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Pulse Biosciences Announces Strategic Alignment to Accelerate Cardiac Catheter Program Following Exceptional Long-Term AFib Clinical Data
HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE), pioneer of the novel nPulse™ platform using proprietary Nanosecond Pulsed Field
About this update from Pulse Biosciences, Inc
[{"type":"text","content":" HAYWARD, Calif.--(BUSINESS WIRE)--\nPulse Biosciences, Inc. (Nasdaq: PLSE), pioneer of the novel nPulse™ platform using proprietary Nanosecond Pulsed Field Ablation (nsPFA™), today announced a new strategic alignment to prioritize and accelerate the development and future commercialization of its nPulse Cardiac Catheter Ablation System.\n\n\n“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.”\n\n\nPaul LaViolette, CEO and Co-Chairman, added: “We are thrilled to be allocating additional resources to the vast potential of our catheter-based EP program. We are fortifying a program that has already shown the potential to be first-in-class and best-in-class.”\n\n\nThis initiative follows the announcement of groundbreaking 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 (AFib).\n\n\nThe Data: Unprecedented Clinical Outcomes\n\n\nThe 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:\n\n\n\n100% Procedural Success at 6 Months: 75/75 evaluable patients achieved acute Pulmonary Vein Isolation (PVI) success.\n\n\n\n96% Sustained Success at 12 Months: Long-term follow-up (45/47 patients) confirmed highly durable Pulmonary Vein Isolation (PVI), exceeding traditional expectations in a field where approximately 20-25% recurrence is common.\n\n\n\nIndustry-Leading Procedural Efficiency:\n\n\nLeft Atrial Dwell Time: 21.0 ± 13.3 minutes, this would reduce the time spent inside the heart.\n\n\n\nTotal Procedure Time: Averaged 65 minutes, including only 9.8 minutes of fluoroscopy.\n\n\n\nEase of Use: Success was achieved with an average of 16.1 applications per procedure.\n\n\n\n\n\n\nSafety Profile: A low 1.3% rate of Serious Adverse Events (SAEs) related to the primary s...