Orchestra BioMed Holdings Inc.BACKBEAT trial on track, FDA Breakthrough Device Designation, and cash runway into Q4 2027.
Orchestra BioMed announced that its BACKBEAT global pivotal trial, conducted in collaboration with Medtronic, is on track to reach its target of 284 evaluable randomized patients by the end of the third quarter of 2026, with primary data presentation targeted for the second quarter of 2027. The company reported a cash balance of $110 million as of June 30, 2026, providing projected runway into the fourth quarter of 2027, following $35 million in strategic capital from Medtronic and Ligand during the quarter. AVIM Therapy received a second FDA Breakthrough Device Designation, now covering both the broad group of patients with uncontrolled hypertension and elevated cardiovascular risk and the pacemaker-indicated group studied in the BACKBEAT Trial. The Virtue pivotal trial for coronary in-stent restenosis is advancing with further site activations and patient enrollments. Orchestra BioMed will host an R&D Day on November 12, 2026, in New York City to review both programs.
Orchestra BioMed Holdings Inc.BACKBEAT trial on track, FDA Breakthrough Device Designation, and cash runway into Q4 2027.
Medtronic PLCCollaboration with Medtronic on BACKBEAT trial and strategic capital investment.
Ligand Pharmaceuticals IncorporatedLigand provided strategic capital to Orchestra BioMed, indicating financial support.