secwatch.observer — SEC 8-K summary
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Issuer:     Harvard Apparatus Regenerative Technology, Inc. (HRGN)
CIK:        0001563665
Form:       8-K
Filed at:   2021-12-06T23:59:59+00:00
Accession:  0001104659-21-146581
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563665/000110465921146581/0001104659-21-146581-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563665/000110465921146581/tm2134645d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-21-146581

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer