enVVeno Medical Reports Second Quarter 2024 Financial Results and Provides Corporate Update
Rhea-AI Summary
enVVeno Medical (NASDAQ:NVNO) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- $39.1 million in cash and investments, sufficient to fund operations through end of 2025
- Positive interim venous ulcer healing data from VenoValve pivotal trial
- On track to file VenoValve FDA approval application in Q4 2024
- Progress on enVVe transcatheter-based replacement venous valve
Financial results:
- Net loss decreased by 23.1% to $5.0 million
- Cash burn of $3.8 million, better than projected $4-5 million
- R&D expenses decreased by 33.3% to $2.8 million
- SG&A expenses remained flat at $2.6 million
Positive
- Cash and investments of $39.1 million, sufficient to fund operations through end of 2025
- 91% of venous ulcer patients evaluated at one year have either fully healed ulcers or improved
- Net loss decreased by 23.1% to $5.0 million in Q2 2024
- Cash burn of $3.8 million, better than projected $4-5 million
- R&D expenses decreased by 33.3% to $2.8 million
Negative
- Company still operating at a net loss of $5.0 million for Q2 2024
News Market Reaction
On the day this news was published, NVNO declined 0.93%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Ended the quarter with
- 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
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
Cash burn for the quarter was
The Company reported net losses of
For the three months ended June 30, 2024, research and development expenses decreased by
For the three months ended June 30, 2024, selling, general and administrative expenses were
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
View the original press release on accesswire.com
FAQ
What were enVVeno Medical's (NVNO) key financial results for Q2 2024?
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