---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-21-146581"
form_type: "8-K"
ticker: "HRGN"
cik: "0001563665"
company_name: "Harvard Apparatus Regenerative Technology, Inc."
filed_at: "2021-12-06T23:59:59+00:00"
generated_at: "2026-06-28T03:30:51.450066+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Biostage highlights first-in-human esophageal success, FDA-approved IND, founder CEO return

## Summary
- First-in-human esophageal implant at Mayo Clinic; paper published Aug 2021 concludes 'considerable clinical use'.
- FDA-approved IND for Phase 1/2 trial (10 patients); two orphan-drug designations provide 7-year exclusivity.
- Founder David Green returned as interim CEO and Chairman in Nov 2021; invested $250k in BSTG; compensation in options.
- Cash ~$1.7M as of Nov 30, 2021; burn ~$250k/month; goals include raising capital, commencing trial, NASDAQ uplist.

## SEC filing metadata
- accession: 0001104659-21-146581
- form_type: 8-K
- ticker: HRGN
- cik: 0001563665
- company_name: Harvard Apparatus Regenerative Technology, Inc.
- filed_at: 2021-12-06T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1563665/000110465921146581/0001104659-21-146581-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1563665/000110465921146581/tm2134645d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-21-146581
- JSON: https://secwatch.observer/filing/0001104659-21-146581.json
- Plain text: https://secwatch.observer/filing/0001104659-21-146581.txt

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