New Interim Venous Ulcer Healing Data from the enVVeno Medical VenoValve(R) Pivotal Trial to be Presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting on June 21, 2024
enVVeno Medical announced the presentation of new interim venous ulcer healing data from the VenoValve U.S. pivotal trial at the Society for Vascular Surgery 2024 Vascular Annual Meeting on June 21, 2024. The data, presented by Dr. Cassius Iyad Ochoa Chaar of Yale School of Medicine, includes healing and improvement rates for venous ulcers among 21 patients reaching the one-year milestone. The study involves patients with severe venous ulcers who had undergone multiple existing treatments. The FDA requires one-year data on all SAVVE patients for the VenoValve's PMA application, expected to be filed in Q4 2024.
- New interim data from VenoValve U.S. pivotal trial to be presented at a key medical meeting.
- Data will include healing and improvement rates for venous ulcers at the one-year milestone.
- Presentation by a prominent vascular surgeon from Yale School of Medicine.
- Addressing an unmet medical need for severe chronic venous insufficiency.
- FDA has asked for one-year data to support the PMA application, showing regulatory interest.
- The study involves patients who had already failed multiple existing treatments, indicating a challenging patient group.
- The FDA requires comprehensive data, potentially delaying the market approval process.
- Potential recurrence of venous ulcers, a factor that will be monitored and reported.
Insights
The interim data from the VenoValve pivotal trial signifies noteworthy developments in the medical device industry, particularly for the treatment of severe Chronic Venous Insufficiency (CVI) with venous ulcers. The trial targets patients who have not responded to conventional treatments, thereby addressing an unmet medical need. If the data shows significant improvement rates in ulcer healing and low recurrence rates, the VenoValve could fill a substantial gap in the treatment options for CVI.
The company's mention of a potential PMA application to the FDA by Q4 2024 adds weight, hinting at future commercialization prospects. Should this application be successful, it could lead to substantial shifts in both market dynamics and patient care standards, offering a new solution to millions.
It is essential to keep an eye on the detailed data that will be presented at the Vascular Annual Meeting. Positive results could accelerate the adoption of this technology and potentially drive up enVVeno's stock value in anticipation of FDA approval.
The news about the VenoValve U.S. pivotal trial data and its upcoming presentation at a respected conference could positively impact enVVeno Medical Corporation's stock. Successful interim results can often lead to increased investor confidence and heightened stock performance, especially when dealing with a product addressing a large market need.
EnVVeno estimates around 2.5 million new CVI patients annually in the U.S. who could be candidates for the VenoValve. If the FDA approves the device, this could translate into significant revenues. As an investor, it’s important to monitor the specifics of these interim results and the market’s reaction post-announcement to time potential investments.
Future revenue projections hinge on these trial outcomes and subsequent FDA actions, making this presentation a important milestone for the company's financial outlook.
IRVINE, CA / ACCESSWIRE / June 17, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that new interim venous ulcer healing data from the VenoValve U.S. pivotal trial will be presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting (VAM2024) being held June 18-22, 2024 in Chicago, IL. The presentation, entitled "The Impact of VenoValve Implantation on Venous Ulcer Healing in Patients with Deep Venous Reflux," will be made on Friday, June 21, 2024 by primary investigator Dr. Cassius Iyad Ochoa Chaar MD, MS, RPVI, Associate Professor of Surgery, Division of Vascular Surgery, Yale School of Medicine, the top enrolling site for the trial.
The data to be presented will include venous ulcer healing and improvement rates for venous ulcer patients who have now reached the one-year milestone in the Company's Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) U.S. pivotal study for the VenoValve. Overall healing or improvement rate data for thirty-one ulcers among twenty-one patients will be presented, and the presentation will also include sub-categories for ulcers that existed for more than one year and less than one year prior to the VenoValve surgery. Recurrence rate data for any venous ulcers that fully healed, and then recurred, will also be presented. Excerpts from the presentation will be made available on the Company's website.
In assessing the benefit and risk of a novel technology such as the VenoValve, which addresses an unmet medical need, the U.S. Food and Drug Administration (FDA) considers whether a medical device provides a clinically meaningful benefit compared to existing technologies. Subjects with venous ulcers who were enrolled in the SAVVE study all received at least three (3) months of conventional treatment with existing technologies (compression therapy, leg elevation, and wound care) and many also received vein ablations for superficial venous disease, and venous stenting for obstruction, if indicated. As a result, the venous ulcer patients in the SAVVE study are the most difficult to treat, having venous ulcers that remained after at least three and as many as five types of existing treatments.
Severe Chronic Venous Insufficiency (CVI) is a debilitating disease that most often occurs when valves inside of the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and increased pressure within the veins of the leg (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, 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 and the Company estimates that there are approximately 2.5 million new patients each year in the U.S. that could be candidates for the VenoValve.
The FDA has asked the Company to collect one year data on all SAVVE patients to support its PMA application seeking FDA approval to market and sell the VenoValve, which the Company expects to file in Q4 of this year. For more information about the 2024 Vascular Annual Meeting, please visit vascular.org/vam-2024.
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 venous disease. The Company's lead product, the VenoValve®, is a potential first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the SAVVE U.S. pivotal trial and the Company is currently performing the final testing necessary to seek approval for the enVVe pivotal trial.
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:
Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(833) 475-8247
SOURCE: enVVeno Medical
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