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"). The ID ...

Core Insights - Orchestra BioMed Holdings, Inc. is actively participating in multiple institutional investor conferences to discuss its innovative biomedical technologies and partnerships [1][2][3] Group 1: Upcoming Conferences - The company will participate in Chardan Capital's Trending Issues in Drug Development Conference on April 29, 2025, featuring a fireside chat with CEO David Hochman [1] - Management will also engage in a live fireside chat at the Jefferies Global Healthcare Conference on June 5, 2025, along with one-on-one meetings with investors [2] - Additionally, a live presentation is scheduled for the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, where management will host one-on-one meetings [3] Group 2: Company Overview - Orchestra BioMed focuses on accelerating high-impact biomedical technologies through risk-reward sharing partnerships with leading medical device companies [4] - The company's lead product candidate is atrioventricular interval modulation (AVIM) therapy for hypertension, a major global health risk [4] - Orchestra BioMed is also developing the Virtue Sirolimus AngioInfusion™ Balloon for atherosclerotic artery disease, which is a leading cause of mortality worldwide [4] - The company has strategic collaborations with Medtronic for AVIM therapy and with Terumo for the Virtue SAB [4]

Company Performance - Orchestra BioMed Holdings, Inc. reported a quarterly loss of $0.43 per share, which aligns with the Zacks Consensus Estimate, compared to a loss of $0.37 per share a year ago [1] - The company posted revenues of $0.25 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 67.85%, and down from $0.26 million year-over-year [2] - Over the last four quarters, the company has surpassed consensus EPS estimates two times and topped consensus revenue estimates just once [2][1] Stock Movement and Outlook - Shares of Orchestra BioMed Holdings, Inc. have increased by approximately 10% since the beginning of the year, contrasting with a decline of -5.1% in the S&P 500 [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the coming quarter is -$0.46 on revenues of $0.74 million, and for the current fiscal year, it is -$1.95 on revenues of $3.84 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Orchestra BioMed belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Financial Condition - Orchestra BioMed Holdings, Inc. has a history of net losses and expects to continue incurring losses for the foreseeable future[18] - As of December 31, 2024, the company's cash, cash equivalents, and short-term investments are insufficient to fund operations for at least the next twelve months, raising substantial doubt about its ability to continue as a going concern[18] - The future sales of shares by existing stockholders may adversely affect the market price of the company's common stock[20] Clinical Studies and Regulatory Approvals - The clinical study process required for regulatory approvals is lengthy, expensive, and carries substantial risks, which could harm the business if studies are unsuccessful or delayed[18] - Interim data from clinical studies may change as more patient data become available, which could result in material changes in final data[18] - The company intends to expand sales internationally but may face difficulties in obtaining regulatory approvals or successfully marketing products abroad[18] - The company intends to expand sales of its products internationally but may face difficulties in obtaining regulatory approvals or successfully marketing products even if approved[18] Dependence on Partners and Supply Chain - The company is highly dependent on partners and third-party vendors for the successful marketing and sale of its initial product candidates, with no assurance of successful partnerships[20] - The company is highly dependent on partners and third-party vendors for manufacturing and providing critical materials, with no assurance of effective supply chain management[20] - The company expects to continue relying on third parties for successful marketing and sales of its initial product candidates, with no assurance of successful partnerships[19] Intellectual Property Risks - The company may not effectively protect or enforce its intellectual property, which could adversely affect its business and financial condition[20] - The company may face substantial costs and liabilities from litigation or proceedings related to intellectual property rights[20] Market and Regulatory Pressures - Healthcare cost-containment pressures and legislative reforms could decrease demand for the company's products and affect pricing and procedure volumes[20] - Healthcare cost-containment pressures and legislative reforms could decrease demand for the company's products and negatively impact pricing and procedure volumes[20] Manufacturing Challenges - The company has limited pharmaceutical manufacturing experience, which may lead to development or manufacturing problems that could limit revenue growth[20] - The company has limited pharmaceutical manufacturing experience, which may lead to development or manufacturing problems that could limit revenue growth[20]

Company Overview - Orchestra BioMed Holdings, Inc. is a biomedical innovation company focused on accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies [4] - The company's lead product candidate is atrioventricular interval modulation (AVIM) therapy for treating hypertension, a significant global health risk [4] - Orchestra BioMed is also developing the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for treating atherosclerotic artery disease, which is the leading cause of mortality worldwide [4] Strategic Partnerships - The company has a strategic collaboration with Medtronic for the development and commercialization of AVIM therapy in pacemaker-indicated patients [4] - Additionally, Orchestra BioMed has partnered with Terumo for the development and commercialization of Virtue SAB for artery disease treatment [4] Upcoming Investor Engagements - Company management will present at the TD Cowen 45th Annual Healthcare Conference on March 3, 2025, at 2:30 PM ET [2] - A fireside chat is scheduled at the Barclays 27th Annual Global Healthcare Conference on March 13, 2025, at 8:00 AM ET [2] - The company will also host one-on-one meetings with investors at the B. Riley Securities Precision Oncology & RadioPharma Conference on February 28, 2025 [3]

Core Viewpoint - Orchestra BioMed Holdings, Inc. has appointed Dr. Vivek Reddy as Executive Chairman of the BACKBEAT Study Steering Committee and Chairman of the Bioelectronic Therapies Scientific Advisory Board to enhance the development of its bioelectronic therapies portfolio and lead the BACKBEAT global pivotal study [1][2] Company Overview - Orchestra BioMed is a biomedical innovation company focused on accelerating high-impact technologies through risk-reward sharing partnerships with leading medical device companies [3][5] - The company's lead product candidate is atrioventricular interval modulation (AVIM) therapy aimed at treating hypertension, a significant global health risk [3][5] BACKBEAT Study - The BACKBEAT global pivotal study is currently enrolling patients to assess the efficacy and safety of AVIM therapy for those with uncontrolled hypertension and a pacemaker indication [4] - The study aims to provide critical scientific evidence and clinical value for AVIM therapy, which is designed to offer an adjustable treatment option that does not depend on patient adherence [2][4] Leadership and Expertise - Dr. Vivek Reddy brings extensive experience in electrophysiology and cardiac rhythm management, currently serving in multiple leadership roles at The Mount Sinai Health System [2][4] - His leadership is expected to enhance awareness and communication regarding AVIM therapy within the clinical community, facilitating the successful completion of the BACKBEAT study [2][4]

Core Insights - Orchestra BioMed announced a late-breaking presentation on the benefits of atrioventricular interval modulation (AVIM) therapy for patients with diastolic dysfunction at the THT 2025 Conference [1][2] - The retrospective analysis from the MODERATO II study showed significant improvements in echocardiographic markers of diastolic dysfunction in hypertensive patients receiving AVIM therapy [1][4] Company Overview - Orchestra BioMed is a biomedical innovation company focused on accelerating high-impact technologies through partnerships with leading medical device companies [9] - The company's lead product candidate is AVIM therapy, aimed at treating hypertension, a major global health risk [9][11] Study Findings - The MODERATO II study involved a treatment-blinded analysis assessing the impact of 6 months of AVIM therapy on systolic blood pressure (SBP) and echocardiographic markers of diastolic dysfunction [4][7] - Among the 36 patients with sufficient echocardiographic data, 61% exhibited evidence of diastolic dysfunction [4] Clinical Data - AVIM therapy resulted in a significant reduction in ambulatory SBP by 8.3±9.7 mmHg and office SBP by 12.1±12.8 mmHg in patients with diastolic dysfunction [7] - Key measures of diastolic function improved significantly, including an increase in e' from 5.9±2.0 to 8.8±3.4 cm/sec and E/A ratio from 0.86±0.39 to 1.60±0.84 [7] Future Directions - The ongoing BACKBEAT global pivotal study aims to further evaluate the safety and efficacy of AVIM therapy in patients with uncontrolled hypertension and diastolic dysfunction [8][11] - The findings from the MODERATO II study suggest a potential new paradigm for treating hypertension and its associated risks, particularly in high-risk populations [8]

Core Viewpoint - Orchestra BioMed Holdings, Inc. has appointed Christopher Cleary as an independent member of its Board of Directors, effective January 30, 2025, bringing over 30 years of experience in corporate development and strategic investments in the medical technology industry [1][2][4] Group 1: Board Appointment - Christopher Cleary's extensive experience includes facilitating over 35 acquisitions and orchestrating a $6 billion sale during his tenure at Medtronic [2][4] - Cleary's role is expected to provide invaluable guidance to enhance the execution of Orchestra BioMed's partnership-enabled business model [2][5] - Eric A. Rose, M.D. will transition to Board Member Emeritus and Strategic Advisor after seven years of service, continuing to support the company's initiatives [3][4] Group 2: Business Model and Collaborations - Orchestra BioMed focuses on risk-reward sharing partnerships with leading medical device companies to drive the commercialization of its products [4][5] - The company's lead product candidate is AVIM therapy for hypertension, which is a significant global health risk [5][7] - Orchestra BioMed has strategic collaborations with Medtronic for AVIM therapy and with Terumo for the Virtue Sirolimus AngioInfusion™ Balloon [5][7] Group 3: AVIM Therapy Details - AVIM therapy is designed to lower blood pressure and has shown promising results in pilot studies, with reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months [7] - The BACKBEAT global pivotal study will further evaluate the safety and efficacy of AVIM therapy in patients indicated for dual-chamber cardiac pacemakers [7]

Company Overview - Orchestra BioMed Holdings, Inc. is a biomedical innovation company focused on accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies [3] - The company's lead product candidate is atrioventricular interval modulation (AVIM) therapy, also known as BackBeat Cardiac Neuromodulation Therapy (CNT™), aimed at treating hypertension, a significant global health risk [3] - Orchestra BioMed is also developing the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for treating atherosclerotic artery disease, which is the leading cause of mortality worldwide [3] Strategic Partnerships - Orchestra BioMed has a strategic collaboration with Medtronic for the development and commercialization of AVIM therapy for hypertension in pacemaker-indicated patients [3] - The company has partnered with Terumo, a global leader in medical technology, for the development and commercialization of Virtue SAB for artery disease treatment [3] Upcoming Events - Company management will present and be available for one-on-one meetings at the Piper Sandler 36th Annual Healthcare Conference in New York from December 3-5, 2024 [1] - The presentation will take place on December 4, 2024, at 3:00 PM EST in a fireside chat format, with a webcast available for viewing [2]

Financial Performance - Orchestra BioMed Holdings, Inc. reported a quarterly loss of $0.41 per share, which was better than the Zacks Consensus Estimate of a loss of $0.44, but worse than the loss of $0.38 per share from the previous year, indicating a year-over-year decline [1] - The company posted revenues of $0.99 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 21.85% and showing significant growth from $0.42 million in the same quarter last year [2] - Over the last four quarters, the company has surpassed consensus EPS estimates three times, but has only topped consensus revenue estimates once [2] Stock Performance - Shares of Orchestra BioMed Holdings, Inc. have declined approximately 32.9% since the beginning of the year, contrasting with the S&P 500's gain of 25.8% [3] - The current Zacks Rank for the stock is 3 (Hold), indicating that shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.44 on revenues of $0.73 million, and for the current fiscal year, it is -$1.67 on revenues of $3.13 million [7] - The trend of estimate revisions for the company is mixed, and future changes in estimates will be closely monitored following the recent earnings report [6][7] Industry Context - The Medical - Biomedical and Genetics industry, to which Orchestra BioMed belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]