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- Data from acute and chronic pressure-volume loop studies support the mechanism of action and show a favorable impact of AVIM therapy on blood pressure and cardiovascular hemodynamics
- AVIM therapy drove statistically significant reductions in systolic blood pressure, intra-cardiac volumes, total peripheral resistance and stroke work, with no adverse impact on stroke volume or contractility.
- Orchestra BioMed and Medtronic (NYSE: MDT) have a strategic collaboration for the development of AVIM therapy for treatment of uncontrolled hypertension in patients indicated for a pacemaker; over 750,000 patients annually that receive pacemakers worldwide are also believed to have hypertension.
- AVIM therapy has FDA Breakthrough Device Designation for the treatment of uncontrolled hypertension in patients with increased cardiovascular risk, a population the Company estimates to comprise over 7.7 million patients in the U.S.
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 the publication of data in the Journal of the American College of Cardiology: Clinical Electrophysiology ("JACC: Clinical EP") from a pressure-volume ("PV") loop study demonstrating favorable hemodynamic effects of AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension. AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study, which Orchestra BioMed is conducting in collaboration with Medtronic, to support potential future global regulatory approvals and commercialization of AVIM therapy-enabled devices.
The publication, titled " Pressure-Volume Analysis Demonstrates Short- and Long-Term Hemodynamic Effects of Atrioventricular Interval Modulation Therapy in Hypertension, " reports findings from an invasive PV loop analysis in 16 hypertensive pacemaker-indicated subjects, as well as noninvasive PV loop analysis from a subgroup of subjects (n=32) from the MODERATO II study receiving chronically administered AVIM therapy. The analyses demonstrated that AVIM therapy reduced systolic blood pressure ("SBP") acutely by decreasing cardiac preload and effective arterial elastance unrelated to pacing lead location, while also improving left ventricular ("LV") end-diastolic and end-systolic volumes. Chronically administered AVIM therapy demonstrated sustained reductions in SBP and end-diastolic volume, indicative of favorable reverse LV remodeling. Results also demonstrated consistently favorable hemodynamic effects using traditional right ventricular ("RV") and conduction system pacing ("CSP") lead placements.
Daniel Burkhoff, M.D., Ph.D., Director, Heart Failure, Hemodynamics, and MCS Research, Cardiovascular Research Foundation and a manuscript author commented: "Pressure-volume loop analysis is regarded as the gold standard for assessing systolic and diastolic function as well as reverse remodeling. These results provide powerful insights on the impact of AVIM therapy to both decrease blood pressure and favorably impact ventricular end-diastolic volume without compromising cardiac output or increasing workload. Notably, these favorable effects were observed consistently and with different pacing lead locations, demonstrating the versatility of AVIM therapy. Publication of these data in a prestigious peer-reviewed journal such as JACC: Clinical Electrophysiology provides further validation from the clinical community reinforcing the therapeutic rationale behind AVIM therapy and further highlighting its potential to deliver differentiated clinical benefit for patients with uncontrolled hypertension."
Key findings include:
- Significantly reduced (p : average decreases of 17.1 mmHg (AVIM via RV pacing) and 19.2 mmHg (AVIM via CSP ), compared to 1.7 mmHg with standard dual-chamber pacing.
- Improved left ventricular hemodynamics with both RV pacing and CSP, respectively, compared to standard pacing :
- End-diastolic volume significantly decreased by 12.6 mL and 18.6 mL compared to 1.4 mL
- End-systolic volume significantly decreased by 11.0 mL and 14.1 mL compared to an increase of 1.8 mL
- End-diastolic pressure significantly decreased by 2.1mmHg and 3.9 mmHg, compared to an increase of 0.3 mmHg
- Significantly reduced (p : Stroke work decreased by 1,596 mL (RV) and 1,870 mL (CSP), compared to 42mL (standard pacing), with minimal impact on stroke volume.
- Significantly reduced total peripheral resistance ("TPR", measured by Ea):
- Effective arterial elastance ("Ea") decreased by 0.23 mmHg/mL (RV) and 0.31 mmHg/mL (CSP), compared to an increase of 0.04 mmHg/mL (standard pacing).
Yuval Mika, Ph.D., Executive Vice President, Bioelectronic Therapies at Orchestra BioMed, stated , "The publication of the PV loop data in JACC: Clinical Electrophysiology marks another important milestone showcasing AVIM therapy's potential ability to significantly reduce blood pressure and favorably impact cardiac function in hypertensive patients with increased cardiovascular risk. The consistent reduction seen in cardiac preload, as well as cardiac afterload with both CSP and RV lead placements in these pilot studies demonstrates that AVIM therapy's mechanism of action works regardless of lead location. Furthermore, acute and chronic PV loop results indicate AVIM therapy's potential to induce positive reverse remodeling of ventricular hypertrophy, highlighting potential to prevent or even treat heart failure. We continue to believe that AVIM therapy has the potential to reshape the standard of care for higher risk patients with uncontrolled hypertension in the pacemaker population and beyond."
The full article is available online in JACC: Clinical Electrophysiology .
About Orchestra BioMed
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 (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing the Virtue ® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com , and follow us on LinkedIn .
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About AVIM Therapy
AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk.
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