Orchestra BioMed Holdings, Inc. OBIO
Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) is a cardio-renal-metabolic medical device company. Its next catalyst on record is AVIM Therapy (BACKBEAT): primary endpoint data presentation, then FDA/global marketing application submissions (Q2 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: AVIM Therapy (BACKBEAT) — primary endpoint data presentation, then FDA/global marketing application submissions (Q2 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| AVIM Therapy (BACKBEAT pivotal trial, partnered with Medtronic) | uncontrolled hypertension | device-combination | NA_NON_THERAPEUTIC |
| Virtue Sirolimus AngioInfusion Balloon (Virtue SAB), US IDE pivotal Virtue Trial | coronary in-stent restenosis | device-combination | NA_NON_THERAPEUTIC |
| FreeHold Duo/Trio intracorporeal organ retractors | surgical retractors (marketed device) | — | NA_NON_THERAPEUTIC |
Recent results and decisions
- Oct 1, 2026completed enrollment BACKBEAT pivotal trial exceeded its 316-patient enrollment target, with 330 randomized at 81 sites in 13 countries as of Sept 30, 2026.
As of September 30, 2026, 330 patients have been randomized in the BACKBEAT Trial at 81 sites across 13 countries.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other cardio-renal-metabolic companies
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- Insulet Corp PODD
- MiniMed Group, Inc. MMED
- Heartflow, Inc. HTFL
- iRhythm Holdings, Inc. IRTC
- Pulse Biosciences, Inc. PLSE
- AtriCure, Inc. ATRC
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.