid nodules over 40% enrolled (expected completion Q1 2026), the NanoClamp AF study for surgical cardiac ablation having treated its first patient, and the M-Pulse Cardiac Catheter IDE study for AFib expected to commence in Q1 2026.
- Pulse Biosciences is advancing its proprietary nanosecond pulsed field ablation (nsPFA) technology, M-Pulse, for tissue ablation, highlighting its advantages over microsecond PFA.
- The company reported a strong balance sheet with $95.2 million in cash at the end of Q3 and generated $86,000 in revenue in Q3 from the limited market release of its FDA-cleared M-Pulse Vibrance percutaneous electrode system.
- Pulse Biosciences is pursuing three significant market opportunities: thyroid intervention (a $1 billion annual market), cardiac surgery for AFib, and electrophysiology for AFib (a $3 billion opportunity), utilizing a hybrid direct and partnership strategy.
- Key clinical developments include the ongoing Precise BTN study for benign thyroid nodules (over 40% enrolled), the initiated NanoClamp AF study for surgical cardiac ablation, and the planned commencement of the pivotal trial for the M-Pulse Cardiac Catheter in Q1 2026.
- Pulse Biosciences reported total revenue of $86,000 for Q3 2025, marking initial revenues from the limited market release of its M-Pulse Vibrance percutaneous electrode system. The company recorded a GAAP net loss of $19.4 million and a non-GAAP net loss of $13.5 million for the quarter.
- As of September 30, 2025, cash and cash equivalents totaled $95.2 million. Cash used in operating activities during Q3 2025 was $13 million.
- The company received FDA investigational device exemption (IDE) approval for the M-Pulse cardiac surgical system (NanoClamp AF) for atrial fibrillation, with the first patient successfully enrolled and treated in the IDE study.
- Progress continues on the M-Pulse 360 catheter IDE submission for AF ablation, with the company expecting to resolve open items and commence the study in Q1. The PRECISE BTN clinical study for benign thyroid nodules is over 40% enrolled.
- Pulse Biosciences generated $86 thousand in total revenue for the third quarter ended September 30, 2025, primarily from the limited market release of its nPulse Vybrance percutaneous electrode system.
- For Q3 2025, the company reported a GAAP net loss of ($19.4) million and a Non-GAAP net loss of ($13.5) million.
- Cash and cash equivalents totaled $95.2 million as of September 30, 2025.
- Significant clinical and regulatory advancements include 40% enrollment in the PRECISE-BTN study for benign thyroid nodules, FDA IDE approval and initial subject enrollment for the nPulse Cardiac Surgery System Study (NANOCLAMP AF), and the submission of an FDA IDE application for endocardial catheter AF ablation, with a study commencing in Q1 2026.
- Pulse Biosciences reported total revenue of $86 thousand for the third quarter ended September 30, 2025.
- For the third quarter ended September 30, 2025, the company recorded a GAAP net loss of ($19.4) million and a Non-GAAP net loss of ($13.5) million.
- As of September 30, 2025, cash and cash equivalents totaled $95.2 million, with $13.0 million used in operating activities during the third quarter of 2025.
- The company initiated the PRECISE-BTN multi-center clinical study for benign thyroid nodules, enrolling 40% of study subjects, and received FDA IDE approval for the NANOCLAMP AF study for surgical AF ablation.
- Pulse Biosciences also submitted an FDA IDE application for its nPulse 360° catheter for endocardial AF ablation, with plans to commence an IDE study in Q1 2026.
- Pulse Biosciences has begun its NANOCLAMP AF clinical trial with the enrollment of the first patient, utilizing the FDA-approved nPulse Cardiac Surgical System for treating atrial fibrillation.
- The nPulse system, which received FDA breakthrough device status in July 2024, employs a novel nanosecond pulsed field ablation (nsPFA) technology designed to offer a nonthermal, precise, and efficient cardiac ablation method.
- Despite this clinical milestone, the company faces significant financial challenges, reporting no revenue or profitability, negative earnings per share, and negative operating margins.
- Pulse Biosciences has a market capitalization of approximately $1.17 billion with 67.3 million shares outstanding, leading analysts to maintain a cautious stance due to ongoing operational costs and lack of revenue.
- Pulse Biosciences, Inc. (PLSE) announced the first patient enrollment in its NANOCLAMP AF Study on October 24, 2025.
- The study is a single-arm, prospective multicenter trial designed to demonstrate the safety and effectiveness of the company's nPulse™ Cardiac Surgical System for treating atrial fibrillation during concomitant surgical procedures.
- The nPulse™ Cardiac Surgical System, which utilizes nanosecond Pulsed Field Ablation (nsPFA™) energy, was granted FDA Breakthrough Device Designation in July 2024.
- Pulse Biosciences (PLSE) announced the first patient enrollment in its NANOCLAMP AF Study for the treatment of atrial fibrillation (AF).
- The study utilizes the nPulse™ Cardiac Surgical System, which employs nonthermal Nanosecond Pulsed Field Ablation (nsPFA) energy, with the first procedure completed at St. Helena Hospital in California.
- The nPulse Cardiac Surgical System received FDA Breakthrough Device Designation in July 2024 and has recent FDA IDE approval, with the study designed to demonstrate its safety and effectiveness for AF treatment in concomitant surgical procedures.
- Pulse Biosciences, Inc. (PLSE) announced positive late-breaking clinical study results for its nPulse™ Cardiac Surgical System from a first-in-human feasibility study for Atrial Fibrillation.
- The study, which included an initial cohort of 24 patients evaluated at approximately three months post-ablation, demonstrated 100% acute success for posterior box isolations in the high-dose cohort and a 94% success rate for pulmonary vein isolation (PVI).
- Key safety findings reported no esophageal or phrenic nerve damage and no ablation-related severe or major adverse events.
- The company highlighted the system's efficiency with an average total ablation time of 50 seconds.
- Pulse Biosciences is on track to initiate an IDE study this year to clinically validate the nPulse Cardiac Surgical System.