- Ended the quarter with $39.1 million cash and investments on hand sufficient to fund operations, through the end of 2025, including potential PMA approval of VenoValve®
- Positive interim venous ulcer healing data showing significant improvement from the VenoValve pivotal trial presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting
- Company on track to file application seeking VenoValve FDA approval in Q4 2024
- Continued progress toward launch of GLP study for enVVe® transcatheter-based replacement venous valve
IRVINE, CA / ACCESSWIRE / August 1, 2024 / 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 second quarter 2024 and provided a corporate update.
"The past few months have been marked by a number of key data announcements from our SAVVE pivotal trial for the VenoValve. In addition to reporting a sustained clinically meaningful benefit as indicated by rVCSS for patients with an average 11-month period since receiving the VenoValve, we reported a significant improvement in venous ulcer healing for our most severe patients (C6). That data is especially impressive because all of these patients have failed conventional treatments, including many requiring years of wound care with poor results. Also important is that none of the patients with healed ulcers have experienced ulcer recurrences, putting an end to the vicious cycle often associated with conventional therapies," commented Robert Berman, CEO of enVVeno Medical. "As we look toward the remainder of this year, we look forward to completing one-year visits for the full cohort of patients, filing our application seeking PMA approval from the FDA, and reporting the definitive data."
Clinical Program Highlights
VenoValve: Surgical Replacement Venous Valve
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Positive interim venous ulcer healing data showing significant improvement from the VenoValve pivotal trial presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting:
91% of venous ulcer patients evaluated at one year have either fully healed ulcers or ulcers that have improved.
100% of venous ulcers with a duration of one year or less prior to VenoValve surgery have fully healed.
89% of venous ulcers with a duration of more than one year prior to VenoValve surgery have fully healed or improved.
No ulcer recurrences.
Company on track to file application seeking VenoValve FDA approval in Q4 2024.
enVVe®:Non-surgical Transcatheter Based Replacement Venous Valve
Ongoing progress with manufacturing for enVVe valves and enVVe delivery systems to start a six-month chronic GLP study, which the Company expects to begin in Q4 of 2024.
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 file the IDE in Q2 2025.
Summary of Financial Results for the Second Quarter 2024
The Company ended the quarter with $39.1 million in cash and investments. Based on management's current expectations, this capital has the potential to fund the Company through several significant milestones, including the release of initial topline efficacy data from SAVVE, 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 $3.8 million, better than the Company's projected cash burn rate of approximately $4-5 million per quarter.
The Company reported net losses of $5.0 million and $6.5 million for the three months ended June 30, 2024 and 2023, respectively, representing a decrease in net loss of $1.5 million or 23.1%, resulting from, a decrease in operating expenses and an increase in other income as described in further detail below.
For the three months ended June 30, 2024, research and development expenses decreased by $1.4 million or 33.3%, to $2.8 million from $4.2 million for the three months ended June 30, 2023. This decrease primarily resulted from $1.7 million in lower costs related the SAVVE study as the study was fully enrolled during 2023 resulting in the reduction of outreach and enrollment related activities and related costs, partially offset by a $0.3 million increase in personnel costs to support the SAVVE study and enVVe development.
For the three months ended June 30, 2024, selling, general and administrative expenses were $2.6 million, flat from the three months ended June 30, 2023, which was also $2.6 million. This was due to the net effect of a $0.1 million decrease in share-based compensation, offset by a $0.1 million increase in legal costs.
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 enVVe pivotal trial.
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
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