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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 3/20/2025 | $12.00 | Buy | BTIG Research |
| 1/2/2025 | $16.00 | Overweight | Barclays |
| 8/22/2024 | $14.00 | Buy | H.C. Wainwright |
| 7/25/2024 | $15.00 | Buy | B. Riley Securities |
| 1/19/2024 | $14.00 | Buy | Jefferies |
| 2/24/2023 | $15.00 | Overweight | Piper Sandler |
| 2/7/2023 | $20.00 | Buy | Chardan Capital Markets |
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 momentum, disciplined operational execution, and a strengthening clinical development pipeline. Q1 2025 Highlights: U.S. Food and Drug Administration ("FDA") Breakthrough Device Design
Secured ten new fully-issued patents related to hypertension treatment during last 12 months, bringing global issued patent estate total for this condition to 120 patentsPatent estate covering atrioventricular interval modulation ("AVIM") therapy now includes 46 issued U.S. patents and 91 patents outside the U.S. that collectively comprise over 2100 claims related to the treatment of hypertension as well as heart failureHeart failure pipeline program now protected by an additional 17 issued global patents FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk, including those at risk of heart fa
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 DesignationsThe 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 SABWith the amended IDE approved by the FDA, Orchestra BioMed is currently targeti
BTIG Research initiated coverage of Orchestra BioMed with a rating of Buy and set a new price target of $12.00
Barclays initiated coverage of Orchestra BioMed with a rating of Overweight and set a new price target of $16.00
H.C. Wainwright initiated coverage of Orchestra BioMed with a rating of Buy and set a new price target of $14.00
4 - Orchestra BioMed Holdings, Inc. (0001814114) (Issuer)
4 - Orchestra BioMed Holdings, Inc. (0001814114) (Issuer)
4 - Orchestra BioMed Holdings, Inc. (0001814114) (Issuer)
Hypertension is the most common comorbidity in the pacemaker population, affecting over 70% of patients or approximately 750,000 people annually worldwideMedtronic plc and Orchestra BioMed have an exclusive strategic collaboration for global development and commercialization of BackBeat Cardiac Neuromodulation Therapy™ (CNT), now also known as Atrioventricular Interval Modulation ("AVIM") therapy, for hypertensive pacemaker patientsBACKBEAT global pivotal study is expected to start before the end of 2023 IDE supported by data from the MODERATO II randomized pilot study that showed AVIM therapy drove significant and sustained reductions in blood pressure in hypertensive pacemaker patients Orc
10-Q - Orchestra BioMed Holdings, Inc. (0001814114) (Filer)
SCHEDULE 13D/A - Orchestra BioMed Holdings, Inc. (0001814114) (Subject)
DEFA14A - Orchestra BioMed Holdings, Inc. (0001814114) (Filer)
SC 13D/A - Orchestra BioMed Holdings, Inc. (0001814114) (Subject)
SC 13D/A - Orchestra BioMed Holdings, Inc. (0001814114) (Subject)
SC 13G/A - Orchestra BioMed Holdings, Inc. (0001814114) (Subject)
4 - Orchestra BioMed Holdings, Inc. (0001814114) (Issuer)
4 - Orchestra BioMed Holdings, Inc. (0001814114) (Issuer)
4 - Orchestra BioMed Holdings, Inc. (0001814114) (Issuer)
NEW HOPE, Pa., March 31, 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 reported its full year 2024 financial results and provided a fourth quarter business update. "We remain highly focused on execution of the BACKBEAT global pivotal study, which we believe has the potential to deliver landmark results that can establish AVIM therapy as a new standard of care for the treatment of uncontrolled hypertension in patients already indicated for a pacemaker. We also believe it can lay the foundation for
The BACKBEAT global pivotal study is currently enrolling patients to evaluate the efficacy and safety of atrioventricular interval modulation ("AVIM") therapy for patients who have uncontrolled hypertension and a pacemaker indicationA globally recognized thought leader and innovator in cardiovascular technologies, including electrophysiology and cardiac rhythm management, Dr. Reddy currently serves as the Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, the Director of Electrophysiology for the Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine a
Medical device industry veteran brings over three decades of expertise in M&A, as well as structured research and development ("R&D") collaborations aligned with Orchestra BioMed's partnership-enabled business model Mr. Cleary previously served as Senior Vice President ("SVP") of Corporate Development at Medtronic plc (NYSE:MDT) ("Medtronic"), where he played a key role in establishing the strategic collaboration between Orchestra BioMed and Medtronic for atrioventricular interval modulation ("AVIM") therapy in hypertension with increased cardiovascular riskEric A. Rose, M.D. to transition from Board Member to Board Member Emeritus and Strategic Advisor, continuing to provide invaluable expe