SEC 8-K filings with transcript text
Apr 29, 2026
2 ex99-1.htm
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
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, a
Feb 4, 2026
2 ex99-1.htm
Exhibit 99.1
enVVeno Medical Regains Compliance with Nasdaq Minimum Bid Price Requirement
Company achieves minimum $1.00 closing bid for 10 consecutive business days; Nasdaq confirms matter is closed
Reports Cash and Investments of Approximately $28 million as of the Year Ended December 31, 2025
– February 4, 2026 – enVVeno Medical Corporation (NASDAQ: NVNO) (“enVVeno Medical” or the “Company”), today announced that it has received formal notice from the Listings Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum bid price of $1.00 per share. Nasdaq confirmed that for the last 10 consecutive business days, from January 20, 2026 through February 2, 2026, the closing bid price of the Company’s common stock was at or above $1.00, and as a result, the matter is now closed.
The Company has made meaningful progress on its 2026 strategic plans and expects to share additional details in the coming weeks. The Company believes that regaining compliance with listing requirements, combined with a year-end cash and investments balance of approximately $28 million as of December 31, 2025, positions it well for 2026.
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.
Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(908) 824-0775
Glenn Silver, FINN Partners
Glenn.Silver@finnpartners.com
(973) 818-8198
Mar 13, 2019
2 ex99-1.htm
Hancock Jaffe Completes $2.7 Million Private Placement of Common Stock
Company Strengthens Financial Position Ahead of Key Milestones
Irvine, California - March 13, 2019 – Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, has closed a private placement of 2,360,051 shares of its common stock for aggregate gross proceeds of approximately $2.7 million with various accredited investors, including participation by a member of HJLI’s management. Investors did not receive warrants. The company intends to use these proceeds to fund the continued development of its two lead products and for working capital and general corporate purposes.
“In advance of key milestones including preliminary data for our VenoValve® first in-human study, and our CoreoGraft® feasibility study, we wanted to strengthen our balance sheet and extend our operational runway,” said Robert Berman, Hancock Jaffe’s Chief Executive Officer. “We remain confident with our projected timeline for these two major milestones at the end of the second quarter of 2019, and this financing will insure that we are adequately capitalized through the release of our results.”
currently has two lead products: the VenoValve; and the CoreoGraft. The VenoValve addresses a debilitating condition known as chronic venous insufficiency (CVI), caused by malfunctioning valves in the deep veins of the patient’s leg, and often resulting in swelling, intense pain, and open sores. Approximately 2.4 million people in the U.S. suffer from deep venous CVI due to valvular incompetence and there are currently no FDA approved treatments for the condition. In February of 2019, Hancock Jaffe implanted the first VenoValve in a patient in Bogota, Colombia. Patient’s receive follow-up assessments 14 days, 30 days, 60 days and 90 days after implantation. Enrollment for the first-in-human study is ongoing and HJLI will provide an update once additional patients are enrolled in the study.
The CoreoGraft is a potential replacement for saphenous vein grafts (SVGs) commonly used to revascularize the heart during coronary artery bypass graft (CABG) surgeries. With approximately 200,000 CABG surgeries performed each year in the U.S., CABG surgery is the most commonly performed cardiac surgical procedure accounting for over 62% of all cardiac surgeries. In addition to the SVG harvest procedure being painful and prone to complications for the patient, SVGs are known to have significant short-term and long-term failure rates, restricting needed blood flow to the heart and resulting in symptoms such as chest pain, shortness of breath, and increased cardiac mortality rates. HJLI is currently conducting a pre-clinical feasibility study for the CoreoGraft at the world renowned Texas Heart Institute and will provide an update once CoreoGrafts are implanted. Hancock Jaffe expects results from the study to be released in June of 2019.
Under the terms of the Private Placement, Hancock Jaffe has agreed to file a registration statement for the resale of the purchasers shares on Form S-1 on or before March 31, 2019 and to use its commercially reasonable efforts to have the registration statement declared effective within ninety days of the filing date. The offering was made pursuant to an exemption from the registration requirements of the U.S. Securities Act of 1933, as amended (the “Securities Act”), solely to accredited investors. Network 1 Financial Securities acted as the exclusive placement agent.
About Hancock Jaffe Laboratories, Inc.
Hancock Jaffe Laboratories (NASDAQ: HJLI) specializes in developing and manufacturing bioprosthetic (tissue based) medical devices to establish improved standards of care for treating cardiac and vascular diseases. Hancock Jaffe currently has two lead product candidates: the VenoValve®, a porcine based valve which is intended to be surgically implanted in the deep venous system of the leg to treat reflux associated with Chronic Venous Insufficiency; and the CoreoGraft®, a bovine tissue based off the shelf conduit intended to be used for coronary artery bypass surgery. Hancock Jaffe has a third product candidate, which is a porcine tissue based heart valve, which may be a candidate for pediatric aortic/mitral valve replacement. Hancock Jaffe has a 19-year history of developing and producing FDA approved medical devices that sustain or support life. The current management team at Hancock Jaffe has been associated with over 80 FDA or CE marked medical devices. For more information, please visit HancockJaffe.com.
Cautionary Note on Forward-Looking Statements
This press release and any statements of stockholders, directors, employees, representatives and partners of Hancock Jaffe Laboratories, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigat
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