---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-101763"
form_type: "8-K"
ticker: "OBIO"
cik: "0001814114"
company_name: "Orchestra BioMed Holdings, Inc."
filed_at: "2023-09-19T23:59:59+00:00"
generated_at: "2026-06-10T13:44:10.934818+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA grants IDE approval for Orchestra BioMed's BACKBEAT pivotal study of BackBeat CNT in hypertensive pacemaker patients

## Summary
- FDA approved IDE for global pivotal BACKBEAT study evaluating AVIM therapy (BackBeat CNT) for hypertension in pacemaker patients.
- Study to randomize ~500 patients 1:1, primary endpoint: change in mean 24-hour ambulatory systolic BP at 3 months.
- Orchestra BioMed collaborating with Medtronic; Medtronic has exclusive global commercialization rights if approved.
- Supported by MODERATO II pilot study: net reduction of 8.1 mmHg in 24-hour aSBP and 12.3 mmHg in oSBP at 6 months.
- Enrollment expected to start before end of 2023; study designed to support future regulatory review and potential approval.

## SEC filing metadata
- accession: 0001104659-23-101763
- form_type: 8-K
- ticker: OBIO
- cik: 0001814114
- company_name: Orchestra BioMed Holdings, Inc.
- filed_at: 2023-09-19T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1814114/000110465923101763/0001104659-23-101763-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1814114/000110465923101763/tm2326382d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-101763
- JSON: https://secwatch.observer/filing/0001104659-23-101763.json
- Plain text: https://secwatch.observer/filing/0001104659-23-101763.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.