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enVVeno Medical Corp

enVVeno Medical Corp was established to address chronic venous insufficiency, a condition affecting millions of Americans, by engineering a permanent,...

enVVeno Medical Corp

enVVeno Medical Corp was established to address chronic venous insufficiency, a condition affecting millions of Americans, by engineering a permanent, bioprosthetic replacement venous valve. The firm is led by CEO Robert Berman and a board of directors with experience in medical-device development and commercialization. The firm's primary focus is the enVVeno Venous Valve — a device designed to replace incompetent venous valves, thereby restoring one-way blood flow and reducing symptoms such as leg swelling, pain, and ulcers. The firm conducts clinical trials in the US and Europe, seeking FDA premarket approval. As a publicly traded company (NASDAQ: NVNO), enVVeno funds operations through equity offerings and debt financing. enVVeno's team includes clinical advisors and regulatory specialists. The firm engages with medical professionals through conference presentations and peer-reviewed publications. As of 2025, the firm had reported positive one-year data from its SAVVE clinical trial, showing safety and durability of the valve implant (per the firm, 2025). A key structural differentiator is enVVeno's orphan-device designation from the FDA, which grants orphan-drug-like exclusivity and development incentives for its lead product. The firm also holds patents around its bioprosthetic valve design and delivery system, creating a narrow moat in a currently productless market.

General information

Firm type

other

Year founded

AUM

Undisclosed

Location

Region

Country

City

Corporate office

Sector focus

Healthcare ServicesMedical Devices

Frequently asked questions

Who runs investment decisions at enVVeno Medical Corp?

enVVeno's investment decisions are managed by its board of directors and senior management, including CEO Robert Berman and CFO Brian L. Firth. The firm allocates capital toward clinical trials, regulatory submissions, and manufacturing infrastructure for its venous valve product.

What is enVVeno's lead product and current development stage?

The lead product is the enVVeno Venous Valve, a bioprosthetic replacement valve for patients with chronic venous insufficiency. As of early 2025, the firm had reported one-year outcomes from the SAVVE clinical trial, with plans to pursue FDA premarket approval.

Does enVVeno generate revenue, or is it a pre-commercial firm?

enVVeno is a pre-commercial medical-device firm with no approved products for sale. The firm does not report product revenue; its financial filings show expenses related to research, clinical development, and operations.

What regulatory designations does enVVeno hold for its venous valve?

The enVVeno Venous Valve has received orphan-device designation from the FDA, which provides development incentives, tax credits, and potential market exclusivity upon approval. This designation reflects the lack of approved alternatives for venous valve replacement.

Is enVVeno a family office, a venture firm, or a corporate entity?

enVVeno Medical Corp is a publicly traded medical-device company listed on NASDAQ under ticker NVNO. It is not a family office or investment firm but a corporate entity focused on device development and commercialization.

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