FDA issues not approvable letter on VenoValve for enVVeno Medical (NASDAQ: NVNO)

Rhea-AI Filing Summary

enVVeno Medical Corporation reported that it received a not approvable letter from the U.S. Food & Drug Administration regarding its Premarket Approval application for VenoValve, a surgical replacement venous valve intended to treat severe deep chronic venous insufficiency. This means the FDA has determined the application cannot be approved in its current form. The company disclosed this development through a press release attached to the report.

enVVeno also reminded readers that statements about future events, including those related to its clinical trials, are forward-looking and subject to significant risks and uncertainties described in its other SEC reports.

Positive

• None.

Negative

• FDA not approvable letter for VenoValve PMA – the U.S. Food & Drug Administration determined enVVeno’s Premarket Approval application for its VenoValve device is not approvable in its current form, a material regulatory setback for a key product candidate.

Insights

Biotech regulatory and risk analyst

FDA not approvable letter is a significant setback for VenoValve.

The company reports that the U.S. Food & Drug Administration issued a not approvable letter for the Premarket Approval application of VenoValve, its surgical replacement venous valve for severe deep chronic venous insufficiency. In FDA practice, this means the current application cannot be approved as submitted and typically requires substantial additional data, analyses, or changes.

Because VenoValve is a key product candidate aimed at a serious vascular condition, this regulatory outcome is likely important for the company’s development plans and timeline. The disclosure also emphasizes that forward-looking statements, including those about clinical trials, are subject to risks and uncertainties referenced in the company’s Annual and Quarterly Reports, underscoring that future progress will depend on how it addresses the FDA’s concerns.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

What did enVVeno Medical Corporation (NVNO) announce in this 8-K?

The company announced it received a not approvable letter from the U.S. Food & Drug Administration for its Premarket Approval application for VenoValve, a surgical replacement venous valve.

What is VenoValve in enVVeno Medical Corporation's pipeline?

VenoValve is described as a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency, a serious condition affecting blood flow in the veins.

What does a 'not approvable letter' from the FDA mean for NVNO?

A not approvable letter indicates the FDA has decided the Premarket Approval application for VenoValve cannot be approved in its current form and typically requires significant additional information or changes.

How did enVVeno Medical Corporation disclose the FDA decision?

The company issued a press release describing the FDA’s not approvable letter for VenoValve, and furnished that press release as Exhibit 99.1 to this report.

What risks does enVVeno highlight related to its forward-looking statements?

enVVeno notes that forward-looking statements, including those about its clinical trials, involve risks and uncertainties described in the Risk Factors section of its most recent Form 10-K and in its Forms 10-Q.

Does this filing change any of enVVeno Medical Corporation’s financial statements?

The report focuses on the regulatory update about VenoValve and the related press release; it does not present new financial statements in the excerpt provided.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Understanding 8-K Material Events →

Accepted by SEC EDGAR 08/20/2025 - 07:10 AM Learn about SEC filing dates

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 20, 2025

enVVeno Medical Corporation

(Exact name of registrant as specified in its charter)

Delaware		001-38325		33-0936180
(State or other jurisdiction		(Commission		(I.R.S. Employer
of incorporation)		File Number)		Identification No.)

70 Doppler

Irvine, California 92618

(Address of principal executive offices) (Zip Code)

(949) 261-2900

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.00001 per share		NVNO		The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On August 20, 2025, enVVeno Medical Corporation (“we,” “us,” “our,” or the “Company”) issued a press release announcing the Company had received a not approvable letter from the U.S. Food & Drug Administration in response to its Premarket Approval application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency. The press release is being furnished as Exhibit 99.1 to this 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 our clinical trials, 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: August 20, 2025	/s/ Robert A. Berman
	Robert A. Berman
	Chief Executive Officer