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PLSE-News
PLSE-Events
Pulse Biosciences Q2 Revenue $400,000, Below Consensus
Reports Q2 revenue $400,000, consensus $533,330. "This was a highly productive quarter for Pulse Biosciences, defined by exceptional momentum in our cardiac catheter program," said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. "We have recently surpassed the halfway point of enrollment in our U.S. pivotal NANOPULSE-AF study, and even after expanding the enrollment target by 19 patients, we continue to anticipate completing enrollment by early Q4. The catheter's ease of use, seamless workflow integration and its demonstrated safety and durability outcomes are driving rapid progress in the study. Together with a meaningfully strengthened balance sheet, we are well positioned to advance the clinical and regulatory milestones that will bring the transformative potential of nanosecond PFA technology to patients and physicians globally."
Pulse Biosciences NANOPULSE-AF Study Surpasses Enrollment Midpoint
Pulse Biosciences announced that the NANOPULSE-AF Study has surpassed its enrollment midpoint after commencing the study in April 2026. "We are very pleased by the strong enrollment trajectory in the NANOPULSE-AF study. Reaching this midpoint milestone so quickly reflects the enthusiasm of our investigational sites for this technology and its potential to deliver leading durability in pulmonary vein isolation, procedural efficiency and consistent safe and effective patient outcomes," said David Kenigsberg, MD, FACC, FHRS, Chief Medical Officer of Pulse Biosciences. "This momentum is driven first by the technology itself. Second, the protocol represents a real-world example of the type of patients we are seeing in clinical practice, where ablation has become a first-line therapy to address patients suffering from atrial fibrillation. We appreciate our close collaboration with the FDA throughout this process, as we move toward completion of our IDE study."
Pulse Biosciences Reports Q1 Revenue of $401k
Reports Q1 revenue $401k. "This was a defining quarter for Pulse Biosciences. We sharpened our strategic focus on electrophysiology based on landmark clinical outcomes that reinforced the durability and efficiency of AF treatment with the nPulse catheter and commenced enrollment in our U.S. IDE pivotal trial of our nPulse Cardiac Catheter System," said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. "Based on high investigator enthusiasm and early pivotal study progress, we are pleased to update our anticipated enrollment completion timing to early-Q4, 2026. The momentum we are building positions us to advance critical clinical and regulatory milestones that will bring the transformative potential of nanosecond PFA technology to patients and physicians globally."
Pulse Biosciences Releases Positive Clinical Data for Cardiac Catheter System
Pulse Biosciences announced late-breaking "positive" clinical data from its nPulse Cardiac Catheter System first-in-human feasibility study at the Heart Rhythm 2026 meeting. Key study findings on the 5 second ablation cohort include: Sustained 100% procedural success of evaluable patients by holter at 6 months; Sustained 96% procedural success of evaluable patients by holter at one year; Sustained 90% Kaplan-Meier estimate of freedom from AF/AFL/AT at one year; Consistently efficient procedural performance, including: Left atrial dwell time: 18.6 +/- 13.0 minutes, Total procedure time: 60.2 +/- 27.7 minutes, Fluoroscopy time: 9.4 +/- 5.9 minutes, Average applications per-patient for PVI: 12.3 +/- 2.6; Safety profile across total cohort: maintained low serious adverse event rate, with 1.7% of subjects experiencing a SAE related to the primary safety endpoint
Pulse Biosciences Releases Positive Clinical Data for Cardiac Catheter System
Pulse Biosciences announced late-breaking positive clinical data from its nPulse Cardiac Catheter System first-in-human feasibility study at the Heart Rhythm 2026 meeting. Key study findings on the 5 second ablation cohort include: Sustained 100% procedural success of evaluable patients by holter at 6 months; Sustained 96% procedural success of evaluable patients by holter at one year; Sustained 90% Kaplan-Meier estimate of freedom from AF/AFL/AT at one year; Consistently efficient procedural performance, including: Left atrial dwell time: 18.6 +/- 13.0 minutes, Total procedure time: 60.2 +/- 27.7 minutes, Fluoroscopy time: 9.4 +/- 5.9 minutes, Average applications per-patient for PVI: 12.3 +/- 2.6; Safety profile across total cohort: maintained low serious adverse event rate, with 1.7% of subjects experiencing a SAE related to the primary safety endpoint
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