--- title: Virtue SAB IDE Approval and What It Means for OBIO Shareholders description: Today, Orchestra BioMed announced a major advancement for its proprietary Virtue® Sirolimus AngioInfusion Balloon™ (Virtue SAB) image: https://www.orchestrabiomed.com/hubfs/Regulatory.png --- [![Orchestra BioMed Logo](https://www.orchestrabiomed.com/hubfs/logo-light.png) ](https://www.orchestrabiomed.com/) × ## Who we are - [Our Approach](https://www.orchestrabiomed.com/our-approach) - [Our People](https://www.orchestrabiomed.com/our-people) - [Careers](https://www.orchestrabiomed.com/careers) ## Our Innovations - [Pipeline](https://www.orchestrabiomed.com/pipeline) - [Therapeutic Areas](https://www.orchestrabiomed.com/therapeutic-areas) - [AVIM Therapy](https://www.orchestrabiomed.com/avim-therapy) - [Virtue® SAB](https://www.orchestrabiomed.com/virtue-sab) ## Content Hub ## Investor Relations - [Overview](https://investors.orchestrabiomed.com) - [News & Events](https://investors.orchestrabiomed.com/news-and-events) - [Stock Quote & Chart](https://investors.orchestrabiomed.com/stock-quote-and-chart) - [Analyst Coverage](https://investors.orchestrabiomed.com/analyst-coverage) - [Corporate Governance](https://investors.orchestrabiomed.com/corporate-governance) - [Financial & Filings](https://investors.orchestrabiomed.com/financials-and-filings) - [IR Resources](https://investors.orchestrabiomed.com/ir-contact) [![Orchestra BioMed Logo](https://www.orchestrabiomed.com/hubfs/logo-light.png) ]({type=EXTERNAL,%20content_id=null,%20href=,%20href_with_scheme=}) ☰   ## Blog Post - Virtue SAB IDE Approval and What It Means for OBIO Shareholders **OBIO | Virtue SAB IDE Approval and What It Means for OBIO Shareholders** #### Fellow Shareholders Today, Orchestra BioMed [**announced a major advancement for its proprietary Virtue® Sirolimus AngioInfusion Balloon**™](https://investors.orchestrabiomed.com/news-releases/news-release-details/orchestra-biomed-receives-fda-approval-ide-initiate-us-coronary) (Virtue SAB), with the **FDA granting approval** of the company’s amended Investigational Device Exemption (IDE) **to initiate a pivotal U.S. clinical trial** designed to **evaluate Virtue SAB head-to-head **against the AGENT™ paclitaxel-coated balloon, the only drug-coated balloon (DCB) currently FDA-approved for coronary use. Virtue SAB stands apart as the only non-coated drug-eluting balloon system delivering a large liquid dose of proprietary extended-release sirolimus — a key differentiator with potential to set a new standard in interventional cardiology. #### **What does this mean for OBIO shareholders?** CEO David Hochman captures the essence of the news in his press release quote: *“We believe there is a multibillion-dollar U.S. market for coronary drug delivery balloons based on the significant unmet clinical need, market demand, and established reimbursement. We made a deliberate, strategic decision to pursue a head-to-head trial with the commercially available AGENT paclitaxel-coated balloon, underscoring our confidence in Virtue SAB as a fundamentally differentiated solution for the treatment of atherosclerosis. We believe this approach offers the most direct path to regulatory approval while also providing the best opportunity to demonstrate what we believe are distinctive and sustainable advantages of our proprietary technology.”* Beyond this perspective, it’s important for investors also to note that key sector opinion leaders are leading the trial: Dr. Dean Kereiakes and Dr. Allen Jeremias. Both physicians are highly respected interventional cardiology leaders whose oversight reinforces clinical credibility and future adoption. *“Virtue SAB has the potential to be one of the most compelling technologies in interventional cardiology. It’s the only product in development that optimizes both the arterial tissue uptake and retention of sirolimus to achieve pharmacokinetics that match or even exceed those of proven ‘limus-eluting stents.”* - Dean J. Kereiakes, M.D. *“In a field largely reliant on paclitaxel drug-coated balloons, Virtue SAB stands out as the only device with a completely different mechanism of action; namely to provide delivery of a large liquid dose of an extended-release formulation sirolimus.”* - Allen Jeremias, M.D. Specifically, we’d highlight **four value drivers** associated with this milestone: 1. **Major U.S. Regulatory Catalyst** *FDA approval of the IDE clears OBIO to initiate a robust non-inferiority trial designed to enroll 740 patients, provide a clear pathway to regulatory approval, and showcase the potential clinical advantages of Virtue SAB.* 1. **Head-to-Head Against the Market Leader** *The Virtue Trial will be the first U.S. head-to-head randomized evaluation of a sirolimus-eluting balloon versus a paclitaxel-coated balloon for the treatment of coronary artery disease.* 1. **Multi-Billion Dollar Market Opportunity** *With significant unmet clinical needs in atherosclerotic disease and established reimbursement pathways, we believe the commercial opportunity for Virtue SAB is large, timely, and highly compelling.* 1. **Strong Foundation from Breakthrough Device Designation** *Virtue SAB has already received FDA Breakthrough Device Designation in key coronary and peripheral artery disease indications — reinforcing its innovation and helping enable a potentially accelerated path to market.* We are currently targeting to initiate the Virtue Trial in the second half of 2025. With a rigorous trial design, strategic head-to-head positioning, and a differentiated drug delivery platform, we believe Virtue SAB represents one of the most exciting device opportunities in cardiovascular medicine. Here, as with our AVIM therapy program and global pivotal study, we remain focused on execution. Our mission is to bring new clinical solutions to millions of patients in need. Orchestra is just warming up. Stay tuned! **—Team OBIO** ![BACKBEAT Timeline Update Reinforces Momentum to Pivotal Trial Data Presentation and Regulatory Submissions by Medtronic](https://www.orchestrabiomed.com/hubfs/Regulatory%202.png) May 2026 ##### [BACKBEAT Timeline Update Reinforces Momentum to Pivotal Trial Data Presentation and Regulatory Submissions by Medtronic](https://www.orchestrabiomed.com/hub/backbeat-timeline-update-reinforces-momentum-to-pivotal-trial-data-presentation-and-regulatory-submissions-by-medtronic) BACKBEAT Timeline Update Reinforces Momentum to Pivotal Trial Data Presentation and Regulatory Submissions by Medtronic ... ![Strategic Capital Supports Pivotal-Stage Execution](https://www.orchestrabiomed.com/hubfs/Finance%202.png) May 2026 ##### [Strategic Capital Supports Pivotal-Stage Execution](https://www.orchestrabiomed.com/hub/strategic-capital-supports-pivotal-stage-execution) Strategic Capital Supports Pivotal-Stage Execution Orchestra BioMed Investor Relations Blog | May 2026 The receipt of $3... ![Strengthening AVIM Therapy’s Regulatory Pathway: A Second FDA Breakthrough Device Designation](https://www.orchestrabiomed.com/hubfs/Regulatory%202.png) April 2026 ##### [Strengthening AVIM Therapy’s Regulatory Pathway: A Second FDA Breakthrough Device Designation](https://www.orchestrabiomed.com/hub/strengthening-avim-therapys-regulatory-pathway-a-second-fda-breakthrough-device-designation) Strengthening AVIM Therapy’s Regulatory Pathway: A Second FDA Breakthrough Device Designation Orchestra BioMed Investor ... ![From Blood Pressure Reduction to Cardiac Function: What New AVIM Therapy Data Signal](https://www.orchestrabiomed.com/hubfs/Clinical.png) April 2026 ##### [From Blood Pressure Reduction to Cardiac Function: What New AVIM Therapy Data Signal](https://www.orchestrabiomed.com/hub/from-blood-pressure-reduction-to-cardiac-function-what-new-avim-therapy-data-signal) From Blood Pressure Reduction to Cardiac Function: What New AVIM Therapy Data Signal Orchestra BioMed Investor Relations... ![Our Clinical Vision: AVIM Therapy for Hypertensive Heart Disease](https://www.orchestrabiomed.com/hubfs/Clinical%202.png) March 2026 ##### [Our Clinical Vision: AVIM Therapy for Hypertensive Heart Disease](https://www.orchestrabiomed.com/hub/avim-therapy-for-hypertensive-heart-disease) Our Clinical Vision: AVIM Therapy for Hypertensive Heart Disease Orchestra BioMed recently announced multiple scientific... ##### Follow us on LinkedIn [![LinkedIn](https://www.orchestrabiomed.com/hubfs/Assets%202024/skill-icons--linkedin.svg) ](https://www.linkedin.com/company/orchestra-biomed/) ![LinkedIn Post](https://www.orchestrabiomed.com/hubfs/1760457247277.jpg) Avi Fischer, M.D., joined forward-thinking leaders exploring the future of treating hypertensive hea... [Learn more](https://www.linkedin.com/posts/orchestra-biomed_orchestratinginnovation-gamedtechsummit-activity-7383892875350237184-LTyD?utm_source=share&utm_medium=member_desktop&rcm=ACoAACQyoIEBJiu1zf2Qtko6wt17ziSn0Nnd8DA) [![LinkedIn](https://www.orchestrabiomed.com/hubfs/Assets%202024/skill-icons--linkedin.svg) ](https://www.linkedin.com/posts/orchestra-biomed_orchestratinginnovation-gamedtechsummit-activity-7383892875350237184-LTyD?utm_source=share&utm_medium=member_desktop&rcm=ACoAACQyoIEBJiu1zf2Qtko6wt17ziSn0Nnd8DA) ![LinkedIn Post](https://www.orchestrabiomed.com/hubfs/1755711749377.jpg) Great ideas need great minds to bring them to life. Our team is dedicated to making a lasting impact... [Learn more](https://www.linkedin.com/posts/orchestra-biomed_hypertension-orchestratinginnovation-medtechleaders-activity-7369825404204851203-F11N?utm_source=share&utm_medium=member_desktop&rcm=ACoAACQyoIEBJiu1zf2Qtko6wt17ziSn0Nnd8DA) [![LinkedIn](https://www.orchestrabiomed.com/hubfs/Assets%202024/skill-icons--linkedin.svg) ](https://www.linkedin.com/posts/orchestra-biomed_hypertension-orchestratinginnovation-medtechleaders-activity-7369825404204851203-F11N?utm_source=share&utm_medium=member_desktop&rcm=ACoAACQyoIEBJiu1zf2Qtko6wt17ziSn0Nnd8DA) ![LinkedIn Post](https://www.orchestrabiomed.com/hubfs/1758048308117.jpg) Where in the world is our CEO? 🌍 David Hochman joined leading voices in hashtag#Cardiology and hash... [Learn more](https://www.linkedin.com/posts/orchestra-biomed_where-in-the-world-is-our-ceo-activity-7373789069291597826-XREZ?utm_source=share&utm_medium=member_desktop&rcm=ACoAACQyoIEBJiu1zf2Qtko6wt17ziSn0Nnd8DA) [![LinkedIn](https://www.orchestrabiomed.com/hubfs/Assets%202024/skill-icons--linkedin.svg) ](https://www.linkedin.com/posts/orchestra-biomed_where-in-the-world-is-our-ceo-activity-7373789069291597826-XREZ?utm_source=share&utm_medium=member_desktop&rcm=ACoAACQyoIEBJiu1zf2Qtko6wt17ziSn0Nnd8DA) ![LinkedIn Post](https://www.orchestrabiomed.com/hubfs/1753992784636.png) Ligand Pharmaceuticals and Medtronic Cardiac and Vascular commit $70 Million in strategic capital to... [Learn more](https://www.linkedin.com/posts/orchestra-biomed_financing-news-activity-7356780339828051970-t1iK?utm_source=share&utm_medium=member_desktop&rcm=ACoAACQyoIEBJiu1zf2Qtko6wt17ziSn0Nnd8DA) [![LinkedIn](https://www.orchestrabiomed.com/hubfs/Assets%202024/skill-icons--linkedin.svg) ](https://www.linkedin.com/posts/orchestra-biomed_financing-news-activity-7356780339828051970-t1iK?utm_source=share&utm_medium=member_desktop&rcm=ACoAACQyoIEBJiu1zf2Qtko6wt17ziSn0Nnd8DA) ![LinkedIn Post](https://www.orchestrabiomed.com/hubfs/1754658413763.jpg) FDA-approved protocol update significantly expands patient eligibility criteria for the BACKBEAT glo... [Learn more](https://www.linkedin.com/posts/orchestra-biomed_backbeat-global-pivotal-study-protocol-update-activity-7359674332731592704-b_pj?utm_source=share&utm_medium=member_desktop&rcm=ACoAACQyoIEBJiu1zf2Qtko6wt17ziSn0Nnd8DA) [![LinkedIn](https://www.orchestrabiomed.com/hubfs/Assets%202024/skill-icons--linkedin.svg) ](https://www.linkedin.com/posts/orchestra-biomed_backbeat-global-pivotal-study-protocol-update-activity-7359674332731592704-b_pj?utm_source=share&utm_medium=member_desktop&rcm=ACoAACQyoIEBJiu1zf2Qtko6wt17ziSn0Nnd8DA)