Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO
Orchestra Biomed — CRT 2026
13 slides from Orchestra Biomed's conference presentation, 2026
Slide 1: Update on AVIM Therapy: A Pacemaker-Based Treatment for Hypertension
Update on AVIM Therapy: A Pacemaker-Based Treatment for Hypertension Daniel Burkhoff MD PhD Director – Heart Failure, Hemodynamics, and MCS Research Cardiovascular Research Foundation New York, NY
Slide 2: Disclosure Statement of Financial Interest
Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest / arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support Abiomed Axon Therapies Ancora Edwards Lifes
Slide 3: High Risk Hypertension Patients Need Better Treatment Options
High Risk Hypertension Patients Need Better Treatment Options: Pacemaker Patients Are Older & At Higher Risk Significant Benefit From oSBP Reduction4,5 Major CV Stroke Heart Ischemic CV Disease Failure Heart Disease Death6 Hypertension: A Global Crisis Intensified in 0 Relative Risk Reduction (%) Ol
Slide 4: AVIM Therapy is a Novel Investigational Treatment to Reduce Blood Pressure
AVIM Therapy is a Novel Investigational Treatment to Reduce Blood Pressure Designed to Have an Immediate, Substantial, and Sustained Effect1 Short AV intervals: reduce cardiac preload, immediately lowering BP Novel & Potent Mechanism1 AVIM Off AVIM On Intermittent longer AV intervals: modulate ANS r
Slide 5: Benefit Shown in Acute Pressure-Volume Study
Benefit Shown in Acute Pressure-Volume Study SBP Reduction (Independent of Lead Position) and Favorable Impact on Hemodynamics1 SBP Reduction, N=16 PV Loops AV Sequential AVIM AVIM 200 Pacing Therapy RV Therapy CSP 0 TPR SBP -14% -13% LV Pressure (mmHg) • Significant reduction in pre- -1.7 150 -5 ±
Slide 6: AVIM Therapy Showed Encouraging Results in the MODERATO II Randomized, Double-Blind Pilot Study
AVIM Therapy Showed Encouraging Results in the MODERATO II Randomized, Double-Blind Pilot Study Substantial and Sustained Reduction in aSBP and oSBP1,2 Reduction in Reduction in 24-Hour aSBP oSBP 1 day 6 Months 6 Months 24 Months 0 -3.1 P=0.17 -0.1 -1.5 P=0.94 • Pacemaker patients with HTN -5 P=0.5
Slide 7: Significant Improvement in Challenging-to-Treat ISH Patients
Significant Improvement in Challenging-to-Treat ISH Patients 5 Reduction in Reduction Reduction Reduction 24-Hr aSBP in aPP in oSBP in oPP • 88% of AVIM therapy +6 Months +6 Months +24 Months +24 Months Δ aSBP (mmHg) 0 0 patients in MODERATO -0.2 II had ISH1 n=13 -2.1 -5 Δ oSBP (mmHg) n=13 • Increas
Slide 8: Induced Reverse Remodeling
Induced Reverse Remodeling Control Group Showed Progressive Control Group Developed AVIM Therapy Showed Reverse Ventricular Remodeling at 6 Months1 Ventricular Remodeling Remodeling at 12 months1 Baseline Baseline 160 6M No-AVIM 160 !2M AVIM 140 140 LV Pressure (mmHg) LV Pressure (mmHg) 120 120 100
Slide 9: AVIM Therapy Demonstrates Sustained aSBP Reductions with Reproducible Effect & No Rebound Hypertension
AVIM Therapy Demonstrates Sustained aSBP Reductions with Reproducible Effect & No Rebound Hypertension p < 0.001 p = 0.001 p = 0.002 • 16 MODERATO II patients with 135 long-term follow-up & no 133.1 AVIM Therapy OFF increase in average number of 132.2 132.2 24-Hr aSBP (mmHg) ± 16.6 130 ± 7.0 ± 13.4
Slide 10: Reduced SBP in Patients with Diastolic Dysfunction (DD)
Reduced SBP in Patients with Diastolic Dysfunction (DD) Significantly Reduced oSBP & aSBP in Retrospective Treatment-Blinded Analysis oSBP 24-Hour aSBP • HTN is the leading cause of DD. Both are AVIM Therapy Control AVIM Therapy Control common in the elderly Δ -12.1 Δ -8.3 and contribute to HF P < 0
Slide 11: AVIM Therapy Improved Echocardiographic Markers of DD
AVIM Therapy Improved Echocardiographic Markers of DD Significantly Increased e’ and E/A, Indicating Improved Myocardial Relaxation and Diastolic Compliance1 e’ E/A Ratio AVIM Therapy Control AVIM Therapy Control P < 0.01 P=0.34 P=0.01 P=0.61 2.0 2.0 10 10 AVIM therapy increased the 8 8.8 8 1.5 1.60
Slide 12: The BACKBEAT Global Pivotal Trial
The BACKBEAT Global Pivotal Trial Designed to Secure Regulatory Approval and Demonstrate Novel Approach to BP Management Patients who have or are scheduled to receive a Medtronic Astra or Azure dual-chamber pacemaker and have hypertension despite medication • Randomized, prospective, multi-center, A
Slide 13: Summary
Summary • AVIM therapy is a novel investigational, pacemaker-delivered treatment designed to have an immediate, substantial, and sustained effect in reducing BP independent of lead position – MODERATO II feasibility study demonstrated efficacy in both isolated systolic and combined hypertension – “A