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]

NEW HOPE, Pa., Nov. 12, 2024 (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 reported its third quarter 2024 financial results and provided a business update. "The Orchestra BioMed team is focused on execution of the BACKBEAT global pivotal study alongside our strategic partner, Medtronic. We are excited about the enthusias ...

Table of Contents | --- | --- | |-------|-----------------------------------------------------------------------------------| | | UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 | | | FORM 10-Q | | | | (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ ...

Orchestra BioMed Holdings, Inc. (OBIO) came out with a quarterly loss of $0.45 per share versus the Zacks Consensus Estimate of a loss of $0.41. This compares to loss of $0.35 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -9.76%. A quarter ago, it was expected that this company would post a loss of $0.40 per share when it actually produced a loss of $0.38, delivering a surprise of 5%. Over the last four quarters, the compan ...

NEW HOPE, Pa., Aug. 12, 2024 (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 reported its second quarter 2024 financial results and provided a business update. "Our work in hypertension and coronary artery disease aligns with a renaissance occurring in cardiac pacing and balloon angioplasty, applying new innovations to enha ...

Orchestra BioMed Holdings, Inc. (OBIO) has been on a downward spiral lately with significant selling pressure. After declining 25.4% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier. Guide to Identifying Oversold Stocks We use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spo ...

Since a changing earnings picture is a powerful factor influencing near-term stock price movements, the Zacks rating system is very useful for individual investors. They may find it difficult to make decisions based on rating upgrades by Wall Street analysts, as these are mostly driven by subjective factors that are hard to see and measure in real time. The change in a company's future earnings potential, as reflected in earnings estimate revisions, has proven to be strongly correlated with the near-term pr ...