Pulse Biosciences, Inc. operates as an immuno-oncology company developing a proprietary oncolytic electroceutical therapy based on its Nano Pulse Stimulation (NPS) technology. It manufactures surgical and medical instruments uses a novel and proprietary platform technology called Nano-Pulse Electro-Signaling. The NPES provides local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic apoptosis of the cells. The company was founded on May 19, 2014 and is headquartered in Hayward, CA.
Clinical Trials
15
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2014
Completed
7
46.7%
Recruiting
6
40.0%
Terminated
2
13.3%
No approval data available
- Pulse Biosciences has surpassed the enrollment midpoint in its 215-patient NANOPULSE-AF IDE pivotal study, which commenced in April 2026, with full enrollment targeted for early Q4 2026. - The single-arm, multicenter trial is evaluating the nPulse nanosecond pulsed field ablation system in patients with recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation. - Investigators cite the system's intuitive platform, minimal learning curve, and seamless workflow integration as key drivers of the rapid enrollment trajectory. - The trial's primary safety and effectiveness endpoints will provide the first controlled clinical data at scale for Pulse's nsPFA technology amid a competitive landscape that includes Abbott's recently approved Volt PFA system.
- Pulse Biosciences received FDA approval for an investigational device exemption study of its nanosecond pulsed field ablation catheter to treat drug-resistant paroxysmal atrial fibrillation. - The company launched a collaboration with MD Anderson Cancer Center to investigate its nPulse technology for treating papillary thyroid microcarcinoma in a first-in-human clinical feasibility study. - The nanosecond pulsed field ablation technology delivers briefer electrical pulses than existing microsecond systems, potentially offering advantages in reducing tissue damage and improving treatment outcomes. - Both studies represent significant advances in minimally invasive ablation techniques, with the cardiac study expected to report data in 2026 and the thyroid cancer study beginning enrollment in early 2026.
- Pulse Biosciences received FDA Breakthrough Device Designation for its Cardiac Surgery System and Investigational Device Exemption approval, enabling clinical studies in atrial fibrillation patients. - The company is pursuing a Premarket Approval (PMA) pathway for its nsPFA technology, targeting the $5 billion atrial fibrillation market projected by 2030. - With $119.3 million in cash reserves extending through mid-2026, Pulse plans to initiate pivotal trials in mid-2025 while expanding European commercial operations. - The company's nanosecond Pulsed Field Ablation platform shows promise in both cardiac surgery and benign thyroid nodule treatment applications.
