Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO
Orchestra Biomed — Investor Presentation (October 2026)
30 slides from Orchestra Biomed's investor presentation, October 2026
Slide 1: Accelerating high-impact technologies to patients through risk-reward sharing partnerships
Accelerating high-impact technologies to patients through risk-reward sharing partnerships Nasdaq: OBIO Corporate Overview | October 2026
Slide 2: Forward-Looking Statements
LEGAL NOTICE Forward-Looking Statements This presentation has been prepared for informational purposes only from information assurance, a prediction, or a definitive statement of fact or probability. Actual supplied by Orchestra BioMed Holdings, Inc., referred to herein as “we,” “our,” events and ci
Slide 3: Accelerating innovation to patients through partnerships
INVESTMENT SUMMARY Accelerating innovation to patients through partnerships CAPITAL-EFFICIENT TWO PIVOTAL-STAGE PROGRAMS WELL-FUNDED & BACKED ROYALTY PARTNERSHIP MODEL TARGETING LARGE MARKETS BY INDUSTRY LEADERS We drive R&D through pivotal trials in Our flagship technologies, AVIM Medtronic, Terumo
Slide 4: Our partnership model optimizes execution and capital efficiency
OUR MODEL Our partnership model optimizes execution and capital efficiency WE FOCUS ON BEING GREAT AT: WE RELY ON GREAT PARTNERS FOR: High-impact innovation Global commercialization differentiated technology established sales, distribution, with strong IP and support Expert clinical execution SHARED
Slide 5: How we are actively bringing high-impact innovation to life
OUR MODEL IN ACTION How we are actively bringing high-impact innovation to life AVIM THERAPY F O C U S E D S T R AT E G I C VIRTUE SAB Atrioventricular Interval Modulation APPROACH Sirolimus AngioInfusion Balloon Therapy for uncontrolled hypertension, the #1 We target unmet needs Superior “leave not
Slide 6: Strategic investments & payments from industry leaders
S T R AT E G I C C A P I TA L Strategic investments & payments from industry leaders > $185M total strategic capital ~ 21%** owned by strategic partners* invested in & paid to OBIO by its partners led by Medtronic at ~15%** $81.6M $40M $65M Equity & $20M strategic capital $35M for revenue participat
Slide 7: AVIM Therapy
AVIM THERAPY Atrioventricular Interval Modulation Therapy
Slide 8: AVIM Therapy: A potent hypertension therapy delivered by a pacemaker
AV I M T H E R A P Y AVIM Therapy: A potent hypertension therapy delivered by a pacemaker Designed to lower blood pressure and improve cardiac function through well-characterized mechanisms IMMEDIATE SUSTAINED Short AV delays reduce blood pressure Longer AV delays maintain BP reduction Short AV inte
Slide 9: Hypertension is leading cardiovascular risk factor, affecting ~1.4B adults WW
AV I M T H E R A P Y | W H Y I T M AT T E R S Hypertension is leading cardiovascular risk factor, affecting ~1.4B adults WW¹ Every 20 mmHg increase in systolic blood pressure approximately doubles risk of death from cardiovascular disease² Modifiable risk factor for of ischemic heart of stroke attri
Slide 10: The global pacing market leader will drive AVIM Therapy commercialization
AV I M T H E R A P Y | S T R A T E G I C C O L L A B O R A T I O N The global pacing market leader will drive AVIM Therapy commercialization DEVELOPMENT & CLINICAL EXECUTION MANUFACTURING & COMMERCIALIZATION Invented AVIM Therapy; owns 120+ HTN patents plus Exclusive global rights to pacemaker-indic
Slide 11: Large, established market of pacemaker patients with hypertension
AV I M T H E R A P Y | M A R K E T & A C C E S S Large, established market of pacemaker patients with hypertension Substantial uncapped royalties can drive significant OBIO topline growth and accelerated profitability AVIM CAN GROW THE COMMERCIAL VALUE OF THE PACEMAKER MARKET OBIO ROYALTY OPPORTUNIT
Slide 12: More than a decade of evidence supporting AVIM Therapy
AV I M T H E R A P Y | C L I N I C A L E V I D E N C E More than a decade of evidence supporting AVIM Therapy P RECLIN ICA L & F IRST - IN - H UMA N RAND OMIZ ED CLINICAL EV ID ENCE PARTNERSH IP & PIV OTAL TRIAL 2012 2016 2019 2021 2022 2024 - PRESENT Feasibility Study in MODERATO I First-in- MODERA
Slide 13: MODERATO II demonstrated immediate, substantial and sustained BP reduction
AV I M T H E R A P Y | C L I N I C A L E V I D E N C E MODERATO II demonstrated immediate, substantial and sustained BP reduction AVIM Therapy significantly reduced systolic blood pressure compared to control with no medication changes & low MACE1 AVIM Therapy Set-Up2 1 Day 6 Months 24 Months oSBP 2
Slide 14: AVIM is designed to address the needs of high-risk, comorbid, older patients
AV I M T H E R A P Y | T A R G E T I N G H Y P E R T E N S I V E H E A R T D I S E A S E AVIM is designed to address the needs of high-risk, comorbid, older patients MODERATO II results show AVIM Therapy offers disease-modifying potential benefits for hypertensive heart disease ALWAYS-ON BLOOD PRESS
Slide 15: The BACKBEAT Global Pivotal Trial – surpassed full enrollment target
AV I M T H E R A P Y | P A T H T O P I V O T A L D A T A The BACKBEAT Global Pivotal Trial – surpassed full enrollment target PATIENTS IMPLANTED WITH OR INDICATED FOR A DUAL-CHAMBER PACEMAKER with uncontrolled hypertension (office and 24-hour ambulatory systolic BP) despite 1–3 anti-HTN medications
Slide 16: BACKBEAT Trial & AVIM Therapy Catalysts
AV I M T H E R A P Y | M I L E S T O N E S BACKBEAT Trial & AVIM Therapy Catalysts Surpassed full Primary endpoint data FDA review of PMA Potential FDA approval Potential OUS enrollment Present BACKBEAT primary submission and commercial launch commercial launches BACKBEAT Global endpoint data OUS re
Slide 17: Significant expansion opportunity beyond the pacemaker market
AV I M T H E R A P Y | E X P A N S I O N O P P O R T U N I T Y Significant expansion opportunity beyond the pacemaker market Second FDA BDD highlights AVIM potential to treat hypertensive heart disease in high-risk, non-pacemaker patients U.S. patient population meeting FDA Breakthrough Designation
Slide 18: Virtue SAB
VIRTUE SAB Virtue Sirolimus AngioInfusion Balloon
Slide 19: Virtue SAB: Designed to Optimize Sirolimus Dosing, Uptake and Release
VIRTUE SAB Virtue SAB: Designed to Optimize Sirolimus Dosing, Uptake and Release Sub-Micron Particle-Encapsulated SirolimusEFR Designed to Optimize Sustained Sirolimus Delivery • Rapidly infuses particles transmurally Proven gold standard sirolimus SirolimusEFR The anti-restenotic and anti-inflammat
Slide 20: Treatment paradigm shift and strong U.S. reimbursement fueling fast-growing opportunity
VIRTUE SAB | MARKET OPPORTUNITY Treatment paradigm shift and strong U.S. reimbursement fueling fast-growing opportunity THE MARKET THE GLOBAL CORONARY INTERVENTION MARKET1 | “LEAVE NOTHING BEHIND” DYNAMIC $7.5B annual global coronary intervention market >$5,000 DCB average selling price in U.S. broa
Slide 21: Why there is a compelling opportunity for Virtue SAB
VIRTUE SAB | OPPORTUNITY DRIVERS Why there is a compelling opportunity for Virtue SAB 1 2 3 SIROLIMUS IS THE GOLD STANDARD FOR PACLITAXEL RESURFACED ON COATED …BUT EVERY COATED BALLOON CARRIES RESTENOSIS, PACLITAXEL IS INFERIOR BALLOONS BECAUSE IT IS EASIER, NOT THE SAME THREE DRUG DELIVERY AND DISA
Slide 22: Sirolimus needs a high enough dose in the artery wall, for enough time, to work
VIRTUE SAB | OPPORTUNITY DRIVERS Sirolimus needs a high enough dose in the artery wall, for enough time, to work 4 EXTENDED RELEASE THROUGH CRITICAL HEALING PERIOD IMPROVED OUTCOMES; RAPID ELUTION SHOWED SUBOPTIMAL OUTCOMES Resolute Demonstrated Significantly Lower LLL and TLF Endeavor Failed to Elu
Slide 23: Virtue delivered & maintained more sirolimus than DES and DCB – published PK studies
VIRTUE SAB | OPPORTUNITY DRIVERS Virtue delivered & maintained more sirolimus than DES and DCB – published PK studies Virtue achieved high drug concentrations in tissue through critical healing period, exceeding published levels of proven DES (Xience) and leading Sirolimus-coated balloons XIENCE VIR
Slide 24: SABRE pilot trial results showcase opportunity for Virtue SAB
VIRTUE SAB | CLINICAL EVIDENCE SABRE pilot trial results showcase opportunity for Virtue SAB VIRTUE® SAB AGENT DCB - AGENT IDE TRIAL Virtue SAB demonstrated encouraging safety and efficacy results in patients with coronary ISR in Boston Scientific’s AGENT DCB demonstrated a reduction in TLF versus P
Slide 25: The Virtue Pivotal Trial actively enrolling
VIRTUE SAB | PATH TO DATA The Virtue Pivotal Trial actively enrolling 740 patients with ISR lesions in arteries 2.00 – 4.00 mm Randomize 1:1 370 pts 370 pts • FDA IDE approved Virtue Sirolimus AngioInfusion AGENT Paclitaxel-Coated • 1:1 RCT vs AGENT DCB Balloon Balloon • N = 740 12 M 12 M • Primary
Slide 26: Virtue SAB offers prospective partners potentially significant and sustainable advantages
VIRTUE SAB | STRATEGIC PARTNERING Virtue SAB offers prospective partners potentially significant and sustainable advantages STRATEGIC PARTNERING PATHWAY FUTURE PARTNERING LANDSCAPE Coronary Right of First Refusal We maintain strategic optionality and • $65M in strategic capital to Orchestra1 opportu
Slide 27: Our product pipeline targets large immediate and future opportunities
OUR PRODUCT PIPELINE Our product pipeline targets large immediate and future opportunities AVIM THERAPY Atrioventricular Interval Modulation L AUNCH M AR KET | P I V O TAL T RI AL ST AGE EX P A N S IO N M A R KET Hypertension + Pacemaker up to $6B Hypertensive Heart Disease up to $16B global annual
Slide 28: Led by a team with a proven cardiovascular innovation track record
LEADERSHIP & GOVERNANCE Led by a team with a proven cardiovascular innovation track record Combined years Average years of Successful product Authored patents 300+ of industry experience 25+ experience across the team 100+ approvals delivered globally 600+ shaping the future of healthcare EXECUTIVE
Slide 29: We deliver value for patients, partners and shareholders
THE BOTTOM LINE We deliver value for patients, partners and shareholders CAPITAL-EFFICIENT ROYALTY TWO LARGE, ESTABLISHED TARGET ECONOMICS MARKETS High-margin potential royalties on partner-driven sales; AVIM and Virtue SAB each target multibillion-dollar annual no sales, marketing or manufacturing
Slide 30: Bringing medical innovations to life through partnerships
BRINGING MEDICAL INNOVATIONS TO LIFE THROUGH PARTNERSHIPS Nasdaq: OBIO | investors.orchestrabiomed.com
Orchestra BioMed Holdings — Investor Presentation (October 2026) on 6ix