---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-040763"
form_type: "8-K"
ticker: "OBIO"
cik: "0001814114"
company_name: "Orchestra BioMed Holdings, Inc."
filed_at: "2025-04-29T23:59:59+00:00"
generated_at: "2026-05-23T04:05:58.072017+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Orchestra BioMed gets FDA Breakthrough Device Designation for AVIM therapy and IDE approval for Virtue SAB trial

## Summary
- FDA granted Breakthrough Device Designation for AVIM therapy; covers >7.7M U.S. hypertension patients.
- AVIM therapy BDD may expedite FDA review and support higher reimbursement (NTAP/TPT).
- FDA approved IDE amendment for Virtue SAB randomized trial vs AGENT paclitaxel DCB for coronary ISR.
- Virtue Trial plans 740 patients across 75 U.S. centers; targeting H2 2025 start.
- Virtue SAB pilot showed 12-month TLF 2.8% and 6-month late lumen loss 0.12mm.

## SEC filing metadata
- accession: 0001104659-25-040763
- form_type: 8-K
- ticker: OBIO
- cik: 0001814114
- company_name: Orchestra BioMed Holdings, Inc.
- filed_at: 2025-04-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1814114/000110465925040763/0001104659-25-040763-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1814114/000110465925040763/tm2513456d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-040763
- JSON: https://secwatch.observer/filing/0001104659-25-040763.json
- Plain text: https://secwatch.observer/filing/0001104659-25-040763.txt

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