Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO
Orchestra Biomed — Technical Presentation (2026)
12 slides from Orchestra Biomed's technical presentation, 2026
Slide 1: Atrioventricular Interval Modulation Therapy
Atrioventricular Interval Modulation Therapy Device-based Therapy for Hypertension and Diastolic Heart Failure David E. Kandzari, MD, FACC, MSCAI Chief, Piedmont Heart Institute and Cardiovascular Services Chief Scientific Officer Director, Interventional Cardiology
Slide 2: Disclosure
Disclosure 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 (Institutional) Medtronic CardioVascular, Biotronik, Orbus Neich, Ablative Sol
Slide 3: AVIM Therapy Mechanisms of Action
Atrioventricular Interval Modulation Therapy Mechanisms of Action Designed to Have an Immediate, Clinically Meaningful, 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
Slide 4: Blood Pressure Reduction: Moderato I Pilot Study
AVIM Therapy and Blood Pressure Reduction Moderato I Pilot Study Reduction in Systolic Blood Pressure (SBP)3 24-Hour Ambulatory SBP (aSBP) Office SBP (oSBP) +1 Day +1M +3M +1M +3M +6M +12M +18M +24M 0 10.1 mmHg A prospective, single-arm Reduction study of 27 patients with in 24-Hour aSBP persistent
Slide 5: Hemodynamic Effects: Moderato I Pilot Study
AVIM Therapy and Hemodynamic Effects Moderato I Pilot Study Significant Reduction in Heart Rate & End-Diastolic Volume at 24 Months1 Heart Rate End-Diastolic Volume End-Systolic Volume Ejection Fraction 3M 24M 3M 24M 3M 24M 3M 24M 5 0 0 5 -2.2 ± 13.1 -2.9 2.4 -5 ± 12.7 ± 6.4 0 0 ∆ EF (%) ∆ HR (bpm)
Slide 6: Blood Pressure Reduction: Moderato II Randomized Pilot Study
AVIM Therapy and Blood Pressure Reduction Moderato II Randomized, Double-Blind Pilot Study Reduction in Reduction in oSBP 24-Hour aSBP 1 day 6 Months 6 Months 24 Months 0 -3.1 P=0.17 -0.1 -1.5 P=0.94 • Pacemaker patients with -5 P=0.5 Δ in SBP (mmHg) hypertension despite medical therapy -11.1 -10 P
Slide 7: Hemodynamic Effects: Acute Pressure Volume Relationship with AVIM
AVIM Therapy and Hemodynamic Effects Acute Pressure Volume Relationship with AVIM SBP Reduction (Independent of Lead Position) & Favorable Impact on Hemodynamics1 SBP Reduction, N=16 PV Loops AV Sequential AVIM AVIM 200 Pacing Therapy RV Therapy CSP TPR 0 -14% SBP -13% Significant reduction in pre-
Slide 8: Hemodynamic Effects: Moderato II Substudy Noninvasive PV Loop Analysis
AVIM Therapy and Hemodynamic Effects Moderato II Substudy Noninvasive PV Loop Analysis 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 AVI
Slide 9: Diastolic Dysfunction: Moderato II Substudy
AVIM Therapy and Diastolic Dysfunction Moderato II Substudy 61% of AVIM Therapy Patients in MODERATO II had Diastolic Dysfunction1,2 oSBP 24-Hour aSBP AVIM Therapy Control AVIM Therapy Control Δ -12.1 Δ -8.3 P < 0.01 P=0.73 P=0.01 P=0.28 180 180 150 150 140 140 160 160 aSBP (mmHg) oSBP (mmHg) 162.4
Slide 10: Diastolic Dysfunction: e' and E/A Improvement
AVIM Therapy and Diastolic Dysfunction Moderato II Substudy Significantly Increased e’ & E/A, Indicating Improved Myocardial Relaxation & Diastolic Compliance e’ E/A Ratio AVIM Therapy Control AVIM Therapy Control P < 0.01 P=0.34 P=0.01 P=0.61 10 10 2.0 2.0 8 8.8 8 1.5 1.5 1.60 e’ (cm/sec) 6 ±3.4 6
Slide 11: Backbeat Global Pivotal Trial
Backbeat Global Pivotal Trial 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, AVIM Therapy double-blind, controlled trial download & set-up • Sponsored by Orchestra BioMe
Slide 12: AVIM for Uncontrolled Hypertension and Heart Failure with Preserved Ejection Fraction
AVIM for Uncontrolled Hypertension and Heart Failure with Preserved Ejection Fraction • 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 – Efficacy in both isolated sys
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