Monitor for first patient enrollment and 30-day safety data from the 10-patient stage 1 cohort. Cash runway into Q3 2027 provides limited buffer—watch for capital raise announcements. The IDE approval is a major derisking milestone, but the stock may experience volatility given micro-cap liquidity and long timeline to potential approval.
Price Chart
Executive Summary
enVVeno Medical received FDA IDE approval to commence the TAVVE pivotal study of its enVVe non-surgical replacement venous valve for severe deep CVI, a first-in-class device addressing a ~3M patient U.S. market. The company has ~$25M cash, expected to fund operations into Q3 2027, but remains pre-revenue with a long path to commercialization.
Key Facts
- FDA IDE approval for first-ever non-surgical replacement venous valve study in the U.S.
- TAVVE pivotal study: 10-patient safety cohort followed by 220-patient randomized pivotal stage (165 device, 55 control).
- 1 year after 220th patient enrolled, company eligible to file for FDA post-marketing approval.
- Cash and investments ~$25M as of March 31, 2026, expected to fund operations into Q3 2027.
- Market cap ~$8M; stock is a micro-cap clinical-stage medical device company.
Financial Impact
No near-term revenue; cash burn ~$1M/quarter; future dilution likely for pivotal study funding.
Risk Factors
- Clinical trial failure or safety signals could halt development.
- Cash runway limited to Q3 2027; likely need for additional financing causing dilution.
- Long timeline to FDA approval (years away) with no near-term revenue.
- Micro-cap stock with low liquidity and high short-interest risk.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001493152-26-019485 |
| Exhibit: ex99-1.htm | 0001493152-26-019485 |
| Document: 0001493152-26-019485-index-headers.html | 0001493152-26-019485 |
| Document: 0001493152-26-019485-index.html | 0001493152-26-019485 |
| Document: 0001493152-26-019485.txt | 0001493152-26-019485 |
| 8-K Data (Synthetic) | 0001493152-26-019485 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Jul 14, 2026 14w ago | 8-K | $10.76 $8.18 | ▼ −24.02% | ▼ −26.56% | $6.67 (−38.01%) |
Apr 29, 2026 25w ago | 8-K | $10.71 $10.39 | ▼ −2.99% | ▼ −7.10% | $6.67 (−37.72%) |
US Market Status
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