enVVeno Medical Corporation
NVNO evidence brief
What we can confirm
- BioSniper Score:
- 4.9 / 10
- Market Cap:
- $6.2M
- Lead Asset:
- envve system (Preclinical)
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 pre-revenue medical device company developing two novel venous valve replacement systems—the VenoValve and the enVVe System—for chronic venous insufficiency (CVI), currently navigating FDA regulatory challenges and advancing clinical trials.
Key risk: Regulatory setback for VenoValve
BioSniper Score
Based on 4 of 6 signals
Market Cap
$6.2M
Cash Runway
—
Lead Asset
envve system (Preclinical)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate for enVVeno Medical Corporation.
enVVeno Medical Corporation (NVNO) is a pre-revenue medical device company developing two novel venous valve replacement systems—the VenoValve and the enVVe System—for chronic venous insufficiency (CVI), currently navigating FDA regulatory challenges and advancing clinical trials.
- Cash & equivalents of $2.8M as of 2026-06-30 [sec].
- Net loss of $3.6M for the three months ended June 30, 2026 [sec_mda · as of 2026-07-30].
- Shareholders' equity of $20.7M as of 2026-06-30 [sec].
- The VenoValve received a non-approvable letter from the FDA in August 2025; the company is now focusing on the enVVe System [sec_mda · as of 2026-05-06].
- The enVVe System pivotal study is expected to begin after FDA IDE approval, with a planned filing in the first quarter of 2026 [sec_mda · as of 2025-10-30].
What works
- The enVVe System features a minimally invasive procedure requiring no general anesthesia or overnight hospital stay, which may improve patient acceptance and procedural efficiency [sec_mda · as of 2026-07-30].
- The company has completed preclinical GLP studies for enVVe, a prerequisite for seeking FDA IDE approval [sec_mda · as of 2025-10-30].
- enVVeno has sufficient cash and investments to fund operations into the third quarter of 2027, providing a runway for clinical development [sec_mda · as of 2026-07-30].
What to weigh
- The VenoValve received a non-approvable letter from the FDA in August 2025, and a subsequent appeal was unsuccessful, representing a major regulatory setback [sec_mda · as of 2026-05-06].
- The company has a high cash burn rate, expected to increase to $4–$5 million per quarter in the second half of 2026, and will need to raise additional capital [sec_mda · as of 2026-07-30].
- enVVeno has no approved products and no revenue, relying entirely on financing activities to fund operations [sec_mda · as of 2026-07-30].
- The enVVe System pivotal study has not yet begun; FDA IDE approval is still pending, creating uncertainty in the development timeline [sec_mda · as of 2025-10-30].
From the filings
Quoted directly from source documents.
The VenoValve received a non-approvable letter from the FDA.
“In August 2025, the Company received a non-approvable letter from the FDA for the VenoValve and a subsequent appeal was unsuccessful.”
SEC MD&A · May 6, 2026
The enVVe System is minimally invasive.
“Minimally invasive procedure requiring no general anesthesia or overnight hospital stay”
SEC filings · July 30, 2026
Cash and investments are sufficient to fund operations into Q3 2027.
“we should have sufficient cash and investments to fund operations into the third quarter of 2027.”
SEC filings · July 30, 2026
The company will need to raise additional capital.
“We will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.”
SEC MD&A · July 30, 2026
Risks & what to watch (4)›
Key risks
- Regulatory setback for VenoValve — FDA non-approvable letter for VenoValve in August 2025; appeal unsuccessful [sec_mda · as of 2026-05-06].
- High cash burn rate — Burn rate expected to increase to $4–$5M per quarter in H2 2026; additional capital needed [sec_mda · as of 2026-07-30].
- No approved products or revenue — Company has no approved products and no revenue, relying solely on financing [sec_mda · as of 2026-07-30].
- enVVe pivotal study not yet started — FDA IDE approval still pending; pivotal study timeline uncertain [sec_mda · as of 2025-10-30].
What to watch
- FDA decision on the enVVe System IDE application, expected filing in Q1 2026 [sec_mda · as of 2025-10-30].
- Initiation and enrollment progress of the enVVe System U.S. pivotal study [sec_mda · as of 2026-07-30].
- Company's ability to raise additional capital to extend cash runway beyond Q3 2027 [sec_mda · as of 2026-07-30].
- Any further regulatory or clinical developments regarding the VenoValve or enVVe [sec_mda · as of 2026-05-06].
Sources: SEC filings · SEC MD&A · Generated October 11, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.10 · 0% dilution
Lead: Preclinical
1 candidate
No upcoming catalysts tracked
0 buys · 1 sell (180d)
Pipeline
Financials
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 pre-revenue medical device company developing two novel venous valve replacement systems—the VenoValve and the enVVe System—for chronic venous insufficiency (CVI), currently navigating FDA regulatory challenges and advancing clinical trials.
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.