Monitor for further clinical trial updates and regulatory milestones, as these positive results could influence future investment and partnership opportunities for Pulse Biosciences.
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Executive Summary
Pulse Biosciences presented positive late-breaking clinical data from its nPulse Cardiac Catheter System first-in-human feasibility study at Heart Rhythm 2026. Key findings include sustained 100% procedural success at 6 months, 96% at one year, and a 90% Kaplan-Meier estimate of freedom from atrial fibrillation, flutter, or tachycardia at one year, along with consistently efficient procedural performance and a maintained low serious adverse event rate of 1.7%.
Key Facts
- Sustained 100% procedural success of evaluable patients by holter at 6 months (95/95)
- Sustained 96% procedural success of evaluable patients by holter at one year (51/53)
- Sustained 90% Kaplan-Meier estimate of freedom from AF/AFL/AT at one year
- Left atrial dwell time: 18.6 ± 13.0 minutes
- Total procedure time: 60.2 ± 27.7 minutes
- Fluoroscopy time: 9.4 ± 5.9 minutes
- Average applications per-patient for PVI: 12.3 ± 2.6
- Safety profile: 1.7% (3/177) of subjects experienced a SAE related to the primary safety endpoint
Financial Impact
No direct financial impact reported; the data is clinical and relates to the performance of the nPulse Cardiac Catheter System.
Risk Factors
- The data is from a first-in-human feasibility study with a limited cohort size (177 patients treated), so larger trials are needed to confirm these results.
- The long-term durability and safety of the nPulse Cardiac Catheter System beyond one year are not yet established.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-013383 |
| Exhibit: ex_950223.htm | 0001437749-26-013383 |
| Document: 0001437749-26-013383-index-headers.html | 0001437749-26-013383 |
| Document: 0001437749-26-013383-index.html | 0001437749-26-013383 |
| Document: 0001437749-26-013383.txt | 0001437749-26-013383 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 14, 2026 13d ago | 8-K | $46.32 | awaiting T+60 | — | $52.91 (+14.23%) |
Oct 7, 2026 20d ago | 8-K | $49.09 | awaiting T+60 | — | $52.91 (+7.78%) |
Sep 15, 2026 6w ago | 8-K | $55.20 | awaiting T+60 | — | $52.91 (−4.15%) |
Aug 6, 2026 11w ago | 8-K | $42.41 | awaiting T+60 | — | $52.91 (−24.76%) |
Aug 6, 2026 11w ago | 424B5 | $42.41 | awaiting T+60 | — | $52.91 (−24.76%) |
Jul 29, 2026 12w ago | 8-K | $34.25 $52.68 | ▲ +53.81% | ▲ +49.08% | $52.91 (+54.48%) |
Jun 12, 2026 19w ago | Institutional Cluster | $24.37 $48.79 | ▲ +100.21% | ▲ +96.94% | $52.91 (+117.11%) |
Jun 10, 2026 19w ago | 8-K | $24.99 $54.71 | ▲ +118.93% | ▲ +112.35% | $52.91 (+111.72%) |
May 15, 2026 23w ago | Insider Cluster | $25.61 $43.32 | ▲ +69.15% | ▲ +64.30% | $52.91 (+106.60%) |
May 11, 2026 24w ago | Insider Cluster | $19.08 $37.90 | ▲ +98.64% | ▲ +94.24% | $52.91 (+177.31%) |
US Market Status
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