Positive Interim Venous Ulcer Healing Data Showing Significant Improvement from the enVVeno Medical VenoValve(R) Pivotal Trial to be Presented Today at the Society for Vascular Surgery 2024 Vascular Annual Meeting
enVVeno Medical announced positive interim data from the SAVVE U.S. pivotal trial for the VenoValve, presented at the Society for Vascular Surgery 2024 Annual Meeting. Of the 21 venous ulcer patients evaluated at one year, 91% have either fully healed ulcers or improved conditions. Specifically, 100% of ulcers existing for a year or less before the VenoValve surgery completely healed, and 89% of ulcers older than one year either healed or improved. Impressively, there have been no ulcer recurrences. The company plans to file for FDA approval in Q4 2024.
The SAVVE study is a prospective, non-blinded, single-arm, multi-center study involving 75 CVI patients across 21 U.S. sites. As of March 31, 2024, enVVeno had $42.9 million in cash and investments.
- 91% of patients showed significant healing or improvement at one year.
- 100% healing rate for ulcers of one year or less duration.
- 89% healing or improvement rate for ulcers older than one year.
- No ulcer recurrences reported.
- Company plans to file FDA approval in Q4 2024.
- Cash and investments totaling $42.9 million, sufficient for operations through the end of 2025.
- None.
Insights
The interim results presented for enVVeno Medical's VenoValve in treating venous ulcers are quite compelling. The data indicates that 91% of patients experienced fully healed or improved ulcers within one year of the procedure. Notably, 100% of patients with ulcers less than a year old before surgery saw complete healing. This suggests that the VenoValve could significantly improve outcomes for this difficult-to-treat patient population where other conventional and invasive treatments have failed.
These results highlight a potential paradigm shift in treating chronic venous insufficiency (CVI) and venous ulcers. The data supports the efficacy of the VenoValve, particularly in treating patients earlier in their disease progression. This could lead to faster and more complete healing, thus reducing the healthcare burden associated with long-term wound care.
Moreover, the lack of ulcer recurrence among fully healed patients further strengthens the case for the VenoValve's long-term effectiveness. It's important to note that this level of success in a population that has failed conventional treatments is a significant milestone.
From a financial perspective, the positive interim results of the VenoValve trial can be seen as a promising indicator for enVVeno Medical's future growth. With approximately 2.5 million new CVI patients each year in the U.S. alone, the potential market for VenoValve is substantial. Additionally, the company is on track to file for FDA approval in Q4 2024, which, if granted, could spur widespread adoption and market penetration.
The company's current cash and investments of
However, investors should remain cautious about potential delays in FDA approval or unforeseen challenges in commercializing the product. While the data is promising, the transition from successful trial results to market availability can face numerous hurdles.
No Ulcer Recurrences
Company on Track to File Application Seeking VenoValve FDA Approval in Q4 2024
IRVINE, CA / ACCESSWIRE / June 21, 2024 / enVVeno Medical Corporation (NASFAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that positive interim venous ulcer healing data showing significant clinical improvement from the SAVVE U.S. pivotal trial for the VenoValve will be presented today at the Society for Vascular Surgery 2024 Vascular Annual Meeting in Chicago.
The data being presented includes twenty-one venous ulcer patients who have now reached the one-year milestone, representing thirty venous ulcers. Overall,
"We are very pleased with the interim VenoValve ulcer healing data, especially when you consider this very difficult to treat population of patients who all failed conventional treatments such as wound care and compression therapy, and many of which did not respond to more invasive treatments for CVI such as ablation therapy for superficial disease and/or stenting for iliofemoral obstruction," said Robert Berman, enVVeno Medical's CEO. "Our data shows the importance of the deep venous system to ulcer healing, supports the VenoValve as a part of a new treatment paradigm for the large population of patients with venous ulcers who have deep venous disease, and provides evidence that it is better to treat venous ulcer patients with the VenoValve sooner after ulcer occurrence (within one year, if possible), for faster and complete ulcer healing."
Venous ulcers in the SAVVE study were evaluated with the help of an U.S. Food and Drug Administration (FDA) registered scientific calibrant applied to each venous ulcer image to track wound healing over time. The technology relies on artificial intelligence to accurately measure wound circumference and progress.
Severe Chronic Venous insufficiency (CVI) is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the 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, 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 Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) U.S. pivotal study for the VenoValve is a prospective, non-blinded, single arm, multi-center study of seventy-five (75) CVI patients enrolled at 21 U.S. sites. The FDA has asked the Company to collect a minimum of one year of data on all SAVVE patients prior to filing its PMA application seeking FDA approval, which the Company expects to file in Q4 of this year. As of March 31, 2024, the Company had cash and investments of
Today's presentation, entitled The Impact of VenoValve Implantation on Venous Ulcer Healing in Patients with Deep Venous Reflux,which will be made by primary investigator Dr. Cassius Iyad Ochoa Chaar, Associate Professor Surgery, Yale School of Medicine, Division of Vascular and Endovascular Surgery. Excerpts will be made available after the presentation on the Company's website.
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 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.
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INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(833) 475-8247
SOURCE: enVVeno Medical Corporation
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FAQ
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