Penumbra, Inc. · NYSE:PEN
Penumbra — Technical Presentation (October 2025)
21 slides from Penumbra's technical presentation, October 2025
Slide 1: Primary Results from STORM-PE
Randomized Controlled Trial of Mechanical Thrombectomy with Anticoagulation Versus Anticoagulation Alone for Acute Intermediate-High Risk Pulmonary Embolism: Primary Results from STORM-PE Robert Lookstein, MD, MHCDL Mount Sinai Health System, New York, USA On behalf of the STORM-PE Investigators Co-
Slide 2: Disclosure of Relevant Financial Relationships
Disclosure of Relevant Financial Relationships Within the prior 24 months, I have had a financial relationship with a company producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients: Nature of Financial Relationship Ineligible Company Boston Scientific,
Slide 3: Background
Background • Endovascular therapy for the treatment of acute PE emerged > 12 years ago • Currently, 7 FDA cleared devices • However, there are no reported RCTs comparing outcomes of mechanical thrombectomy (MT) + anticoagulation (AC) vs AC alone • STORM-PE is the first completed RCT in over 10 years
Slide 4: RV/LV Ratio
RV/LV Ratio An elevated RV/LV ratio (≥ 1.0) is associated with a greater than 3 • two-fold increase in the risk of early death1 and • three-fold increase in the risk of PE death1 RV/LV Ratio Survival Small changes in RV strain are associated with incrementally better or worse prognosis2 RV/LV, right
Slide 5: Endpoints: Primary Efficacy
Endpoints: Primary Efficacy PRIMARY EFFICACY ENDPOINT Endpoint Change in RV/LV ratio at 48 hours Change in RV/LV ratio on original therapy assessed by CTPA between baseline (defined as initial CTPA for PE diagnosis) and 48 ± 6 hours Definition* Adjudicated by an independent blinded core laboratory H
Slide 6: Endpoints: Secondary Safety
Endpoints: Secondary Safety Major Adverse Events ≤ 7 days MAE Components Definition Test NEWS2 ≥ 9 and rescue therapy (eg, Clinical Deterioration mechanical thrombectomy, thrombolytics, Requiring Rescue Therapy CPR, ECMO, surgical embolectomy, etc) Mortality deemed PE-related by the CEC, The proport
Slide 7: Visit Schedule & Data Collection
Visit Schedule & Data Collection ✓ Standardized treatment: initiated within 24 hours from baseline CTPA and ≤ 12 hours from randomization ✓ Objective criteria required for crossover: NEWS2 ≥ 9 Baseline Day 0 48 Hours Discharge 30 Days 90 Days Randomization Primary Endpoint Safety Endpoint Final Visi
Slide 8: Trial Device & Procedure
Trial Device & Procedure • Lightning Flash timeline: Computer assisted vacuum thrombectomy • FDA cleared in Dec 2022 (CAVT) using the 16F catheter system • Commercially available in Jan 2023 Microprocessor with thrombus removal • First STORM-PE patient enrolled Jul algorithm USB port on 2023 back of
Slide 9: Key Eligibility Criteria, Sites & Enrollment
Key Eligibility Criteria, Sites & Enrollment Inclusion Patients enrolled July 2023 – June 2025 ✓ Clinical signs & symptoms of acute PE (≤ 14 days) 1 site 6 enrolled ✓ CTPA showing filling defect in ≥ 1 main or 1 site proximal lobar pulmonary artery 6 enrolled ✓ RV/LV ratio ≥ 1.0 on CTPA ✓ Elevated
Slide 10: Patient Flow for STORM-PE RCT
Patient Flow for STORM-PE RCT 767 Assessed for eligibility 667 Excluded • 546 Did not meet eligibility criteria • 86 Declined to participate • 30 Inability to treat in randomization window 100 • 5 Trial operator not available Randomized (ITT population) 47 CAVT arm 53 AC arm 1 Missing CTPA 1 Missing
Slide 11: Baseline & Medical History Information
Baseline & Medical History Information CAVT AC CAVT AC N = 47 N = 53 N = 47 N = 53 Demographic Characteristics Index PE Presentation Data Age, years 59.5 ± 13.2 61.2 ± 14.2 Syncope 9 (19.1%) 8 (15.1%) Female Sex 18 (38.3%) 28 (52.8%) Hemoglobin, g/dL 14.1 ± 1.88 13.9 ± 1.74 Race Abnormal†† 4 (8.5%)
Slide 12: Baseline Functional Assessments & Quality of Life
Baseline Functional Assessments & Quality of Life CAVT AC N=47 N=53 Functional Assessments Borg Dyspnea Scale* 4.6 ± 2.90 4.5 ± 2.85 Baseline characteristics, Functional assessments, and QOL were comparable mMRC ≥ 1* 43 (93.5%) 51 (96.2%) between groups. PVFS* 3.0 ± 0.97 2.9 ± 1.01 Quality of Life B
Slide 13: Anticoagulation Strategy
Anticoagulation Strategy No difference between CAVT & AC arm CAVT AC % of Patients Reaching Therapeutic Level of (N=47) (N=53) Anticoagulation Within 48-hour Visit AC Strategy 100.0% 90.4% 87.0% LMWH Alone 7 (14.9%) 10 (18.9%) 75.0% UFH Alone 28 (59.6%) 31 (58.5%) 50.0% LMWH & UFH 12 (25.5%) 12 (22.
Slide 14: CAVT Arm Procedural Information & Details
CAVT Arm Procedural Information & Details Thrombectomy Time, min (median) 25.0 [15.0, 41.0] Procedure Time, min (median) 56.0 [42.0, 69.0] Estimated Blood Loss, mL 296.5 ± 179.4 Technical Success 47/47 (100%) Ability of catheter to access clot and perform aspiration Systolic PA Pressure Reduction, m
Slide 15: Primary Efficacy Endpoint: RV/LV Ratio Change at 48 h
Primary Efficacy Endpoint: RV/LV Ratio Change at 48 h Superior reduction in the CAVT arm P < 0.001 CAVT AC 29.7% vs 13.1% RV/LV Ratio P value relative reduction relative reduction (N=46) (N=52) 2.00 1.63 1.56 Baseline 1.63 ± 0.36 1.56 ± 0.35 0.397 1.60 1.32 1.20 1.11 48 Hours 1.11 ± 0.28 1.32 ± 0.31
Slide 16: 48 h RV/LV Reduction > 0.2 and RV/LV ≤ 1.0
48 h RV/LV Reduction > 0.2 48 h RV/LV ≤ 1.0 Significantly more patients in the CAVT arm Significantly more patients in the CAVT arm had a treatment effect had a normalized RV/LV ratio P = 0.011 P = 0.005 100% 100% 78.3% 80% 80% 60% 51.9% 60% 39.1% 40% 40% 20% 20% 13.5% 0% 0% CAVT (N=46) AC (N=52) CA
Slide 17: Secondary Safety Endpoint: Major Adverse Events ≤ 7 d
Secondary Safety Endpoint: Major Adverse Events ≤ 7 d Safety comparable between CAVT & AC arm CAVT AC MAE Composite, Components, & Additional Details P value (N = 47) (N = 53) Composite MAE ≤ 7 Days 2 (4.3%) 4 (7.5%) 0.681 Clinical Deterioration Requiring Rescue Therapy 1 (2.1%) 3 (5.7%) 0.620 PE-re
Slide 18: Safety Event Details
Safety Event Details PE-related Mortality Clinical Deterioration Requiring Rescue Therapy CAVT (N=2*) vs AC (N=0) CAVT (N=1*) vs AC (N=3) P = 0.218 P = 0.620 Description NEWS2 Rescue Therapy Cardiac arrest from hemoptysis during index procedure. Day 1 9 CAVT (16 F) Day 0* No pathological evidence of
Slide 19: Conclusion
Conclusion STORM-PE is the first RCT to report the results of mechanical thrombectomy (MT) with anticoagulation (AC) versus AC alone. CAVT successfully decreased PA pressure with a statistically superior reduction in RV/LV ratio compared to AC alone. There was a comparable safety profile between the
Slide 20: Thank You
Thank You In partnership with The PERT Consortium® Sites Ascension Seton Kingwood Hospital Rush University Medical Center Austin, TX, USA Kingwood, TX, USA Chicago, IL, USA Auckland City Hospital Krakowski Szpital Specjalistyczny św. Jana Pawła II Sentara Norfolk General Hospital Grafton, Auckland,
Slide 21: STORM-PE RCT Steering Committee
STORM-PE RCT Steering Committee I I -P -P CO CO AL AL GLOB GLOB Dr. Rachel Rosovsky Dr. Robert Lookstein Dr. Richard Channick Hematology Interventional Radiology Pulmonology Massachusetts General Mount Sinai UCLA Hospital Dr. Stavros Konstantinides Dr. John Moriarty Dr. Ido Weinberg Cardiology Inter