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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.
| 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?
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.
- 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 .