---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-069162"
form_type: "8-K"
ticker: "OBIO"
cik: "0001814114"
company_name: "Orchestra BioMed Holdings, Inc."
filed_at: "2023-06-08T23:59:59+00:00"
generated_at: "2026-06-14T05:11:21.121309+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Orchestra BioMed reports positive clinical data; plans pivotal trials H2 2023

## Summary
- BackBeat CNT showed 8.1 mmHg net reduction in 24-hour aSBP at 6 months and 17.5 mmHg oSBP reduction at 2 years.
- Virtue SAB in coronary ISR: 0.12 mm late lumen loss at 6 months, 2.8% target lesion failure at 1 year.
- Pivotal trials for BackBeat CNT and Virtue SAB intend to start in H2 2023.
- Medtronic collaboration: double-digit revenue share and $50M equity investment; Terumo: 10-15% royalty and $30M upfront.
- Target markets: >$10B (BackBeat CNT) and >$3B (Virtue SAB); strong balance sheet with committed investors.

## SEC filing metadata
- accession: 0001104659-23-069162
- form_type: 8-K
- ticker: OBIO
- cik: 0001814114
- company_name: Orchestra BioMed Holdings, Inc.
- filed_at: 2023-06-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1814114/000110465923069162/0001104659-23-069162-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1814114/000110465923069162/tm2318000d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-069162
- JSON: https://secwatch.observer/filing/0001104659-23-069162.json
- Plain text: https://secwatch.observer/filing/0001104659-23-069162.txt

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