NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) outlined a 2027 timeline for pivotal hypertension trial data and potential FDA submissions as the company and partner Medtronic advance development of a pacemaker-based therapy targeting millions of patients with uncontrolled high blood pressure.
The company said enrollment in its global BACKBEAT Trial evaluating Atrioventricular Interval Modulation Therapy, or AVIM Therapy, is expected to be completed by the end of the third quarter of 2026.
Assuming the study meets its primary endpoints, Orchestra BioMed and Medtronic plc plan to pursue presentation of the data at a major cardiovascular conference in the second quarter of 2027, followed by regulatory submissions to the U.S. Food and Drug Administration and international agencies.
The timeline update follows FDA approval of a reduced trial sample size targeting 284 evaluable randomized patients, with overall enrollment expected to total 316 patients accounting for potential attrition.
The company also disclosed that the FDA granted a second Breakthrough Device Designation for AVIM Therapy covering patients with uncontrolled hypertension who also require pacemakers.
Orchestra BioMed stated the combined Breakthrough Device designations apply to patient populations representing more than 7.7 million people in the United States.
Chief Executive Officer David Hochman said the company expects several major clinical and regulatory milestones over the next two years.
“We are pleased to provide clarity on the expected timeline for the BACKBEAT Trial highlighting objectives for enrollment completion, late-breaking clinical trial presentation, and plans for potential regulatory submissions by our strategic collaborator Medtronic,” Hochman stated.
The company also reported continued progress in its Virtue Trial evaluating Virtue Sirolimus AngioInfusion Balloon technology against commercially available drug-coated balloon treatments for coronary in-stent restenosis.
Orchestra BioMed said site activation and patient enrollment in the Virtue Trial are continuing throughout 2026.
The company received $35 million in strategic funding during the quarter through agreements with Medtronic and Ligand Pharmaceuticals Incorporated, including a $20 million payment from Medtronic tied to previously disclosed financing arrangements supporting completion of the BACKBEAT Trial.
Cash, cash equivalents, and marketable securities totaled $94.4 million as of March 31. Orchestra BioMed projected its current cash runway into the fourth quarter of 2027.
Net loss attributable to common stockholders widened to $20.7 million, or $0.33 per share, from $18.8 million, or $0.49 per share, a year earlier.
Research and development expenses increased 17% to $15.8 million, driven primarily by costs associated with the BACKBEAT Trial and the Virtue SAB program.
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