---
schema_version: "secwatch.filing_event.v1"
accession: "0001563665-22-000023"
form_type: "8-K"
ticker: "HRGN"
cik: "0001563665"
company_name: "Harvard Apparatus Regenerative Technology, Inc."
filed_at: "2022-12-28T23:59:59+00:00"
generated_at: "2026-06-20T22:27:04.236177+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Biostage selects IQVIA as CRO for FDA-approved esophageal implant trial

## Summary
- IQVIA, a global CRO with GI and cell-therapy trial experience, to manage Biostage's first clinical trial.
- Trial is FDA-approved open-label study for up to 10 patients requiring removal of up to 6cm esophagus (cancer, trauma, birth defects).
- Primary endpoint: continuous biological conduit at 3 months; first human use met endpoint by 1 month (JTO CRR, Aug 2021).
- Preliminary contract covers first stage; second comprehensive contract expected. Trial duration 4-6 years with staggered enrollment and 2-year follow-up.
- CEO: current 5-year survival for esophageal cancer only 20%; >600k new cases annually worldwide.

## SEC filing metadata
- accession: 0001563665-22-000023
- form_type: 8-K
- ticker: HRGN
- cik: 0001563665
- company_name: Harvard Apparatus Regenerative Technology, Inc.
- filed_at: 2022-12-28T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1563665/000156366522000023/0001563665-22-000023-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1563665/000156366522000023/tmb-20221228x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001563665-22-000023
- JSON: https://secwatch.observer/filing/0001563665-22-000023.json
- Plain text: https://secwatch.observer/filing/0001563665-22-000023.txt

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