enVVeno Medical Reports Third Quarter 2026 Financial Results and Prepares to Treat First Patients in FDA-Approved TAVVE Pivotal Study

The planned trial advances toward patient enrollment as enVVeno anticipates a higher cash burn rate in the first half of 2027.

Rhea-AI Summary

enVVeno Medical (NASDAQ:NVNO) reported third-quarter financial results and expects to begin its TAVVE pivotal study before the end of 2026.

At September 30, cash and investments totaled $18.5 million. Quarterly cash burn was approximately $3 million. Operating expenses fell to $4.5 million from $4.9 million a year earlier; net loss narrowed to $4.4 million, or $6.29 per share, from $4.5 million, or $7.89 per share. The company expects funding to last into the fourth quarter of 2027, with its burn rate rising to $4 million–$5 million in the first half of 2027.

TAVVE operates under an FDA-approved investigational device exemption. Part 1 will include up to 10 patients receiving the enVVe venous valve. Their 30-day safety data will precede a planned 220-patient randomized stage, subject to FDA requirements. A potential marketing application depends on study results and completion of the randomized stage's 12-month follow-up and analysis.

5 points · 1 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

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0 major · 4 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major point. Forward-looking: it has not happened yet and may not happen.Cash and investments of $18.5 million are expected to fund operations into the fourth quarter of 2027.
• Moderate pointTAVVE has an FDA-approved investigational device exemption; clinical sites are being activated.
• Moderate point. Forward-looking: it has not happened yet and may not happen.TAVVE Part 1 is expected to begin before year-end 2026, initially monitoring up to 10 patients for safety.
• Minor pointOperating expenses fell to $4.5 million in third-quarter 2026 from $4.9 million a year earlier.
• Minor pointNet loss narrowed to $4.4 million, or $6.29 per share, versus $4.5 million, or $7.89, a year earlier.

Negative

• Moderate pointQuarterly cash burn was approximately $3 million.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Cash burn rate is expected to increase to $4 million–$5 million in the first half of 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Planned 220-patient Part 2 follows submission of initial 30-day safety results and remains subject to applicable FDA requirements.
• Minor point. Forward-looking: it has not happened yet and may not happen.Planned premarket approval application depends on study results, regulatory requirements, and randomized-stage 12-month follow-up and analysis.

Key Figures

Cash and investments: $18.5 million Quarterly cash burn: $3 million Expected quarterly cash burn: $4 million to $5 million +5 more

Cash and investments

$18.5 million

At September 30, 2026

Quarterly cash burn

$3 million

Third quarter 2026

Expected quarterly cash burn

$4 million to $5 million

First half of 2027

Operating expenses

$4.5 million vs. $4.9 million

Third quarter 2026 vs. third quarter 2025

Net loss

$4.4 million vs. $4.5 million

Third quarter 2026 vs. third quarter 2025

Part 1 safety cohort

Up to 10 patients

Initial stage of the TAVVE pivotal study

Part 2 randomized cohort

220 patients (165 enVVe; 55 control)

Second stage of the TAVVE pivotal study

Expected cash runway

Into the fourth quarter of 2027

Company estimate based on cash and investments

Previous Earnings Reports

2 past events · Latest: Jul 31

Same Type 2 events

1. Jul 31

   Q2 2026 earnings

   24h Move

   -0.3%

   Reported cash and burn alongside FDA IDE approval and TAVVE pivotal-study advancement.

2. May 07

   Q1 2026 earnings

   24h Move

   +1.5%

   Reported IDE approval, expected TAVVE enrollment, and cash-runway information.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

investigational device exemption (ide), premarket approval (pma), regurgitant volume, revised venous clinical severity score (rvcss), +1 more

5 terms

investigational device exemption (ide) regulatory

"The study is being conducted under an FDA-approved Investigational Device Exemption (IDE)."

An investigational device exemption (IDE) is a regulatory permission that allows a medical device to be used in clinical studies so companies can gather safety and effectiveness data before full market approval. For investors, an IDE is a key milestone because it lets a company test real-world performance and move toward commercial clearance or approval—much like a trial run that, if successful, can unlock larger revenue opportunities and reduce regulatory risk.

premarket approval (pma) regulatory

"the Company intends to submit a premarket approval (PMA) application to the FDA"

Premarket Approval (PMA) is the strict regulatory review process used by the U.S. authority for high-risk medical devices to prove they are safe and effective before they can be sold. For investors, a granted PMA is like receiving a key to a locked market: it can open exclusive sales opportunities, reduce near-term competition, and justify higher valuations, while also signaling that the company has cleared a costly, time-consuming hurdle.

regurgitant volume medical

"measured as regurgitant volume in the target vein zone at 12 months"

The volume of blood that flows backward through a heart valve during one heartbeat or one cardiac cycle because the valve does not close properly, usually reported in milliliters (mL) per beat or per cycle. Clinicians estimate regurgitant volume from imaging tests (commonly Doppler echocardiography or cardiac MRI) by comparing forward stroke volume to total stroke volume or by direct flow measurements; it is a raw volume measure distinct from regurgitant fraction, which expresses that backward flow as a percentage of total stroke volume. Measurement method and timing affect reported values, so values from different techniques are not always directly comparable.

revised venous clinical severity score (rvcss) medical

"clinical improvement using the revised Venous Clinical Severity Score (rVCSS)"

A clinician‑administered scoring system that quantifies the severity of chronic venous disease by rating a set of signs and symptoms (such as pain, varicose veins, edema, skin pigmentation, inflammation, and ulcers) on a numeric scale. The revised Venous Clinical Severity Score (rVCSS) is a modification of the original VCSS designed for repeated clinical use and outcome tracking; it assigns ordinal scores for several clinical items which are summed to give an overall severity score used to compare patients or to measure change over time. It captures only the observable clinical features and recent history recorded by the examiner and does not replace objective tests (like duplex ultrasound) or formal diagnostic criteria.

chronic venous insufficiency (cvi) medical

"severe deep chronic venous insufficiency (CVI)"

A long-term condition in which leg veins cannot move blood efficiently back to the heart, usually because vein valves are weakened or damaged; this causes blood to pool in the lower legs. Symptoms and signs can include swelling, aching, heaviness, skin discoloration or thickening, and in advanced cases open sores (venous ulcers); treatment aims to reduce symptoms and prevent complications by improving blood flow and controlling swelling.

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IRVINE, CA / ACCESS Newswire / October 30, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today reported financial results for the third quarter ended September 30, 2026. Cash and investments at the end of the quarter were $18.5 million, with a quarterly burn of approximately $3 million. The Company is on track to begin Part 1 of the TAVVE^® U.S. pivotal study for its enVVe^® system, a first-in-class, non-surgical replacement venous valve, in the fourth quarter of this year. The study is being conducted under an FDA-approved Investigational Device Exemption (IDE).

"Clinical sites for Part 1 of TAVVE pivotal study are being activated and coming online and we are on schedule to enroll our first patient before the end of the year," said Robert Berman, Chief Executive Officer of enVVeno Medical. "We did a nice job of managing our operating expenses in the quarter while still pursuing our immediate priority of getting the TAVVE pivotal study underway."

Part 1 of the TAVVE pivotal study will consist of up to 10 patients who will initially be monitored for safety. Thirty-day safety data from the Part 1 patients will be submitted to the FDA, at which time the Company will seek to enroll Part 2 of the TAVVE pivotal study. Part 2 of the TAVVE study will consist of 220 randomized patients, 165 of which will receive the enVVe valve, and 55 of which will be in a control arm.

The primary safety endpoint for all TAVVE patients will consist of a composite of all cause mortaility, pulmonary embolism, enVVe Valve embolization, enVVe valve infection, thrombus in the treated vein segment (Target Vein Zone), Target vein Zone perforation and access site bleeding.

The enVVe System is a first-in-class, non-surgical replacement venous valve designed to treat permanently damaged valves in the deep veins of the leg. Delivered through a catheter, the enVVe valve is designed to restore one-way blood flow toward the heart and reduce backward blood flow. The Company estimates that approximately 3 million people in the United States suffer from severe deep chronic venous insufficiency (CVI).

Third Quarter 2026 and Recent Business Highlights

• Readied TAVVE for launch: After the FDA approved the IDE, the Company advanced enVVe product development, testing and operational readiness for the TAVVE pivotal study.
• Presented enVVe to specialists: Karen B. Garby, MD, DABVLM, RPhS, presented the investigational enVVe System at The VEINS 2026 Innovation Summit in Las Vegas, Nevada.
• Kept spending disciplined: Total operating expenses were $4.5 million, compared with $4.9 million in the third quarter of 2025, even as the Company prepared to launch the TAVVE pivotal study.
• Ended the quarter with $18.5 million in cash and investments: The Company believes these resources will fund operations into the fourth quarter of 2027, including the planned initiation of TAVVE.

Upcoming Clinical and Corporate Milestones

• Initial 10-patient stage: Expected to begin before year end, the first stage will evaluate 10 patients whose 30-day safety results will be submitted to the FDA for review. These patients will continue to be followed as a separate cohort, with safety and efficacy results reported periodically.
• Randomized 220-patient stage: Following submission of the initial cohort's 30-day safety results and subject to applicable FDA requirements, the second stage is expected to enroll 220 patients randomized 3:1, with 165 receiving the enVVe System and 55 receiving standard-of-care treatment. Participating investigators are expected to include vascular surgeons, interventional radiologists and interventional cardiologists.
• Potential PMA submission: Following completion of the randomized stage's 12-month follow-up and analysis of the results, the Company intends to submit a premarket approval (PMA) application to the FDA, subject to the TAVVE pivotal study results and applicable regulatory requirements.

The TAVVE pivotal study's primary efficacy endpoints will assess changes in backward blood flow, measured as regurgitant volume in the target vein zone at 12 months and evaluated by a core laboratory, and clinical improvement using the revised Venous Clinical Severity Score (rVCSS).

Summary of Financial Results for the Third Quarter 2026

As of September 30, 2026, enVVeno had cash and investments of approximately $18.5 million, consisting of $2.6 million in cash and cash equivalents and $15.9 million in short-term investments.

Cash burn for the quarter was $3 million. The Company anticipates that its cash burn rate will likely increase to between $4 million and $5 million in the first half of 2027 as the TAVVE study continues enrolling patients.

Net loss for the third quarter of 2026 was $4.4 million, or $6.29 per basic and diluted share, compared with a net loss of $4.5 million, or $7.89 per basic and diluted share, for the third quarter of 2025.

About enVVeno Medical Corporation

enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late 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.

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:

JTC Team, LLC
Jenene Thomas
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.

When will enVVeno Medical begin the TAVVE pivotal study?

enVVeno expects to begin Part 1 of TAVVE before the end of 2026. This stage will include up to 10 patients initially monitored for safety. Their 30-day safety results will be submitted to the FDA before the company seeks to enroll Part 2.

How long does enVVeno Medical expect its cash to last?

enVVeno expects its cash and investments to fund operations into the fourth quarter of 2027, including the planned initiation of TAVVE. At September 30, 2026, approximately $18.5 million consisted of $2.6 million in cash and cash equivalents and $15.9 million in short-term investments.

How will enVVeno Medical's randomized TAVVE stage be structured?

Part 2 is expected to enroll 220 patients randomized 3:1, with 165 receiving the enVVe System and 55 receiving standard-of-care treatment. Patients from the initial stage will continue to be followed as a separate cohort, with safety and efficacy results reported periodically.

What will enVVeno Medical's TAVVE study measure?

TAVVE's primary efficacy endpoints assess backward blood flow at 12 months and clinical improvement using the revised Venous Clinical Severity Score. A core laboratory will evaluate backward blood flow. The primary safety endpoint combines all-cause mortality, pulmonary embolism, valve embolization or infection, treated-vein thrombosis or perforation, and access-site bleeding.