What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-07-30 compared with 2026-05-06 · 144 added, 143 removed, 124 unchanged (70% of the section changed)

26 unchanged sentences

or the “Company” are to enVVeno Medical Corporation

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.

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.

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

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.

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.

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.

enVVe Valve is a first-in-class transcatheter based replacement venous valve being developed for the treatment of severe, deep venous

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.

April 2026, the U.S.

Food and Drug Administration (“FDA”) awarded the Company an Investigational Device Exemption (“IDE”) approval to proceed with

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.

IDE approval positions the Company to advance what could become the first effective treatment option for the approximately 3 million

patients who suffer from the debilitating impact of severe CVI due to malfunctioning valves in the deep veins of the leg.

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 220 th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA

post-marketing approval.

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).

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.

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.

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.

develop and manufacture our products in a 14,507 sq.

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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.

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

28 unchanged sentences

has been estimated to exceed $20 billion

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.

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.

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.

Key features of the enVVe System

invasive procedure requiring no general anesthesia or overnight hospital stay;

Self-expanding

frame made from a specially formulated biocompatible nickel and titanium alloy;

geometry that accommodates the natural dilation and contraction of the vein;

enVVe valve sizes to ensure a proper fit across a broad range of vein sizes;

mono-cusp leaflet design that is laser cut from porcine pericardium tissue;

profile of only 13 Fr (4.3 mm) when crimped, giving it the smallest profile of any replacement valve currently in use for the cardiovascular

via an over-the-wire, coaxial, single-stage pull system for ease of use.

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.

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.

from the SAVVE pivotal study has been presented at vascular conferences throughout the world and has been very well received.

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.

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.

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.

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.

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

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.

features of the enVVe System include:

Minimally invasive procedure

requiring no general anesthesia or overnight hospital stay;

Self-expanding frame made

from a specially formulated biocompatible nickel and titanium alloy;

Frame geometry that accommodates

the natural dilation and contraction of the vein;

3 enVVe valve sizes to

ensure a proper fit across a broad range of vein sizes;

Unique, mono-cusp leaflet

design that is laser cut from porcine pericardium tissue;

Delivery profile of only

13 Fr (4.3 mm) when crimped, giving it the smallest profile of any replacement valve currently in use for the cardiovascular system;

Delivery via an over-the-wire,

coaxial, single-stage pull system for ease of use.

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.

have historically funded our operations through financing activities such as the capital raises.

We will need to raise additional capital

in the future.

have historically funded our operations through financing activities such as capital raises and an at-the-market equity program.

need to raise additional capital in the future.

Any inability to raise additional financing would have a material adverse effect on us.

upon our cash and working capital as of March 31, 2026, we have sufficient capital resources to meet our obligations as they become due

upon our cash and working capital as of June 30, 2026, we have sufficient capital resources to meet our obligations as they become due

within at least one year after the date of this Quarterly Report and sustain operations.

of Operations

of the three months ended March 31, 2026 and 2025

reported net losses of $3.8 million and $4.5 million for the three months ended March 31, 2026 and 2025, respectively, representing a

of the three months ended June 30, 2026 and 2025

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

4 unchanged sentences

and Development Expenses

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.

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.

General and Administrative Expenses

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 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, as well as a net decrease in various other expenses.

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.

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.

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

1 unchanged sentence

Treasury securities.

of the six months ended June 30, 2026 and 2025

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.

a developmental stage Company, our revenue, if any, is expected to be diminutive and dependent on our ability to commercialize our product

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.

and Development Expenses

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

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.

General and Administrative Expenses

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.

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.

and Capital Resources

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

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.

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

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 March 31, 2026, is $2.6 million.

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.

13 unchanged sentences

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.

have historically funded our operations through financing activities such as the capital raises.

We will need to raise additional capital

in the future.

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.

have historically funded our operations through financing activities such as capital raises and an at-the-market equity program.

need to raise additional capital in the future.

Any inability to raise additional financing would have a material adverse effect on us.

upon our cash and working capital as of March 31, 2026, we have sufficient capital resources to meet our obligations as they become due

upon our cash and working capital as of June 30, 2026, we have sufficient capital resources to meet our obligations as they become due

within at least one year after the date of this Quarterly Report and sustain operations.

12 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis