enVVeno Medical Corp. Files 8-K Report

TL;DR

enVVeno Medical filed an 8-K, mostly routine stuff, check for financials.

AI Summary

On August 20, 2025, enVVeno Medical Corp. filed an 8-K report. The filing primarily concerns Regulation FD disclosures and the submission of financial statements and exhibits. No specific financial figures or material events were detailed in the provided excerpt.

Why It Matters

This filing indicates routine corporate reporting, including financial statements and exhibits, which are important for investors to stay updated on the company's status.

Risk Assessment

Risk Level: low — The filing is a standard 8-K for disclosures and exhibits, not indicating any immediate negative or positive material events.

Key Players & Entities

• enVVeno Medical Corp. (company) — Registrant
• Hancock Jaffe Laboratories, Inc. (company) — Former company name
• August 20, 2025 (date) — Date of earliest event reported

FAQ

Key Financial Figures

• $0.00001 — ch registered Common Stock, par value $0.00001 per share NVNO The NASDAQ Stock Mar

Filing Documents

• form8-k.htm (8-K) — 37KB
• ex99-1.htm (EX-99.1) — 16KB
• ex99-1_001.jpg (GRAPHIC) — 7KB
• 0001493152-25-012181.txt ( ) — 226KB
• nvno-20250820.xsd (EX-101.SCH) — 3KB
• nvno-20250820_lab.xml (EX-101.LAB) — 33KB
• nvno-20250820_pre.xml (EX-101.PRE) — 22KB
• form8-k_htm.xml (XML) — 3KB

From the Filing

UNITED 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. 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

View Full Filing

View this 8-K filing on SEC EDGAR