Published: Monday, May 12, 2025 · 9:45 PM | Updated: Monday, May 12, 2025 · 9:45 PM
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- Orchestra BioMed (OBIO, Financial) received FDA Breakthrough Device Designation for AVIM therapy targeting hypertension.
- FDA approved the IDE for a pivotal U.S. trial of the Virtue SAB, a sirolimus-based technology.
- Q1 2025 revenue increased to $0.9 million, up from $0.6 million in Q1 2024.
Orchestra BioMed (OBIO) announced significant regulatory progress and financial results for the first quarter of 2025. The company acquired the FDA Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy, which targets uncontrolled hypertension and increased cardiovascular risk. This designation promises accelerated regulatory interactions and potentially enhanced reimbursement pathways.
Moreover, Orchestra BioMed secured FDA Investigational Device Exemption (IDE) approval for the Virtue Sirolimus AngioInfusion Balloon (SAB) U.S. pivotal trial. This trial will conduct a head-to-head comparison against the AGENT paclitaxel-coated balloon, in efforts to explore their proprietary technology’s efficacy.
Financially, Orchestra BioMed reported a cash position of $49.9 million as of March 31, 2025. The company’s Q1 2025 revenue increased to $0.9 million, a 50% rise from $0.6 million in Q1 2024. However, the net loss widened to $18.8 million ($0.49 per share) compared to $13.5 million ($0.38 per share) in the same quarter last year, primarily due to increased research and development expenses driven by the BACKBEAT global pivotal study.
The AVIM therapy’s patent portfolio now includes 137 issued patents worldwide, with strategic clinical collaborations, such as the one with Medtronic for the BACKBEAT study, continuing to advance Orchestra BioMed’s innovative therapeutic options.
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