PULSE BIOSCIENCES, INC. Q3 FY2025 earnings call

• Soft tissue ablation device: The nPulse Vybrance percutaneous electrode system saw over 200 patients treated across pilot, PRECISE-BTN study, and commercial procedures. Procedure volumes grew sequentially with positive outcomes. New product and technology naming rolled out, with strong product-market fit. PRECISE-BTN study is progressing with over 40% enrollment to date.
• Surgical ablation clamp: FDA granted approval of IDE pivotal study for nPulse surgical ablation clamp for AF treatment, with first patient enrolled. Feasibility study in EU continues with positive early results, including data presented at EAC meeting.
• nPulse 360 Catheter for AF ablation: Making progress on IDE submission, expecting to commence study in Q1. Feasibility study in Europe has enrolled 150 patients, with anticipation of sharing new safety and efficacy data, including 1-year follow-up data, at a scientific meeting in Q1. Exploring potential partnerships in EP ablation market.

In the third quarter, Pulse Biosciences generated initial revenues of $86,000, consisting of nPulse capital and Vybrance disposable sales as part of the limited market release. Total revenue was $86,000, with these initial revenues from the nPulse Vybrance percutaneous electrode system and related disposables.

• Expect disposables and full system sales to grow as procedure acceptance increases.
• Cash use is expected to increase due to enrollment in cardiac surgery pivotal trial and commencement of EP study in the next couple of months, aligned with 2025 priorities to support development and commercial adoption of nPulse technology.

Risks and uncertainties are more fully described in the press release issued earlier today and in filings with the U.S. Securities and Exchange Commission. Investors are cautioned not to place undue reliance on forward-looking statements.

Q: Paul, congrats on all the progress. Three questions on clinical trials: Regarding NANOCLAMP, how should we think about the pre-op lesion work set? Is it one size fits all? And clarification on left atrial appendage closure in the trial.

A: The lesion set varies with Afib burden severity; surgeon determines lesion set. Left atrial appendage occlusion is occurring but not part of the protocol, and strokes will be adjudicated per norm.

Q: Paul, in NS 360, the pivotal trial expected in Q1: Is Pulse going to fund it unilaterally or still expecting a strategic partner?

A: Base case is funding the study as the sponsor. Remain committed to partnership strategy, which could manifest at commercialization and possibly during the study.

Q: Paul, PRECISE-BTN: Can you share additional details on performance criteria?

A: Look at patient outcomes in quality of life against thyroid patient scale, volume reduction, total symptoms burden. Speed of symptom burden elimination is a new measure, as raw elimination of compressive symptoms isn't sufficient alone since gland removal does that but has downstream consequences.