Business
Orchestra BioMed Announces Rollout of FDA-Approved BACKBEAT Global Pivotal Study Protocol Update Significantly Expanding Patient Eligibility
FDA-approved protocol update significantly expands patient eligibility criteria for the BACKBEAT global pivotal study (“BACKBEAT study”), resulting in an estimated more than 24-fold increase in the potentially eligible patient pool as compared to original study protocolExpanded eligibility criteria now include screening of any hypertensive patients who have received or are scheduled to receive a Medtronic Azure™ or Astra™ pacemaker, including device replacements NEW HOPE, Pa., Aug. 08, 2025 (GLO
About this update from Orchestra Biomed Holdings, Inc.
[{"type":"image","alt":"Orchestra BioMed Holdings, Inc.","displaySize":"","headline":null,"caption":"Orchestra BioMed Holdings, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":97,"url":"https://media.zenfs.com/en/globenewswire.com/82bb98ef85c6f29f82627c7205a5e888"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/PcUBlKSAoIj3BMZ.626pqg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEzNjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/82bb98ef85c6f29f82627c7205a5e888","width":300,"height":97}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"FDA-approved protocol update significantly expands patient eligibility criteria for the BACKBEAT global pivotal study (“BACKBEAT study”), resulting in an estimated more than 24-fold increase in the potentially eligible patient pool as compared to original study protocol","length":270,"tagName":"p"}]},{"val":[{"type":"text","content":"Expanded eligibility criteria now include screening of any hypertensive patients who have received or are scheduled to receive a Medtronic Azure™ or Astra™ pacemaker, including device replacements ","length":206,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":476,"olType":false},{"type":"text","content":"NEW HOPE, Pa., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the roll out of a protocol update, approved by the U.S. Food and Drug Administration (“FDA”), that significantly expands patient eligibility criteria for enrollment of the BACKBEAT study evaluating AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications.","length":585,"tagName":"p"},{"type":"text","content":"Key updates to eligibility criteria now include patients with:","length":62,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Medtronic Astra or Azure dual-chamber pacemakers with sufficient battery life implanted for any reason;","length":103,"tagName":"p"}]},{"val":[{"type":"text","content":"Medtronic Astra or Azure dual-chamber pacemakers that are first device implants or implanted to replace an existing pacemaker; and","length":130,"tagName":"p"}]}...