enVVeno Medical to Present Definitive One Year Data from the VenoValve U.S. Pivotal Trial Today at the 51st Annual VEITH Symposium
85% Clinical Meaningful Benefit Responder Rate
7.91 Point Average rVCSS Improvement for the Clinically Meaningful Benefit Responder Cohort
75% Median Reduction in Pain (VAS)
87% Median Ulcer Area Reduction
97% Target Vein Patency Rate
Improvement in All Patient Reported Quality-of-Life Indicators
Company to Host Video Conference Call with VEITH Presenters Today at 2:00 PM Eastern Time - Click Here to Access
IRVINE, CA / ACCESSWIRE / November 20, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, will present one year data on all subjects from the VenoValve U.S. pivotal trial today at the 51st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium in New York City. The definitive one-year data supports the application submitted earlier this week by enVVeno Medical seeking pre-market authorization (PMA) from the U.S. Food and Drug Administration (FDA) to market and sell the VenoValve in the U.S.
Among the data being presented at VEITH are:
Eighty five percent (85%) of the subjects in the VenoValve pivotal study that reached the one-year milestone achieved a clinically meaningful benefit of a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS).
7.91 point average rVCSS improvement among the rVCSS responder cohort.
Clinical meaningful benefit was shown across all CEAP diagnostic classes of subjects (C4(b), C4(c), C5, C6) enrolled in the study.
Ninety seven percent (97%) Target Vein Patency rate at one year.
Hemodynamic data from the study showed a positive correlation between rVCSS improvement and systemic reflux time improvement.
rVCSS is a clinically validated scoring system used to track the regression or progression of venous diseases. The FDA previously indicated to the Company that a 3 or more-point improvement in rVCSS would be evidence of the VenoValve's clinical meaningful benefit.
Subjects in the VenoValve pivotal study also experienced a median reduction in pain of seventy-five percent (75%) at one year as measured by Visual Analog Scale (VAS). Additionally, among subjects with venous ulcers (CEAP C6), the median ulcer area was reduced by eighty seven percent (87%) at 12 months. Patient reported outcomes in the VenoValve pivotal study also demonstrated improvements in quality of life and disease symptoms (VEINESqol/sym, EQ5D).
"The number one concern for clinicians and where other attempts to replace venous valves have failed in the past is that they have occluded or completely blocked blood flow in the targeted refluxing vein. With a ninety seven percent (97%) Target Vein patency rate at one year, and eighty-five percent (85%) of the subjects in the VenoValve study experiencing a clinical meaningful benefit, the VenoValve should be a compelling potential option for physicians and patients with no effective treatment options from the devastating impacts of severe, deep venous CVI," said Robert Berman, enVVeno Medical's Chief Executive Officer. "We are pleased with the one-year safety and efficacy profile of the VenoValve from the pivotal study and look forward to our upcoming interactions with the FDA as they evaluate our clinical data and complete the additional steps that are a part of the PMA review process."
The Company will also update the pivotal trial safety profile of the VenoValve at VEITH, reporting Major Adverse Events (MAEs) through one year of: one (1) death (unrelated to the VenoValve), zero (0) pulmonary embolisms, twelve (12) Target Vein Thromboses, ten (10) Surgical Pocket Hematomas, four (4) Other Bleeds, and seven (7) Deep Wound Infections. Of the subjects that experienced an MAE, there was no long-term negative impact on clinical improvement as ninety-four percent (94%) of the subjects who experienced an MAE (not including the unrelated death) also experienced a clinical meaningful benefit (≥ 3 point rVCSS improvement) at one-year, compared to baseline.
Severe, deep venous 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, dressing, 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. Estimates indicate that CVI costs the U.S. healthcare system in excess of $4 billion each year.
The VenoValve® is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the VenoValve. The Company is also developing enVVe®, a next-generation, transcatheter based replacement venous valve, that could appeal to an even larger market in terms of both patients and physicians.
The Company will host a video conference call today at 2:00 PM Eastern Time following the VEITH presentation, with the presenting Primary Investigators. To access the call visit the Events page on the Investor section of the Company's website or click here.
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 study and the Company is currently performing the final testing necessary to seek approval for the pivotal trial for enVVe.
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
[email protected]
(908) 824-0775
SOURCE: enVVeno Medical Corporation
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