NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has announced its financial results for the first quarter ended March 31, 2025, alongside significant regulatory and clinical milestones that highlight the company’s ongoing progress in developing innovative cardiovascular therapies. The quarter marked noteworthy advancements in the company’s atrioventricular interval modulation (AVIM) therapy for hypertensive heart disease and its Virtue® Sirolimus AngioInfusion Balloon (SAB) program for coronary artery disease.
Regulatory Momentum
The U.S. Food and Drug Administration (FDA) awarded Breakthrough Device Designation (BDD) to AVIM therapy, recognizing its potential to improve outcomes for patients with hypertensive heart disease and associated risks. This designation brings accelerated regulatory pathways and could unlock additional reimbursement opportunities, positioning the therapy as a significant development for addressing chronic high blood pressure and its complications.
David Hochman, Chairman and CEO of Orchestra BioMed, emphasized the importance of the recognition, stating, “We believe the FDA’s Breakthrough Device Designation for AVIM therapy signals meaningful recognition of its potential to meet the clinical needs of millions living with hypertensive heart disease, a population in which chronic high blood pressure can lead to various heart problems like left ventricular hypertrophy, diastolic dysfunction, heart failure, and coronary artery disease. We believe that AVIM therapy has the potential to provide a potent additional therapeutic option for these patients.”
The company also secured FDA Investigational Device Exemption (IDE) approval for the U.S. pivotal trial of Virtue SAB. This trial, scheduled to begin in the second half of 2025, will compare Virtue SAB with the AGENT™ paclitaxel-coated balloon in a head-to-head study, evaluating its safety and efficacy as a novel sirolimus drug-eluting balloon.
Commenting on the Virtue Trial, Hochman stated, “We believe the updated design of the trial… offers the most direct path to regulatory approval while showcasing the distinctive pharmacokinetic and therapeutic advantages of our proprietary technology.”
Pipeline and Clinical Advances
The company continued enrollment in the BACKBEAT global pivotal study for AVIM therapy, conducted in strategic collaboration with Medtronic. New clinical data presented at THT 2025 highlighted the therapy’s benefits for cardiac function in patients with diastolic dysfunction, a major contributor to heart failure. Concurrently, Orchestra BioMed expanded the AVIM therapy patent estate to 137 issued patents, reinforcing its intellectual property leadership across indications, including hypertension and heart failure.
Financial Results
For the first quarter, Orchestra BioMed reported $49.9 million in cash, cash equivalents, and marketable securities. Revenue grew to $0.9 million, compared to $0.6 million in Q1 2024, driven by partnership revenues under its agreement with Terumo.
Research and development expenses increased to $13.5 million from $9.1 million in the prior year’s first quarter, reflecting escalated costs related to the BACKBEAT study. Selling, general, and administrative expenses also rose to $6.3 million, up from $5.9 million, driven by higher stock-based compensation and professional fees. The company reported a net loss of $18.8 million, or $0.49 per share, compared to $13.5 million, or $0.38 per share, in the same period last year, with the rise primarily due to increased operational investments.
Looking Ahead
Orchestra BioMed’s first-quarter accomplishments underscore its steadfast commitment to delivering groundbreaking therapies in cardiovascular and related fields. With pivotal studies for both AVIM therapy and Virtue SAB set to advance later this year, the company is poised to create significant clinical and regulatory momentum in 2025.
The strategic alignment with Medtronic, robust intellectual property estate, and growing body of clinical evidence highlight Orchestra BioMed’s potential to transform patient care while building long-term value across its stakeholder ecosystem.
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