– Ended the quarter with $42.7 million in cash and investments
– Burn rate of $4.5 million for the quarter
– Runway extends through the end of 2024 including release of SAVVE topline pivotal trial data and initiation of TAVVE first in human study
IRVINE, CA / October 27, 2022 / 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 third quarter ended September 30, 2022.
“We are making solid progress with our SAVVE pivotal trial with August and September representing our highest enrollment months to-date. Additionally, we unveiled enVVe, our next generation, non-surgical transcatheter based replacement venous valve, which is on track to enter a first-in-human study in the first quarter of next year. We continue to advance the Company while carefully managing our burn, resulting in a very strong financial position and enough cash to last through key upcoming milestones,” commented Robert Berman, CEO of enVVeno Medical.
Clinical Program Highlights
VenoValve®: Surgical replacement venous valve
- There are currently no effective treatments for patients with deep venous CVI resulting from malfunctioning valves.
- Approximately 2.5 million people in the U.S. have the type of CVI for which the VenoValve is being evaluated.
- Ongoing SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal trial.
- SAVVE trial enrollment is expected to be completed at the end of the first quarter of 2023, with primary safety and efficacy data expected in the second half of 2023.
Patients suffering from lower leg swelling, pain, non-healing leg sores, enlarged veins, and/or brownish or blueish skin discoloration – who may also have leg pain when standing or walking – may be candidates for the SAVVE trial. Interested patients can learn more about the SAVVE trial and fill out a pre-qualification questionnaire by visiting www.VenoValve.com.
enVVe™: Non-surgical transcatheter based replacement venous valve
- 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 plans to conduct a first-in-human trial, which will be known as the Transcatheter Anti-reflux, Venous Valve Endoprosthesis (TAVVE) FIH study.
- The initial phase of the TAVVE FIH study will seek to enroll 3 to 5 patients across multiple sites in Colombia.
- The Company is awaiting regulatory approval to begin the TAVVE FIH study, which is expected in the first quarter of 2023.
Summary of Financial Results for the Third Quarter 2022
- The Company ended the quarter with $42.7 million in cash and cash equivalents, and investments. Based on management’s current expectations, the Company believes it has sufficient cash to sustain operations through the end of 2024.
- The Company’s burn rate for the third quarter was $4.5 million, in line with previous guidance of $4.0 – $5.0 million expected cash burn per quarter.
- The Company reported net losses of $6.1 million and $2.4 million for the three months ended September 30, 2022 and 2021, respectively, representing an increase in net loss of $3.7 million, or 154%, resulting from an increase in operating expenses.
- For the three months ended September 30, 2022, selling, general and administrative expenses increased by $2.1 million or 140%, to $3.6 million from $1.5 million for the three months ended September 30, 2021. Of this increase, $1.9 million was due to share-based compensation cost which increased to $2.2 million in 2022 from $0.3 million in 2021. The remaining $0.2 million increase reflects higher legal expenses related to building the Company’s patent portfolio.
- For the three months ended September 30, 2022, research and development expenses increased by $1.3 million or 108%, to $2.5 million from $1.2 million for the three months ended September 30, 2021. This increase primarily resulted from $0.8 million in costs related the SAVVE study, $0.3 million in lab costs to support the SAVVE study and VenoValve continued development, and $0.2 million increase in personnel costs due to additional staff.
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 first-in-human 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.
JTC Team, LLC
SOURCE: enVVeno Medical Corporation
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