enVVeno Medical Reports Second Quarter 2023 Financial Results and Provides Corporate Update
- Ended the quarter with $29.8 million in cash and investments with quarterly burn of $4.4 million - in line with Company guidance IRVINE, CA / ACCESSWIRE / July 31, 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 second quarter ended June 30, 2023. Cash burn for the quarter was $4.4 million, which is in line with the Company's guidance of burning between $4 million and $5 million per quarter. "The positive feedback we continue to receive from our investigators on the VenoValve® to date, as highlighted during our recent KOL event on July 18th (replay link here), strengthens our confidence in the potential for the VenoValve to be the first effective treatment for millions of patients suffering from deep venous CVI. We remain on track to complete enrollment in our ongoing SAVVE® pivotal study by the end of this year," commented Robert Berman, CEO of enVVeno Medical. "On the financial front, we continue to advance the Company while maintaining our moderate, budgeted burn rate and have sufficient capital to fund our operations through SAVVE topline data and additional key Company milestones." Clinical Program Highlights VenoValve: Surgical Replacement Venous Valve enVVe®:Non-surgical Transcatheter Based Replacement Venous Valve Summary of Financial Results for the Second Quarter 2023 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. ### INVESTOR CONTACT: Jenene Thomas, JTC Team, LLC SOURCE: enVVeno Medical Corporation
- Cash on hand sufficient to fund its current operations past the release of topline safety and efficacy data from the SAVVE® study and through the end of 2024
NVNO@jtcir.com
(833) 475-8247
The Company recently hosted a KOL event featuring two principal investigators from its ongoing SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal study for the VenoValve, a surgically based replacement venous valve for the treatment of Chronic Venous Insufficiency (CVI). KOLs for the event included Dr. David Dexter, Sentara Healthcare, Associate Professor Surgery, Eastern Virginia Medical School, and Dr. Eric Hager, Co-Director Venous Services and Associate Professor Surgery, University of Pittsburgh Medical Center. A webcast replay of the event is now available here.
Enrollment continues to progress in the ongoing SAVVE pivotal trial. As previously announced, the Company expects enrollment to be completed by the end of 2023.
The enVVe valve will be implanted without the need for general anesthesia, an open surgical procedure, and an overnight hospital stay.
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 is seeking regulatory approval to initiate an early feasibility study for enVVe, which will be known as the Transcatheter Anti-reflux, Venous Valve Endoprosthesis study (TAVVE-EFS).
The initial phase of the TAVVE® EFS study will seek to enroll 3 to 5 patients across multiple sites.
The Company ended the quarter with $29.8 million in cash and investments. Based on management's current expectations, the Company believes it has sufficient cash and investments to sustain operations through the end of 2024.
Cash burn for the quarter was $4.4 million, consistent with the Company's cash burn rate guidance of approximately $4 - 5 million per quarter.
The Company reported net losses of $6.5 million and $7.1 million for the three months ended June 30, 2023 and 2022, respectively, representing a decrease in net loss of $0.6 million, or 8%, resulting from a decrease in operating expenses and an increase in other income.
For the three months ended June 30, 2023, selling, general and administrative expenses decreased by $1.3 million or 33%, to $2.6 million from $3.9 million for the three months ended June 30, 2022. This decrease was due to a $1.2 million decrease in share-based compensation, and a $0.1 million decrease in professional fees. Share-based compensation decreased because the expense related to portions of grants made during 2021 has been fully amortized and subsequent grants have been of smaller value.
For the three months ended June 30, 2023, research and development expenses increased by $1.1 million or 35%, to $4.2 million from $3.1 million for the three months ended June 30, 2022. This increase primarily resulted from $1.0 million in costs related the SAVVE study, $0.1 million increase in personnel costs due to additional staff, and $0.1 million in travel costs, both mainly to support the SAVVE, partially offset by a decrease of $0.1 million in lab costs for VenoValve continued development.
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