PLSE News & Events

Pulse Biosciences announced a new strategic alignment to prioritize and accelerate the development and future commercialization of its nPulse Cardiac Catheter Ablation System. "The European feasibility data from over 150 patients sends a definitive message," said Bob Duggan, co-chairman of Pulse Biosciences. "The nPulse clinical performance demonstrates a clear potential to change clinical practice for the health treatment of millions of patients. Our mission to support this program deserves our highest priority, and we are updating our capital allocation to align with this extraordinary opportunity." This initiative follows the announcement of clinical outcomes from the company's 150-patient European feasibility study, which demonstrated that nsPFA delivers a unique combination of speed, safety, and long-term durable efficacy in treating Atrial Fibrillation. The company said, "The decision to centralize resources on the Cardiac Catheter program is backed by data recently presented at the 31st Annual AF Symposium, which positions nPulse as a best-in-class solution: 100% Procedural Success at 6 Months: 75/75 evaluable patients achieved acute Pulmonary Vein Isolation success. 96% Sustained Success at 12 Months: Long-term follow-up confirmed highly durable Pulmonary Vein Isolation, exceeding traditional expectations in a field where approximately 20-25% recurrence is common. Industry-Leading Procedural Efficiency: Left Atrial Dwell Time: 21.0 +/- 13.3 minutes, this would reduce the time spent inside the heart. Total Procedure Time: Averaged 65 minutes, including only 9.8 minutes of fluoroscopy. Ease of Use: Success was achieved with an average of 16.1 applications per procedure. Safety Profile: A low 1.3% rate of Serious Adverse Events (SAEs) related to the primary safety endpoint. Strategic Resource Alignment: Focus on High-Value Growth. To capitalize on these groundbreaking results, Pulse Biosciences is modifying its capital allocation to prioritize the Electrophysiology market development program: Primary Focus: The majority of R&D and clinical investment is now dedicated to the nPulse Cardiac Catheter program's upcoming pivotal IDE study in the United States and Europe and corresponding regulatory submission. Surgical Program Calibration: While the Company remains committed to the Surgical Clamp IDE enrollment, it will reduce short term market development investments in cardiac surgery. Soft-Tissue Ablation Optimization: Operations for the percutaneous soft-tissue ablation system have been streamlined to reduce spend on sales and marketing and focusing on market development by progressing the Vybrance Percutaneous Electrode System towards an on-label indication for the treatment of benign thyroid nodules, driving real-world utilization data, and validating reimbursement rates, thereby allowing for a reduction in investment that can be redirected to the catheter program."

Pulse Biosciences announced clinical data on outcomes durability from the nPulse Vybrance Percutaneous Electrode System First-in-Human ablation study of benign thyroid nodules using nsPFA energy. The long-term follow-up from this study demonstrates significant and sustained volume reduction of treated benign thyroid nodules at 15-22 months, with no tissue regrowth and no serious adverse events. These data were presented at the North American Society for Interventional Thyroidology 2026 meeting, which took place in Portland, Oregon. Durable 15-22 month results with an average of 74% volume reduction of treated benign thyroid nodules with overwhelming patient satisfaction reported, Continued volume reduction improvements from 1 month through 22 months, No regrowth of nodules at 15-22 months. Patient-reported Cosmetic Satisfaction: 100% were Highly Satisfied at final follow-up. Patient-reported overall satisfaction: 95% were highly satisfied at final follow-up. No serious adverse events. No intranodular fibrosis detected on ultrasounds at 15-22 months. Potential for clinical durability of benign thyroid ablation. A total of 21 patients were subsequently monitored between 15 and 22 months to evaluate volume reduction trends over time.