secwatch.observer — SEC 8-K summary
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Issuer:     Harvard Apparatus Regenerative Technology, Inc. (HRGN)
CIK:        0001563665
Form:       8-K
Filed at:   2026-04-28T23:59:59+00:00
Accession:  0001437749-26-013677
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Harvard Apparatus Regenerative Technology treats first patient in Phase 1 esophageal implant trial
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- First patient treated with Cellspan Esophageal Implant (CEI) in Phase 1 clinical trial at Mayo Clinic.
- Phase 1 trial is a feasibility and safety study in up to 10 patients under an FDA-approved IND, with three active clinical sites.
- Primary endpoint: establishment of a continuous biological neoconduit by three months post-surgery; secondary: mucosal lining by 12 months.
- CEI combines a polyurethane scaffold with autologous adipose-derived mesenchymal stromal cells; scaffold removed endoscopically at 21-42 days.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563665/000143774926013677/0001437749-26-013677-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563665/000143774926013677/hrgn20260427_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-013677

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