Workflow
Virtue Sirolimus AngioInfusion™ Balloon (Virtue SAB)
icon
Search documents
Orchestra BioMed Announces AVIM Therapy and Virtue SAB Program Presentations at ICI Meeting
Globenewswire· 2025-12-08 12:00
Core Insights - Orchestra BioMed is collaborating with Medtronic to develop and commercialize AVIM Therapy for treating uncontrolled hypertension in patients indicated for a pacemaker [1][4] - The company presented at the 2025 Innovation in Cardiology Intervention meeting, focusing on AVIM Therapy and Virtue Sirolimus AngioInfusion™ Balloon [1][2] Company Overview - Orchestra BioMed is a biomedical innovation company that accelerates high-impact technologies through strategic collaborations with leading medical device companies [4] - The two flagship products, AVIM Therapy and Virtue SAB, represent multi-billion-dollar annual global market opportunities [4] AVIM Therapy - AVIM Therapy is designed to lower blood pressure significantly and persistently in patients with hypertension who are also indicated for a pacemaker [5][6] - Pilot studies showed net reductions of 8.1 mmHg in ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months compared to control patients [6] - The BACKBEAT global pivotal study is currently evaluating the safety and efficacy of AVIM Therapy in patients with systolic blood pressure above target despite anti-hypertensive medication [6] Virtue Sirolimus AngioInfusion™ Balloon (Virtue SAB) - Virtue SAB is a novel drug delivery system designed for coronary artery disease treatment, utilizing a non-coated microporous AngioInfusion™ Balloon [3][7] - The system delivers a proprietary extended-release formulation of sirolimus, achieving sustained tissue levels above the therapeutic concentration required to inhibit restenosis [7] - Virtue SAB has shown positive three-year clinical data in coronary in-stent restenosis and has received Breakthrough Device Designation from the FDA for multiple indications [7]
Orchestra BioMed Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-11-26 21:05
Core Insights - Orchestra BioMed Holdings, Inc. has granted stock options to 12 newly hired employees, totaling 151,250 shares, as part of its 2025 New Hire Inducement Plan [1][2] - The stock options will vest 25% on the first anniversary of employment, with the remainder vesting quarterly over three years [2] Company Overview - Orchestra BioMed is focused on accelerating high-impact biomedical technologies through partnerships with leading global medical device companies [3] - The company's flagship products include Atrioventricular Interval Modulation (AVIM) Therapy for hypertension and Virtue Sirolimus AngioInfusion™ Balloon (Virtue SAB) for atherosclerotic artery disease, both targeting multi-billion-dollar market opportunities [3] - AVIM Therapy aims to provide significant blood pressure reduction in patients with hypertensive heart disease and has FDA Breakthrough Device Designation [3] - Virtue SAB is a novel drug delivery system for treating coronary ISR, small vessel disease, and below-the-knee peripheral artery disease, also granted Breakthrough Device Designation by the FDA [3]