Beat (music)

Orchestra BioMed Reports Full Year 2023 Financial Results and Provides Fourth Quarter Business Update

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Wednesday, March 27, 2024

Globally, the treatment of coronary in-stent restenosis and other challenging artery disease indications is rapidly shifting toward drug-coated balloons.

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Globally, the treatment of coronary in-stent restenosis and other challenging artery disease indications is rapidly shifting toward drug-coated balloons.
Financial Results for the Year Ended December 31, 2023
Cash and cash equivalents and marketable securities totaled $87.6 million as of December 31, 2023.
Net loss for 2023 was $49.1 million, or ($1.48) per share, compared with a net loss of $33.6 million, or ($2.24) per share, for 2022.
Net loss for the year-ended 2023 included non-cash stock-based compensation expense of $7.6 million, compared with $3.4 million for the same period in 2022.

Orchestra BioMed Demonstrates Strength of Cardiovascular Pipeline with Virtue® SAB and AVIM Therapy Presentations at CRT 2024 Annual Meeting

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Wednesday, March 13, 2024

A second presentation featured recently reported clinical data on atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT), an investigational therapy delivered via standard dual-chamber pacemakers designed to immediately, substantially and persistently lower blood pressure.

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A second presentation featured recently reported clinical data on atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT), an investigational therapy delivered via standard dual-chamber pacemakers designed to immediately, substantially and persistently lower blood pressure.
The AVIM presentation also outlined the design of the currently enrolling BACKBEAT global pivotal study evaluating AVIM therapy in hypertensive pacemaker patients in collaboration with Medtronic.
Specifically, the presented PK data showed that:
Molecular weight of Sostenocel remained unchanged prior to elimination, showing no evidence of in-vivo degradation.
AVIM therapy demonstrated:
Consistent favorable hemodynamic effects using both conduction system, as well as traditional right ventricular lead placements.

Orchestra BioMed Announces Presentation of Results from Clinical Study Demonstrating Favorable Hemodynamic Effects of AVIM Therapy In Hypertensive Pacemaker Patients

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Wednesday, March 6, 2024

Blood pressure, PV, HOPE, Beat (music), Overalls, Cardiac output, Stroke, Safety, Hypertension, Aorta, Patient, Hemodynamics, RV, DDD, Heart failure, Medical device

These data demonstrate the favorable impact of AVIM therapy compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system andstandard pacing lead locations.

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These data demonstrate the favorable impact of AVIM therapy compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system andstandard pacing lead locations.
The PV loop study was conducted at Na Homolce Hospital in Prague by Prof. Petr Neužil, M.D.
AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure.
“Well-conducted invasive PV loop studies are a robust way to evaluate the impact of a novel therapy like AVIM on hemodymanics and overall cardiac function.

Orchestra BioMed Presents New Data Showing Sustained Clinically Meaningful Reduction in 24-Hour Ambulatory Systolic Blood Pressure in Hypertensive Pacemaker Patients Treated with AVIM Therapy for Over 3 Years

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Monday, February 26, 2024

Blood pressure, Innovation, Senior, Mercury (element), Beat (music), Orchestra, Risk, Hypertension, Patient, Pharmaceutical industry

“These new long-term follow up data demonstrate AVIM therapy’s ability to drive a substantial and sustained reduction in 24-hour ambulatory systolic blood pressure, the gold standard, and most accurate measure of hypertension.

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“These new long-term follow up data demonstrate AVIM therapy’s ability to drive a substantial and sustained reduction in 24-hour ambulatory systolic blood pressure, the gold standard, and most accurate measure of hypertension.
Each patient’s aSBP was measured an average of 3.6 (±0.6) years following original initiation of AVIM therapy.
AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure.
Orchestra BioMed and Medtronic plc (NYSE: MDT) (“Medtronic”) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022.

Donner to Exhibit a Variety of New Gear Showcased by Leading Performers During The 2024 NAMM Show

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Wednesday, January 17, 2024

School, NAMM, Grammy Awards, Multimedia, Isogai, Beat (music), Student, Musicians Institute, NAMM Show, School of Rock, Music

ANAHEIM, Calif., Jan. 17, 2024 /PRNewswire/ -- Donner is excited to announce its participation in The 2024 NAMM Show, from January 25–28, 2024, in Anaheim, California, where it will release a wide range of innovative new gear at its Booth 3620 in Hall D.

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With more information on this groundbreaking product to come, the collaboration will be a must-see for any guitar player and effects enthusiast.
Additionally, Donner will also officially launch its BackBeat, the company's latest electronic drum kit.
On the piano side of the market, Donner will introduce its new DDP-80 Pro, a modern, home-style digital piano.
Isogai's popularity extends beyond borders, making him a captivating addition to the Donner NAMM Show lineup.

Orchestra BioMed Announces Initiation of BACKBEAT Pivotal Study of AVIM Therapy in Hypertensive Pacemaker Patients

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Monday, January 8, 2024

Blood pressure, Bradycardia, Risk, Orchestra, Collection, Consultant, Hypertension, Mortality, Disease, HOPE, Stroke, Comorbidity, Patient, Safety, Heart failure, Beat (music), BioMed Central, OSBP, Pharmaceutical industry

AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure.

Key Points:

AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure.
Orchestra BioMed and Medtronic, Inc. (NYSE: MDT) (“Medtronic”) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022.
Orchestra BioMed is actively screening patients for enrollment in the BACKBEAT pivotal study.
The study will randomize approximately 500 patients 1:1 to AVIM therapy combined with continued medical therapy (treatment) or continued medical therapy and standard pacing alone (control).

Orchestra BioMed Reports Third Quarter 2023 Financial Results and Provides Business Update

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Monday, November 13, 2023

“This past quarter marked two major regulatory milestones for Orchestra BioMed, with the FDA granting IDE approval for pivotal studies for both BackBeat CNT (AVIM therapy) and Virtue SAB.

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“This past quarter marked two major regulatory milestones for Orchestra BioMed, with the FDA granting IDE approval for pivotal studies for both BackBeat CNT (AVIM therapy) and Virtue SAB.
Financial Results for the Third Quarter Ended September 30, 2023
Cash and cash equivalents and Marketable securities totaled $108.5 million as of September 30, 2023.
Revenue for the third quarter of 2023 was $0.4 million, compared with $1.2 million for the same period in 2022.
Net loss for the third quarter of 2023 included non-cash stock-based compensation expense of $3.5 million, compared with $2.2 million for the same period in 2022.

Orchestra BioMed Granted FDA Approval of IDE to Initiate BACKBEAT Pivotal Study of BackBeat CNT™ for the Treatment of Hypertension in Pacemaker Patients

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Tuesday, September 19, 2023

Orchestra BioMed and Medtronic plc (NYSE: MDT) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022.

Key Points:

Orchestra BioMed and Medtronic plc (NYSE: MDT) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022.
Under the collaboration, Medtronic is providing Orchestra BioMed with development, clinical, and regulatory support for the BACKBEAT global pivotal study, which Orchestra BioMed is sponsoring.
Orchestra BioMed will share in the revenues generated from Medtronic sales of the AVIM-enabled pacing systems.
“We are thrilled to receive IDE approval from the FDA and move forward with plans to initiate the BACKBEAT global pivotal study, which is designed to support potential future regulatory review and potential approval of AVIM therapy for hypertensive patients indicated for a pacemaker.

Orchestra BioMed Reports Second Quarter 2023 Financial Results and Provides Business Update

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Thursday, August 10, 2023

SAB, Insurance, Orchestra, Investigational device exemption, Investigational New Drug, Partnership, HOPE, Virtue, Food and Drug Administration, ISR, Beat (music), Research, Patient, Physician, R, IDE, FDA, Food, Pharmaceutical industry

This latest milestone kicks off what is expected to be a busy second half of 2023 for Orchestra BioMed, which we believe will feature the initiation of pivotal studies for both of our flagship partnered development programs.

Key Points:

This latest milestone kicks off what is expected to be a busy second half of 2023 for Orchestra BioMed, which we believe will feature the initiation of pivotal studies for both of our flagship partnered development programs.
Revenue for the second quarter of 2023 was $0.9 million, compared with $0.4 million for the same period in 2022.
Research and development (R&D) expenses for the second quarter of 2023 were $8.5 million, compared with $5.0 million for the same period in 2022.
Selling, general and administrative expenses for the second quarter of 2023 were $5.3 million, compared with $2.9 million for the same period in 2022.

Orchestra BioMed Reports First Quarter 2023 Financial Results and Provides Business Update

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Friday, May 12, 2023

NEW HOPE, Pa., May 12, 2023 (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 reported its first quarter 2023 financial results and provided a business update.

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NEW HOPE, Pa., May 12, 2023 (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 reported its first quarter 2023 financial results and provided a business update.
“The first quarter of 2023 was a transformational period for Orchestra BioMed marked by our successful entrance into the public markets.
Revenue: Orchestra BioMed recognized $1.2 million of revenue for the first quarter of 2023 compared to $0.9 million for the first quarter of 2022.
Other Income (Expense): Other income was $0.6 million for the first quarter of 2023, compared to other expense of $0.6 million for the first quarter of 2022.