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enVVeno Medical Participates in a New Virtual Investor "What This Means" Segment to Discuss How President Trump's Recent CVI Diagnosis May Impact the Company

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enVVeno Medical (NASDAQ:NVNO) participated in a Virtual Investor segment discussing how former President Trump's Chronic Venous Insufficiency (CVI) diagnosis could impact awareness of their VenoValve treatment. The company's CEO Rob Berman and CMO Dr. Marc Glickman discussed the condition's progressive nature and potential treatment options.

The company's VenoValve targets approximately 2.5 million potential patients in the U.S. suffering from severe deep CVI. enVVeno has submitted a pre-market authorization (PMA) application to the FDA, with a decision expected in the second half of 2025.

enVVeno Medical (NASDAQ:NVNO) ha partecipato a una sessione virtuale per investitori, durante la quale si è discusso di come la diagnosi di Insufficienza Venosa Cronica (CVI) dell'ex Presidente Trump possa aumentare la consapevolezza riguardo al trattamento VenoValve. Il CEO dell'azienda, Rob Berman, e il CMO, il dottor Marc Glickman, hanno illustrato la natura progressiva della patologia e le possibili opzioni terapeutiche.

Il dispositivo VenoValve dell'azienda si rivolge a circa 2,5 milioni di potenziali pazienti negli Stati Uniti affetti da CVI profonda grave. enVVeno ha presentato una domanda di autorizzazione pre-mercato (PMA) alla FDA, con una decisione attesa nella seconda metà del 2025.

enVVeno Medical (NASDAQ:NVNO) participó en un segmento virtual para inversores donde se discutió cómo el diagnóstico de Insuficiencia Venosa Crónica (CVI) del expresidente Trump podría aumentar la conciencia sobre su tratamiento VenoValve. El CEO de la compañía, Rob Berman, y el CMO, el Dr. Marc Glickman, hablaron sobre la naturaleza progresiva de la enfermedad y las opciones de tratamiento disponibles.

El VenoValve de la empresa está dirigido a aproximadamente 2.5 millones de pacientes potenciales en EE. UU. que sufren de CVI profunda severa. enVVeno ha presentado una solicitud de autorización previa al mercado (PMA) a la FDA, con una decisión esperada en la segunda mitad de 2025.

enVVeno Medical (NASDAQ:NVNO)은 � 대통령 트럼프의 만성 정맥 부전증(CVI) 진단� 자사� VenoValve 치료� 인식� 미칠 영향� 대� 논의하는 가� 투자� 세그먼트� 참여했습니다. 회사� CEO 로브 버먼� 최고 의학 책임�(CMO) 마크 글릭만 박사� � 질환� 진행� 특성� 잠재� 치료 옵션� 대� 설명했습니다.

회사� VenoValve� 미국 � 중증 심부 CVI 환자 � 250� �� 대상으� 합니�. enVVeno� FDA� 사전 시장 승인(PMA) 신청서를 제출했으�, 결정은 2025� 하반�� 예상됩니�.

enVVeno Medical (NASDAQ:NVNO) a participé à une session virtuelle pour investisseurs, au cours de laquelle a été discuté l'impact que le diagnostic d'insuffisance veineuse chronique (CVI) de l'ancien président Trump pourrait avoir sur la sensibilisation à leur traitement VenoValve. Le PDG de la société, Rob Berman, et le directeur médical, le Dr Marc Glickman, ont abordé la nature progressive de la maladie ainsi que les options de traitement possibles.

Le dispositif VenoValve de la société cible environ 2,5 millions de patients potentiels aux États-Unis souffrant de CVI profonde sévère. enVVeno a soumis une demande d'autorisation préalable à la mise sur le marché (PMA) à la FDA, avec une décision attendue dans la seconde moitié de 2025.

enVVeno Medical (NASDAQ:NVNO) nahm an einem virtuellen Investorensegment teil, in dem diskutiert wurde, wie die Diagnose der chronischen venösen Insuffizienz (CVI) des ehemaligen Präsidenten Trump das Bewusstsein für ihre VenoValve-Behandlung beeinflussen könnte. Der CEO des Unternehmens, Rob Berman, und der CMO, Dr. Marc Glickman, erläuterten die fortschreitende Natur der Erkrankung und mögliche Behandlungsoptionen.

Das VenoValve des Unternehmens richtet sich an etwa 2,5 Millionen potenzielle Patienten in den USA, die an schwerer tiefer CVI leiden. enVVeno hat einen Antrag auf Marktzulassung (PMA) bei der FDA eingereicht, eine Entscheidung wird in der Zweiten Hälfte 2025 erwartet.

Positive
  • Large addressable market of 2.5 million potential U.S. patients
  • FDA decision on VenoValve PMA expected in 2H 2025
  • High-profile CVI case could increase disease awareness
Negative
  • FDA approval still pending with no guaranteed outcome
  • Product not yet commercially available for potential patients

- enVVeno is developing the VenoValve as a potential treatment option for the approximately 2.5 million patients in the U.S. suffering from severe deep Chronic Venous Insufficiency

- FDA decision expected in 2H'2025

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IRVINE, CA / / August 4, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it participated in a entitled, "enVVeno Medical - Making Veins Work Again - How President Trump's CVI Diagnosis is Raising Awareness."

Rob Berman, CEO and Dr. Marc Glickman, CMO of enVVeno Medical discussed the progressive nature of chronic veinous insufficiency and whether President Trump may one day be a candidate for the VenoValve® following U.S. Food and Drug Administration (FDA) approval.

The Company estimates that there are approximately 2.5 million patients in the U.S. that could be candidates for the VenoValve. The Company has submitted a pre-market authorization (PMA) application for the VenoValve to the FDA, with a decision anticipated in the second half of 2025.

The "What This Means" segment can be accessed .

About CVI

Severe deep venous CVI is a serious and 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 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 that repair deep venous valve dysfunction, the #1 cause of severe CVI-a disease estimated to cost the U.S. healthcare system in excess of $26 billion each year.

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. 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®. 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 VenoValve U.S. pivotal study and the Company is currently performing the final testing necessary to seek approval for the pivotal trial for enVVe.

INVESTOR CONTACT:

Jenene Thomas, JTC Team, LLC
[email protected]
(908) 824-0775

MEDIA CONTACT:
Glenn Silver, FINN Partners
[email protected]
(973) 818-8198

SOURCE: enVVeno Medical Corporation



View the original on ACCESS Newswire

FAQ

What is the potential market size for enVVeno Medical's VenoValve?

enVVeno Medical estimates there are approximately 2.5 million patients in the U.S. who could be candidates for the VenoValve treatment.

When is the FDA expected to make a decision on enVVeno Medical's VenoValve?

The FDA is expected to make a decision on the VenoValve's pre-market authorization (PMA) application in the second half of 2025.

How might President Trump's CVI diagnosis affect enVVeno Medical (NVNO)?

President Trump's CVI diagnosis could increase public awareness of Chronic Venous Insufficiency and potentially highlight enVVeno Medical's VenoValve as a treatment option, pending FDA approval.

What is enVVeno Medical's VenoValve designed to treat?

The VenoValve is designed to treat severe deep Chronic Venous Insufficiency (CVI), a progressive condition affecting blood flow in the deep veins of the legs.

What stage of approval is NVNO's VenoValve currently in?

enVVeno Medical has submitted a pre-market authorization (PMA) application to the FDA and is awaiting a decision expected in the second half of 2025.
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