PULSE BIOSCIENCES, INC.
PULSE BIOSCIENCES, INC. Q3 FY2024 earnings call
October 30, 2024 · fiscal period ended 2024-09
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2024-10-30
Management highlights
- Pulse is a novel medical company using Nano-Pulse Stimulation Technology. - Third quarter was productive with treating first AF patients in Europe, Cardiac Surgical System getting FDA breakthrough device designation and TAP program enrollment, and completing a $60 million rights offering with potential for additional $66 million via warrants. - Soft tissue ablation: CellFX Percutaneous Electrode System has pilot program in US for benign thyroid nodules, expecting to expand and start pivotal study in mid-2025. - Surgical ablation: First-in-human study in Netherlands with 9 patients treated, engaged with FDA on IDE pivotal study. - Catheter-based endocardial AF ablation: 360 catheter study in Prague with over 50 patients treated, designing pivotal study, and added key medical advisors.
Segment performance
Pulse Biosciences has three main product applications. For soft tissue ablation, the CellFX Percutaneous Electrode System received FDA 510(k) clearance, with a pilot program ongoing in the US for benign thyroid nodules. For surgical ablation, the first-in-human feasibility study in the Netherlands is underway with two sites and 9 patients treated. For catheter-based endocardial AF ablation, the 360 cardiac catheter feasibility study in Prague has treated over 50 patients with positive performance.
Guidance
- Continue initial clinical experiences with three products into 2025. - Advance clinical understanding of device performance and move forward in regulatory processes. - Build team and infrastructure for three pivotal clinical studies starting in 2025.
Risks
- Actual results may differ materially from forward-looking statements due to certain risks and uncertainties described in press releases and SEC filings.
Q&A highlights
Q: Are there any questions?
A: It appears that there are no questions at this time.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.16 | $-0.24 | +33.3% | $-0.15 |
| Revenue | — | — | — | — |
Transcript
October 30, 2024Full transcript unavailable for redistribution
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