enVVeno Medical Corp

enVVeno Medical Corp is a U.S.-based medical device company focused on developing bioprosthetic venous valve technologies for severe chronic venous insufficiency. Its lead program, VenoValve, is a surgical replacement venous valve, and its second program, enVVe, is a transcatheter replacement venous valve under development for the deep veins of the leg.

13.58

13.58

— enVVeno Medical Corp
%
VenoValve0% Surgical replacement venous valve designed to restore one-way blood flow in the deep veins of the leg.
enVVe0% Non-surgical, transcatheter-based replacement venous valve intended for deep venous insufficiency.
Clinical development services100% Research, testing, and clinical trial activities supporting product advancement and regulatory approval.

The company’s end users are patients with severe chronic venous insufficiency, but the near-term economic customer is...

  • Patients with severe chronic venous insufficiencyprimary

    They are the ultimate beneficiaries of VenoValve and enVVe, which are designed to improve venous blood flow and reduce symptoms of deep venous reflux.

  • Physicians and clinical investigatorsprimary

    Vascular and interventional specialists evaluate, implant, and study the devices in clinical trials and will drive adoption after approval.

  • Hospitals and specialty treatment centerssecondary

    These facilities would purchase and use the devices for procedural treatment of advanced venous disease once commercialized.

enVVeno Medical Corp is headquartered in the United States and conducts its development, regulatory, and clinical...

  • •Headquartered in the United States
  • •Clinical and regulatory work is centered on the U.S. FDA pathway
  • •VenoValve pivotal study is a U.S. program
  • •enVVe IDE filing and pivotal study planning are U.S.-focused
  • •No meaningful commercial geography yet because products are not approved

The company’s strategy is to advance VenoValve through the FDA appeal and regulatory pathway while continuing clinical...

01
Secure regulatory pathway for VenoValveshort-term

Approval is the key gating item for first commercialization and for validating the category.

02
Advance enVVe into pivotal developmentmedium-term

A second product broadens the platform and reduces dependence on one device program.

03
Prepare for commercializationmedium-term

Commercial readiness is needed to convert clinical success into revenue after approval.

The company faces high regulatory risk because both products depend on FDA approval and, in VenoValve’s case, on...

critical

Regulatory approval risk

The business depends on FDA clearance/approval for both product candidates, and VenoValve requires acceptance of a new effectiveness pathway.

Scope
VenoValve and enVVe
Materiality
high
high

Clinical development risk

Trial outcomes, safety endpoints, and pre-clinical results determine whether the programs can advance.

Scope
SAVVE study and enVVe GLP/IDE pathway
Materiality
high
high

Financing and dilution risk

The company is pre-revenue and relies on external capital to fund R&D and commercialization preparation.

Scope
Corporate funding needs
Materiality
high
medium

Commercial adoption risk

Even after approval, physicians and hospitals must adopt a new device category with limited precedent.

Scope
Future U.S. commercialization
Materiality
medium
Research and development expense recognition
Quarterly operating loss
Pre-commercialization spending
Operating expenses
Lease accounting
Cash flow and liabilities

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: 29/04/2026