What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-07-31 compared with 2025-04-30 · 186 added, 153 removed, 107 unchanged (76% of the section changed)

26 unchanged sentences

or the “Company” are to enVVeno Medical Corporation

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 deep 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.

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 deep 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.

Company’s lead product is the VenoValve ® , a potential first of its kind surgical replacement venous valve currently

9 unchanged sentences

Food and Drug Administration (FDA).

We expect the VenoValve

to be eligible for FDA approval first, followed approximately 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 our Annual Report on Form 10-K/A, filed with the SEC on February 28, 2025).

are currently no devices FDA approved as surgical or non-surgical replacement venous valves, and there are currently no effective

treatments for deep venous CVI caused by incompetent valves.

We expect the VenoValve to

be eligible for FDA approval first, followed approximately 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 our Annual Report on Form 10-K/A, filed with the SEC on February 28, 2025).

There are currently no devices

FDA approved as surgical or non-surgical replacement venous valves, and there are currently no effective treatments for deep venous CVI

caused by incompetent valves.

team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and that

25 unchanged sentences

CVI sufferers experience a significantly reduced quality of life.

Daily activities such as preparing meals, housework, and personal

hygiene (washing and bathing) become difficult due to reduced mobility.

For many severe CVI sufferers, intense pain, which

frequently occurs at night, prevents them from getting adequate sleep.

Severe CVI sufferers with venous leg ulcers (VLU) are known to miss approximately 40% more workdays than the average worker without the condition.

A high percentage of venous ulcer

patients also experience severe itching, leg swelling, and an odorous discharge.

Wound dressing changes, which occur several times a

week, can be extremely painful.

Venous ulcers from deep venous CVI are very difficult to heal, and a significant percentage of

venous ulcers remain unhealed for more than a year.

Even if healed, recurrence rates for venous ulcers are known to be high (20% to

40%) within the first year and as high as 60% after five years.

Patients with severe CVI often become housebound and experience

social isolation due to difficulty with ambulation.

As a result, studies have shown that patients with active venous ulcers

experience higher rates of anxiety and depression, with reported rates of anxiety of up to 30% and depression up to 40%.

depression caused by venous ulcers among the elderly are even higher, with 48% of elderly venous ulcer patients having severe

depressive symptoms.

Daily activities such as preparing meals, housework, and personal hygiene

(washing and bathing) become difficult due to reduced mobility.

For many severe CVI sufferers, intense pain, which frequently occurs

at night, prevents them from getting adequate sleep.

Severe CVI sufferers with venous leg ulcers (VLU) are known to miss approximately

40% more workdays than the average worker without the condition.

A high percentage of venous ulcer patients also experience severe itching,

leg swelling, and an odorous discharge.

Wound dressing changes, which occur several times a week, can be extremely painful.

Venous ulcers

from deep venous CVI are very difficult to heal, and a significant percentage of venous ulcers remain unhealed for more than a year.

Even if healed, recurrence rates for venous ulcers are known to be high (20% to 40%) within the first year and as high as 60% after five

Patients with severe CVI often become housebound and experience social isolation due to difficulty with ambulation.

studies have shown that patients with active venous ulcers experience higher rates of anxiety and depression, with reported rates of

anxiety of up to 30% and depression up to 40%.

Rates of depression caused by venous ulcers among the elderly are even higher, with 48%

of elderly venous ulcer patients having severe depressive symptoms.

is generally defined as the portion of the population that has a given condition.

Estimates indicate that the prevalence of people

Estimates indicate that the prevalence of people in

with severe, deep venous CVI (C4 to C6 disease) with reflux to be approximately 20 million.

Incidence is generally

defined as the number of new cases of an ailment that develop in a given time period.

We estimate that approximately 3.5 million new

patients with severe deep venous CVI are diagnosed each year in the U.S.

including approximately 1.5 million patients that develop

venous leg ulcers (C6 patients).

The average patient seeking treatment of a venous ulcer spends as much as $30,000 a year on wound

care, and the total direct medical costs from venous ulcer sufferers in the U.S.

has been estimated to exceed $3 billion a

VenoValve is a surgically implanted replacement venous valve developed

by enVVeno Medical, designed for use in the deep veins of the leg to treat severe CVI caused by valvular incompetence.

By lowering pressure

(venous hypertension) within the deep venous system of the leg, the VenoValve has the potential to reduce or eliminate the symptoms of

severe deep venous CVI, including the potential to heal recurring venous leg ulcers.

The VenoValve is implanted into the femoral vein

of the patient in an open surgical procedure via a 5-to-6-inch incision in the upper thigh.

The surgical approach for implanting the VenoValve

is referred to as the SAVVE ® procedure, which enables physicians to implant the VenoValve to restore valve function in

the deep veins of the leg.

As our planned initial entrant to the replacement venous valve market, we estimate that approximately 2.5 million

people each year with severe deep venous CVI in the U.S.

would be candidates for the VenoValve, including approximately 1.5 million people

with active venous ulcers.

The VenoValve has been granted Breakthrough Device designation by the FDA.

Incidence is generally defined as

the number of new cases of an ailment that develop in a given time period.

We estimate that approximately 3.5 million new patients with

severe deep venous CVI are diagnosed each year in the U.S.

including approximately 1.5 million patients that develop venous leg ulcers

(C6 patients).

The average patient seeking treatment of a venous ulcer spends as much as $30,000 a year on wound care, and the total

direct medical costs from venous ulcer sufferers in the U.S.

has been estimated to exceed $3 billion a year.

VenoValve is a surgically implanted replacement venous valve developed by enVVeno Medical, designed for use in the deep veins of the

leg to treat severe CVI caused by valvular incompetence.

By lowering pressure (venous hypertension) within the deep venous system of

the leg, the VenoValve has the potential to reduce or eliminate the symptoms of severe deep venous CVI, including the potential to heal

recurring venous leg ulcers.

The VenoValve is implanted into the femoral vein of the patient in an open surgical procedure via a 5-to-6-inch

incision in the upper thigh.

The surgical approach for implanting the VenoValve is referred to as the SAVVE ® procedure,

which enables physicians to implant the VenoValve to restore valve function in the deep veins of the leg.

As our planned initial entrant

to the replacement venous valve market, we estimate that approximately 2.5 million people each year with severe deep venous CVI in the

would be candidates for the VenoValve, including approximately 1.5 million people with active venous ulcers.

The VenoValve has been

granted Breakthrough Device designation by the FDA.

Clinical Status

March of 2021 we received IDE approval from the FDA to begin the VenoValve

pivotal study.

An investigational device exemption or IDE from the FDA is required before a medical device company can proceed with a

pivotal trial for a Class III medical device.

This approval allowed us to proceed with our U.S.

pivotal study for the VenoValve, a prospective,

non-blinded, single arm, multi-center clinical study.

March of 2021 we received IDE approval from the FDA to begin the VenoValve pivotal study.

An investigational device exemption or IDE

from the FDA is required before a medical device company can proceed with a pivotal trial for a Class III medical device.

This approval

allowed us to proceed with our U.S.

pivotal study for the VenoValve, a prospective, non-blinded, single arm, multi-center clinical study.

The seventy-five patient U.S.

pivotal study reached full enrollment on September

1, 2023 and is now in the post-enrollment follow-up period.

VenoValve is implanted using the SAVVE ® procedure, an open surgical approach that enables precise placement of the

device within the femoral vein to restore valve function.

endpoints for the U.S.

pivotal study include rVCSS scores, which are used to provide evidence of clinically meaningful benefit, as

well as reflux time measurements, VAS pain scores, quality of life measurements, ulcer healing (for CEAP class C6 patients), and

intra-operative and one-year vein patency and valve functionality.

Safety endpoints include device related events and procedure

related events including mortality, pulmonary embolism, ipsilateral deep vein thrombosis, infection and bleeding.

pivotal study reached full enrollment on September 1, 2023 and is now in the post-enrollment follow-up

VenoValve is implanted using the SAVVE ® procedure, an open surgical approach that enables precise placement of the device

within the femoral vein to restore valve function.

Efficacy endpoints for the U.S.

pivotal study include rVCSS scores, which are used

to provide evidence of clinically meaningful benefit, as well as reflux time measurements, VAS pain scores, quality of life measurements,

ulcer healing (for CEAP class C6 patients), and intra-operative and one-year vein patency and valve functionality.

Safety endpoints include

device related events and procedure related events including mortality, pulmonary embolism, ipsilateral deep vein thrombosis, infection

and bleeding.

November 2024, one year efficacy and safety data from the U.S.

study was presented at the 51th Annual VEITH Symposium.

The data indicated that eighty-five percent (85%) of the patients enrolled in

the trial experienced a clinical meaningful benefit from the VenoValve, defined as a three (3) or more point improvement in revised Venous

Clinical Severity Score (rVCSS), at one year, compared to baseline.

The average rVCSS improvement in the clinically meaningful responder

cohort was 7.91 points.

Patients in the study also experienced a seventy-five percent (75%) median reduction in pain and improvements

in quality-of-life indicators.

For patients with venous ulcers (CEAP C6 patients), ulcer area was reduced a median average of eighty-seven

percent (87%).

Over the course of the one (1) year period, there was one (1) death (unrelated to the VenoValve), zero (0) pulmonary embolisms,

twelve (12) target vein thromboses, ten (10) surgical pocket hematomas, four (4) other bleeds, and seven (7) deep wound infections.

Ninety-four percent (94%) of the patients that experienced a material safety event also went on to experience a clinically meaningful benefit

from the VenoValve.

Also, the reported target vein patency rates at thirty (30) days and one (1) year were ninety one percent (91%) and

ninety seven percent (97%), respectively.

pivotal study was presented at the 51th Annual VEITH Symposium.

indicated that eighty-five percent (85%) of the patients enrolled in the trial experienced a clinical meaningful benefit from the VenoValve,

defined as a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS), at one year, compared to baseline.

The average rVCSS improvement in the clinically meaningful responder cohort was 7.91 points.

Patients in the study also experienced a

seventy-five percent (75%) median reduction in pain and improvements in quality-of-life indicators.

For patients with venous ulcers (CEAP

C6 patients), ulcer area was reduced a median average of eighty-seven percent (87%).

Over the course of the one (1) year period, there

was one (1) death (unrelated to the VenoValve), zero (0) pulmonary embolisms, twelve (12) target vein thromboses, ten (10) surgical pocket

hematomas, four (4) other bleeds, and seven (7) deep wound infections.

Ninety-four percent (94%) of the patients that experienced a material

safety event also went on to experience a clinically meaningful benefit from the VenoValve.

Also, the reported target vein patency rates

at thirty (30) days and one (1) year were ninety one percent (91%) and ninety seven percent (97%), respectively.

June 2025, the Company announced that interim two-year follow-up data on forty-two (42) subjects from the seventy-five (75) patient VenoValve

pivotal trial at the Society for Vascular Surgery 2025 Vascular Annual Meeting.

The data indicated that eighty-three percent (83.3%)

of patients enrolled in the trial (n=35/42) maintained a clinically meaningful benefit from the VenoValve, defined as an improvement

of 3 or more points in the revised Venous Clinical Severity Score (rVCSS), at year two, compared to baseline.

The average rVCSS improvement

in the clinically meaningful responder cohort was 9.1 points.

Patients in the study also experienced a seventy-four percent (74%) median

reduction in leg pain, as measured by the Visual Analog Scale (VAS).

For patients with venous ulcers, wound healing outcomes in seventeen

(17) patients with twenty-five (25) ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in size.

Patient-reported outcomes also demonstrated sustained improvements across all venous specific QoL indicators (VEINES-QoL/Sym).

the patients (n=30), a 100% valve patency rate was observed at the two-year follow up.

All values were calculated comparing each patient’s

baseline levels to the reported values at the patient’s 24-month visit.

The Revised Venous Clinical Severity Score (rVCSS) is a

clinically validated scoring system used to track the progression or regression of venous diseases.

November 19, 2024, the Company submitted the final module of its PMA application for review by the FDA.

9 unchanged sentences

December 16, 2024, we announced the successful completion of the final wave of implants for the six-month pre-clinical GLP study for

The first wave of implants, for the long-term subjects, was successfully completed in October 2024, and the final wave for

the shorter-term subjects was completed in December 2024.

The GLP study is a prerequisite to seeking IDE approval from the FDA to

begin the enVVe U.S.

The first wave of implants, for the long-term subjects, was successfully completed in October 2024, and the final wave for the

shorter-term subjects was completed in December 2024.

The GLP study is a prerequisite to seeking IDE approval from the FDA to begin the

pivotal study.

The Company expects to file for IDE approval for the enVVe pivotal study in the third quarter of 2025.

finished 2024 with approximately $43.2 million of cash and investments and had approximately $38.9 million of cash and investments at

March 31, 2025.

finished 2024 with approximately $43.2 million of cash and investments and had approximately $35.1 million of cash and investments as

of June 30, 2025.

Our future capital requirements will remain dependent upon a variety of factors, especially including the success of

1 unchanged sentence

We anticipate that

our cash burn rate will increase from current levels of approximately $4 million to $5 million per quarter as we conduct our clinical

trials and work toward bringing our product candidates to market.

our cash burn rate will increase from current levels of approximately $4 million per quarter to between $5 million and $7 million per

quarter as we conduct our clinical trials and work toward bringing our product candidates to market.

of Operations

of the three months ended March 31, 2025 and 2024

reported net losses of $4.5 million and $5.0 million for the three months ended March 31, 2025 and 2024, respectively, representing a

decrease in net loss of $0.5 million, or 10%, resulting from a decrease in operating expenses, partially offset by a decrease in other income.

of the three months ended June 30, 2025 and 2024

reported net losses of $6.7 million and $5.0 million for the three months ended June 30, 2025 and 2024, respectively, representing an

increase in net loss of $1.7 million, or 35%, due to an increase in operating expenses of $1.6 million and a decrease in other income

of $0.1 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 product candidates after receiving FDA approval, if ever.

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 three months ended March 31, 2025, research and development expenses decreased by $0.5 million or 19%, to $2.6 million from $3.1

million for the three months ended March 31, 2024.

This decrease primarily resulted from $0.5 million in lower costs related to the

VenoValve pivotal study and $0.3 million in lower lab related costs.

VenoValve pivotal study costs were lower as the amount of

follow-up for each participant decreases over time.

Lab costs were lower due to less assembly and test activity for the VenoValve

once the VenoValve pivotal study reached full enrollment.

These decreases were partially offset by a $0.3 million increase in

personnel costs resulting from additional personnel.

the three months ended June 30, 2025, research and development expenses increased by $0.1 million or 2%, to $2.9 million from $2.8 million

for the three months ended June 30, 2024.

This increase primarily resulted from $0.2 million in higher compensation costs from additional

personnel, as well as higher professional fees, partially offset by $0.1 million in lower costs related the VenoValve pivotal study as

the amount of follow-up for each participant decreases over time.

General and Administrative Expenses

the three months ended March 31, 2025, selling, general and administrative expenses decreased $0.1 million or 4%, to $2.4 million

from $2.5 million for the three months ended March 31, 2024.

The decrease was due to a $0.4 million decrease in share-based

compensation, partially offset by $0.2 million in higher other compensation costs, and $0.1 million in higher consulting costs, both

related to activities to prepare for potential commercialization of the VenoValve.

the three months ended March 31, 2025, other income decreased $0.1 million or 25% to $0.4 million from $0.5 million for the three

months ended March 31, 2024.

Other income in both periods reflects realized gains, interest, and unrealized gains and losses from

our program to invest excess cash in US Treasury bills.

the three months ended June 30, 2025, selling, general and administrative

expenses increased by $1.6 million or 58%, to $4.2 million from $2.6 million for the three months ended June 30, 2024.

Of this increase,

$0.4 million was due to compensation costs from the net effect of higher stock-based compensation from the issuance of additional option

grants, a non-recurring severance expense of $0.3 million recorded in 2025, and $0.2 million related to higher compensation costs from

additional personnel.

This increase was also due to a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical

costs resulting from payments made to a vendor that were not passed through from the vendor to clinical sites, as contractually required,

and a net $0.1 million increase related to various other expenses.

the three months ended June 30, 2025, other income decreased $0.1 million or 29% to $0.4 million from $0.5 million for the three months

ended June 30, 2024.

Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest

excess cash in US Treasury bills.

of the six months ended June 30, 2025 and 2024

reported net losses of $11.2 million and $10.0 million for the six months ended June 30, 2025 and 2024, respectively, representing an

increase in net loss of $1.2 million or 13%, due to an increase in operating expenses of $1.0 million and a decrease in other income

of $0.2 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, 2025, research and development expenses decreased by $0.5 million or 7%, to $5.4 million from $5.9 million

for the six months ended June 30, 2024.

This decrease primarily resulted from $0.9 million in lower costs related to the VenoValve study

as the amount of follow-up for each participant decreases over time, partially offset by $0.4 million in higher compensation costs from

additional personnel, as well as higher professional fees.

General and Administrative Expenses

the six months ended June 30, 2025, selling, general and administrative

expenses increased $1.5 million or 29%, to $6.6 million from $5.1 million for the six months ended June 30, 2024.

Of this increase, $0.3

million was due to a non-recurring severance expense recorded in 2025 and $0.4 million related to higher compensation costs from additional

This increase was also due to a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical costs resulting

from payments made to a vendor that were not passed through from the vendor to clinical sites, as contractually required, and a net $0.2

million increase related to various other expenses.

(Income) Expense

the six months ended June 30, 2025, other income decreased $0.2 million to $0.8 million from $1.0 million for the six months ended June

Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess cash

and Capital Resources

the three months ended March 31, 2025, the Company incurred losses from operations of $5.0 million and used $4.0 million cash in operating

The net cash used in operating activities during the 2025 period increased by $0.4 million from $3.6 million for the quarter

ended March 31, 2024.

losses and the uses of cash are primarily due to our product research and development activities, including clinical studies, and

administrative activities.

Research and development activities are for continued product development and clinical studies for our

product candidates, currently the VenoValve and enVVe.

Administrative functions relate to costs to support our public reporting and

investor relations activities, internal administrative functions and, starting in 2024, costs to prepare for commercialization of

the VenoValve.

The Company will continue to incur these costs, and we anticipate these costs will increase, as we work to complete

our clinical studies, enhance products, develop new products, bring those products to market, and operate as a public

the six months ended June 30, 2025, the Company incurred losses from operations of $12.0 million and used $7.7 million cash in operating

The net cash used in operating activities during the 2025 period increased by $0.2 million from $7.5 million for the period

ended June 30, 2024.

losses and the uses of cash are primarily due to our product research and development activities, including clinical studies, and administrative

Research and development activities are for continued product development and clinical studies for our product candidates,

currently the VenoValve and enVVe.

Administrative functions relate to costs to support our public reporting and investor relations activities,

internal administrative functions and, starting in 2024, costs to prepare for commercialization of the VenoValve.

The Company will continue

to incur these costs, and we anticipate these costs will increase, as we work to complete our clinical studies, enhance products, develop

new products, bring those products to market, and operate as a public company.

are not currently generating revenue and do not expect significant revenue until we successfully commercialize one or more of our product

4 unchanged sentences

for commercialization of the VenoValve and continue development of enVVe.

future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical

studies 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 as we conduct our clinical studies

and work toward bringing our product candidates to market.

future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical studies

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 between $5 million and $7 million per quarter as we conduct our clinical

studies and work toward bringing our product candidates to market.

have historically funded our operations through financing activities, such as the capital raise completed in 2024, and will need to raise

1 unchanged sentence

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

on our cash and working capital as of March 31, 2025, we have sufficient capital resources to meet our obligations as they become due

on our cash and working capital as of June 30, 2025, we have sufficient capital resources to meet our obligations as they become due

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

Accounting Estimates

preparation of our consolidated financial statements requires management to make judgments, estimates and assumptions

that affect the reported amounts of expenses, assets and liabilities, and the accompanying disclosures, and the disclosure of contingent

liabilities, if any.

Critical accounting estimates are those for which uncertainty about the assumptions and estimates could result in

outcomes that require a material adjustment to the carrying amount of assets or liabilities in future periods if the actual outcomes

differ from estimates.

We do not have any matters that have a significant risk of causing a material adjustment to the carrying amounts of assets and

liabilities within the next fiscal year.

preparation of our consolidated financial statements requires management to make judgments, estimates and assumptions that affect the

reported amounts of expenses, assets and liabilities, and the accompanying disclosures, and the disclosure of contingent liabilities,

Critical accounting estimates are those for which uncertainty about the assumptions and estimates could result in outcomes that

require a material adjustment to the carrying amount of assets or liabilities in future periods if the actual outcomes differ from estimates.

do not have any matters that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities

within the next fiscal year.

Sheet Arrangements

4 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