NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has announced the first patient was randomized in its BACKBEAT pivotal study in late December 2023. This marks a significant milestone in the development of Atrioventricular Interval Modulation (AVIM) therapy, also known as BackBeat CNT™, for the treatment of pacemaker-indicated patients with uncontrolled hypertension.
For investors, this is a development worth watching closely. The AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker. It is designed to reduce blood pressure immediately, substantially, and persistently.
The strategic collaboration between Orchestra BioMed and Medtronic, Inc. (NYSE: MDT) formed in July 2022 is set to develop and commercialize AVIM therapy for hypertensive pacemaker patients. If approved, Medtronic will have exclusive global rights to commercialize AVIM-enabled pacing systems for this target population, and Orchestra BioMed will share in the revenues generated from Medtronic sales of the AVIM-enabled pacing systems. This could potentially lead to a substantial revenue stream for Orchestra BioMed, a factor that may make the company an attractive prospect for investors.
The BACKBEAT pivotal study is a global, multi-center, prospective, randomized, double-blind study investigating the efficacy and safety of AVIM therapy. Approximately 500 patients will be randomized to receive either AVIM therapy combined with continued medical therapy or continued medical therapy and standard pacing alone. The primary efficacy endpoint will determine whether AVIM-treated patients experience a statistically significant reduction in daily average blood pressure compared to control patients.
The initiation of the BACKBEAT pivotal study follows encouraging results from the MODERATO II pilot study, which showed that patients treated with AVIM therapy experienced significant reductions in blood pressure and no major adverse cardiac events, compared to the control group.
As Orchestra BioMed progresses with its pivotal study, investors should consider the potential market for this bioelectronic therapy. With a significant number of pacemaker-indicated patients suffering from uncontrolled hypertension despite medication use, there could be a substantial demand for a successful AVIM treatment. Furthermore, the strategic partnership with Medtronic, a leading player in the medical devices field, could ensure a smooth path to market and robust sales performance.
However, investors should also bear in mind the risks inherent in clinical trials. The success of the BACKBEAT pivotal study is not guaranteed, and further trials will be needed to confirm the safety and efficacy of AVIM therapy. As always, careful evaluation and due diligence are crucial when considering investment in biotech firms.
More information on the BACKBEAT pivotal study can be found here.
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