enVVeno Medical Corp
For the period ended Dec 31, 2025. Filed Mar 26, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 26, 2026
NVNO$6.73-3.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-02-28.
0001493152-25-008581
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-26.
0001493152-26-012928
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 28 previous paragraphs and 32 current paragraphs.
12 unchanged; 12 reworded; 8 added; 4 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 1 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (8)
Current report
The Company has completed pre-clinical testing on the enVVe System and has begun discussions with the FDA regarding the enVVe pivotal trial, which it expects to begin in 2026.
Current report
Recent Developments
Current report
At the annual meeting of the Company’s stockholders held on December 11, 2025 (the “2025 Annual Meeting”), the Company’s stockholders approved an amendment to the Company’s amended and restated certificate of incorporation to effect a reverse stock split of our common stock, at a ratio between one-for-five (1:5) and one-for-thirty-five (1:35).
Current report
On January 2, 2026, the Company’s board of directors approved a one-for-thirty-five (1:35) reverse stock split of the outstanding shares of our common stock (the “Reverse Stock Split”). On January 16, 2026, the Company filed an amendment to the amended and restated certificate of incorporation with the Secretary of State of the State of Delaware to effect the Reverse Stock Split, which became effective on January 20, 2026. The amendment did not change the number of authorized shares of our common stock.
Current report
Except as the context otherwise requires, all common stock share numbers, share price amounts (including exercise prices, conversion prices, and closing market prices) and shares issued upon the exercise of warrants contained in this Annual Report on Form 10-K have been retroactively adjusted to reflect the Reverse Stock Split.
Current report
Overview
Current report
As a developmental stage Company, our revenue, if any, is expected to be diminutive and dependent on our ability to commercialize our product candidates. We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our lead product candidate after receiving FDA approval, if ever.
Current report
For the year ended December 31, 2025, research and development expenses decreased by $2.2 million or 19%, to $10.0 million from $12.2 million for the year ended December 31, 2024. The decrease primarily resulted from $2.4 million in lower costs related to the VenoValve study as the amount of follow-up for each participant decreases over time, partially offset by $0.2 million in higher compensation costs from additional personnel. We expect a moderate overall increase in expenses from current levels as costs related to the VenoValve pivotal study continue and costs related to the enVVe pivotal study would begin if IDE approval from the FDA is received.
Removed paragraphs (4)
Previous report
As a late-stage clinical medical device Company, we are not currently generating revenue and our future revenue, if any, is dependent on our ability to commercialize our product candidates. We will not begin generating revenue with respect to any of our product candidates until after we obtain FDA approval, if at all. We hope to eventually achieve revenues by commercializing and selling our products or licensing our technologies to companies that have the resources and infrastructure in place to manufacture, market and sell our products. The commercialization and/or licensing of any of our products may take several years, if it is to occur at all, and depends on our ability to obtain regulatory approval.
Previous report
Net Loss
Previous report
For the year ended December 31, 2024, research and development expenses decreased by $1.4 million or 10%, to $12.2 million from $13.6 million for the year ended December 31, 2023. The decrease is due to a decrease of $2.2 million in costs for the SAVVE trial, and a $0.3 million decrease in other lab costs, partially offset by an increase of $0.9 million in employee compensation from the increases in staffing, and an increase of $0.2 million in costs related to the GLP study for the enVVe. Costs related to SAVVE decreased in 2024 because, after full enrollment in 2023, activity shifted to ongoing monitoring, data collection, and preparation and filing of the PMA. The increase in compensation cost is due to the hiring of additional personnel supporting ongoing VenoValve testing and trial activity in addition to the preparation for the enVVe GLP study.
Previous report
We are not currently generating revenue. However, with the filing of our final PMA module completed in December 2024, we hope to receive FDA approval during 2026, and we have commenced limited activity toward commercial launch in anticipation of that approval. To-date, this activity is primarily market research and attendance at conferences. If and when we receive FDA approval of our PMA, we expect to significantly increase costs related to commercial launch and to direct spending toward establishing our market presence and generating revenue.
Reworded paragraphs (12)
Previous wording
enVVeno Medical Corporation is a 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. Chronic Venous Disease (CVD) is the world’s most prevalent chronic disease, impacting approximately 70% of the adult population of the U.S. Chronic Venous Insufficiency (CVI), is a large subset of CVD, which most often 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. The Company is developing surgical and non-surgical replacement venous valves for patients suffering from severe CVI of the deep venous system of the leg.
Current wording
enVVeno Medical Corporation is a 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. Chronic Venous Disease (“CVD”) is the world’s most prevalent chronic disease, impacting approximately 70% of the adult population of the U.S. Chronic Venous Insufficiency (“CVI”), is a large subset of CVD, which most often 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. The Company is developing a replacement venous valve for patients suffering from severe CVI of the deep venous system of the leg.
Previous wording
The Company’s lead product is the VenoValve®, which is a first-in-class surgical replacement venous valve that is currently being evaluated in a U.S. pivotal study. The Company is also developing a second product called enVVe®, which is a first-in-class, non-surgical, transcatheter based replacement venous valve. The Company is currently conducting pre-clinical testing on enVVe. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs.
Current wording
The Company first developed the VenoValve®, which was a first-in-class surgical replacement venous valve. On August 19, 2025, the Company received a not-approvable letter from the U.S. Food and Drug Administration (“FDA”) in response to its PMA application for the VenoValve. The Company is now focused on its next-generation, non-surgical venous valve product, called the enVVe® system. The enVVe System consists of the enVVe Valve, enVVe Delivery System, enVVe Nose Cone, the enVVe Delivery System Accessories, and the enVVe Crimping System. The enVVe Valve is a first-in-class, non-surgical, transcatheter based replacement venous valve being developed for the treatment of severe CVI. The enVVe Valve is designed to act as a one-way valve, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs. The Company has completed pre-clinical testing on the enVVe System and has begun discussions with the FDA regarding the enVVe pivotal trial.
Previous wording
The VenoValve and enVVe are being developed first for approval by the U.S. Food and Drug Administration (FDA). We expect the VenoValve to be eligible for FDA approval first, followed two to three years later by enVVe. If approved, we expect the VenoValve and enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option, although we cannot provide any assurance that either the VenoValve or enVVe will receive approval from the FDA (see the section entitled “Risk Factors” in this Annual Report on Form 10-K). There are currently no devices approved as surgical or non-surgical replacement venous valves, and there are currently no effective treatments for deep venous CVI caused by incompetent valves.
Current wording
enVVe is being developed for approval by the FDA. We cannot provide any assurance that either enVVe will receive approval from the FDA (see the section entitled “Risk Factors” in this Annual Report on Form 10-K). There are currently no devices approved as surgical or non-surgical replacement venous valves, and there are currently no effective treatments for deep venous CVI caused by incompetent valves.
Previous wording
Our team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and that have been commercially successful. We develop and manufacture our products in connection with our clinical trials in a 14,507 sq. ft. leased manufacturing facility in Irvine, California, which has been ISO 13485-2016 certified for the design, development and manufacturing of tissue based implantable medical devices.
Current wording
We develop and manufacture our products in connection with our clinical trials in a 14,507 sq. ft. leased manufacturing facility in Irvine, California, which has been ISO 13485-2016 certified for the design, development and manufacturing of tissue based implantable medical devices.
Previous wording
We 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, as described in further detail below, a decrease in operating expenses of $1.5 million, and an increase in other income of $0.2 million.
Current wording
We reported net losses of $19.5 million and $21.8 million for the years ended December 31, 2025 and 2024, respectively, representing a decrease in net loss of $2.3 million or 11%, resulting from, as described in further detail below, a decrease in operating expenses of $2.9 million, and a decrease in other income of $0.6 million.
Previous wording
For the year ended December 31, 2024, selling, general and administrative expenses decreased by $0.1 million or 1%, to $11.6 million from $11.7 million for the year ended December 31, 2023. This decrease is primarily driven by share-based compensation which decreased $1.1 million from 2023 to 2024. Selling, general and administrative expenses also decreased $0.1 million from lower travel cost, and $0.1 million from lower insurance cost in 2024. These decreases were partially offset by a $0.7 million increase in legal costs and a $0.5 million increase in costs related to conferences, and market research as the Company started increasing its market visibility in anticipation of commercialization activity if FDA approval of the VenoValve PMA is received.
Current wording
For the year ended December 31, 2025, selling, general and administrative expenses decreased by $0.7 million or 6%, to $10.9 million from $11.6 million for the year ended December 31, 2024. This decrease is primarily driven by $1.1 million in non-recurring legal costs incurred during the year ended December 31, 2024 and $0.7 million from the net effect of lower stock-based compensation cost incurred as option grants are issued and vest. These decreases were partially offset by a $0.3 million non-recurring severance expense recorded in 2025, $0.4 million related to higher compensation costs from additional personnel, and a net $0.4 million increase related to various other expenses.
Previous wording
For the year ended December 31, 2024, other income increased $0.3 million to $2.0 million from $1.7 million for the year ended September 30, 2023. Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess cash in U.S. Treasury securities.
Current wording
For the year ended December 31, 2025, other income decreased $0.6 million to $1.4 million from $2.0 million for the year ended December 31, 2024 as a result of the Company holding less U.S. Treasury securities in 2025 than 2024. Other income in both periods reflects net realized gains, interest, and unrealized losses from our program to invest excess cash in U.S. Treasury securities.
Previous wording
For the year ended December 31, 2024, the Company incurred losses from operations of $23.8 million and used $16.8 million cash in operating activities. The net cash used in operating activities during 2024 decreased by $2.1 million from $18.9 million for the year ended December 31, 2023, primarily due to the decrease in research and development expenses from 2023 to 2024. Our cash balance as of December 31, 2024, is $1.8 million. In addition, we have $41.4 million in investments, for total cash and investments of $43.2 million.
Current wording
For the year ended December 31, 2025, the Company incurred losses from operations of $20.9 million and used $15.6 million cash in operating activities. The net cash used in operating activities during 2025 decreased by $1.2 million from $16.8 million for the year ended December 31, 2024, primarily due to the decrease in research and development expenses from 2024 to 2025. Our cash balance as of December 31, 2025, is $3.1 million. In addition, we have $25.1 million in investments, for total cash and investments of $28.2 million.
Previous wording
The operating losses and the uses of cash are primarily due to the Company’s product research and development and administrative activities. Administrative functions relate to costs to support the Company’s public reporting and investor relations activities as well as internal administrative functions. Research and development activities are for continued product development and clinical trials for VenoValve and for enVVe. The Company will continue to incur these costs to complete its clinical trials, enhance products, develop new products, and operate as a public company for the foreseeable future as we seek to obtain regulatory approval for our studies and product candidates.
Current wording
The operating losses and the uses of cash are primarily due to the Company’s product research and development and administrative activities. Administrative functions relate to costs to support the Company’s public reporting and investor relations activities as well as internal administrative functions. Research and development activities were for product development and clinical trials for the VenoValve and for the enVVe System. The Company will continue to incur these costs to complete its clinical trials for the VenoValve and the enVVe System, enhance products, develop new products, and operate as a public company for the foreseeable future as we seek to obtain regulatory approval for our studies and product candidates.
Previous wording
We do not currently have material commitments for capital expenditures or other expenditures with the exception of our facility lease commitment of $0.3 million per year. We expect a modest increase in purchases of property and equipment and in facility lease costs as we continue SAVVE, commence TAVVE, and plan for commercialization of the VenoValve.
Current wording
We do not currently have material commitments for capital expenditures or other expenditures with the exception of our facility lease commitment of $0.4 million per year. We expect a nominal increase in purchases of property and equipment and in facility lease costs as we commence TAVVE.
Previous wording
Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials and related product development costs and our ability to successfully bring products to market. We anticipate that our cash burn rate will increase from current levels of approximately $4 million to $5 million per quarter to $5 million to $6 million per quarter in 2025. Even after considering this increase, we should have sufficient cash to fund operations through mid-2026.
Current wording
Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials and related product development costs and our ability to successfully bring products to market. We anticipate that our cash burn rate may increase from current levels of approximately $4 million per quarter to between $4 million and $5 million per quarter in 2026. Even after considering this increase, we should have sufficient cash to fund operations through mid-2027.
Previous wording
We have historically funded our operations through financing activities such as the capital raises completed in 2024 and 2023. We will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.
Current wording
We have historically funded our operations through financing activities such as the capital raises. We will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.