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, 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.
- Pulse Biosciences announced positive late-breaking clinical study results from the nPulse™ Cardiac Surgical System first-in-human feasibility study for the treatment of Atrial Fibrillation (AF) at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting.
- The study, which has treated 44 patients to date, showed that in the initial 24 patients evaluated at approximately three months, there was 100% acute success for posterior box isolations in the high-dose cohort and a 94% success rate for pulmonary vein isolation (PVI) per vein.
- Key findings highlighted no reports of esophageal or phrenic nerve damage and no ablation-related severe or major adverse events, with an average total ablation time of 50 seconds.
- Pulse Biosciences states it is the first company to bring Pulsed Field Ablation (PFA) into the cardiac surgical field for AF treatment and plans to initiate an IDE study this year to clinically validate the system.
- Pulse Biosciences (PLSE) will present early clinical data for its nPulse™ Cardiac Surgical System at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting, taking place from October 8-11th, 2025, in Copenhagen, Denmark.
- The nPulse™ Cardiac Surgical System uses Nanosecond Pulsed Field Ablation (nsPFA™) energy for the treatment of atrial fibrillation (AF).
- The FDA recently approved an IDE study for the nPulse™ Cardiac Surgical System, which Co-Chairman and CEO Paul LaViolette noted as a significant development milestone.
- Pulse Biosciences (PLSE) reported a strong balance sheet with over $100 million in cash at the end of the quarter, supporting its plan to execute two Investigational Device Exemptions (IDEs) and an expanded pilot launch. The company has invested almost $400 million in its nanosecond PFA (NSPFA) technology and clinical applications.
- The company's proprietary NSPFA technology offers a thousand-fold faster pulse duration compared to other PFA technologies, enabling deeper lesions with less energy and avoiding neuromuscular stimulation, which is a key differentiator in its target markets.
- Pulse Biosciences is pursuing a hybrid market entry strategy for its three target indications—thyroid intervention, cardiac surgery, and EP ablation—which represent a current $6 billion market opportunity expected to more than double. The company is currently in an active pilot with about 10 centers for its thyroid indication, aiming to provide a less invasive alternative for 150,000 annual surgical removals in the US.
- The company expects to receive FDA approval for its IDEs and commence pivotal studies for both its cardiac surgery and EP ablation programs, which have breakthrough designations, between now and 2025.
- Financial Performance: Q1 2025 saw a GAAP net loss of $16.8M and non-GAAP net loss of $11.4M with GAAP expenses rising to $18M (up from $10.6M), while the cash position strengthened to $119.3M through warrant exercise proceeds.
- Clinical and Commercial Advancements: Achieved FDA clearances for soft tissue applications with early clinical successes in benign thyroid disease and atrial fibrillation treatments using nsPFA technology.
- Expansion of Clinical Studies: Feasibility studies in Europe for the nsPFA 360 catheter and surgical clamp reported high acute and durable pulmonary vein isolation rates, paving the way for pivotal IDE trials.
- Additional nsPFA Progress: Updates include advancements in soft tissue ablation, AF catheter ablation, and EU approval to expand the AF study.
- Future Product Plans: Launching the nsPFA Percutaneous Electrode in H2 2025 and initiating U.S. clinical trials for both the nsPFA Cardiac Surgery and 360° Cardiac Catheter Systems.
- Management Changes: Appointed CEO Paul LaViolette (now Co-Chairman) with extensive med tech experience and CFO Jon Skinner to drive commercialization and financial discipline .
- Financial Performance: Reported a GAAP net loss of $19.4M for Q4 2024 and ended with $118M in cash, including $47.9M from warrant exercises, strengthening the balance sheet .
- Clinical Progress: Advanced its nsPFA platform with encouraging clinical data for treatments in atrial fibrillation and benign thyroid nodules, highlighting strong market potential .
- Clinical Development: Updated on soft tissue ablation, surgical AF ablation, and endocardial catheter ablation studies, with plans to initiate U.S. clinical trials in mid-2025 .