enVVeno Medical Reports First Quarter 2026 Financial Results and Provides Business Update Highlighting Strategic Advancement of the enVVe System

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.

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

Argus May 7 session

+1.49% close to close Open Argus

Details

News Market Reaction – NVNO

On May 7, the day this news came out, NVNO closed 1.49% above the previous close.

Data tracked by StockTitan Argus for the May 7 session.

Market Context

This announcement details Q1 2026 results and emphasizes a cash position of $24.9M with runway into ...

Analysis

This announcement details Q1 2026 results and emphasizes a cash position of $24.9M with runway into Q3 2027, supporting initiation of the TAVVE pivotal study. Historically, earnings updates have highlighted adequate funding and stepwise progress of venous valve programs. Investors may watch how the projected $4–5M quarterly burn evolves, the pace of site activation and enrollment, and whether future milestones maintain alignment with previous guidance.

Key Figures

Cash & investments: $24.9M Cash & investments prior: $28.2M Cash runway: Into Q3 2027 +5 more

Cash & investments

$24.9M

As of March 31, 2026

Cash & investments prior

$28.2M

As of December 31, 2025

Cash runway

Into Q3 2027

Management’s funding outlook including TAVVE pivotal study

Q1 2026 cash burn

$3.3M

First quarter 2026 cash burn

Projected cash burn

$4–5M per quarter

Expected as TAVVE pivotal study prepares and initiates

Net loss Q1 2026

$3.8M

First quarter 2026 net loss

EPS Q1 2026

$5.89 net loss per share

Basic and diluted, first quarter 2026

Net loss Q1 2025

$4.5M

First quarter 2025 net loss for comparison

Previous Earnings Reports

5 past events · Latest: Mar 27

Same Type 5 events

1. Mar 27

   Full-year earnings

   24h Move

   +0.8%

   Reported 2025 results, cash of $28.2M, and outlined 2026 pivotal trial plans.

2. Oct 31

   Quarterly earnings

   24h Move

   +1.1%

   Q3 2025 results with $31.0M cash, typical burn, and VenoValve regulatory update.

3. Aug 01

   Quarterly earnings

   24h Move

   +5.6%

   Q2 2025 results, $35.1M cash, and progress toward IDE and FDA decisions.

4. Aug 01

   Quarterly earnings

   24h Move

   -0.9%

   Q2 2024 update with $39.1M cash and positive VenoValve data and outlook.

5. May 08

   Quarterly earnings

   24h Move

   -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.

Key Terms

ide, pivotal study, transcatheter venous valve endoprosthesis, non-surgical replacement venous valve, +1 more

5 terms

ide regulatory

"Company recently received FDA IDE approval to commence TAVVE U.S. Pivotal Study"

An IDE (Investigational Device Exemption) is a regulatory permission that allows a company to test an unapproved medical device in human clinical trials to gather safety and effectiveness data. Think of it as a temporary road permit for a new product: getting the IDE moves a technology from concept toward approval and market access, which can reduce uncertainty and increase value for investors, while delays or denials raise development risk and potential costs.

pivotal study regulatory

"FDA IDE approval to commence TAVVE U.S. Pivotal Study for non-surgical replacement"

A pivotal study is a large, definitive clinical trial designed to show whether a medical product works and is safe enough for regulators to approve and for doctors to use. Think of it as the final exam that determines whether a drug or device moves from testing into the market; its results can dramatically change a company’s approval chances, future sales prospects, and therefore its stock value.

transcatheter venous valve endoprosthesis technical

"the Company's Transcatheter Venous Valve Endoprosthesis (TAVVE) pivotal study"

A transcatheter venous valve endoprosthesis is a small, one-way valve made of medical-grade materials that is delivered through a thin tube threaded into a vein and deployed inside the body to restore proper blood flow toward the heart. Think of it as a replaceable flap installed without open surgery to stop backward flow; for investors, its importance lies in potential market demand, clinical and regulatory approval paths, reimbursement prospects, and risks around adoption, manufacturing and long-term performance.

non-surgical replacement venous valve medical

"pivotal study of a non-surgical replacement venous valve"

A non-surgical replacement venous valve is a medical device placed inside a vein through a small incision or catheter to restore the one-way flow that damaged vein valves normally provide, avoiding open surgery. Think of it as a plug-in valve that corrects backflow like fixing a leaky one-way gate; for investors, it matters because successful devices can reduce hospital time, lower procedure costs, expand patient access, and drive revenue through device sales, procedures, and related follow-up care.

chronic venous insufficiency medical

"for the treatment of patients with severe deep chronic venous insufficiency (CVI)"

A long-term condition in which the one-way valves in leg veins do not work properly, causing blood to pool, swelling, pain, skin changes or ulcers; think of it as a plumbing problem where backflow wears out pipes and fixtures. Investors care because it is a common, chronic market with ongoing demand for treatments, devices and wound-care products, and outcomes depend on clinical data, regulatory approvals and reimbursement decisions that affect revenue streams.

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Company ended the first quarter with approximately $25 million in cash and investments

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 $25 million in cash and investments and confirming the Company's strategic focus on the development of its next-generation enVVe^® System for the treatment of deep venous insufficiency.

"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 $24.9 million as of March 31, 2026, compared to $28.2 million as of December 31, 2025. The Company believes its current cash and investment resources are sufficient to fund operations into the third quarter of 2027, including advancement of the TAVVE pivotal study.

Cash burn for the first quarter was $3.3 million, consistent with the Company's projected cash burn rate of approximately $3 million to $4 million per quarter. The Company anticipates that its cash burn rate may increase to approximately $4 million to $5 million per quarter in 2026 as it prepares for and initiates the TAVVE pivotal study.

Net loss for the first quarter of 2026 was $3.8 million, or a net loss of $5.89 per basic and diluted common share, compared to a net loss of $4.5 million, or a net loss of $7.75 per basic and diluted common share, in the first quarter of 2025.

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did enVVeno (NVNO) announce about FDA approval for the enVVe System on May 7, 2026?

The company announced FDA IDE approval for the TAVVE U.S. pivotal study of the enVVe System. According to the company, this is the first FDA IDE for a non-surgical replacement venous valve and enables planned U.S. patient enrollment later in 2026.

How much cash did NVNO report at the end of Q1 2026 and what is the stated runway?

enVVeno reported approximately $24.9 million in cash and investments as of March 31, 2026. According to the company, those resources are expected to fund operations into the third quarter of 2027, including the TAVVE study.

What was enVVeno's cash burn and how will it change in 2026 (NVNO)?

Cash burn for Q1 2026 was $3.3 million, consistent with prior guidance. According to the company, cash burn may increase to about $4 million to $5 million per quarter in 2026 as TAVVE study preparations begin.

What were NVNO's reported net loss and earnings per share for Q1 2026?

enVVeno reported a net loss of $3.8 million, or $5.89 per basic and diluted share, for Q1 2026. According to the company, this compares to a net loss of $4.5 million, or $7.75 per share, in Q1 2025.

When will enVVeno (NVNO) start enrolling patients in the TAVVE pivotal study?

Patient enrollment is expected to commence later in 2026, pending site selection and initiation steps. According to the company, TAVVE site selection is underway as the study prepares to begin U.S. enrollment.