Monitor for interim data readouts from the Phase 1 trial (primary endpoint at 3 months post-surgery). Additional patient enrollments and safety updates will be key catalysts. No immediate trading catalyst beyond the announcement.
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Executive Summary
Harvard Apparatus Regenerative Technology announced that the first patient has been treated with its Cellspan Esophageal Implant in a Phase 1 feasibility and safety clinical trial at the Mayo Clinic. This is a milestone for the company's lead program but represents early-stage clinical progress with no financial data or near-term approval catalyst.
Key Facts
- 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 ten patients under an FDA-approved IND
- Three clinical trial sites activated: Mayo Clinic, University of Michigan Medical Center, University of Southern California
- Primary endpoint: establishment of continuous biological neoconduit at three months post-surgery
- Secondary endpoint: development of mucosal lining in esophagus by twelve months post-surgery
Financial Impact
No financial impact disclosed; clinical-stage company with no revenue
Risk Factors
- Clinical trial failure or delays
- Regulatory hurdles for FDA approval
- Need for additional financing to complete development
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-013677 |
| Exhibit: ex_951211.htm | 0001437749-26-013677 |
| Document: 0001437749-26-013677-index-headers.html | 0001437749-26-013677 |
| Document: 0001437749-26-013677-index.html | 0001437749-26-013677 |
| Document: 0001437749-26-013677.txt | 0001437749-26-013677 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 14, 2026 6w ago | 8-K | $1.96 $2.12 | ▼ −8.16% | ▼ −5.65% | $1.96 (−0.10%) |
Aug 3, 2026 12w ago | 8-K | $1.00 $1.58 | ▼ −58.00% | ▼ −56.76% | $1.96 (−96.20%) |
Apr 28, 2026 25w ago | 8-K | $1.57 $1.30 | ▼ −17.04% | ▼ −23.09% | $1.96 (+25.21%) |
Apr 15, 2026 27w ago | 8-K | $1.57 $1.50 | ▼ −4.58% | ▼ −10.40% | $1.96 (+24.81%) |
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