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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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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 SHOWCASES AVIM THERAPY AS PURPOSE-BUILT SOLUTION FOR HYPERTENSIVE HEART DISEASE AT CSI FRANKFURT 2025

NEW HOPE, PA., MAY 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 FIRST QUARTER ENDED MARCH 31, 2025, AND PROVIDED A BUSINESS UPDATE HIGHLIGHTING CONTINUED REGULATORY MOMENTUM, DISCIPLINED OPERATIONAL EXECUTION, AND A STRENGTHENING CLINICAL DEVELOPMENT PIPELINE.

ORCHESTRA BIOMED REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS AND HIGHLIGHTS RECENT REGULATORY AND CLINICAL MILESTONES

NEW HOPE, PA., MAY 07, 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 CONTINUED EXPANSION OF ITS GLOBAL INTELLECTUAL PROPERTY (IP) ESTATE SUPPORTING ITS PROPRIETARY AVIM THERAPY PIPELINE (FORMERLY KNOWN AS CARDIAC NEUROMODULATION THERAPY OR CNT). OVER THE PAST 12 MONTHS, THE COMPANY HAS SECURED 10 NEW PATENTS RELATED TO TREATMENT OF HYPERTENSION. THE COMPANY HAS ALSO SECURED A TOTAL OF 17 PATENTS COVERING APPLICATION OF THE TECHNOLOGY FOR TREATMENT OF HEART FAILURE, SIGNIFICANTLY EXPANDING THE REACH OF ITS IP PLATFORM.

ORCHESTRA BIOMED'S AVIM THERAPY GLOBAL INTELLECTUAL PROPERTY ESTATE REACHES 137 ISSUED PATENTS FOR THE TREATMENT OF HYPERTENSION AND HEART FAILURE

ORCHESTRA BIOMED'S VIRTUE  SIROLIMUS ANGIOINFUSION BALLOON  (VIRTUE SAB) IS THE ONLY NON-COATED DRUG-ELUTING BALLOON SYSTEM UNDER CLINICAL INVESTIGATION WORLDWIDE AND HAS BEEN AWARDED MULTIPLE FDA BREAKTHROUGH DEVICE DESIGNATIONS THE VIRTUE TRIAL WILL BE THE FIRST U.S. IDE HEAD-TO-HEAD RANDOMIZED EVALUATION OF A SIROLIMUS-ELUTING BALLOON VERSUS A COMMERCIALLY AVAILABLE PACLITAXEL-COATED BALLOON (AGENT) FOR THE TREATMENT OF CORONARY IN-STENT RESTENOSIS (ISR) ROBUST NON-INFERIORITY TRIAL IS DESIGNED TO PROVIDE A CLEAR PATHWAY TO REGULATORY APPROVAL AS WELL AS POTENTIALLY SHOWCASE CLINICAL ADVANTAGES OF VIRTUE SAB WITH THE AMENDED IDE APPROVED BY THE FDA, ORCHESTRA BIOMED IS CURRENTLY TARGETING INITIATION OF THE VIRTUE TRIAL DURING THE SECOND HALF OF 2025 NEW HOPE, PA., APRIL 29, 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 THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS APPROVED ITS INVESTIGATIONAL DEVICE EXEMPTION (IDE) AMENDMENT TO INITIATE AN UPDATED DESIGN OF THE COMPANY'S PLANNED VIRTUE SAB IN THE TREATMENT OF CORONARY ISR TRIAL (VIRTUE TRIAL).

ORCHESTRA BIOMED RECEIVES FDA APPROVAL OF IDE TO INITIATE U.S. CORONARY PIVOTAL TRIAL RANDOMIZING FIRST-IN-CLASS SIROLIMUS-ANGIOINFUSION BALLOON, VIRTUE SAB, HEAD-TO-HEAD WITH PACLITAXEL-COATED BALLOON

Orchestra BioMed Holdings, Inc.

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