enVVeno Medical Corp
For the period ended Jun 30, 2026. Filed Jul 30, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Jul 30, 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-Q
Period ended 2026-03-31; filed 2026-05-06.
0001493152-26-021490
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-07-30.
0001493152-26-035452
ITEM 2. 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 53 previous paragraphs and 61 current paragraphs.
33 unchanged; 15 reworded; 8 added; 5 removed; 0 previous and 5 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 IDE approval positions the Company to advance what could become the first effective treatment option for the approximately 3 million U.S. patients who suffer from the debilitating impact of severe CVI due to malfunctioning valves in the deep veins of the leg.
Current report
Comparison of the six months ended June 30, 2026 and 2025
Current report
Overview
Current report
Revenues
Current report
Research and Development Expenses
Current report
Selling, General and Administrative Expenses
Current report
For the six months ended June 30, 2026, selling, general and administrative expenses decreased by $2.9 million or 44%, to $3.7 million from $6.6 million for the six months ended June 30, 2025. The decrease was due to the net effect of lower stock-based compensation cost incurred as option grants are issued and vest representing $1.3 million, as well as a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical costs and a non-recurring severance expense of $0.3 million recorded during the six months ended June 30, 2025, and a net $0.7 million related to various other expenses.
Removed paragraphs (5)
Previous report
We cannot provide any assurance that the enVVe System will receive pre-market approval from the FDA to be marketed and sold in the U.S. (see the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 26, 2026). 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 report
VenoValve
Previous report
In March 2021, the Company received IDE approval from the FDA to initiate the Surgical Anti-reflux Venous Valve Endoprosthesis (“SAVVE®”) U.S. pivotal clinical study evaluating the VenoValve. The prospective, multi-center, single-arm study enrolled 75 patients with severe CVI. An application seeking pre-market approval for the VenoValve was filed in November 2024. In August 2025, the Company received a non-approvable letter from the FDA for the VenoValve and a subsequent appeal was unsuccessful.
Previous report
Most medical devices start out as surgical iterations and transition to less invasive, trans-catheter delivered versions over time. The Company’s strategy was to first develop the VenoValve, and then to transition to enVVe. That strategy remains intact. The enVVe System could not have been developed without the experience gained from the VenoValve. Because the VenoValve was not approved by the FDA, the Company has elected to forego any potential approval and commercialization efforts outside of the U.S. for the VenoValve and to instead focus its resources on bringing the enVVe System to market.
Previous report
Data from the SAVVE pivotal study has been presented at vascular conferences throughout the world and has been very well received. Clinicians recognize the need for a replacement venous valve for patients suffering from deep venous CVI and we believe that both the short-term and long-term VenoValve efficacy data has been extremely promising for this difficult to treat patient population. Although interest in a surgical replacement venous valve has been strong, clinicians recognize that long-term the large potential market is best served via a trans-catheter delivered iteration of the device. There continues to be significant interest from clinicians wanting to participate in the TAVVE pivotal study.
Reworded paragraphs (15)
Previous 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.
Current wording
enVVeno Medical Corporation is a late-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 permanently 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 non-surgical replacement venous valve for patients suffering from severe CVI of the deep venous system of the leg.
Previous wording
The Company first developed the VenoValve®, which was a first-in-class surgical replacement venous valve (the Company received a not-approvable letter from the FDA in response to its PMA application for the VenoValve in August 2025). 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.
Current wording
The Company is focused on its next-generation, non-surgical replacement venous valve, 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 transcatheter based replacement venous valve being developed for the treatment of severe, deep venous 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.
Previous wording
On April 29, 2026, the Company announced that the FDA had approved the Company’s Investigational Device Exemption (“IDE”) application, authorizing the Company to commence a study of a non-surgical replacement venous valve. The Transcatheter Venous Valve Endoprosthesis (“TAVVE**®**”) pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe deep CVI. The first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220 th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.
Current wording
The first stage of the TAVVE study, which is expected to commence in the second half of 2026, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.
Previous wording
The human leg contains three vein systems: the deep vein system, the superficial vein system, and the perforator vein system which connects the deep system to the superficial system. The deep venous system is located below the muscle and facia in the center portion of the leg and is responsible for approximately 90% of the blood flow. In order for blood to return to the heart from the foot, ankle, and lower leg, the calf muscle serves as a pump and pushes the blood up the veins of the leg against gravity and through a series of one-way valves. Each valve is supposed to open as blood passes through, and then close as blood progresses up the veins of the leg to the next valve. CVI occurs when the one-way valves in the veins of the leg fail and become incompetent. When the valves fail, gravity causes the blood to flow backwards and in the wrong direction (reflux). As blood pools in the lower leg, pressure inside the veins increases (venous hypertension). Reflux, and the resulting venous hypertension, causes the leg to swell, resulting in debilitating pain, and in the most severe cases, venous ulcers.
Current wording
The human leg contains three vein systems: the deep vein system, the superficial vein system, and the perforator vein system which connects the deep system to the superficial system. The deep venous system is located below the muscle and facia in the center portion of the leg and is responsible for approximately 90% of the blood flow. In order for blood to return to the heart from the foot, ankle, and lower leg, the calf muscle serves as a pump and pushes the blood up the veins of the leg against gravity and through a series of one-way valves. Each valve is supposed to open as blood passes through, and then close as blood progresses up the veins of the leg to the next valve. CVI occurs when the one-way valves in the veins of the leg fail and become permanently damaged. When the valves fail, gravity causes the blood to flow backwards and in the wrong direction (reflux). As blood pools in the lower leg, pressure inside the veins increases (venous hypertension). Reflux, and the resulting venous hypertension, causes the leg to swell, resulting in debilitating pain, and in the most severe cases, venous ulcers.
Previous wording
The enVVe System is designed to treat severe deep CVI through a minimally invasive, catheter-based approach. The procedure is performed without the need for open surgery or an overnight hospital stay. Built on the clinical foundation of the VenoValve program, the enVVe Valve incorporates design enhancements intended to improve performance, strength and long-term durability. The enVVe System seeks to address prior FDA concerns discerned in the clinical trial process for the VenoValve related to venous valves implanted via open surgical procedures. In addition to eliminating open surgical complications, its transcatheter approach is expected to broaden adoption by appealing to a wider range of implanting physicians including vascular surgeons, interventional radiologists, and interventional cardiologists.
Current wording
The enVVe System is designed to treat severe deep CVI through a minimally invasive, catheter-based procedure. The procedure is performed without the need for open surgery or an overnight hospital stay. Built on the clinical foundation of the VenoValve® surgical replacement venous valve program, which demonstrated significant clinical improvement in severe CVI patients, the enVVe System seeks to address prior FDA concerns related to the VenoValve’s open surgical implantation procedure. In addition to eliminating open surgical complications, the enVVe System’s transcatheter approach is expected to broaden adoption by appealing to a wider range of implanting physicians including vascular surgeons, interventional radiologists, and interventional cardiologists.
Previous wording
The Company has completed pre-clinical testing on the enVVe System and, on April 29, 2026, the Company announced that the FDA had approved the Company’s IDE application, authorizing the Company to commence a study of a non-surgical replacement venous valve. The TAVVE pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe deep CVI. The first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220 th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.
Current wording
On April 29, 2026, the Company announced that the FDA had approved the Company’s IDE application, authorizing the Company to commence a pivotal study for the enVVe System. The TAVVE pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe deep CVI. The first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220 th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.
Previous wording
We finished 2025 with approximately $28.2 million of cash and investments and had approximately $24.9 million of cash and investments as of March 31, 2026. Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials, 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 $3 million to $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 and investments to fund operations into the third quarter of 2027.
Current wording
We finished 2025 with approximately $28.2 million of cash and investments and had approximately $21.5 million of cash and investments as of June 30, 2026. Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials, 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 $3 million to $4 million per quarter to between $4 million and $5 million per quarter in the second half of 2026. Even after considering this increase, we should have sufficient cash and investments to fund operations into the third quarter of 2027.
Previous 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.
Current wording
We have historically funded our operations through financing activities such as capital raises and an at-the-market equity program. We will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.
Previous wording
We reported net losses of $3.8 million and $4.5 million for the three months ended March 31, 2026 and 2025, respectively, representing a decrease in net loss of $0.7 million, or 15%, due to a decrease in operating expenses of $0.9 million, partially offset by a decrease in other income of $0.2 million, as described in further detail below.
Current wording
We reported net losses of $3.6 million and $6.7 million for the three months ended June 30, 2026 and 2025, respectively, representing a decrease in net loss of $3.1 million, or 46%, due to a decrease in operating expenses of $3.3 million, partially offset by a decrease in other income of $0.2 million, as described in further detail below.
Previous wording
For the three months ended March 31, 2026, research and development expenses decreased by $0.5 million or 17%, to $2.1 million from $2.6 million for the three months ended March 31, 2025. This decrease primarily resulted from $0.7 million in lower costs related the VenoValve pivotal study as the amount of follow-up for each participant decreases over time and our focus has shifted to the development of the enVVe System, as well as a net decrease of $0.2 million in various other expenses. These decreases were partially offset by an increase of $0.4 million in product development, testing and other expenses related to the enVVe System being developed for approval by the FDA.
Current wording
For the three months ended June 30, 2026, research and development expenses decreased by $0.8 million or 28%, to $2.1 million from $2.9 million for the three months ended June 30, 2025. This decrease primarily resulted from $1.1 million in lower costs related to the VenoValve pivotal study as the amount of follow-up for each participant decreases over time, as well as a net decrease of $0.1 million in various other expenses. These decreases were partially offset by an increase of $0.4 million as our focus has shifted to product development, testing and other expenses related to the enVVe System being developed for approval by the FDA.
Previous wording
For the three months ended March 31, 2026, selling, general and administrative expenses decreased by $0.4 million or 19%, to $2.0 million from $2.4 million for the three months ended March 31, 2025. The decrease was due to the net effect of lower stock-based compensation cost incurred as option grants are issued and vest, as well as a net decrease in various other expenses.
Current wording
For the three months ended June 30, 2026, selling, general and administrative expenses decreased by $2.5 million or 59%, to $1.7 million from $4.2 million for the three months ended June 30, 2025. The decrease was due to the net effect of lower stock-based compensation cost incurred as option grants are issued and vest representing $1.0 million, as well as a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical costs and a non-recurring severance expense of $0.3 million recorded during the three months ended June 30, 2025, and a net $0.6 million related to various other expenses.
Previous wording
For the three months ended March 31, 2026, other income decreased $0.3 million or 53% to $0.2 million from $0.5 million for the three months ended March 31, 2025. Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to invest excess cash in U.S. Treasury securities.
Current wording
For the three months ended June 30, 2026, other income decreased $0.2 million or 45% to $0.2 million from $0.4 million for the three months ended June 30, 2025. Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to invest excess cash in U.S. Treasury securities.
Previous wording
For the three months ended March 31, 2026, the Company incurred losses from operations of $4.1 million and used $3.2 million cash in operating activities. The net cash used in operating activities during the 2026 period decreased by $0.8 million from $4.0 million for the three months ended March 31, 2025 primarily due to the decrease in research and development expenses from 2025 to 2026. Our cash balance as of March 31, 2026, is $2.6 million. In addition, we have $22.3 million in investments, for total cash and investments of $24.9 million.
Current wording
For the six months ended June 30, 2026, the Company incurred losses from operations of $7.9 million and used $6.8 million cash in operating activities. The net cash used in operating activities during the 2026 period decreased by $0.9 million from $7.7 million for the six months ended June 30, 2025 primarily due to the decrease in research and development expenses from 2025 to 2026. Our cash balance as of June 30, 2026, is $2.8 million. In addition, we have $18.7 million in investments, for total cash and investments of $21.5 million.
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 may increase from current levels of approximately $3 million to $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 and investments to fund operations into the third quarter of 2027.
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 $3 million to $4 million per quarter to between $4 million and $5 million per quarter in the second half of 2026. Even after considering this increase, we should have sufficient cash and investments to fund operations into the third quarter of 2027.
Previous 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.
Current wording
We have historically funded our operations through financing activities such as capital raises and an at-the-market equity program. We will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
In April 2026, the U.S. Food and Drug Administration (“FDA”) awarded the Company an Investigational Device Exemption (“IDE”) approval to proceed with a U.S. pivotal study of the enVVe System. The Transcatheter Venous Valve Endoprosthesis (“TAVVE”) pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe CVI.
Current report — wording carried from elsewhere
We reported net losses of $7.4 million and $11.2 million for the six months ended June 30, 2026 and 2025, respectively, representing a decrease in net loss of $3.8 million, or 33%, due to a decrease in operating expenses of $4.2 million, partially offset by a decrease in other income of $0.4 million, as described in further detail below.
Current report — wording carried from elsewhere
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 — wording carried from elsewhere
For the six months ended June 30, 2026, research and development expenses decreased by $1.3 million or 23%, to $4.2 million from $5.5 million for the six months ended June 30, 2025. This decrease primarily resulted from $1.8 million in lower costs related to the VenoValve pivotal study as the amount of follow-up for each participant decreases over time, as well as a net decrease of $0.4 million in various other expenses. These decreases were partially offset by an increase of $0.9 million as our focus has shifted to product development, testing and other expenses related to the enVVe System being developed for approval by the FDA.
Current report — wording carried from elsewhere
For the six months ended June 30, 2026, other income decreased $0.4 million or 49% to $0.4 million from $0.8 million for the six months ended June 30, 2025. Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to invest excess cash in U.S. Treasury securities.