Orchestra BioMed Holdings, Inc. Ordinary Shares
OBIOOrchestra BioMed Holdings, Inc. is a medical device company focused on developing and commercializing innovative solutions for cardiovascular and other medical conditions. The company leverages a combination of proprietary technologies and strategic partnerships to bring minimally invasive and durable devices to market. Its portfolio includes products aimed at improving treatment outcomes and patient quality of life.
Company News
Orchestra BioMed initiated a pivotal U.S. clinical trial comparing its Virtue Sirolimus AngioInfusion Balloon to a paclitaxel-coated balloon for treating coronary in-stent restenosis, with 740 patients expected to be enrolled across 75 centers by mid-2027.
Orchestra BioMed presented clinical data showing AVIM therapy can sustainably reduce blood pressure in patients, with effects that are reversible and reproducible upon reactivation after a washout period.
Orchestra BioMed received FDA approval to expand patient eligibility for its BACKBEAT study, potentially increasing the eligible patient pool by over 24-fold and supporting its mid-2026 enrollment target for AVIM therapy in treating uncontrolled hypertension.
Orchestra BioMed's AVIM therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension in patients with increased cardiovascular risk, regardless of pacemaker indication. The company is currently enrolling the BACKBEAT global pivotal study to further evaluate the safety and efficacy of AVIM therapy.
Orchestra BioMed presented data at the THT 2025 Conference showing that its AVIM therapy significantly improved echocardiographic markers of diastolic dysfunction, an important component in the development of heart failure, in hypertensive patients.
