enVVeno Medical (NVNO)
Develops a catheter-delivered tissue valve for severe deep chronic venous insufficiency.
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Develops the enVVe tissue-based replacement venous valve and catheter delivery system for severe deep chronic venous insufficiency. The pre-revenue business is concentrated on an FDA-authorized U.S. pivotal study; commercial sales require clinical success and FDA approval.
Develops bioprosthetic replacement venous valves for severe deep chronic venous insufficiency, in which damaged valves allow blood to pool in the legs. The enVVe System pairs a tissue-based one-way valve with a transcatheter delivery platform intended to restore upward blood flow without open surgery. Design, development, and manufacturing are integrated at an ISO-certified Irvine facility.
The earlier VenoValve surgical program supplied the clinical and engineering foundation for enVVe, but its approval and commercialization path ended after an FDA rejection and unsuccessful appeal. Resources now center on enVVe and the FDA-authorized TAVVE U.S. pivotal study. With no approved products or revenue, commercialization depends on pivotal-trial results, FDA approval, qualified tissue and component suppliers, and hospital and insurer acceptance.
Company facts
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No analyst consensus on record.
EPSReportedEstimate
RevenueReportedEstimate
Balance sheet, Jun 30, 2026Cash & short-term investments $21.5M · Total debt $505.0K · Total assets $22.7M · Shareholders' equity $20.7M
- Revenue
- $0
- Operating income
- −$3.8M
- Net income
- −$3.6M
No dividends on record.
| Institutions17 holders · as of Mar 31, 2026 | 14.72% | 100.5K shares | |
| Insiders5 holders · as of Jun 12, 2026 | 1.43% | 9.8K shares | |
| Otherremainder | 83.85% | 572.4K shares |
682.7K company shares as of Sep 3, 2026 · institutions as of Mar 31, 2026 · holders as of their latest filing
Two share counts disagree (682.7K in the company's Sep 3, 2026 report, 16.5K elsewhere); stakes use the report.
A stock split fell inside the quarter, so quarter-on-quarter changes are not shown.
Top shareholders13F · 13D/G · Form 4
| Holder | Stake | Shares | Evidence |
|---|---|---|---|
Kingdon Capital Management, L.L.C.Institution | 5.30% | 36,166 | 13Fas of Mar 31, 2026 |
CM Management, LLCInstitution | 5.23% | 35,714 | 13Fas of Mar 31, 2026 |
Geode Capital Management, LLCInstitution | 1.53% | 10,455 | 13Fas of Mar 31, 2026 |
Robert Andrew BermanInsiderdirector, officer: Chief Executive Officer | 0.93% | 6,350 | Form 4filed Dec 19, 2024 ↗ |
Vanguard Capital Management LLCInstitution | 0.92% | 6,287 | 13Fas of Mar 31, 2026 |
| See all 25 → | |||
13F — a manager's quarterly holdings · Form 4 — an insider's transaction report
Insider tradesForm 4
| Date | Insider | Role | Shares | Avg price |
|---|---|---|---|---|
| Jun 11, 2026 | Francis Duhay | director | −140 | $10.31 |
| Mar 12, 2026 | Francis Duhay | director | −140 | $11.52 |
| Dec 11, 2025 | Francis Duhay | director | −4,900 | $0.3556 |
| Sep 15, 2025 | Francis Duhay | director | −4,900 | $0.8300 |
Not reported.