Presentation underscores unique potential for atrioventricular interval modulation (“AVIM”) therapy to manage blood pressure in older, high-risk patients who have indicators of diastolic dysfunction and progression to heart failure with preserved ejection fraction (“HFpEF”)Hypertensive heart disease represents over 7.7 million U.S. patients, the same population with hypertension and elevated cardiovascular risk cited in the recent FDA Breakthrough Device Designation (“BDD”) for AVIM therapy NEW HOPE, Pa., J ...

Orchestra BioMed Holdings (OBIO) 2025 Conference June 05, 2025 03:45 PM ET Speaker0 Okay, Speaker1 good to go. So thanks everybody for joining for our next session. I'm Matt Taylor, the US Medical Supplies and Devices analyst here at Jefferies. I'm joined by David Hockman, the CEO of Orchestra Lab. Speaker0 Nice to be here. Speaker1 And we have about half an hour for moderated Q and A. And I'll get things rolling here with kind of a high level question. So I think let's start with your business model is rea ...

Analyst's Disclosure: I/we have a beneficial long position in the shares of OBIO either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Orchestra BioMed Holdings (NASDAQ: OBIO ) is having a breakthrough momentum that does not appear to be reflected by its stock price. The compa ...

Summary of Orchestra BioMed Holdings (OBIO) Conference Call Company Overview - **Company Name**: Orchestra BioMed Holdings (OBIO) - **Ticker Symbol**: OBIO - **Founded**: 2018 - **Business Model**: Leveraging partnerships with established market leaders in the medical device space to drive commercialization of products, focusing on generating revenue through long-term revenue shares with partners [3][5][41] Key Programs 1. Atrioventricular Interval Modulation (AVIM) Therapy - **Target Condition**: High blood pressure (hypertension) in older, high-risk patients - **Addressable Market**: Estimated at $17 billion worldwide [4] - **Efficacy Data**: Strong statistically significant results from phase two double-blind studies; currently enrolling patients in the BackBeat global pivotal study [4][28] - **FDA Designation**: Recently awarded breakthrough device designation [5][22] - **Partnership**: Collaborating with Medtronic, a leader in pacemaker technology, with a double-digit revenue share [5][15] - **Market Opportunity**: - Immediate market opportunity for AVIM therapy is approximately $2 billion, targeting 750,000 patients who receive pacemakers annually [13] - Broader market potential includes over 3.7 million patients globally with hypertension and increased cardiovascular risk, representing a potential market of over $15 billion [15] - **Revenue Potential**: Projected royalty stream of up to $750 million annually based on a $1,000 average royalty per device sold [19] 2. Virtu Sirolimus Angio Infusion Balloon (SAB) - **Target Condition**: Treatment of coronary and peripheral artery disease - **Initial Market Size**: Estimated at $4 billion annually [6] - **Efficacy Data**: Strong safety and efficacy data from multicenter pilot studies; recently received FDA approval to run the Virtu trial against Boston Scientific's paclitaxel-coated balloon [6][32] - **Partnership**: Collaborating with Terumo, with a high revenue share [40] - **Market Shift**: Transitioning from drug-eluting stents to drug-coated balloons, with Virtu positioned as a best-in-class product [31][33] Industry Context - **Market Dynamics**: Medtech companies spend significantly less on R&D compared to biopharma, with averages of 7% versus 20% of revenue [7] - **Competitive Landscape**: Medtronic faces competition from companies like Abbott and Boston Scientific, which often engage in discounting strategies to secure market share [46] Additional Insights - **Clinical Impact**: AVIM therapy aims to provide significant clinical benefits without the side effects associated with traditional drug therapies [44] - **Regulatory Pathway**: The BackBeat study is expected to establish a new standard of care for blood pressure management in the pacemaker population [29] - **Future Opportunities**: Potential applications for Virtu in treating below-the-knee artery disease, addressing a high unmet medical need [48] Conclusion - Orchestra BioMed is positioned for significant growth through its innovative therapies and strategic partnerships, particularly with Medtronic and Terumo, while addressing critical healthcare needs in hypertension and coronary artery disease [41][42]

Orchestra BioMed Holdings, Inc. (OBIO) came out with a quarterly loss of $0.49 per share versus the Zacks Consensus Estimate of a loss of $0.46. This compares to loss of $0.38 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -6.52%. A quarter ago, it was expected that this company would post a loss of $0.43 per share when it actually produced a loss of $0.43, delivering no surprise.Over the last four quarters, the company has s ...

FDA Breakthrough Device Designation Awarded to AVIM Therapy FDA IDE Approved for Virtue SAB U.S. Pivotal Trial for Launch 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 m ...

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 March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number: 001-39421 ORCHESTRA BIOMED HOLDINGS, INC. (Exact name of registrant as specif ...

Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed's partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed's lead product candidate is atrioventricular interval modulation (AVIM) therapy for the trea ...

The market expects Orchestra BioMed Holdings, Inc. (OBIO) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report might help the stock move higher if these key numbers are better than expectations. On the oth ...

Summary of Orchestra BioMed Holdings (OBIO) Conference Call Company Overview - **Company**: Orchestra BioMed Holdings (OBIO) - **Focus**: Biomedical innovation company specializing in high-impact medical device therapies through strategic partnerships [2][3] Core Technologies - **AVIM Therapy Program**: - Treatment for hypertension delivered via an implantable pulse generator (pacemaker) [2][3] - Significant blood pressure reduction observed in clinical studies, with a 11 mmHg reduction in systolic blood pressure at six months [7][8] - No major adverse cardiac events reported in treatment group [9] - **Virtu's Sirolimus Angio Infusion Balloon**: - Combines drug and device for treating coronary and peripheral artery disease [3][32] - Recently received IDE approval for a pivotal head-to-head study against a competing product [32][36] Market Potential - Both programs target established multibillion-dollar markets with significant unmet needs [3] - AVIM therapy has a potential addressable patient population of approximately 8 million in the U.S. with uncontrolled hypertension [20][27] - Breakthrough designation for AVIM therapy could lead to additional reimbursement opportunities, with potential revenue share of up to $1,600 per device [30][31] Clinical Study Insights - **AVIM Therapy**: - Pivotal study design adjustments made to optimize patient evaluation and enrollment [10][14] - Collaboration with Medtronic enhances regulatory interactions and study execution [15][21] - **Virtu's SAB**: - Head-to-head study design allows for showcasing product advantages and regulatory approval probability [36][40] - Focus on delivering a higher drug payload compared to existing products [38][39] Regulatory Interactions - Positive interactions with the FDA noted, with timely approvals and thoughtful communication [43][45] - Breakthrough designation and IDE approval achieved on schedule, reflecting effective collaboration with regulatory bodies [47][48] Strategic Partnerships - Partnership with Medtronic is crucial for leveraging their market presence and regulatory expertise [21][22] - Collaboration enhances Orchestra's ability to navigate complex regulatory landscapes and optimize clinical trial designs [15][21] Conclusion - Orchestra BioMed is positioned to make significant advancements in hypertension and cardiovascular disease treatment through innovative therapies and strategic partnerships, with promising clinical data and regulatory support paving the way for future growth and market entry [23][47]