Orchestra BioMed Holdings Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved a significant protocol update for the BACKBEAT global pivotal study, which evaluates AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension. This update expands patient eligibility criteria, now including hypertensive patients with Medtronic Azure™ or Astra™ dual-chamber pacemakers, significantly increasing the eligible patient pool by more than 24-fold compared to the original protocol. This expansion is expected to enhance the study's relevance and potential impact, aligning with the characteristics of the FDA Breakthrough Device Designation for AVIM therapy. The full implementation of the updated protocol is anticipated by the fourth quarter of 2025, supporting Orchestra BioMed's target to complete enrollment by mid-2026.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。