Slides
Page 1
Welcome to Pulse Biosciences AF Symposium 2026 Analyst Event ©2026 Pulse Biosciences, Inc. All rights reserved. 1 Friday February 6th 12:00-12:30 pm – Lunch 12:30- Prepared Remarks followed by Q&A
Page 2
Today's Speakers: Joining for Q&A: Dr. David Kenigsberg Medical Director of Cardiac Electrophysiology at HCA Westside Hospital and Chief Medical Officer, Electrophysiology at Pulse Biosciences Presenting: Pulse Biosciences IDE Overview 2nd Speaker: Darrin Uecker Chief Technology Officer Director Dr. Vivek Reddy Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY , and principal investigator of the study Presenting: Clinical Data Overview Paul LaViolette Chief Executive Officer Co-Chairman of the Board ©2026 Pulse Biosciences, Inc. All rights reserved. 2 1st Speaker:
Page 3
22mm inner ring ablation electrode 30mm outer ring ablation electrode Graphical User Interface Epicenter Catheter nPulse Console 12 sensing electrodes (10 on spline, 2 on shaft) 1 EM Sensor internal Nanosecond PFA System Characteristics
Page 4
nsPFA Catheter PVI Workflow ❖Two Applications per PV – Single ostial application – Single antral application ❖Depending on Anatomy – Single anterior carina applications on each side – Potential additional right-sided lesions on the PV anterior aspect Ostial PF Application Antral PF Application
Page 5
nsPFA FIH Trial Study Overview Study Objective: ❖ To assess initial safety (rate of acute adverse events within 30 days post- ablation) and effectiveness (acute procedural success at 6 and 12 months) the Epicenter Catheter System. Study Population: ❖ Adult patients who have failed or poorly tolerated at least one AAD with paroxysmal atrial fibrillation who are clinically indicated for catheter ablation. Study Design: ❖ Prospective, non-randomized, open-label, single-arm feasibility study to evaluate initial clinical safety and device performance of nsPFA to treat AF – 3 Centers (Homolka – P .Neuzil; Jessa/Belguim – J.Vijgen; Rome – A.Natale) – Total number of operators = 9 ❖ Primary safety & effectiveness endpoints assessed at 1, 6 & 12 mo post-ablation 2.5-s lesions N = 36 Total Cohort N = 150 5-s lesions N = 114
Page 6
Procedure Time and %Success 6 Total Population 5s Total Cohort 5s PVI + PWI # of Subjects 150 114 63 Procedure Time, mins 65 ± 27 65 ± 28 55 ± 31 LA Dwell Time, mins 21.3 ± 13.5 21.0 ± 13.3 20.8 ± 12.7 Fluoroscopy Time, mins 8.9 ± 5.4 9.8 ± 5.8 11.6 ± 6.3 Avg # Applications 15.9 ± 4.9 16.1 ± 5.2 17.6 ± 3.5 (12.8 ± 2.5)* Acute PVI Success, % 100 100 100 # of Subjects Completing EAM at 3M 135 99 43 3M PVI Success/Vein, % 89% (469/529) 92% (356/387) 94% (158/168) 3M PVI Success/Patient, % 80% (108/135) 87% (86/99) 88% (38/43) 6M Procedure Success by Holter, % 98.1% (104/106) 100% (75/75) 100% (32/32) 12M Procedure Success by Holter, % 94.0% (63/67) 95.7% (45/47) 100% (23/23) *PV ablations only
Page 7
nsPFA FIH Trial Primary Safety Endpoint Total Population N=150 5.0-Sec Cohort N=114 Asymptomatic Cerebral Embolism -- -- Atrio-esophageal Fistula -- -- Bleeding Requiring Transfusion -- -- Cardiac Perforation/Tamponade * 1 1 Death -- -- Esophageal Injury Resulting in Perforation -- -- Myocardial Infarction -- -- Pericarditis Requiring Intervention or Hospitalization -- -- Phrenic Nerve Injury/Diaphragmatic Paralysis -- -- Pulmonary Edema/Respiratory Insufficiency -- -- Pulmonary Vein Stenosis (≥70% diameter reduction) -- -- Stroke or Transient Ischemic Attack † 1 1 Vagal Nerve Injury Resulting in Esophageal Dysmotility or Gastroparesis -- -- Vascular Access Complication Requiring Intervention -- -- Total 2 / 150 (1.3%) 2 / 114 (1.8%) * Effusion developed over course of 5 days; during pericardiocentesis, pericardial bleeding → successful surgical repair. † Stroke – mild neurological deficit (NIHSS 4) of left arm hemiparesis, hypoesthesia, leg drift (brain MRI lesions observed).
Page 8
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Per PV Per Patient Total Population 5-Sec Cohort 89% 80% 92% 87% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Per PV Per Patient Total Population 5-Sec Cohort nsPFA FIH Trial 3M Remapping: PVI Durability ❖Total no. of patients completing 3M electroanatomical mapping: ✓ Total Cohort: 135 pts ✓ 5-Sec Cohort: 99 pts Acute Post Map - April Re-map February 6, 2026
Page 9
nsPFA FIH Trial Freedom from AF/AFL/AT ❖ Follow-up: TTMs (weekly) & 24hr-Holters (6 & 12 M)
Page 10
nsPFA FIH Trial Conclusions ❖Nanosecond PFA is: ✓ Efficient ✓ Average No. of applications for PVI/pt = 12.8±2.5 ✓ Left atrial dwell time = 21.0±13.3 min ✓ Safe ✓ Durable ✓ Excellent clinical outcomes ❖Limitations: – Intermittent monitoring follow-up – Most cases performed with minimal EAM support → now integrated
Page 11
IDE Overview Dr. David Kenigsberg – Chief Medical Officer, Electrophysiology Pulse Biosciences ©2025 Pulse Biosciences, Inc. All rights reserved. 11
Page 12
NANOPULSE-AF Study Overview Participating Sites Up to 30 centers in the United States and Europe Study Population Paroxysmal Atrial Fibrillation Up to 215 patients including roll-ins Primary Effectiveness Endpoint Bayesian analysis to allow prediction of 12 month freedom from treatment failure when all patients are through 6 months Primary Safety Endpoint Composite rate of defined device and/or procedure- rated serious adverse events occurring within a specified time post procedure (7-days, 30-days, or 6-months depending on event) ©2025 Pulse Biosciences, Inc. All rights reserved. 12 A prospective, multi-center, single-arm clinical investigation IDE trial evaluating the nPulse Cardiac Catheter Ablation System
Page 13
Questions ©2025 Pulse Biosciences, Inc. All rights reserved. 13