- Achieved more than half of enrollment in U.S. SAVVE pivotal trial of VenoValve® in 2022
- Multiple near-term milestones expected across VenoValve® and enVVe™ clinical programs
- Ended the year with $39.1 million in cash and investments including $3.6 million burn for Q4
- 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 / March 2, 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 fourth quarter and year-end of 2022.

"We made solid progress during the fourth quarter of 2022 and look forward to building momentum throughout 2023 as we approach several key clinical milestones for both the VenoValve and enVVe. To date, we have enrolled 43 patients in the SAVVE pivotal trial for the VenoValve. Industrywide hospital staffing turnover and shortages have slowed clinical trials across the U.S., including in SAVVE where enrollment has been somewhat inconsistent, even while patient interest is strong. During the fourth quarter of 2022 and first quarter of 2023, we added four full time clinical technologists to provide additional support to our clinical sites and to help with staffing issues. With topline safety data from SAVVE expected approximately 120 days after full enrollment, we still expect safety data to be available before the end of 2023," commented Robert Berman, CEO of enVVeno Medical.

"Additionally, we are waiting for regulatory approval to begin the first-in-human trial for enVVe, our next generation, non-surgical transcatheter based replacement venous valve. Enrollment for the enVVe first in-human study will begin immediately after regulatory approval and we expect to begin to report interim, topline data regarding technical success, safety, and effectiveness starting in the second half of 2023. With a number of near-term milestones ahead, 2023 is poised to be an exciting year," Mr. Berman added.

Clinical Program Highlights

VenoValve^®: Surgical Replacement Venous Valve

• 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.
• Initial topline safety data from the SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal trial is expected before the end of 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, pending regulatory approval.
• The initial phase of the TAVVE FIH study will seek to enroll 3 to 5 patients across multiple sites in Colombia.

Summary of Financial Results for the Full Year 2022

• The Company ended the year with $39.1 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.
• The Company reported net losses of $24.7 million and $16.5 million for the years ended December 31, 2021 and 2022, respectively, representing an increase in net loss of $8.2 million or 50%, due to an increase in operating expenses of $8.0 million, and a decrease in other expense (income) of $0.2 million.
• Cash burn for the quarter was $3.6 million, slightly below the Company's projected cash burn of $4 million to $5 million per quarter.
• For the year ended December 31, 2022, selling, general and administrative expenses increased by $3.8 million or 34%, to $15.0 million from $11.2 million for the year ended December 31, 2021. The net increase reflects increases in compensation due to share-based compensation from grants made during 2021, and $0.2 million from warrants issued to a vendor in 2022, which together increased share-based compensation cost to $9.0 million in 2022 from $6.0 million in 2021. The remaining $0.8 million increase reflects costs to support staffing increases and operating improvements as the Company begins to prepare for commercialization.
• For the year ended December 31, 2022, research and development expenses increased by $4.2 million or 74%, to $9.9 million from $5.7 million for the year ended December 31, 2021. The increase is primarily due to an increase of $2.5 million in costs for the SAVVE trial and preparation for the enVVe first-in-human trial, $1.1 million in higher lab quality testing to prepare for regulatory audits, support the SAVVE trial and support enVVe product development, $0.3 million in compensation from the increases in staffing also to support the SAVVE trial and continued product development, and $0.3 million in higher travel costs primarily for the SAVVE trial.

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