Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO
Orchestra Biomed — Investor Presentation (October 2025)
24 slides from Orchestra Biomed's investor presentation, Oct 30, 2025
Slide 1: Orchestra BioMed Corporate Overview October 2025
Orchestra BioMed Corporate Overview October 2025 Nasdaq: OBIO
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation has been prepared for informational purposes only from information supplied by Orchestra BioMed Holdings, Inc., referred to herein as “we,” “our,” “Orchestra BioMed,” and “the Company,” and from third-party sources indicated herein. Such third-party infor
Slide 3: Key Investment Highlights
AVIM Therapy Programmable, pacemaker-delivered treatment for high blood pressure and hypertensive heart disease Virtue SAB Proprietary, non-coated sirolimus balloon angioplasty system for atherosclerotic artery disease and other indications Key Investment Highlights Leveraging Partnerships to Bring
Slide 4: Expert Leadership, Proven Impact
Expert Leadership, Proven Impact 300+ Combined years in the industry experience 25+ Average years of experience, bringing deep expertise to every challenge 100+ Successful product approvals, delivering innovation globally 600+ Authored patents shaping the future of healthcare Our leadership team is
Slide 5: Advancing High-Impact Pipeline
Target Disease Program Target Population Preclinical Clinical Feasibility Clinical Pivotal Hypertensive Heart Disease Atrioventricular Interval Modulation (AVIM) Therapy Hypertension (HTN) & Pacemaker HTN with Increased CV Risk (Non-pacemaker indicated) HTN & Heart Failure AVIM/Cardiac Neuromodulati
Slide 6: Over $147M in Strategic-Driven Financing Secured Since August 2025
Over $147M in Strategic-Driven Financing Secured Since August 2025 $85M of Strategic Capital Commitments + $62.6M Equity Financing Expected to Provide Runway into Q4 2027 $35 million committed to purchase royalty-based revenue interest; plus $5 million equity investment $31.6 million additional stra
Slide 7: Atrioventricular Interval Modulation (AVIM) therapy
Atrioventricular Interval Modulation (AVIM) therapy Also known as BackBeat CNT 7 | Corporate Overview October 2025
Slide 8: AVIM Therapy Overview
AVIM Therapy Overview Hypertension is the leading global risk factor for death, affecting 1.2B patients Uncontrolled HTN in older, higher-risk patients drives MI, stroke and heart failure Reductions as small as 5 mmHg in office systolic blood pressure substantially decrease the relative risk of majo
Slide 9: $17 Billion Annual Global Opportunity
$17 Billion Annual Global Opportunity Highly Selected Target Patient Population for AVIM Represents Large Global Opportunity Leveraging Existing Reimbursement Pathways* HTN & Pacemaker ~70% of pacemaker patients1 750,000 highly addressable patients >$2 Billion HTN with Increased CV Risk / HFpEF ~0.3
Slide 10: AVIM Therapy Strategic Collaboration with Medtronic
Developed AVIM Therapy from concept stage Owns all related intellectual property: 120 issued global patents related to hypertension Conducted all prior development and the MODERATO I & II clinical studies Sponsor for the BACKBEAT Global Pivotal Study Global market leader in cardiac pacing therapy: >
Slide 11: AVIM Therapy is a Novel Investigational Treatment for Hypertension
AVIM Therapy is a Novel Investigational Treatment for Hypertension AVIM On Systolic BP (mmHg) Short AV intervals: Reduce cardiac preload, immediately lowering blood pressure Intermittent longer AV intervals: modulate autonomic nervous system response (baroceptor reflex) and reduce afterload (total p
Slide 12: MODERATO II Randomized, Double-Blind Results
Substantial -11.1 mmHg Reduction in 24-Hour aSBP at 6 months Sustained -17.5 mmHg Reduction in oSBP at 2 years 0% Major Adverse Cardiac Events vs. 14.3% in control group at 6 months4 AVIM Therapy showed encouraging results in MODERATO II, a prospective, multi-center, randomized, controlled, double-b
Slide 13: The BACKBEAT Study – Global Pivotal Hypertension Trial
The BACKBEAT Study – Global Pivotal Hypertension Trial Designed to Secure Regulatory Approval & Showcase Novel Approach to Blood Pressure Management Primary Efficacy Endpoint: Mean change in 24-hour aSBP at 3-months Primary Safety Endpoint: Freedom from unanticipated serious adverse device events at
Slide 14: Virtue Sirolimus AngioInfusion Balloon (SAB)
Virtue® Sirolimus AngioInfusion Balloon (SAB) 14 | Corporate Overview October 2025
Slide 15: Virtue SAB Overview
Virtue® SAB Overview Drug-coated balloons (DCB) emerging as new standard of care for key coronary and peripheral indications Boston Scientific’s AGENT Paclitaxel-coated balloon US commercialization underway with positive indications of sales growth Paradigm Shift Unlocks High-Growth Opportunity in L
Slide 16: Large Global Opportunity for Virtue SAB
Large Global Opportunity for Virtue SAB* Coronary ~3,700,000 patients >$7.5 Billion Peripheral ~1,250,000 patients >$2.5 Billion >$10 Billion Annual Global Opportunity Large mature market with suboptimal treatments for coronary in-stent restenosis, coronary small vessel de novo and below-the-knee Mu
Slide 17: Compelling Opportunity For Virtue SAB
Compelling Opportunity For Virtue SAB Coatings have challenges, such as limited dosing, risk of emboli from large particulates, and drug loss in transit A Novel Solution is Required to Realize Advantages of Sirolimus 1Xinlin Zhang, et. al. PLOS ONE 2014 May 20;9(5):e97934 Superiority of sirolimus sa
Slide 18: Protected Delivery of Extended Release Sirolimus
Protected Delivery of Extended Release Sirolimus Virtue® SAB – Optimal Drug, Dose and Delivery 1Granada et al. EuroIntervention 2016;12:740-747. 2 Animals included in the analysis of distant organs received average dose of 20.4 mg ≈10X the largest clinical dose SirolimusEFR Microporous AngioInfusion
Slide 19: Compelling SABRE Trial Results in Coronary ISR Patients
Low 2.8% Target Lesion Failure (TLF) at 1 year Low 0.12mm Late Lumen Loss (LLL) at 6-months 0% Target Lesion Revascularization (TLR) between 1-3 years Virtue® SAB demonstrated encouraging safety and efficacy results in patients with coronary in-stent restenosis (ISR) in prospective, multi-center SAB
Slide 20: AGENT & SELUTION4ISR IDE Trial Results Show Clear Opportunity for Virtue SAB
Target Lesion Failure 13.5% (AGENT) and 13.2% (SELUTION) (TLF) at 1 year No angiographic follow-up in both IDE AGENT LLL = 0.397mm at 6 months4; SELUTION LLL not reported for coronary ISR AGENT & SELUTION4ISR IDE Trial Results Show Clear Opportunity for Virtue SAB 0% 5% 10% 15% 20% 25% 20.2% 13.5% 1
Slide 21: The Virtue Trial – U.S. Randomized Pivotal Coronary ISR Trial
The Virtue Trial – U.S. Randomized Pivotal Coronary ISR Trial Designed to Secure Regulatory Approval & Showcase Differentiation of Virtue SAB R 740 Pts with ISR Lesions in Arteries 2.00 – 4.00mm Virtue Sirolimus AngioInfusion Balloon 1:1 370 Pts. 370 Pts. 12 M 12 M Clinical Follow-Up out to 5 Years
Slide 22: Virtue SAB Strategic Partnership with Terumo
Orchestra developed Virtue SAB from concept stage, owns all related IP, conducted all prior studies, and retains all development and distribution rights in all indications Terumo is a global leader in interventional cardiology devices: >$2.4B in annual revenues1 Terumo purchased ROFR for Virtue SAB
Slide 23: Key Investment Highlights
Pivotal Stage, High-Impact Therapies Large, Established Target Markets Partnership-Enabled Business Model Expected Funding into Q4 2027 23 | Corporate Overview October 2025 Key Investment Highlights Leveraging Partnerships to Bring Innovation to Patients & Yield Exceptional Future Profitability
Slide 24: Bringing Medical Innovations to Life Through Partnerships
Bringing Medical Innovations to Life Through Partnerships
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