Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has received a significant nod from the U.S. Food and Drug Administration (FDA) for their pioneering investigational device exemption (IDE). This approval marks a pivotal moment in the medical field, as it allows Orchestra BioMed to commence the global BACKBEAT study. This study aims to evaluate the efficacy and safety of atrioventricular interval modulation (AVIM) therapy, also known as BackBeat CNT, designed to treat hypertensive patients requiring a dual-chamber cardiac pacemaker.
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Hypertension, commonly known as high blood pressure, is a global health concern affecting millions of individuals worldwide. However, it is particularly prevalent among pacemaker patients, impacting over 70% of this population annually, translating to approximately 750,000 people. This staggering statistic underscores the urgent need for innovative solutions to manage hypertension in this specific patient demographic.
Orchestra BioMed initiated a strategic collaboration with Medtronic plc in July 2022, a partnership that laid the foundation for this groundbreaking development. Under this collaboration, Medtronic plays a crucial role by providing essential support for development, clinical trials, and regulatory processes for the BACKBEAT global pivotal study. If successful, Medtronic will secure exclusive global rights to commercialize AVIM-enabled pacing systems for this specific target population. In turn, Orchestra BioMed will share in the resulting revenues.
The FDA's IDE approval stands as a significant milestone for Orchestra BioMed, achieved just over a year after the commencement of their partnership with Medtronic. David Hochman, Chairman, Chief Executive Officer, and Founder of Orchestra BioMed, expressed their optimism, stating, "We believe this innovative therapy has the potential to substantially improve the standard of care for hypertensive pacemaker patients, and we look forward to initiating the study before the end of 2023."
AVIM therapy offers a promising avenue to address hypertension in pacemaker patients. Dr. David Kandzari, Chief of the Piedmont Heart Institute and Chief Scientific Officer for Piedmont Healthcare, emphasizes the importance of this device-based treatment, stating, "A device-based treatment like AVIM therapy has the potential to complement existing standards of care and reduce blood pressure to improve clinical outcomes."
The BACKBEAT pivotal study is meticulously designed as a global, multi-center, prospective, randomized, double-blind study. Its primary objective is to assess the efficacy and safety of AVIM therapy in patients who have recently undergone a Medtronic dual-chamber cardiac pacemaker implant and are grappling with uncontrolled hypertension despite the use of antihypertensive medications. Approximately 500 patients will be randomized, with half receiving AVIM therapy in conjunction with continued medical therapy and pacing, while the other half will receive continued medical therapy and pacing alone.
The primary efficacy endpoint of the study is the difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) at three months post-randomization. The primary safety endpoint pertains to freedom from unanticipated serious adverse device effects in the treatment arm at three months post-randomization. The study will maintain double-blind follow-up for 12 months to gather additional clinical data. Orchestra BioMed plans to commence enrollment in the BACKBEAT study by the close of 2023, pending standard clinical trial initiation procedures, including approvals from Institutional Review Boards.
Hypertension's high prevalence among pacemaker patients is a significant concern since these patients are typically older and at a higher risk for cardiovascular events. AVIM therapy offers the potential for a transformative treatment approach, as it can be administered using the same pacemaker already implanted and managed by the same medical team. Dr. Andrea Russo, Co-Principal Investigator of the BACKBEAT Study, expresses excitement about this innovative therapy, stating, "We are eager to participate in the BACKBEAT study, which has been thoughtfully designed to evaluate the safety and efficacy of this novel therapy."
The FDA's IDE approval for the BACKBEAT study is well-supported by encouraging results from the MODERATO II pilot study. This earlier study demonstrated that patients treated with AVIM therapy experienced significant reductions in blood pressure compared to control patients, with a net reduction of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months.
In summary, the FDA's IDE approval for the BACKBEAT study by Orchestra BioMed marks a substantial stride in the field of hypertension treatment for pacemaker patients. This innovative therapy holds the promise of substantially enhancing the quality of care and outcomes for this specific patient population. To stay updated on this groundbreaking development and learn more about the study, click here: https://investorconsensus.com/stock-ticker?symbol=OBIO