This presentation and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical, Inc. (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 (including, without limitation, with respect to our name change, our progress with the VenoValve® and the expected timeline related to the SAAVE U.S. pivotal trial, including the timing of beginning patient enrollment, the VenoValve®'s ability to fill the unmet medical needs of CVI sufferers and our development of a second device for the treatment of venous disease) may differ significantly from those set forth or implied in the forward-looking statements. These 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.
Nasdaq: NVNO | enVVeno.com
Investment Overview
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Chronic Venous Insufficiency (CVI) is Caused by the Failure of Valves in the Veins of the Leg
There are Currently No Effective Treatment Options for Deep Venous CVI
Surgical replacement venous valve Ongoing SAVVE U.S. pivotal trial Potential U.S. TAM: 2.5 million patients
Non-surgical replacement venous valve IDE for pivotal trial expected Q4 2024 Potential U.S. TAM: 3.5 million patients
Expect to File PMA Application for VenoValve in Q4 2024
Sufficient Capital to Fund Operations Through the End of 2025
Nasdaq: NVNO | enVVeno.com
Chronic Venous
Insufficiency (CVI)
Learn More
Nasdaq: NVNO | enVVeno.com
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Chronic Venous Insufficiency (CVI)
Occurs as a result of increased venous pressure (venous hypertension) within
the veins of the leg, due to failure of valves within the veins
Leads to:
• Reflux - blood flows in the wrong direction
• Blood pooling in the lower leg
• Venous hypertension
• Pain
• Edema
• Ulceration
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Nasdaq: NVNO | enVVeno.com
CVI Patients Need an Effective Treatment
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~2.5M ~3.5M
People in the U.S.1
~$30k
Spent on wound care per patient per year2
20-40%
1-Year ulcer recurrence1
~$3B
Direct medical
costs2
~40%
More workdays
missed3
1.
Yost, Mary, The Sage Group, Chronic Venous Disease, Epidemiology, Costs, and Consequences, 2016
Nasdaq: NVNO | enVVeno.com
2.
Sachdev, Ulka, et. al. Suppressed Networks of Inflammatory Mediators Characterize Chronic Venous Insufficiency, Journal of Vascular Surgery: Venous and Lymphatic Disorders, May 2018
3.
Rice, J. Bradford, Burden of Venous Leg Ulcers in the United States, Journal of Medical Economics, Volume 17, 2014
Deep Venous CVI: Current Standard of Care
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Compression Garments
Nasdaq: NVNO | enVVeno.com
Leg Elevation
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enVVeno.com
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First-In-Class Surgical Replacement Venous Valve
Ongoing U.S. Pivotal Trial
Significant Opportunity with~2.5 million
Potential Patients in the U.S.
PMA Application Expected Q4 2024
FDA Breakthrough Device Designation
Nasdaq: NVNO | enVVeno.com
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Nasdaq: NVNO | enVVeno.com
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enVVeno Medical Corp. published this content on
02 April 2024 and is solely responsible for the information contained therein. Distributed by
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02 April 2024 23:32:04 UTC.
enVVeno Medical Corporation is a late-stage clinical med-tech company. The Company is focused on the advancement of bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The Company is developing surgical and non-surgical replacement venous valves for patients suffering from severe Chronic Venous Insufficiency (CVI) of the deep venous system of the leg. The Company's lead product, VenoValve, which is a porcine based replacement venous valve developed to surgically implanted in the deep venous system of the leg to treat severe CVI. The VenoValve is implanted into the femoral vein of the patient in an open surgical procedure via a five-to-six-inch incision in the upper thigh. The VenoValve is being evaluated in the surgical anti-reflux venous valve endoprosthesis (SAVVE) United States clinical trial. The Company is also developing a second product called enVVe, which is a non-surgical, transcatheter based replacement venous valve.