- Ended the quarter with $34.2 million in cash and investments with quarterly burn of $4.9 million - in line with Company projections

- Cash expected to support operations through the end of 2024, including release of SAVVE topline data and TAVVE first-in-human study data

IRVINE, CA / ACCESSWIRE / May 1, 2023 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today provided a corporate update and reported financial results for the first quarter ended March 31, 2023. Cash burn for the quarter was $4.9 million, which is in line with the Company's guidance of burning $4 million to $5 million per quarter.

"We remain focused on enrollment and clinical execution as we advance our ongoing pivotal SAVVE trial for the VenoValve for the treatment of Chronic Venous Insufficiency. We have also continued to be financially responsible, maintaining a consistent quarterly burn, and have sufficient capital to fund our operations through multiple key milestones through the end of 2024, including topline data from the SAVVE pivotal trial for the VenoValve, our surgical replacement venous valve, and data from our anticipated first-in-human trial for enVVe, our transcatheter based replaced venous valve," commented Robert Berman, CEO of enVVeno Medical.

Clinical Program Highlights

VenoValve®: Surgical Replacement Venous Valve

• Enrollment continues to progress in the ongoing SAVVE pivotal trial for the VenoValve, a surgically based replacement venous valve for the treatment of Chronic Venous Insufficiency (CVI).
• There are currently no effective treatments for patients with deep venous CVI resulting from malfunctioning valves.
• Approximately 2.5 million people in the U.S. have the type of CVI for which the VenoValve is being evaluated.
• The Company previously announced guidance for enrollment of the SAVVE study to be completed by the end of the second quarter 2023.

Patients suffering from lower leg swelling, pain, non-healing leg sores, enlarged veins, and/or brownish or blueish skin discoloration - who may also have leg pain when standing or walking - may be candidates for the SAVVE trial. Interested patients can learn more about the SAVVE trial and fill out a pre-qualification questionnaire by visiting www.VenoValve.com.

enVVe™: Non-surgical Transcatheter Based Replacement Venous Valve

• enVVe potentially expands the Company's total addressable market to include people living with less severe CVI and people with co-morbidities or for whom an open surgical procedure may pose too much risk.
• Estimated U.S. market for enVVe is approximately 3.5 million patients.
• The Company plans to initiate a first-in-human trial, which will be known as the Transcatheter Anti-reflux, Venous Valve Endoprosthesis (TAVVE) FIH study.
• The initial phase of the TAVVE FIH study will seek to enroll 3 to 5 patients across multiple sites.

Summary of Financial Results for the First Quarter 2023

• The Company ended the quarter with $34.2 million in cash and investments. Based on management's current expectations, the Company believes it has sufficient cash to sustain operations through the end of 2024.
• Cash burn for the quarter was $4.9 million, consistent with the Company's projected cash burn rate of approximately $4 - 5 million per quarter.
• The Company reported net losses of $6.4 million and $5.3 million for the three months ended March 31, 2023 and 2022, respectively, representing an increase in net loss of $1.1 million, or 21%, resulting from an increase in operating expenses.
• For the three months ended March 31, 2023, selling, general and administrative expenses decreased by $0.6 million or 16%, to $3.2 million from $3.8 million for the three months ended March 31, 2022. Of this decrease, $0.4 million was due to share based compensation, which decreased to $1.8 million in 2023 from $2.2 million in 2022, primarily because of the timing of vesting of grants made in 2021. The remaining $0.2 million decrease reflects $0.1 million from lower Delaware franchise taxes in 2023, and $0.1 million from lower outside services costs related to investor relations and the Company's website update.
• For the three months ended March 31, 2023, research and development expenses increased by $2.0 million or 125%, to $3.6 million from $1.6 million for the three months ended March 31, 2022. This increase primarily resulted from $1.6 million in costs related to the SAVVE study, $0.3 million increase in lab and personnel costs to support the VenoValve pivotal trial and enVVe development, and $0.1 million in travel costs, also related to the SAVVE study.

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 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™. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. 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 SAVVE U.S. pivotal study and the company is currently waiting for regulatory approval to begin the TAVVE first-in-human trial for enVVe.

Cautionary Note on Forward-Looking Statements

This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (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 and timing (may differ significantly from those set forth or implied in the forward-looking statements. 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.

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INVESTOR CONTACT:

Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(833) 475-8247

SOURCE: enVVeno Medical Corporation