Full Press Release Details
11 Month Topline Efficacy Data Showing Significant Clinical Improvement from enVVeno Medical's VenoValve Pivotal Trial to
be Presented Today at the 46th Annual Charing Cross Symposium
8.46 Average Revised Venous Clinical Severity Score (rVCSS) Improvement Per Patient for Patients Showing Clinical Meaningful Benefit
(rVCSS Improvement 3 Points) including:
Points for Patients at the Two-Year Milestone
Points for Patients at the One-Year Milestone
Points for Patients at the Six-Month Milestone
of the Study Patients Showing Clinical Meaningful Benefit from the VenoValve at a Weighted Average of 11 Months Post Surgery
of VenoValve Study Patients Showing Clinical Improvement at a Weighted Average of Eleven Months Post Surgery (rVCSS Improvement
on Track to File Application Seeking VenoValve FDA Approval in Q4 2024
Calif. - April 24, 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 the presentation of positive topline efficacy
data showing significant clinical improvement from the SAVVE U.S. pivotal trial for the VenoValve at the 2024 Charing Cross International
Symposium in London, UK.
data being presented shows that for patients experiencing a Clinical Meaningful Benefit (Revised Venous Clinical Severity Score (rVCSS)
improvement 3 points), the overall average rVCSS improvement was 8.46 points, including 9.29 points for patients at the two-year
milestone, 8.08 points for patients at the one-year milestone, and 8.71 points for patients at the six-month milestone. All rVCSS evaluations
were based on the patient's most recent clinical visit, compared to baseline, for a weighted average of eleven months following
VenoValve implantation for the Clinical Meaningful Benefit patient cohort.
94% of the study patients receiving the VenoValve have shown clinical improvement as measured by rVCSS at a weighted-average patient
follow-up of 11.04 months for the clinical improvement cohort, and 72% of the study patients have improved the three or more rVCSS points
needed to demonstrate the VenoValve's Clinical Meaningful Benefit, at a weighted-average patient follow-up of 11.64 months for
the Clinical Meaningful Benefit cohort. Total patient follow-up was 762 months and 582 months, respectively, for the two patient cohorts.
see patients with a more than 9-point average rVCSS improvement at 24 months post VenoValve surgery is extremely encouraging and exceeds
our expectations," said Robert Berman, enVVeno Medical's CEO. "While we would have been satisfied with merely maintaining
the clinical improvement levels demonstrated at six-months as patients approach the one-year and two-year post-surgery milestones, instead
we are seeing even higher levels of clinical improvement. It is so exciting to be achieving what was previously thought to be impossible,
and to be continually raising the bar for the potential of the VenoValve. We are hopeful and determined to bring relief with the VenoValve
to the millions of patients suffering from severe deep venous CVI, who have no effective treatment options."
rVCSS is an objective grading system used by vascular specialists throughout the world to report clinical outcomes and responses to treatments
for venous diseases such as Chronic Venous Insufficiency (CVI). The score consists of 10 categories graded from 0 to 3 and includes patient
reported outcomes and physician assessments.
assessing the benefit and risk of a novel technology such as the VenoValve, which addresses an unmet medical need, the FDA considers
a variety of factors including whether a medical device provides a clinical meaningful benefit compared to existing technologies. Patients
who were enrolled in the SAVVE trial all showed little or no improvement after at least three months of conventional treatment with existing
technologies (compression therapy, leg elevation, and wound care for venous ulcer patients). For severe CVI patients, an improvement
in the rVCSS of 3 or more points is considered by the FDA to be evidence of clinical meaningful benefit.
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.
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 have completed collecting in September of 2024. As of December 31, 2023, the Company had cash
and investments of $46.4 million on hand, which the Company expects to be sufficient capital to fund operations through an FDA decision
on the VenoValve and the end of 2025.
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 presentation,
entitled Efficacy Results of the SAVVE Trial: Long-term Results for Use of a Bioprosthetic Valve for Patients with Chronic Deep Venous
Reflux, will be made by primary investigator Dr. David Dexter, Sentara Hospital, Norfolk, Virginia and Associate Professor of Surgery,
Eastern Virginia Medical School. A copy of the VenoValve CX Symposium slides will be made available after the presentation on Company's
enVVeno Medical Corporation
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.
Note on Forward-Looking Statements
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.
Thomas, JTC Team, LLC