enVVeno Medical Reports First Quarter 2026 Financial Results and Provides Business Update Highlighting Strategic Advancement of the enVVe System
Rhea-AI Summary
enVVeno Medical (NASDAQ:NVNO) reported Q1 2026 results and a business update highlighting FDA IDE approval for the TAVVE U.S. pivotal study of the enVVe System. Cash and investments were approximately $24.9M as of March 31, 2026, with an expected runway into Q3 2027. The company expects increased cash burn as it prepares to start patient enrollment later in 2026.
Positive
- FDA IDE approval granted for TAVVE pivotal study
- Cash and investments of $24.9M as of March 31, 2026
- Estimated funding runway into Q3 2027
- First-quarter cash burn consistent at $3.3M
Negative
- Cash decreased from $28.2M on Dec 31, 2025 to $24.9M
- Company forecasts higher 2026 burn of $4M–$5M per quarter
- Net loss widened per share to $5.89 in Q1 2026
News Market Reaction – NVNO
In the May 7 session, NVNO gained 1.49%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 27 | Full-year earnings | Positive | +0.8% | Reported 2025 results, cash of $28.2M, and outlined 2026 pivotal trial plans. |
| Oct 31 | Quarterly earnings | Neutral | +1.1% | Q3 2025 results with $31.0M cash, typical burn, and VenoValve regulatory update. |
| Aug 01 | Quarterly earnings | Positive | +5.6% | Q2 2025 results, $35.1M cash, and progress toward IDE and FDA decisions. |
| Aug 01 | Quarterly earnings | Positive | -0.9% | Q2 2024 update with $39.1M cash and positive VenoValve data and outlook. |
| May 08 | Quarterly earnings | Positive | -2.5% | Q1 2024 results with $42.9M cash and improving loss and burn metrics. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings releases have generally produced modest single‑digit moves, with a mix of small gains and occasional declines despite cash runway updates and pipeline progress.
Recent earnings and updates have focused on funding runway and progression of venous valve programs. Prior reports highlighted cash and investments between $31.0M and $28.2M, with projected cash burn of $4–5M per quarter and runway extending into 2027. Earlier periods showed cash balances above $35.1M and positive interim clinical data. Today’s Q1 2026 update continues that theme, with cash resources earmarked to support the pivotal TAVVE study and operations into Q3 2027.
Key Terms
ide regulatory
pivotal study regulatory
transcatheter venous valve endoprosthesis technical
non-surgical replacement venous valve medical
chronic venous insufficiency medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Company ended the first quarter with approximately
Capital on hand should fund operations through multiple key milestones into Q3 2027
Company recently received FDA IDE approval to commence TAVVE U.S. Pivotal Study for non-surgical replacement venous valve, enVVe System
TAVVE site selection is underway with patient enrollment expected to commence later this year
IRVINE, CA / ACCESS Newswire / May 7, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today reported financial results for the first quarter 2026, ending the quarter with approximately
"With a strong balance sheet, significant physician interest in the enVVe valve, and a clearly defined regulatory pathway, we are well positioned to execute the TAVVE study and advance the Company towards multiple near-term and long-term milestones," said Robert Berman, Chief Executive Officer of enVVeno Medical.
Landmark FDA IDE Approval for TAVVE Study
In April 2026, enVVeno Medical announced that the U.S. Food and Drug Administration (FDA) granted IDE approval for the Company's Transcatheter Venous Valve Endoprosthesis (TAVVE) pivotal study, marking the first-ever FDA approval for a U.S. pivotal study of a non-surgical replacement venous valve. The study will evaluate the Company's minimally invasive enVVe® System for the treatment of patients with severe deep chronic venous insufficiency (CVI), a condition affecting approximately 3 million patients in the United States with limited treatment options.
Summary of Financial Results for the First Quarter 2026
Cash and investments totaled
Cash burn for the first quarter was
Net loss for the first quarter of 2026 was
About enVVeno Medical Corporation
enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company is currently developing the enVVe System, which includes a first-in-class non-surgical replacement venous valve being developed for the treatment of severe Deep Venous Insufficiency (DVI). The enVVe valve is designed to act as one-way valve, to help assist in propelling blood up the leg, and back to the heart and lungs. As a transcatheter delivered device, the enVVe procedure will be performed under light sedation and should not require an over-night hospital stay.
Cautionary Note on Forward-Looking Statements
This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.
INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(908) 824-0775
SOURCE: enVVeno Medical Corporation
View the original press release on ACCESS Newswire