Tag: Orchestra BioMed

Orchestra BioMed™ Announces Peer-Reviewed Publication of MODERATO II Study Results Showing a Statistically Significant Reduction in Blood Pressure in Pacemaker-Indicated Patients Treated with BackBeat Cardiac Neuromodulation Therapy™

Double-blind, randomized trial data show a clinically meaningful and statistically significant net reduction of 8.1 mmHg in 24-hour ambulatory systolic blood pressure at 6 months in treated vs. control patients Very high (85%) response rate to therapy despite 81% of […]

Orchestra BioMed™ Announces Clinical Data Demonstrating a Significant and Sustained Reduction in Blood Pressure in MODERATO II Control Patients After Crossover to BackBeat Cardiac Neuromodulation Therapy™

Clinically meaningful and statistically significant reduction in systolic blood pressure is consistent with the decrease previously observed in the study treatment group during the same time period. Ambulatory Systolic Blood Pressure (aSBP) decreased by an average of 10.3 mmHg (p<0.01) at 6 […]

Orchestra BioMed™ Announces Clinical Data Showing Significant and Sustained Reduction in Systolic Blood Pressure Out to Two Years with BackBeat Cardiac Neuromodulation Therapy™

Clinically meaningful and statistically significant reduction of 16.6 mmHg in systolic blood pressure out to two years 88% of the treated patients had isolated systolic hypertension (ISH) 70.6% of all treated patients and 80% of treated ISH patients had their […]

Orchestra BioMed™ Appoints Drug-Device Combination Expert Jagdish Parasrampuria as Vice President of Pharmaceutical Development

NEW HOPE, Pa., July 13, 2020 (GLOBE NEWSWIRE) — Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company focused on developing transformative therapeutic products for large unmet needs in procedure-based medicine, today announced the appointment of Jagdish Parasrampuria […]

Orchestra BioMed™ Enhances Management Team with Appointment of Regulatory Affairs and Combination Product Expert Bob Laughner as Vice President, Regulatory Affairs

NEW HOPE, Pa., April 28, 2020 (GLOBE NEWSWIRE) — Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing transformative therapeutic products for large unmet needs in procedure-based medicine, today announced the appointment of Bob Laughner, an […]

Orchestra BioMed Announces Late-Breaking Clinical Results Showing BackBeat Cardiac Neuromodulation Therapy™ Drives Significant Reduction in Systolic Blood Pressure

Double-blind, randomized trial data demonstrates clinically meaningful and statistically significant difference of 8.1 mmHg in reduction of 24-hour ambulatory systolic blood pressure at 6 months vs. control High responder rate despite 88.5% of treated patients having isolated systolic hypertension (ISH) […]

Orchestra BioMed™ Announces FDA Breakthrough Device Designation for Virtue® Sirolimus-Eluting Balloon for Treatment of Below-the-Knee Peripheral Artery Disease

First and only non-coated sirolimus-eluting angioplasty balloon system to receive Breakthrough Device designation for below-the-knee disease Follows Breakthrough Device designation for Virtue Sirolimus-Eluting Balloon in coronary in-stent restenosis granted in Q2 2019 NEW HOPE, Pa., Sept. 17, 2019 (GLOBE NEWSWIRE) […]

Orchestra BioMed Receives CE Mark for BackBeat Cardiac Neuromodulation Therapy™ (CNT) for Hypertension

Late-breaking BackBeat CNT™ randomized, double-blind clinical results selected by Cardiovascular Research Foundation for presentation at TCT 2019 NEW HOPE, Pa., Sept. 04, 2019 (GLOBE NEWSWIRE) — Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact […]