enVVeno Medical Reports Fourth Quarter and Year-End 2024 Financial Results and Progress Towards VenoValve FDA Approval Expected in 2H25

Associated Press

28-02-2025

Cash Burn of $5.2 million in Q4 remains in line with projected $4-5 million quarterly range
Cash and investments on hand are sufficient to fund operations beyond the anticipated regulatory approval of VenoValve and the initiation of the enVVe pivotal trial
PMA application for the VenoValve submitted, with FDA decision expected in the second half of 2025
On track for enVVe IDE application submission by mid-2025, pending GLP study results
IRVINE, CA / ACCESS Newswire / February 28, 2025 / 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 2024.
'Throughout 2024, we executed on our primary objectives - the successful submission of our PMA application for the VenoValve®, and the advancement of enVVe towards its U.S. pivotal trial, both critical milestones for enVVeno Medical,' commented Robert Berman, CEO of enVVeno Medical. 'We also added two key members to our Executive team in order to begin preparations for the commercialization of the VenoValve and will continue to add to our team following a positive decision from the FDA.'
Mr. Berman added, 'We are on the precipice of achieving what no other company has been able to achieve, a viable solution for the millions of patients that suffer from severe deep venous Chronic Venous Insufficiency.'
Summary of Financial Results for the Full Year 2024
The Company ended the year with $43.2 million in cash and investments. Based on management's current expectations, this capital has the potential to fund the Company through the anticipated FDA pre-market approval filing for VenoValve, the initiation of commercialization preparations for VenoValve and the commencement of the enVVe pivotal trial.
Cash burn for the quarter was $5.2 million, consistent with the Company's projected cash burn rate of approximately $4-5 million per quarter. The Company anticipates that its cash burn rate will increase from current levels of approximately $4 million to $5 million per quarter to $5 million to $7 million per quarter in 2025.
The Company reported net losses of $21.8 million and $23.5 million for the years ended December 31, 2024 and 2023, respectively, representing a decrease in net loss of $1.7 million or 7%, resulting from a decrease in operating expenses of $1.5 million, and an increase in other income of $0.2 million.
Clinical Program Highlights
VenoValve PMA application seeking U.S. Food and Drug Administration (FDA) approval submitted; Decision expected in H2 2025.
Interim two-year follow-up data from 34 subjects in the SAVVE U.S. pivotal trial for the VenoValve demonstrated sustained clinical improvement and continued patient benefit, from 12 months to 24 months.
78% of subjects maintained a clinically meaningful benefit of more than 3 points in rVCSS at 24 months, with an average improvement of 8.2 points among the responder cohort.
Subjects continued to experience a median 75% reduction in pain at 24 months.
Interim follow-up data indicate sustained improvements across all venous specific quality-of-life (QoL) indicators.
Reported one-year efficacy and safety data from the SAAVE U.S. pivotal trial at the 51st Annual VEITH Symposium. The data indicated:
85% of the patients enrolled in SAVVE experienced a clinical meaningful benefit from the VenoValve, defined as a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS), at one year, compared to baseline.
The average rVCSS improvement in the clinically meaningful responder cohort was 7.91 points.
Patients in the SAVVE study also experienced a seventy-five percent (75%) median reduction in pain and improvements in quality-of-life indicators.
For patients with venous ulcers (CEAP C6 patients), ulcer area was reduced a median average of eighty-seven percent (87%).
Over the course of the 1-year period, there was one (1) death (unrelated to the VenoValve), zero (0) pulmonary embolisms, twelve (12) target vein thromboses, ten (10) surgical pocket hematomas, four (4) other bleeds, and seven (7) deep wound infections. Ninety four percent (94%) of the patients that experienced a material safety event also went on to experience a clinically meaningful benefit from the VenoValve. Also, the reported target vein patency rates at thirty (30) days and one (1) year were ninety one percent (91%) and ninety seven percent (97%), respectively.
enVVe ®:Non-Surgical Transcatheter Based Replacement Venous Valve
Successfully completed final wave for the shorter-term subjects in 6-month pre-clinical GLP study. Completion of GLP study expected in Q1 2025.
The GLP study should be the final step necessary before filing the Investigational Device Exemption (IDE) seeking FDA approval to start the enVVe pivotal study.
The Company expects to be in a position to file for IDE approval for the enVVe pivotal trial mid-2025.
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 performing the final testing necessary to seek approval for the pivotal 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.