Orchestra BioMed presents BACKBEAT trial update, targets primary data in Q2 2027
OBIO•Orchestra BioMed randomized 349 patients in its BACKBEAT pivotal trial, exceeding its enrollment target, and is targeting presentation of primary AVIM Therapy endpoint data at HRS in Q2 2027. The company targets potential FDA approval and a Medtronic commercial launch in the first half of 2028; it says current cash provides runway through 2028.
1. Trial and commercial targets
Orchestra BioMed said it randomized 349 patients in its BACKBEAT pivotal trial, surpassing its enrollment target. It is targeting presentation of primary endpoint data for AVIM Therapy at HRS in the second quarter of 2027, with potential FDA approval and a Medtronic commercial launch targeted for the first half of 2028.
2. Cash and collaboration
The company said its current cash provides runway through 2028 and that strategic partners have invested or paid more than $185 million. Its Medtronic collaboration provides an uncapped, double-digit royalty-based revenue share on every AVIM Therapy-enabled device sold.
