Pulse Biosciences Reports Exceptional 6- and 12-Month Data from nPulse Cardiac Catheter Feasibility Study

summarizeSummary

Pulse Biosciences released compelling clinical data for its nPulse Cardiac Catheter, demonstrating high procedural success and a strong safety profile in treating atrial fibrillation, positioning the company for a pivotal study.

check_boxKey Events

• Strong Clinical Efficacy

  The nPulse Cardiac Catheter achieved 100% procedural success in evaluable patients at 6 months (75/75) and 96% at one year (45/47) in its first-in-human feasibility study for atrial fibrillation.

• Favorable Safety Profile

  The study reported a low 1.3% (2/150) serious adverse event rate related to the primary safety endpoint, indicating a strong safety profile for the device.

• Efficient Procedure Times

  The nPulse system demonstrated rapid procedure times, with average total procedure and fluoroscopy times of 65 and 9.8 minutes, respectively, highlighting workflow efficiency.

• Advancing Towards Pivotal Study

  The company is poised to initiate its pivotal IDE study, a crucial step towards potential regulatory approval and commercialization in the U.S. and Europe.

auto_awesomeAnalysis

Pulse Biosciences announced highly positive 6- and 12-month data from its nPulse Cardiac Catheter first-in-human feasibility study for atrial fibrillation. The reported 100% procedural success at 6 months and 96% at 12 months, coupled with a low 1.3% serious adverse event rate, significantly de-risks the nPulse system. These strong results, presented at a major cardiology symposium, validate the technology's safety and effectiveness and pave the way for the upcoming pivotal IDE study, marking a critical step towards potential commercialization and addressing a substantial market need.