enVVeno Medical Corp

Invention:	Surgical venous valve
Trademark:	VenoValve®
Invention:	Non-surgical transcatheter venous valve
Trademark:	enVVe™
Patents:	4
NASDAQ:	NVNO

​The inventions

​VenoValve® and enVVe™ are implantable valve products aimed at patients suffering from severe Chronic Venous Insufficiency (CVI) of the deep venous system in the leg, a condition where damaged vein valves lead to blood reflux, pooling, increased venous pressure, and potentially severe venous ulcers.
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VenoValve

enVVe

VenoValve®:

• Type: A first-in-class surgical replacement venous valve.
• Development Stage: Currently being evaluated in a U.S. pivotal study.
• Approach: Designed to be surgically implanted.
• Performance Advantages: The VenoValve® aims to reduce or eliminate symptoms of severe CVI, including the potential to heal recurring venous leg ulcers. It acts by reducing reflux and lowering venous hypertension within the deep venous system.

​enVVe™:

• Type: A first-in-class non-surgical, transcatheter-based replacement venous valve.
• Development Stage: Awaiting regulatory approval to begin a first-in-human study.
• Approach: Designed to be delivered via a transcatheter  approach.
• Performance advantage: Minimally invasive, non-surgical option that does not require general anesthesia or overnight hospital stays.

Both products are engineered to function as one-way valves to help rectify the backward flow of blood caused by valve failure, addressing the core problem of CVI. 

Intellectual property

As of December 31, 2022, enVVeno Medical has been granted a total of seventeen (17) patents, including four (4) within the United States. Additionally, the company has another seventeen (17) patent applications in various stages of review, with six (6) of these applications being within the United States​​.

The addressable markets

enVVeno Medical's inventions, the VenoValve and enVVe, target the substantial market of patients suffering from severe Chronic Venous Insufficiency (CVI) in the United States:
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• VenoValve® Market Size: The VenoValve is estimated to be suitable for approximately 2.5 million people in the U.S. with severe deep venous CVI. This population represents the candidates who could benefit from the surgical implantation of the VenoValve to address their condition​​.

 

• enVVe™ Market Size: The enVVe, designed as a minimally invasive solution, targets a broader patient population, including those with less severe CVI or those not eligible for surgical interventions. The estimated U.S. market for enVVe is approximately 3.5 million patients​​.

The incumbents

The existing therapies for Chronic Venous Insufficiency (CVI) that enVVeno Medical is aiming to improve or replace include:

1. Compression Garments: These are currently a standard non-invasive treatment option for managing symptoms of CVI. They work by applying pressure to the legs, helping to improve blood flow and reduce edema and discomfort. However, compression garments do not address the underlying valve dysfunction that causes CVI.
2. Leg Elevation: Another conservative treatment method involves elevating the legs to reduce venous pressure and facilitate venous return to the heart. Like compression garments, leg elevation offers symptomatic relief but does not correct the valve insufficiency causing CVI.

These conventional treatments provide temporary relief from symptoms but do not offer a permanent solution to the underlying problem of venous valve failure. 

There are currently no FDA-approved devices for surgical or non-surgical replacement venous valves.

Ownership
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Here are the largest shareholders as at Dec 31 2022:
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​Upside

As at 12th February 2024, the company's market cap is USD$68m, indicating substantial upside in the event of PMA. 

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Sources

Envveno Medical Corp annual report 2023
https://s3.amazonaws.com/sec.irpass.cc/2632/0001493152-23-006587.pdf

Envveno Medical Corp investor presentation 2024
https://s3.amazonaws.com/b2icontent.irpass.cc/2632/192898.pdf