Associated tags: Beat (music), SAB, Hypertension, Death, Patient, BioMed Central, Medtronic, Mortality, HOPE, Orchestra, Pharmaceutical industry
Retrieved on:
Wednesday, March 27, 2024
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Pharmaceutical industry Globally, the treatment of coronary in-stent restenosis and other challenging artery disease indications is rapidly shifting toward drug-coated balloons.
Key Points:
- 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.
HOPE,
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Siemens Healthineers,
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Management Mr. Pacitti is currently the President of Siemens Medical Solutions USA, Inc. and Head of the Americas, Siemens Healthineers.
Key Points:
- Mr. Pacitti is currently the President of Siemens Medical Solutions USA, Inc. and Head of the Americas, Siemens Healthineers.
- Prior to joining Siemens Healthineers, he was Division Vice President of U.S. Commercial Operations, Sales, and Marketing at Abbott Vascular, overseeing the company’s business in North America.
- “It’s an honor to welcome Dave to the Orchestra BioMed Board where we expect to benefit from his wealth of experience in driving the adoption of transformational device therapies and procedural imaging modalities,” said David Hochman, chairman, chief executive officer and founder of Orchestra BioMed.
- I look forward to contributing my perspective to help Orchestra BioMed realize the full potential of its cardiovascular pipeline, strategic partnerships and differentiated business model.”
Retrieved on:
Wednesday, March 13, 2024
Blood pressure,
CRT,
Investigational device exemption,
HOPE,
Patient,
Inflammation,
Stroke,
Gold,
Restenosis,
ISR,
Medtronic,
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Trial of the century,
Virtue,
Sirolimus,
Stent,
Safety,
Pharmacokinetics,
SAB,
Hypertension,
Molecular mass,
Food,
Medical device 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.
Key Points:
- 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.
NEW HOPE, Pa., March 07, 2024 (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 that company management will present and be available for one-on-one meetings at multiple conferences throughout March 2024.
Key Points:
- NEW HOPE, Pa., March 07, 2024 (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 that company management will present and be available for one-on-one meetings at multiple conferences throughout March 2024.
- Details on the presentations are shown below.
Blood pressure,
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Hypertension,
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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.
Key Points:
- 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.
Retrieved on:
Monday, February 26, 2024
“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.
Key Points:
- “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.
Blood pressure,
Bradycardia,
Risk,
Orchestra,
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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).
Retrieved on:
Monday, November 13, 2023
Beat (music),
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Terumo “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.
Key Points:
- “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.
Retrieved on:
Tuesday, September 19, 2023
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Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
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Hypertension 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.
Retrieved on:
Thursday, August 10, 2023
SAB,
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R,
IDE,
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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.
