Orchestra Biomed’s New Study: A Game Changer in Coronary Treatment?

Orchestra Biomed Holdings, Inc. ((OBIO)) announced an update on their ongoing clinical study.

Study Overview: Orchestra Biomed Holdings, Inc. is conducting a study titled ‘Virtue® SAB in the Treatment of Coronary ISR Trial.’ This prospective, multi-center, single-blind, randomized study aims to compare the clinical outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) with the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) for treating coronary artery in-stent restenosis (ISR). The study’s significance lies in its potential to improve treatment options for coronary artery disease.

Intervention/Treatment: The study is testing two devices: the Virtue Sirolimus AngioInfusion Balloon and the AGENT™ Paclitaxel Drug-Coated Balloon. Both are used in percutaneous coronary interventions to treat coronary artery disease by preventing restenosis.

Study Design: This is an interventional study with a randomized allocation and a parallel intervention model. It is single-blind, meaning the participants are unaware of which treatment they receive. The primary purpose is treatment-focused, aiming to establish non-inferiority between the two devices.

Study Timeline: The study is not yet recruiting, with an initial submission date of June 16, 2025. The latest update was submitted on October 10, 2025. These dates are crucial as they indicate the study’s progress and readiness to begin participant recruitment.

Market Implications: The update on this study could influence Orchestra Biomed’s stock performance and investor sentiment, as successful outcomes may enhance the company’s competitive position in the coronary artery disease treatment market. Investors should watch for developments, as they may impact industry dynamics and competitor strategies.

Closing Sentence: The study is ongoing, with further details available on the ClinicalTrials portal.