相关临床试验
2
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1995
招募中
2
100.0%
暂无批准数据
- Orchestra BioMed has enrolled the first patients in the Virtue Trial, a pivotal U.S. study comparing its novel Virtue SAB sirolimus-eluting balloon to the FDA-approved AGENT paclitaxel-coated balloon for treating coronary in-stent restenosis. - The Virtue SAB represents a first-of-its-kind non-coated drug delivery system designed to overcome limitations of traditional drug-coated balloons by delivering large liquid doses of extended-release sirolimus through microporous balloon technology. - Coronary in-stent restenosis affects up to 10% of stented patients in the first year and continues at 3% annually thereafter, representing over 325,000 cases worldwide that require treatment. - The randomized trial will enroll 740 patients across 75 U.S. centers with completion planned for mid-2027, aiming to support regulatory approval for the breakthrough-designated device.
- Orchestra BioMed received FDA approval for a protocol update that expands patient eligibility for the BACKBEAT pivotal study by more than 24-fold compared to the original protocol. - The expanded criteria now include any hypertensive patients with Medtronic Azure or Astra pacemakers, including device replacements and those with NYHA class I or II heart failure. - The company targets mid-2026 for completion of enrollment in the study evaluating AVIM therapy for uncontrolled hypertension in pacemaker patients. - AVIM therapy previously demonstrated net reductions of 8.1 mmHg in ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure in the MODERATO II pilot study.
- Orchestra BioMed received FDA Breakthrough Device Designation for its atrioventricular interval modulation therapy, designed to reduce blood pressure in high-risk patients with uncontrolled hypertension. - The designation provides accelerated FDA review and potential pathways for higher reimbursement for AVIM-enabled pacemakers, benefiting an estimated 7.7 million eligible patients in the U.S. - The therapy is currently being evaluated in the BACKBEAT pivotal study in partnership with Medtronic, with Orchestra BioMed's stock surging over 25% following the announcement.
• Orchestra BioMed has appointed renowned cardiac electrophysiologist Dr. Vivek Reddy as Executive Chairman of the BACKBEAT Study Steering Committee, strengthening leadership for their global pivotal trial. • Dr. Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai, will also chair the Bioelectronic Therapies Scientific Advisory Board to advance the company's therapeutic portfolio. • The appointment leverages Dr. Reddy's expertise in cardiac electrophysiology to enhance the development and clinical validation of Orchestra BioMed's bioelectronic therapies.
