Independent Health Economic Study Recently Published in Journal of Vascular Surgery Reports Economic Dominance of enVVeno Medical's Replacement Venous Valve Therapy Compared to Standard of Care Treatments

Rhea-AI Summary

enVVeno Medical (NASDAQ: NVNO) announced results from an independent, peer-reviewed health economic analysis in the Journal of Vascular Surgery: Venous and Lymphatic Disorders evaluating prosthetic venous valve replacement for severe deep venous reflux. The modeled five-year analysis found enVVeno’s first-generation VenoValve economically dominant versus compression therapy and wound care, projecting over $32,000 average healthcare savings and about 2.2 fewer venous ulcers per patient, plus improved QALYs and lower overall costs. The study estimated roughly $4,100 savings per rVCSS point of improvement and suggested potential annual system-wide savings of about $5.9 billion with broader venous valve replacement use, supporting the health-economic rationale for the company’s investigational, minimally invasive enVVe system now in the TAVVE pivotal trial.

Positive

• $32,000+ projected five-year healthcare savings per patient with VenoValve versus standard care
• Modeled avoidance of approximately 2.2 venous ulcers per patient over five years
• Projected healthcare savings of about $4,100 per rVCSS point of clinical improvement
• Publication estimates potential $5.9 billion annual savings with broader venous valve replacement adoption
• TAVVE pivotal trial underway to evaluate minimally invasive enVVe replacement venous valve

Negative

• None.

Market reaction after health economic study: NVNO +6.57%

+6.57% $11.20

15m delay

+6.57% Vs previous close

+6.8% Peak in 1 hr 25 min

$11.20 Last Price

$10.50 $11.80 Day Range

$7.61M Market Cap

0.5x Rel. Volume

Following this news, NVNO has gained 6.57%, reflecting a notable positive market reaction. Argus tracked a peak move of +6.8% during the session. Our momentum scanner has triggered 8 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $11.20.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Market Context

Historical events 1082172 and 1078729 showed -1.28% and -0.73% reactions to patent announcements, ad...

Analysis

Historical events 1082172 and 1078729 showed -1.28% and -0.73% reactions to patent announcements, adding a cautionary comparator to this study. The platform also records low short positioning; reimbursement evidence and TAVVE data remain key.

Key Figures

Projected savings per patient: more than $32,000 Venous ulcers avoided: approximately 2.2 fewer venous ulcers per patient Savings per rVCSS point: approximately $4,100 +3 more

6 metrics

Projected savings per patient more than $32,000 over five years versus standard of care

Venous ulcers avoided approximately 2.2 fewer venous ulcers per patient versus standard of care

Savings per rVCSS point approximately $4,100 per rVCSS point of clinical improvement

Cost-effectiveness timing approximately Year 2 treatment became cost-effective

Net savings timing between Years 2 and 3 projected net healthcare savings

Annual healthcare savings approximately $5.9 billion estimated with broader adoption of effective venous valve replacement therapy

Historical Context

5 past events · Latest: Jul 15 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 15	Patent milestone update	Positive	-1.3%	Virtual Investor segment highlighted newly issued enVVe patent and pivotal-trial progress.
Jul 07	Patent issuance	Positive	-0.7%	U.S. patent covered core enVVe valve, support-frame, crimping, and delivery components.
Jun 22	Investor presentation	Neutral	+5.0%	Company scheduled a Webull webinar covering FDA IDE approval and pivotal-trial plans.
Jun 02	Investor event	Neutral	+0.7%	CEO scheduled a Virtual Investor Closing Bell discussion of FDA IDE approval.
May 12	FDA IDE approval	Positive	-5.7%	FDA granted IDE approval for a U.S. pivotal replacement-venous-valve study.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

The two recent patent announcements and the FDA IDE announcement each recorded negative 24-hour reactions despite positive development headlines.

Key Terms

quality-adjusted life years, investigational device exemption, transcatheter

3 terms

quality-adjusted life years medical

"improved quality-adjusted life years (QALYs)"

A quality-adjusted life year (QALY) is a single measure that combines how many years of life a medical treatment adds with the quality of those years, where one QALY equals one year in perfect health. Health economists and payers use QALYs like a cost-per-mile metric to compare treatments, so they matter to investors because QALY-based assessments influence pricing, reimbursement and the commercial value of therapies.

investigational device exemption regulatory

"received FDA Investigational Device Exemption (IDE) approval"

An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.

transcatheter technical

"minimally invasive transcatheter replacement venous valve"

Transcatheter describes medical procedures or devices delivered through a thin, flexible tube (catheter) that is threaded through blood vessels or small body openings to reach the heart or other organs without open surgery. It matters to investors because transcatheter approaches enable faster recovery, shorter hospital stays and larger patient pools for treatments that once required major operations, which can expand market demand and affect device and hospital revenues.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Published economic health study shows both short- and long-term cost-effectiveness of replacement venous value therapy versus standard-of-care treatments for deep venous CVI, generating compelling evidence that will be used to support future coverage determinations and reimbursement policies for enVVeno Medical's enVVe non-surgical replacement venous valve

Publication Highlights:

• Peer-reviewed publication in the Journal of Vascular Surgery: Venous and Lymphatic Disorders

• More than $32,000 projected healthcare savings per patient over five years

• Approximately 2.2 fewer venous ulcers per patient compared to standard of care

• Approximately $4,100 projected cost savings per each rVCSS* point of clinical improvement

• Economically dominant versus compression therapy and wound care in the modeled analysis

• Approximately $5.9 billion estimated annual healthcare savings with broader adoption of effective venous valve replacement therapy

*rVCSS (revised Venous Clinical Severity Score) is a validated clinical tool used to evaluate disease severity and treatment response in patients with chronic venous disease.

IRVINE, CA / ACCESS Newswire / August 4, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today highlighted the publication of a landmark, peer-reviewed health economic analysis in the Journal of Vascular Surgery: Venous and Lymphatic Disorders demonstrating the potential clinical and economic benefits of venous valve replacement therapy for patients with severe deep venous reflux.

The publication titled, "Cost-effectiveness of a prosthetic venous valve versus compression therapies and wound care for treatment of infra-inguinal deep vein reflux," concluded that venous valve replacement therapy has the potential to improve patient outcomes while reducing overall healthcare costs compared with current conservative management. The analysis found that VenoValve, enVVeno's first-generation surgical venous valve technology, was economically dominant versus standard of care over a five-year period, projecting average healthcare savings of more than $32,000 per patient, avoidance of approximately 2.2 venous ulcers per patient, improved quality-adjusted life years (QALYs), and lower overall healthcare costs. The study also projected that treatment became cost-effective by approximately Year 2 and generated net healthcare savings between Years 2 and 3. These findings provide important health economic support for the therapeutic potential of enVVeno's next-generation enVVe® device, which is currently being studied in the TAVVE pivotal trial.

The peer-reviewed publication further highlighted the significant burden of chronic deep venous insufficiency and estimated that broader adoption of effective venous valve replacement therapy could translate into approximately $5.9 billion in annual healthcare savings, underscoring the substantial clinical and commercial opportunity for therapies that address the underlying cause of deep venous disease.

"Publication in a peer-reviewed scientific journal represents one of the strongest forms of independent scientific validation, as the research undergoes rigorous evaluation by experts in the field," said Robert Berman, Chief Executive Officer of enVVeno Medical. "This first-of-its-kind, landmark economic study focused solely on the costs of treating deep venous CVI and will provide compelling evidence for a technology like our enVVe system, compared to standard of care treatments. Once we have the data that we need from the TAVVE pivotal trial, we can apply that clinical data to the results of this published health economic study to make a compelling argument for broad reimbursement coverage."

Chronic deep venous insufficiency affects millions of patients worldwide and remains one of the largest unmet needs in vascular medicine. As venous valves fail, patients often experience chronic pain, swelling, skin changes, recurrent venous leg ulcers and declining quality of life. Current treatment options primarily rely on lifelong compression therapy and wound care designed to manage symptoms rather than correct the underlying cause of disease.

Earlier this year, enVVeno received FDA Investigational Device Exemption (IDE) approval to initiate the TAVVE pivotal trial, representing the first FDA-approved U.S. pivotal study evaluating a minimally invasive replacement venous valve for patients suffering from severe deep venous reflux.

The Company is developing the investigational enVVe® System, the first minimally invasive transcatheter replacement venous valve designed to restore one-way blood flow in the deep veins and directly address the underlying cause of chronic deep venous insufficiency. Building on the clinical foundation established by the Company's pioneering first-generation VenoValve technology, the enVVe® System is designed to advance the field through a minimally invasive transcatheter approach with the potential to expand physician adoption and improve patient access.

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.

INVESTOR CONTACT:
JTC Team, LLC
Jenene Thomas
NVNO@jtcir.com
(908) 824-0775

SOURCE: enVVeno Medical Corporation

View the original press release on ACCESS Newswire

FAQ

What did the August 4, 2026 health economic study reveal about enVVeno Medical (NVNO)?

The study projected that venous valve replacement with VenoValve could reduce healthcare costs and complications versus standard care. According to enVVeno Medical, modeled five-year savings exceeded $32,000 per patient with fewer venous ulcers, better QALYs, and lower overall costs.

How much cost savings per patient did the NVNO venous valve study project over five years?

The analysis projected more than $32,000 in healthcare savings per patient over five years. According to enVVeno Medical, VenoValve was economically dominant versus compression therapy and wound care, with cost-effectiveness achieved around Year 2 and net savings between Years 2 and 3.

What is the estimated healthcare system impact of enVVeno Medical’s venous valve therapy (NVNO)?

The publication estimated about $5.9 billion in annual healthcare savings with broader use of effective venous valve replacement. According to enVVeno Medical, this reflects modeled reductions in venous ulcers, improved quality-adjusted life years, and lower long-term management costs for deep venous insufficiency.

How does enVVeno’s VenoValve compare to standard compression therapy in the NVNO study?

The modeled analysis found VenoValve economically dominant compared with compression therapy and wound care. According to enVVeno Medical, projections showed over $32,000 five-year savings per patient, roughly 2.2 fewer venous ulcers per patient, and improved quality-adjusted life years versus conservative management.

What is the relationship between the VenoValve study and enVVeno Medical’s enVVe system (NVNO)?

The economic findings from VenoValve provide health-economic support for the investigational enVVe system. According to enVVeno Medical, enVVe is a minimally invasive transcatheter replacement venous valve now being evaluated in the FDA-approved TAVVE pivotal trial for severe deep venous reflux.