FDA clears enVVeno (NASDAQ: NVNO) pivotal enVVe CVI valve study
Rhea-AI Filing Summary
enVVeno Medical Corporation reported that the FDA approved its Investigational Device Exemption (IDE) application, allowing the Company to begin the Transcatheter Venous Valve Endoprosthesis (TAVVE®) pivotal study of its minimally invasive enVVe® replacement venous valve for severe deep Chronic Venous Insufficiency (CVI).
The study will start with 10 patients whose 30‑day safety data will be reviewed by the FDA, followed by a second stage enrolling 220 patients, including 165 treated with enVVe and 55 controls receiving standard care, at up to 40 U.S. clinical sites. One year after the 220th second‑stage patient is enrolled, the Company would be eligible to file for FDA post‑marketing approval.
enVVeno also disclosed that as of March 31, 2026, it had approximately $25 million in cash and investments, which it expects will fund operations into the third quarter of 2027.
Positive
- First-ever IDE for non-surgical replacement venous valve pivotal study: FDA approval of the TAVVE® pivotal trial allows systematic evaluation of the enVVe® system in severe deep CVI and is a major regulatory milestone for the program.
- Defined path toward potential FDA post-marketing approval: The Company states it would be eligible to file for FDA post-marketing approval one year after the 220th second-stage patient is enrolled, giving a clear clinical development framework.
- Cash runway into Q3 2027: Approximately $25 million in cash and investments as of March 31, 2026 is expected to fund operations into the third quarter of 2027, supporting near-term trial activities.
Negative
- None.
Insights
FDA IDE approval enables a pivotal enVVe trial and extends NVNO’s clinical and cash runway.
The FDA’s IDE approval for the TAVVE® pivotal study is a key regulatory step. It allows enVVeno Medical to clinically evaluate the enVVe® transcatheter venous valve in severe deep CVI, a condition affecting about 3 million U.S. patients and linked to over $20 billion in annual healthcare costs.
The trial design includes an initial 10‑patient safety cohort, then 220 randomized patients (165 enVVe, 55 standard care) across up to 40 U.S. sites. This structure can generate comparative safety and efficacy data that the Company states could support an FDA post‑marketing approval filing one year after the 220th second‑stage enrollee.
Financially, approximately $25 million in cash and investments as of March 31, 2026 is expected to fund operations into Q3 2027, covering the early phases of TAVVE execution. Actual outcomes will depend on enrollment pace, study results, and future regulatory decisions described in the Company’s risk factor disclosures.
8-K Event Classification
Key Figures
Key Terms
Investigational Device Exemption regulatory
pivotal study medical
post-marketing approval regulatory
Chronic Venous Insufficiency medical
transcatheter medical
bioprosthetic medical
UNITED STATES
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FORM
CURRENT REPORT
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Item 8.01 Other Events.
On April 29, 2026, enVVeno Medical Corporation (“we,” “us,” “our,” or the “Company”) announced that the Company received notification from the FDA that it had approved the Company’s IDE application, authorizing the Company to commence a study of a non-surgical replacement venous valve. The Transcatheter Venous Valve Endoprosthesis (TAVVE®) pivotal study will evaluate the Company’s minimally invasive enVVe® System for patients with severe deep Chronic Venous Insufficiency (CVI). The first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.
Key features of enVVe system include:
| ● | Minimally invasive procedure requiring no general anesthesia or overnight hospital stay; | |
| ● | Self-expanding frame made from a specially formulated biocompatible nickel and titanium alloy; | |
| ● | Frame geometry that accommodates the natural dilation and contraction of the vein; | |
| ● | 3 enVVe valve sizes to ensure a proper fit across a broad range of vein sizes; | |
| ● | Unique, mono-cusp leaflet design that is laser cut from porcine pericardium tissue; | |
| ● | Delivery profile of only 13 Fr (4.3 mm) when crimped, giving it the smallest profile of any replacement valve currently in use for the cardiovascular system; and | |
| ● | Delivery via an over-the-wire, coaxial, single-stage pull system for ease of use. |
Please refer to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 for more information regarding the enVVE System, including, without limitation, the section entitled “Risk Factors” therein.
Additionally, on April 29, 2026, the Company announced that as of March 31, 2026, the Company had approximately $25 million cash and investments on hand which is expected to fund operations into the third quarter of 2027.
Item 2.02 Results of Operations and Financial Condition.
The statements concerning the Company’s cash position as of March 31, 2026 are incorporated by reference into this Item 2.01.
Item 7.01 Regulation FD Disclosure.
On April 29, 2026, the Company issued a press release announcing the Company had received a favorable decision from the U.S. Food & Drug Administration in connection with the Company’s Investigational Device Exemption application for the Transcatheter Venous Valve Endoprosthesis (TAVVE®) pivotal study. The press release is being furnished as Exhibit 99.1 to this Current Report.
Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect our current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning the enVVe System and our TAAVE pivotal study, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A - Risk Factors” and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this Current Report.
Item 9.01 Financial Statements and Exhibits.
Set forth below is a list of Exhibits included as part of this Current Report:
| Exhibit No. | Description | |
| 99.1 | Press Release | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ENVVENO MEDICAL CORPORATION | |
| Dated: April 29, 2026 | /s/ Robert A. Berman |
| Robert A. Berman | |
| Chief Executive Officer |
Exhibit 99.1
enVVeno Medical Receives First-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-Surgical Replacement Venous Valve
First-in-Class enVVe system to be evaluated in TAVVE U.S. Pivotal Trial
Clinical site activation and patient enrollment expected to commence later this year
Large unmet clinical need for approximately 3 million U.S. patients with severe deep Chronic Venous Insufficiency
Potential
multi-billion-dollar untapped U.S. market
Company has approximately $25 million in cash and investments to fund operations into Q3 2027
IRVINE, Calif. – April 29, 2026 – enVVeno Medical Corporation (Nasdaq: NVNO) (“enVVeno” or the “Company”), a company setting new standards of care for the treatment of deep venous disease, today announced that the U.S. Food and Drug Administration (FDA) has awarded the Company the first-ever IDE approval to proceed with a U.S. pivotal study of a non-surgical replacement venous valve. The Transcatheter Venous Valve Endoprosthesis (TAVVE®) pivotal study will evaluate the Company’s minimally invasive enVVe® System for patients with severe deep Chronic Venous Insufficiency (CVI).
This IDE approval positions the Company to advance what could become the first effective treatment option for the approximately 3 million U.S. patients who suffer from the debilitating impact of severe CVI due to malfunctioning valves in the deep veins of the leg.
“We have been working very closely with the FDA to ensure that the TAVVE study is structured to provide everything that the FDA wants to see in evaluating the safety and efficacy of enVVe and that we are in complete alignment,” said Robert Berman, enVVeno Medical’s Chief Executive Officer. “We have also been busy speaking with clinical sites that are interested in participating in the TAVVE study. A transcatheter-based non-surgical replacement venous valve has always been considered the “holy-grail” for patients with severe CVI and the interest and enthusiasm among physicians and their clinical teams has been extremely high. We are excited to be able to officially start the process of selecting and activating clinical sites and look forward to the first implantation procedure using the enVVe System.”
About the TAVVE Study
The first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.
Key features of enVVe system include:
| ● | Minimally invasive procedure requiring no general anesthesia or overnight hospital stay; | |
| ● | Self-expanding frame made from a specially formulated biocompatible nickel and titanium alloy; | |
| ● | Frame geometry that accommodates the natural dilation and contraction of the vein; | |
| ● | 3 enVVe valve sizes to ensure a proper fit across a broad range of vein sizes; | |
| ● | Unique, mono-cusp leaflet design that is laser cut from porcine pericardium tissue; | |
| ● | Delivery profile of only 13 Fr (4.3 mm) when crimped, giving it the smallest profile of any replacement valve currently in use for the cardiovascular system; and | |
| ● | Delivery via an over-the-wire, coaxial, single-stage pull system for ease of use. |
enVVeno also announced that as of March 31, 2026, the Company had approximately $25 million cash and investments on hand which is expected to fund operations into the third quarter of 2027.
About CVI
Deep venous CVI occurs when insufficient blood is returned to the heart and lungs from the lower leg. The disease is most often caused by blood clots (deep vein thromboses or DVTs) resulting in permanently damaged valves in the deep veins of the leg. When valves inside the deep veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension).
Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, dressing and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that there are approximately 3 million patients in the U.S. with severe deep venous CVI, costing the U.S. healthcare system in excess of $20 billion each year.
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 enVVe system, which includes a first-in-class non-surgical replacement venous valve being developed for the treatment of severe deep Chronic Venous Insufficiency (CVI). 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:
JTC Team, LLC
Jenene Thomas
NVNO@jtcir.com
(908) 824-0775