- $51.4 million cash on hand sufficient to fund current operations, including multiple value driving milestones, through the end of 2025

- Achieved full enrollment for VenoValve® U.S. pivotal trial

- Expedited development plan for the enVVe® transcatheter-based replacement venous valve

IRVINE, CA / ACCESSWIRE / October 26, 2023 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today reported financial results for the third quarter ended September 30, 2023. Cash burn for the quarter was $4.1 million, which is in line with the Company's previous guidance of burning between $4 million and $5 million per quarter.

"Our team has continued to make significant progress on multiple fronts while keeping our cash burn in line with previous guidance. Notably, we reached full enrollment, ahead of schedule, in the VenoValve U.S. pivotal trial, further strengthened our balance sheet with the closing of a $28 million private placement on terms that are favorable to both the company and investors, and in light of our stronger cash position, announced our plans to expedite the development of enVVe, our transcatheter replacement venous valve," commented Robert Berman, CEO of enVVeno Medical. "Although we expect our quarterly cash burn to begin to increase over time as we get closer to commercialization of the VenoValve, we now have the capital that we need to get us past several significant milestones, including what we expect will be regulatory approval of the VenoValve and the beginning the enVVe pivotal trial."

Clinical Program Highlights

VenoValve®: Surgical Replacement Venous Valve

• Achieved completion of enrollment in the SAVVE U.S. pivotal study.
• Initial topline safety data from SAVVE is now expected in Q4 of this year.
• Initial topline efficacy data from SAVVE is now expected in Q2 of 2024.
• PMA eligibility to file for FDA approval of the VenoValve is expected to occur in Q3 of 2024.

enVVe®:Non-Surgical Transcatheter Based Replacement Venous Valve

• Six-month GLP study (final step before seeking pivotal study approval) to begin in Q1 of 2024.
• IDE application seeking approval for enVVe pivotal trial expected to be filed in Q4 of 2024.
• Approval for enVVe pivotal study expected in early 2025.

Summary of Financial Results for the Third Quarter 2023

• The Company ended the quarter with $25.7 million in cash and investments. Subsequent to the quarter, the Company closed a private placement raising approximately $28.0 million gross cash proceeds. This financing has the potential to fund the Company through several significant milestones, including the release of initial topline efficacy data from SAVVE, our anticipated FDA pre-market approval of the VenoValve, the beginning of preparations for VenoValve commercialization, and accelerated plans for the pivotal trial for enVVe.
• Cash burn for the quarter was $4.1 million, consistent with the Company's projected cash burn rate of approximately $4-5 million per quarter.
• The Company reported net losses of $5.0 million and $6.1 million for the three months ended September 30, 2023 and 2022, respectively, representing a decrease in net loss of $1.1 million or 18%, due to a decrease in operating expenses of $0.8 million, and a net increase in other income and expense of $0.3 million.
• For the three months ended September 30, 2023, selling, general and administrative expenses decreased by $1.1 million or 30%, to $2.6 million from $3.7 million for the three months ended September 30, 2022. This decrease was due to share-based compensation reflecting the reduction in expense from grants made during 2021, the cost for portions of which have been fully recognized.
• For the three months ended September 30, 2023, research and development expenses increased by $0.3 million or 12%, to $2.8 million from $2.5 million for the three months ended September 30, 2022. This increase primarily resulted from $0.2 million in increased personnel costs to support the SAVVE study, and $0.1 million in lab costs, also to support the SAVVE study and continued product development.

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 early feasibility study 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