Progress in nPulse Vybrance System Adoption
The nPulse Vybrance percutaneous electrode system for soft tissue ablation showed strong product market fit in the pilot program. Over 200 patients have been treated, and procedure volumes increased sequentially this quarter.
Regulatory and Clinical Trial Advancements
Received FDA investigational device exemption approval for the nPulse cardiac surgery system for atrial fibrillation. Initiated NANOCLAMP AF study, the first PFA study approved by FDA for a surgical cardiac ablation device.
Positive Clinical Outcomes for nPulse 360 Catheter
Encouraging initial clinical outcomes from Europe for the nPulse 360 Catheter confirm its potential for advancing AF treatment. 150 patients enrolled in the ongoing feasibility study.
Initial Revenues Generated
Pulse Biosciences recognized initial revenues of $86,000 from nPulse capital and Vybrance disposable sales during the limited market release.