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Orchestra BioMed Holdings, Inc. operates as a biomedical innovation company. The company's flagship product candidates include BackBeat Cardiac Neuromodulation Therapy (CNT) for the treatment of hypertension; and Virtue Sirolimus AngioInfusion Balloon (SAB) for the treatment of atherosclerotic artery disease. Its products also comprise FreeHold retractors that are minimally invasive surgical device solutions. The company has a strategic collaboration with Medtronic for the development and commercialization of BackBeat CNT for the treatment of hypertension in pacemaker-indicated patients; and a strategic partnership with Terumo Corporation for the development and commercialization of Virtue SAB for the treatment of artery disease. Orchestra BioMed Holdings, Inc. is based in New Hope, Pennsylvania.

Orchestra BioMed Holdings, Inc.

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NEW AGREEMENT GRANTS TERUMO VIRTUE SAB CORONARY INDICATION RIGHT OF FIRST REFUSAL AND SUPERSEDES PRIOR DISTRIBUTION AGREEMENT TERUMO TO PAY A TOTAL OF $30 MILLION TO ORCHESTRA BIOMED ORCHESTRA BIOMED RETAINS ALL DEVELOPMENT AND DISTRIBUTION RIGHTS TO VIRTUE SAB IN ALL INDICATIONS ORCHESTRA BIOMED RECENTLY INITIATED PATIENT ENROLLMENT FOR THE VIRTUE TRIAL, ITS U.S. PIVOTAL IDE TRIAL OF VIRTUE SAB IN THE TREATMENT OF CORONARY IN-STENT RESTENOSIS (ISR) NEW HOPE, PA., OCT. 28, 2025 (GLOBE NEWSWIRE) -- ORCHESTRA BIOMED HOLDINGS, INC. (NASDAQ: OBIO, ORCHESTRA BIOMED OR THE COMPANY), A BIOMEDICAL COMPANY ACCELERATING HIGH-IMPACT TECHNOLOGIES TO PATIENTS THROUGH STRATEGIC PARTNERSHIPS WITH MARKET-LEADING GLOBAL MEDICAL DEVICE COMPANIES, TODAY ANNOUNCED THAT IT HAS ENTERED INTO A TERMINATION AND RIGHT OF FIRST REFUSAL AGREEMENT (THE ROFR AGREEMENT) WITH TERUMO CORPORATION (TYO:4543) AND TERUMO MEDICAL CORPORATION (COLLECTIVELY, TERUMO) WITH RESPECT TO VIRTUE SIROLIMUS ANGIOINFUSIONBALLOON (SAB) FOR THE TREATMENT OF CORONARY ARTERY DISEASE WORLDWIDE.

ORCHESTRA BIOMED AND TERUMO ENTER INTO NEW $30 MILLION VIRTUE SAB STRATEGIC AGREEMENTS

NEW HOPE, PA., OCT. 27, 2025 (GLOBE NEWSWIRE) -- ORCHESTRA BIOMED HOLDINGS, INC. (NASDAQ: OBIO, ORCHESTRA BIOMED OR THE COMPANY), A BIOMEDICAL COMPANY ACCELERATING HIGH-IMPACT TECHNOLOGIES TO PATIENTS THROUGH STRATEGIC PARTNERSHIPS WITH MARKET-LEADING GLOBAL MEDICAL DEVICE COMPANIES, TODAY ANNOUNCED THE FIRST PATIENT ENROLLMENTS IN THE VIRTUE SAB IN THE TREATMENT OF CORONARY ISR TRIAL (VIRTUE TRIAL), THE COMPANY'S U.S. IDE PIVOTAL TRIAL COMPARING ITS HIGHLY DIFFERENTIATED VIRTUE SIROLIMUS ANGIOINFUSIONTM BALLOON (VIRTUE SAB) TO THE AGENT PACLITAXEL-COATED BALLOON, CURRENTLY THE ONLY DRUG-COATED BALLOON (DCB) FDA-APPROVED FOR A CORONARY INDICATION. THE INITIAL CASES WERE SUCCESSFULLY COMPLETED BY THE TEAMS AT THE CHRIST HOSPITAL HEART & VASCULAR INSTITUTE IN CINCINNATI, OH, AND ST. FRANCIS HOSPITAL & HEART CENTER IN ROSLYN, NY, MARKING THE INITIATION OF THE VIRTUE TRIAL. DEAN J. KEREIAKES, M.D., FACC, MSCAI, CHAIRMAN OF THE CHRIST HOSPITAL HEART & VASCULAR INSTITUTE AND MEDICAL DIRECTOR OF THE CHRIST HOSPITAL RESEARCH INSTITUTE AND ALLEN JEREMIAS M.D., DIRECTOR OF INTERVENTIONAL CARDIOLOGY RESEARCH AND ASSOCIATE DIRECTOR, CARDIAC CATHETERIZATION LABORATORY, ST. FRANCIS HOSPITAL & HEART CENTER ARE CO-PRINCIPIAL INVESTIGATORS OF THE VIRTUE TRIAL. DESIGNED TO SUPPORT REGULATORY APPROVAL OF VIRTUE SAB, THE VIRTUE TRIAL IS EXPECTED TO ENROLL 740 PATIENTS AT UP TO 75 CENTERS IN THE UNITED STATES WITH ENROLLMENT COMPLETION CURRENTLY PLANNED FOR MID-2027.

ORCHESTRA BIOMED ANNOUNCES FIRST PATIENTS ENROLLED IN VIRTUE SAB US PIVOTAL IDE CORONARY TRIAL

PRESENTATION TO PROVIDE COMPREHENSIVE OVERVIEW OF AVIM THERAPY CLINICAL EVIDENCE DEMONSTRATING THE POTENTIAL TO HALT THE PROGRESSION OF HYPERTENSIVE HEART DISEASE ORCHESTRA BIOMED AND MEDTRONIC (NYSE: MDT) HAVE A STRATEGIC COLLABORATION TO DEVELOP AND COMMERCIALIZE AVIM THERAPY FOR THE TREATMENT OF UNCONTROLLED HYPERTENSION IN PATIENTS INDICATED FOR A PACEMAKER, AN ESTIMATED GLOBAL POPULATION OF OVER 750,000 PATIENTS ANNUALLY AVIM THERAPY HAS RECEIVED FDA BREAKTHROUGH DEVICE DESIGNATION FOR THE TREATMENT OF UNCONTROLLED HYPERTENSION IN PATIENTS WITH INCREASED CARDIOVASCULAR RISK, AN ESTIMATED U.S. POPULATION OF OVER 7.7 MILLION PATIENTS NEW HOPE, PA., OCT. 09, 2025 (GLOBE NEWSWIRE) -- ORCHESTRA BIOMED HOLDINGS, INC. (NASDAQ: OBIO, ORCHESTRA BIOMED OR THE COMPANY), A BIOMEDICAL COMPANY ACCELERATING HIGH-IMPACT TECHNOLOGIES TO PATIENTS THROUGH STRATEGIC PARTNERSHIPS WITH MARKET-LEADING GLOBAL MEDICAL DEVICE COMPANIES, TODAY ANNOUNCED A DATA SUMMARY SUPPORTING THE TRANSFORMATIVE POTENTIAL OF ATRIOVENTRICULAR INTERVAL MODULATION (AVIM) THERAPY IN THE MANAGEMENT OF HYPERTENSIVE HEART DISEASE WILL BE PRESENTED IN A KEYNOTE TALK AT THE GEORGIA INNOVATION SUMMIT IN TBILISI, GEORGIA ON OCTOBER 10, 2025.

ORCHESTRA BIOMED TO SHOWCASE TRANSFORMATIVE POTENTIAL OF AVIM THERAPY IN KEYNOTE PRESENTATION ON HYPERTENSIVE HEART DISEASE AT GEORGIA INNOVATION SUMMIT

NEW HOPE, PA., SEPT. 04, 2025 (GLOBE NEWSWIRE) -- ORCHESTRA BIOMED HOLDINGS, INC. (NASDAQ: OBIO, ORCHESTRA BIOMED OR THE COMPANY), A BIOMEDICAL COMPANY ACCELERATING HIGH-IMPACT TECHNOLOGIES TO PATIENTS THROUGH RISK-REWARD SHARING PARTNERSHIPS, TODAY ANNOUNCED NEW DATA FROM ITS AVIM THERAPY PROGRAM, PRESENTED AT THE HRX LIVE 2025 MEETING, IN ATLANTA, GA, DEMONSTRATING THAT THE BLOOD PRESSURE-LOWERING EFFECTS OF AVIM THERAPY MAY BE SUSTAINED FOR YEARS AFTER ACTIVATION, ARE REVERSIBLE WITH NO EVIDENCE OF REBOUND HYPERTENSION OR BLOOD PRESSURE EXCEEDING INITIAL BASELINE VALUES, AND CAN BE RESTORED UPON REACTIVATION. THESE DATA FURTHER SUPPORT AVIM THERAPY'S POTENTIAL ROLE AS A CONTROLLABLE, PROGRAMMABLE, AND DURABLE DEVICE-BASED THERAPY FOR UNCONTROLLED HYPERTENSION.

ORCHESTRA BIOMED PRESENTS NEW AVIM THERAPY CLINICAL DATA AT HRX DEMONSTRATING SUBSTANTIAL AND SUSTAINED BLOOD PRESSURE REDUCTIONS THAT ARE REPRODUCIBLE UPON REACTIVATION FOLLOWING WASHOUT

NEW HOPE, PA., AUG. 26, 2025 (GLOBE NEWSWIRE) -- ORCHESTRA BIOMED HOLDINGS, INC. (NASDAQ: OBIO, ORCHESTRA BIOMED OR THE COMPANY), A BIOMEDICAL COMPANY ACCELERATING HIGH-IMPACT TECHNOLOGIES TO PATIENTS THROUGH RISK-REWARD SHARING PARTNERSHIPS, TODAY ANNOUNCED THE PUBLICATION OF DATA IN THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY: CLINICAL ELECTROPHYSIOLOGY (JACC: CLINICAL EP) FROM A PRESSURE-VOLUME (PV) LOOP STUDY DEMONSTRATING FAVORABLE HEMODYNAMIC EFFECTS OF AVIM THERAPY IN PACEMAKER-INDICATED PATIENTS WITH UNCONTROLLED HYPERTENSION. AVIM THERAPY IS CURRENTLY BEING EVALUATED IN THE BACKBEAT GLOBAL PIVOTAL STUDY, WHICH ORCHESTRA BIOMED IS CONDUCTING IN COLLABORATION WITH MEDTRONIC, TO SUPPORT POTENTIAL FUTURE GLOBAL REGULATORY APPROVALS AND COMMERCIALIZATION OF AVIM THERAPY-ENABLED DEVICES.

ORCHESTRA BIOMED ANNOUNCES PUBLICATION OF CLINICAL DATA DEMONSTRATING FAVORABLE BLOOD PRESSURE AND HEMODYNAMIC EFFECTS OF AVIM THERAPY IN JACC: CLINICAL ELECTROPHYSIOLOGY

ECHOCARDIOGRAPHIC DATA ANALYSIS DEMONSTRATED FAVORABLE IMPACT OF ATRIOVENTRICULAR INTERVAL MODULATION (AVIM) THERAPY ON MODERATO II STUDY PATIENTS WITH DIASTOLIC DYSFUNCTION, A KEY COMPONENT IN THE DEVELOPMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFPEF) HYPERTENSION IS THE LEADING CAUSE OF DIASTOLIC DYSFUNCTION AND THE MOST COMMON COMORBIDITY IN OLDER PATIENTS INDICATED FOR A PACEMAKER NEW HOPE, PA., AUG. 14, 2025 (GLOBE NEWSWIRE) -- ORCHESTRA BIOMED HOLDINGS, INC. (NASDAQ: OBIO, ORCHESTRA BIOMED OR THE COMPANY), A BIOMEDICAL INNOVATION COMPANY ACCELERATING HIGH-IMPACT TECHNOLOGIES TO PATIENTS THROUGH RISK-REWARD SHARING PARTNERSHIPS, TODAY ANNOUNCED THE PUBLICATION OF CLINICAL DATA IN JACC: ADVANCES DEMONSTRATING THAT AVIM THERAPY SIGNIFICANTLY IMPROVED CARDIAC FUNCTION IN PATIENTS WITH HYPERTENSION AND DIASTOLIC DYSFUNCTION (DD), KEY CONTRIBUTORS TO THE DEVELOPMENT OF HFPEF.

ORCHESTRA BIOMED ANNOUNCES PUBLICATION OF AVIM THERAPY CLINICAL DATA IN JACC: ADVANCES DEMONSTRATING POTENTIAL TO IMPROVE CARDIAC FUNCTION IN PATIENTS WITH HYPERTENSION AND DIASTOLIC DYSFUNCTION

NEW HOPE, PA., AUG. 12, 2025 (GLOBE NEWSWIRE) -- ORCHESTRA BIOMED HOLDINGS, INC. (NASDAQ: OBIO, ORCHESTRA BIOMED OR THE COMPANY), A BIOMEDICAL COMPANY ACCELERATING HIGH-IMPACT TECHNOLOGIES TO PATIENTS THROUGH RISK-REWARD SHARING PARTNERSHIPS, TODAY ANNOUNCED FINANCIAL RESULTS FOR THE SECOND QUARTER ENDED JUNE 30, 2025, AND PROVIDED A BUSINESS UPDATE HIGHLIGHTING RECENT FINANCIAL AND REGULATORY MILESTONES.

ORCHESTRA BIOMED REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS AND HIGHLIGHTS RECENT BUSINESS UPDATES

NEW HOPE, PA., AUG. 08, 2025 (GLOBE NEWSWIRE) -- ORCHESTRA BIOMED HOLDINGS, INC. (NASDAQ: OBIO, ORCHESTRA BIOMED OR THE COMPANY), A BIOMEDICAL COMPANY ACCELERATING HIGH-IMPACT TECHNOLOGIES TO PATIENTS THROUGH RISK-REWARD SHARING PARTNERSHIPS, TODAY ANNOUNCED THE ROLL OUT OF A PROTOCOL UPDATE, APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), THAT SIGNIFICANTLY EXPANDS PATIENT ELIGIBILITY CRITERIA FOR ENROLLMENT OF THE BACKBEAT STUDY EVALUATING AVIM THERAPY IN PACEMAKER-INDICATED PATIENTS WITH UNCONTROLLED HYPERTENSION DESPITE THE USE OF ANTIHYPERTENSIVE MEDICATIONS.

ORCHESTRA BIOMED ANNOUNCES ROLLOUT OF FDA-APPROVED BACKBEAT GLOBAL PIVOTAL STUDY PROTOCOL UPDATE SIGNIFICANTLY EXPANDING PATIENT ELIGIBILITY

NEW HOPE, PA., AUG. 05, 2025 (GLOBE NEWSWIRE) -- ORCHESTRA BIOMED HOLDINGS, INC. (NASDAQ: OBIO, ORCHESTRA BIOMED OR THE COMPANY), A BIOMEDICAL COMPANY ACCELERATING HIGH-IMPACT TECHNOLOGIES TO PATIENTS THROUGH RISK-REWARD SHARING PARTNERSHIPS, TODAY ANNOUNCED THE SUCCESSFUL COMPLETION OF STRATEGIC TRANSACTIONS AND CONCURRENT PUBLIC AND PRIVATE EQUITY OFFERINGS TOTALING AN EXPECTED $111.2 MILLION IN GROSS PROCEEDS TO SUPPORT CONTINUED ADVANCEMENT OF THE COMPANY'S LATE-STAGE ATRIOVENTRICULAR INTERVAL MODULATION (AVIM) THERAPY AND VIRTUE SIROLIMUS ANGIOINFUSION BALLOON (SAB) CLINICAL PROGRAMS.

ORCHESTRA BIOMED SECURES OVER $111 MILLION IN PROCEEDS AND COMMITTED CAPITAL FOLLOWING COMPLETION OF STRATEGIC TRANSACTIONS AND CONCURRENT PUBLIC AND PRIVATE EQUITY OFFERINGS

NEW HOPE, PA., AUG. 01, 2025 (GLOBE NEWSWIRE) -- ORCHESTRA BIOMED HOLDINGS, INC. (NASDAQ: OBIO, ORCHESTRA BIOMED OR THE COMPANY), A BIOMEDICAL COMPANY ACCELERATING HIGH-IMPACT TECHNOLOGIES TO PATIENTS THROUGH RISK-REWARD SHARING PARTNERSHIPS, ANNOUNCED TODAY THE PRICING OF AN UNDERWRITTEN PUBLIC OFFERING OF 9,413,637 SHARES OF ITS COMMON STOCK AT A PRICE TO THE PUBLIC OF $2.75 PER SHARE AND, IN LIEU OF COMMON STOCK TO CERTAIN INVESTORS, PRE-FUNDED WARRANTS TO PURCHASE 5,136,363 SHARES OF ITS COMMON STOCK AT A PRICE TO THE PUBLIC OF $2.7499 PER PRE-FUNDED WARRANT, WHICH REPRESENTS THE PER SHARE PUBLIC OFFERING PRICE FOR THE SHARES OF COMMON STOCK LESS THE $0.0001 PER SHARE EXERCISE PRICE FOR EACH PRE-FUNDED WARRANT (THE OFFERING). IN ADDITION, THE COMPANY GRANTED THE UNDERWRITERS A 30-DAY OPTION TO PURCHASE UP TO AN ADDITIONAL 2,182,500 SHARES OF ITS COMMON STOCK AT THE PUBLIC OFFERING PRICE PER SHARE, LESS UNDERWRITING DISCOUNTS AND COMMISSIONS. ALL OF THE SECURITIES ARE BEING OFFERED BY THE COMPANY. THE OFFERING IS EXPECTED TO CLOSE ON AUGUST 4, 2025, SUBJECT TO CUSTOMARY CLOSING CONDITIONS.

ORCHESTRA BIOMED ANNOUNCES PRICING OF $40 MILLION PUBLIC OFFERING

NEW HOPE, PA., JULY 31, 2025 (GLOBE NEWSWIRE) -- ORCHESTRA BIOMED HOLDINGS, INC. (NASDAQ: OBIO, ORCHESTRA BIOMED OR THE COMPANY), A BIOMEDICAL COMPANY ACCELERATING HIGH-IMPACT TECHNOLOGIES TO PATIENTS THROUGH RISK-REWARD SHARING PARTNERSHIPS, ANNOUNCED TODAY THAT IT HAS COMMENCED AN UNDERWRITTEN PUBLIC OFFERING OF SHARES OF ITS COMMON STOCK AND, IN LIEU OF COMMON STOCK TO CERTAIN INVESTORS, PRE-FUNDED WARRANTS TO PURCHASE SHARES OF ITS COMMON STOCK (THE OFFERING). ALL OF THE SECURITIES ARE BEING OFFERED BY THE COMPANY. IN ADDITION, THE COMPANY INTENDS TO GRANT THE UNDERWRITERS A 30-DAY OPTION TO PURCHASE UP TO AN ADDITIONAL 15% OF SHARES OF ITS COMMON STOCK AND PRE-FUNDED WARRANTS SOLD IN THE OFFERING AT THE PUBLIC OFFERING PRICE PER SHARE, LESS UNDERWRITING DISCOUNTS AND COMMISSIONS. THE OFFERING IS SUBJECT TO MARKET AND OTHER CONDITIONS, AND THERE CAN BE NO ASSURANCE AS TO WHETHER OR WHEN THE OFFERING MAY BE COMPLETED, OR AS TO THE ACTUAL SIZE OR TERMS OF THE OFFERING.

ORCHESTRA BIOMED ANNOUNCES PROPOSED PUBLIC OFFERING

NEW HOPE, PA., JUNE 18, 2025 (GLOBE NEWSWIRE) -- ORCHESTRA BIOMED HOLDINGS, INC. (NASDAQ: OBIO, ORCHESTRA BIOMED OR THE COMPANY), A BIOMEDICAL COMPANY ACCELERATING HIGH-IMPACT TECHNOLOGIES TO PATIENTS THROUGH RISK-REWARD SHARING PARTNERSHIPS, TODAY ANNOUNCED THE PRESENTATION OF KEY CLINICAL INSIGHTS INTO THE ROLE OF AVIM THERAPY FOR THE TREATMENT OF HIGH-RISK HYPERTENSION AT THE CONGENITAL, STRUCTURAL, AND VALVULAR HEART DISEASE INTERVENTIONS (CSI) 2025 MEETING. THE DATA HIGHLIGHT AVIM THERAPY'S UNIQUE POTENTIAL TO ADDRESS HYPERTENSIVE HEART DISEASE, A SIGNIFICANT AND UNDER-RECOGNIZED CARDIOVASCULAR SYNDROME THAT AFFECTS A GROWING SEGMENT OF THE AGING HYPERTENSION POPULATION.

Orchestra BioMed Holdings, Inc.

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