enVVeno Medical Corporation
NVNO evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for NVNO—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · NVNO
enVVeno Medical Corporation (NVNO) is a clinical-stage medical device company developing surgical and non-surgical treatments for venous disease, with lead candidates VenoValve and enVVe undergoing FDA regulatory processes.
Key risk: No revenue and reliance on financing
BioSniper Score
Based on 5 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate for enVVeno Medical Corporation.
enVVeno Medical Corporation (NVNO) is a clinical-stage medical device company developing surgical and non-surgical treatments for venous disease, with lead candidates VenoValve and enVVe undergoing FDA regulatory processes.
- Cash and equivalents of $2.8M as of 2026-06-30 [sec].
- Net loss of $3.6M for the three months ended 2026-06-30 [sec].
- Shareholders' equity of $27.1M as of 2026-06-30 [sec].
- Completed pre-clinical GLP study for enVVe in December 2024, a prerequisite for IDE filing [sec_mda · as of 2025-04-30].
- Cash runway expected to fund operations into Q3 2027 based on current burn rate [sec_mda · as of 2026-07-30].
What works
- Completed the pre-clinical GLP study for enVVe, a key step toward FDA IDE submission [sec_mda · as of 2025-04-30].
- Management expects sufficient cash to fund operations into Q3 2027, providing a multi-year development runway [sec_mda · as of 2026-07-30].
- The company has two product candidates (VenoValve and enVVe) targeting a large venous disease market, diversifying its pipeline [sec_mda · as of 2025-07-30].
What to weigh
- No revenue generated to date; the company is entirely dependent on financing to fund operations [sec_mda · as of 2025-07-31].
- Cash burn is expected to increase to $4M–$5M per quarter in 2026, raising the need for additional capital [sec_mda · as of 2026-05-06].
- Regulatory timelines for VenoValve and enVVe remain uncertain, with IDE filing for enVVe delayed from mid-2025 to first quarter 2026 [sec_mda · as of 2025-10-30].
- Accumulated deficit and ongoing net losses of $3.6M per quarter as of 2026-06-30 indicate a high cash consumption rate [sec].
From the filings
Quoted directly from source documents.
Completed pre-clinical GLP study for enVVe in December 2024
“On December 16, 2024, we announced the successful completion of the final wave of implants for the six-month pre-clinical GLP study for enVVe.”
SEC MD&A · April 30, 2025
Cash runway into Q3 2027
“we should have sufficient cash and investments to fund operations into the third quarter of 2027.”
SEC MD&A · July 30, 2026
Risks & what to watch (4)›
Key risks
- No revenue and reliance on financing — Company has no product revenue and must raise additional capital to continue operations [sec_mda · as of 2025-07-31].
- Increasing cash burn rate — Quarterly cash burn expected to rise to $4M–$5M in 2026, accelerating need for funds [sec_mda · as of 2026-05-06].
- Regulatory approval uncertainty — FDA approval for VenoValve and enVVe is not guaranteed; timelines have shifted previously [sec_mda · as of 2025-10-30].
- Clinical trial execution risk — Success of pivotal trials for both candidates is critical and subject to enrollment and data outcomes [sec_mda · as of 2026-05-06].
What to watch
- FDA decision on VenoValve PMA application and any updates on the SAVVE pivotal trial data [sec · filed 2024-11-19].
- Timing of IDE submission for enVVe U.S. pivotal study, currently expected in first quarter 2026 [sec_mda · as of 2025-10-30].
- Quarterly cash burn rate and any new financing activities to extend runway beyond Q3 2027 [sec_mda · as of 2026-07-30].
- Progress in the TAVVE study and any preclinical or clinical milestones for enVVe [sec_mda · as of 2026-03-26].
Sources: SEC filings · SEC MD&A · Generated August 22, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
17.5 months
D/E 0.10 · 0% dilution
Lead: Preclinical
1 candidate
No upcoming catalysts tracked
0 buys · 2 sells (180d)
Runway
Pipeline
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
12
Total value held
$643K
| Holder | Shares | Value |
|---|---|---|
| kingdon capital management, l.l.c. | 36,166 | $366K |
| vanguard capital management llc | 12,574 | $127K |
| geode capital management, llc | 10,455 | $106K |
| vanguard fiduciary trust co | 2,184 | $22K |
| blackrock, inc. | 1,840 | $19K |
| wells fargo & company/mn | 114 | $1K |
| vanguard global advisers, llc | 77 | $780 |
| morgan stanley | 76 | $770 |
| osaic holdings, inc. | 7 | $70 |
| group one trading llc | 2 | $20 |
Showing top 10 of 12 institutional holders of enVVeno Medical Corporation. Open the full 13F history after sign-in.
Short Interest
as of May 12, 2026- % of float
- 11.7%
- Days to cover
- 7.8
- Shares short
- 76,169
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
NVNO short interestGovernance
Frequently asked questions
What is the AI investment thesis for enVVeno Medical Corporation?
enVVeno Medical Corporation (NVNO) is a clinical-stage medical device company developing surgical and non-surgical treatments for venous disease, with lead candidates VenoValve and enVVe undergoing FDA regulatory processes.
What is enVVeno Medical Corporation's lead drug candidate?
enVVeno Medical Corporation's most advanced tracked candidate is envve system (Preclinical) for severe Chronic Venous Insufficiency (CVI).
Who is the CEO of enVVeno Medical Corporation?
Mr. Robert A. Berman is the chief executive officer of enVVeno Medical Corporation (NVNO).
Where is enVVeno Medical Corporation headquartered?
enVVeno Medical Corporation (NVNO) is headquartered in Irvine, CA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.