Orchestra BioMed Holdings, Inc. (OBIO) will present new clinical and mechanistic data for its Atrioventricular Interval Modulation (AVIM) Therapy at the Heart Rhythm Society (HRS) 2026 Annual Meeting in Chicago. The presentation of data from the MODERATO II randomized, prospective, multi‑center, double‑blind, controlled trial is scheduled for Saturday, April 25, 2026, from 10:06 to 10:18 am in Room S102 at McCormick Place. A second session featuring a pressure‑volume loop analysis of AVIM Therapy in patients with uncontrolled hypertension will take place on Friday, April 24, 2026.
MODERATO II demonstrated a significant reduction in ambulatory systolic blood pressure among pacemaker‑indicated patients, with an average 13.2 mmHg drop in office systolic blood pressure and a 8.1 mmHg reduction in 24‑hour ambulatory systolic blood pressure at six months compared with control. The trial also showed a 97 % responder rate, defined as a >5 mmHg reduction in systolic pressure. These findings reinforce the platform’s ability to lower blood pressure by modulating cardiac preload and arterial elastance without compromising left‑ventricular contractility, a key safety feature for patients with existing pacemakers.
AVIM Therapy has received FDA Breakthrough Device designation and is being evaluated in the global BACKBEAT pivotal trial in partnership with Medtronic. The data presented at HRS 2026 will strengthen the evidence base that underpins the therapy’s potential to provide sustained blood‑pressure control without additional drug therapy, addressing a substantial unmet need in the hypertension market. The presentation also highlights the therapy’s applicability to the subset of patients who already require pacemakers, a niche that could accelerate adoption and market penetration.
Orchestra BioMed’s recent Q4 2025 earnings, posted on March 12, 2026, showed an earnings per share of $0.26 versus an estimate of –$0.38, and revenue of $30.92 million against an estimate of $0.93 million, underscoring the company’s improving financial position. With a strong cash balance and ongoing collaboration with Medtronic, the company is well positioned to advance its AVIM pipeline and pursue commercial launch once regulatory milestones are achieved.
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