secwatch.observer — SEC 8-K summary
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Issuer:     Harvard Apparatus Regenerative Technology, Inc. (HRGN)
CIK:        0001563665
Form:       8-K
Filed at:   2022-12-28T23:59:59+00:00
Accession:  0001563665-22-000023
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563665/000156366522000023/0001563665-22-000023-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563665/000156366522000023/tmb-20221228x8k.htm
  HTML page:      https://secwatch.observer/filing/0001563665-22-000023

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