What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-04-30 compared with 2024-10-31 · 191 added, 243 removed, 69 unchanged (86% 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 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®, which is a potential first-in-class surgical replacement venous valve that is currently

being evaluated in a U.S.

pivotal study called the SAVVE trial (Surgical Anti-reflux Venous Valve Endoprosthesis).

Definitive one year data from SAVVE is expected to be released in the fourth quarter of 2024.

Company is also developing the next generation replacement venous valve called enVVe®, which will be delivered via transcatheter

as opposed to an open surgery.

The Company is conducting pre-clinical testing on enVVe and currently expects to be ready to file for

IDE approval for the enVVe pivotal trial in mid

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.

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

in post-enrollment follow-up of its U.S.

pivotal study.

The Company is also developing a second product called enVVe ® ,

a potential next-generation, 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.

VenoValve and enVVe are being developed first for approval by the U.S.

Food and Drug Administration (FDA).

be eligible to file for FDA approval of the VenoValve in the fourth quarter of 2024 followed approximately three years later by enVVe.

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

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

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.

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have been commercially successful.

We develop and manufacture both the VenoValve and EnVVe in a 14,000 sq.

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.

We develop and manufacture our products in connection with our clinical trials in a 14,507 sq.

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.

venous disease (“CVD”) is the world’s most prevalent chronic disease.

CVD is clinically classified using a standardized system known

as CEAP (clinical, etiological, anatomical, and pathophysiological).

The CEAP system consists of seven clinical classifications (C0 to

C6) with C4, C5 and C6 being the most severe categories of CVD.

CVD is clinically classified using a standardized

system known as CEAP (clinical, etiological, anatomical, and pathophysiological).

The CEAP system consists of seven clinical classifications

(C0 to C6) with C4, C5 and C6 being the most severe categories of CVD.

Venous Insufficiency (“CVI”) is a large subset of CVD and is generally used to describe patients with C4 to C6 CVD.

CVI is a debilitating

condition that affects the venous system of the leg causing pain, swelling, edema, skin changes, and ulcerations.

a debilitating condition that affects the venous system of the leg causing pain, swelling, edema, skin changes, and ulcerations.

human leg contains three vein systems:

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CVI sufferers experience a significantly reduced quality of life.

Daily activities such as preparing meals, housework, dressing, and

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

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 are known to miss approximately 40% more

workdays than the average worker.

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.

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.

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%.

Rates of depression caused by venous ulcers among the elderly are even

higher, with 48% of elderly venous ulcer patients having severe depressive symptoms.

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.

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

Estimates indicate that the prevalence of people in

Estimates indicate that the prevalence of people

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 patients that develop venous leg ulcers (C6 patients).

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 replacement venous valve developed at enVVeno Medical to be surgically implanted in the deep venous system

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.

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.

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

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.

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 which is called the SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis)

clinical study.

The SAVVE study is a prospective, non-blinded, single arm, multi-center study of seventy-five (75) CVI patients enrolled

endpoints for the SAVVE 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.

achieved full enrollment of 75 subjects in the SAVVE trial on September 1, 2023, having enrolled eighteen (18) patients over the final

two (2) months of the study.

November 16, 2023, we presented preliminary device related thirty-day Device Related Material Adverse Event (“MAE”) data

at the 50th Annual VEITH Symposium.

The preliminary device related MAE rate for the fully enrolled 75 subject study was eight percent

MAEs for the SAVVE study are defined as all-cause mortality, pulmonary embolisms (“PEs”), ipsilateral deep vein thromboses

(“DVTs”), bleeding, and deep wound infections, occurring within thirty (30) days of enrollment in the study, being either

device or procedure related.

The device related MAEs presented at the conference indicated no deaths, no pulmonary embolisms, and six

(6) DVTs, from the fully enrolled cohort of 75 patients.

Subsequent to the VEITH presentation, two (2) of the DVTs were adjudicated by

the SAVVE Clinical Events Committee (“CEC”) as being moderate and four (4) of the DVTs were adjudicated as being mild.

addition to the DVTs, the safety report also noted a higher-than-expected rate of pocket wound hematomas (anti-coagulation related bleeding

outside of the target vein within the surgical cavity) within the first two (2) weeks after surgery, which were deemed to be moderate

in severity by the CEC, as well as an expected rate of procedure related wound infections at the site of the skin incisions.

and wound infections were acute in nature and had no lasting negative impact on patient health or clinical outcomes.

March 6, 2024, we released initial, six-month topline preliminary revised Venous Clinical Severity Score (rVCSS) efficacy data from the

SAVVE study at the VENOUS2024 American Venous Forum Annual Meeting, in Tampa Florida.

The data released at VENOUS 2024 indicated that,

overall, 97% of the study patients receiving the VenoValve showed clinical improvement as measured by rVCSS at six months, compared to

baseline, with 74% of the study patients improving the three (3) or more rVCSS points needed to demonstrate VenoValve’s clinical

meaningful benefit (the “Clinical Meaningful Benefit”).

The average improvement among the Clinical Meaningful Benefit cohort

was 8 points, more than two and a half times the amount of rVCSS improvement required to demonstrate that the VenoValve provides Clinical

Meaningful Benefit.

April 24, 2024, follow-on preliminary rVCSS data was presented at the 46th Annual Charing Cross Symposium in London, England.

At a weighted

average subject follow-up of 11.64 months, the average improvement among the Clinical Meaningful Benefit (≥ 3 point rVCSS improvement)

patient cohort was 8.46 points, including 9.29 points for patients at the two-year milestone, 8.08 points for patients at the one-year

milestone, and 8.71 points for patients at the six-month milestone.

All rVCSS evaluations were based on the patient’s most recent

clinical visit, compared to baseline.

Overall, 94% of the study patients receiving the VenoValve showed clinical improvement as measured

by rVCSS, at a weighted-average patient follow-up of 11.04 months for the clinical improvement cohort, and 72% of the study patients

improved the three or more rVCSS points needed to demonstrate the VenoValve’s Clinical Meaningful Benefit, at a weighted-average

patient follow-up of 11.64 months for the Clinical Meaningful Benefit cohort.

Total patient follow-up was 762 months for the clinical

improvement cohort and 582 months for the Clinical Meaningful Benefit cohort.

June 21, 2024, the Company presented data showing significant improvement for patients with venous ulcers enrolled in the SAVVE study

at the Society for Vascular Surgery 2024 Vascular Annual Meeting in Chicago.

The data presented included twenty-one venous ulcer patients

who had reached their one-year milestone, representing thirty venous ulcers.

Overall, 91% of venous ulcer patients evaluated at one year

either had fully healed ulcers or ulcers that had improved.

Of that group, 100% of venous ulcers with a duration of one year or less

prior to VenoValve surgery were fully healed, with the majority (67%) fully healed 90 days after VenoValve surgery.

For those with venous

ulcers with a duration of more than one year prior to VenoValve surgery, 89% were either fully healed or improved at one year, representing

a decrease in average of total ulcers of 85%.

In addition, none of the patients with a fully healed venous ulcer had experienced an ulcer

FDA has indicated that one-year data on all patients will be necessary prior to completing the application seeking

pre-market approval (“PMA”) for the VenoValve.

On August 14, 2024, the Company announced it had filed and the FDA had approved four of the required five modules

of its PMA application.

The Company expects to file the fifth and final module of its PMA application in Q4 of

September 21, 2022, we announced the development of a non-surgical transcatheter based replacement venous valve called enVVe®, for

the treatment of CVI of the deep veins of the leg.

enVVe is designed to be delivered into the femoral vein of the patient via a minimally invasive

procedure requiring no general anesthesia and no overnight hospital stay.

Due to the minimally invasive nature of the procedure, we expect

to be able to reach patients with less severe CVI or who may otherwise be poor candidates for a surgical device, and estimate the U.S.

market for enVVe to be approximately 3.5 million patients.

On October 28,

2024, we announced the successful start to a six-month pre-clinical GLP study for enVVe.

The first wave of implants, for the

long-term subjects, was successfully completed, with the final wave for the shorter-term subjects scheduled for December.

study is a prerequisite to seeking IDE approval from the FDA to begin the enVVe U.S.

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

pivotal study.

The Company expects to file for IDE approval for the enVVe pivotal study in mid 2025.

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.

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.

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

The VenoValve is designated as

a breakthrough product and, as a result, its PMA application is subject to priority review.

This may serve to shorten the PMA review

Regardless, it is difficult to predict precisely how long the PMA process will take, and the Company’s best estimate is

to expect an FDA decision during the second half of 2025.

September 21, 2022, we announced the development of a non-surgical transcatheter based replacement venous valve called enVVe ® ,

for the treatment of CVI of the deep veins of the leg.

Initial preliminary bench testing and pre-clinical testing for enVVe have been

successfully completed.

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.

pivotal study.

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

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

September 30, 2024.

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.

March 31, 2025.

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

1 unchanged sentence

trials and work toward bringing our product candidates to market.

September 30, 2024, we closed a public offering raising approximately $13.6 million net cash proceeds.

Based on management’s

current expectations, this capital has the potential to fund the Company through several significant milestones, including the anticipated FDA pre-market approval of the VenoValve, the beginning of preparations for

VenoValve commercialization, and the initial stages of the pivotal trial for enVVe.

Although we expect our quarterly cash burn rate will increase over time to support these milestones, after the additional

proceeds from our offering, we believe we have sufficient cash to fund operations past what we expect will be regulatory approval of

the VenoValve and the start of the enVVe pivotal trial.

of the three months ended September 30, 2024 and 2023

reported net losses of $5.6 million and $5.0 million for the three months ended September 30, 2024 and 2023, respectively, representing

an increase in net loss of $0.6 million or 12%, due to an increase in operating expenses of $0.8 million, and an increase in other income

of $0.2 million.

a developmental stage Company, we are not currently generating revenue and our future revenue, if any, is expected to be diminutive in

the near future and dependent on our ability to commercialize our product candidates.

and Development Expenses

the three months ended September 30, 2024, research and development expenses increased by $0.1 million or 2%, to $2.9 million from $2.8

million for the three months ended September 30, 2023.

This increase primarily resulted from $0.2 million in increased personnel costs

to support the SAVVE study and enVVe development, partially offset by a $0.1 million decrease in lab costs.

General and Administrative Expenses

the three months ended September 30, 2024, selling, general and administrative expenses increased by $0.7 million or 27%, to $3.3

million from $2.6 million for the three months ended September 30, 2023.

This increase was due to a $0.2 million increase in

consulting expense related to market research for the Company’s products, and a $0.7 million increase in legal costs,

partially offset by a $0.1 million decrease in share-based compensation, and a $0.1 million decrease in travel expenses due to full

enrollment of the SAVVE study during 2023 resulting in less travel to study sites in 2024.

the three months ended September 30, 2024, other income increased $0.2 million or 52.0% to $0.5 million from $0.3 million for the three

months ended September 30, 2023.

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 nine months ended September 30, 2024 and 2023

reported net losses of $15.6 million and $17.9 million for the nine months ended September 30, 2024 and 2023, respectively, representing

a decrease in net loss of $2.3 million, or 13%, due to a decrease in operating expenses of $1.8 million, and an increase in other income

of $0.4 million.

a developmental stage Company, we are not currently generating revenue and our future revenue, if any, is expected to be diminutive in

the near future and dependent on our ability to commercialize our product candidates.

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.

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.

and Development Expenses

the nine months ended September 30, 2024, research and development expenses decreased by $1.9 million or 18%, to $8.7 million from $10.6

million for the nine months ended September 30, 2023.

decrease resulted from a $2.7 million reduction in costs related the SAVVE study as it reached full enrollment during the 2023 period

requiring less study related enrollment activity during the 2024 period, partially offset by $0.8 million higher compensation cost due

to increases in staffing.

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.

General and Administrative Expenses

the nine months ended September 30, 2024, selling, general and administrative expenses of $8.4 million

were flat when compared to the nine months ended September 30, 2023.

This is due to $1.0 million in lower share-based compensation

from the reduction in expense from grants made during 2021, the cost for portions of which have been fully recognized, a $0.1 million

decrease in travel expenses due to full enrollment of the SAVVE study during 2023 resulting in less travel to study sites in 2024, partially

offset by $0.8 million in higher legal cost and a $0.3 million increase in consulting expense related to market research for the Company’s

the nine months ended September 30, 2024, other income increased $0.4 million to $1.5 million from $1.1 million for the nine months ended

September 30, 2023.

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

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.

and Capital Resources

the nine-months ended September 30, 2024, the Company incurred a net loss of $15.6 million and used $11.7 million cash in operating activities.

Net cash used in operating activities for the period ended September 30, 2024 decreased by $2.2 million from $13.9 million for the period

ended September 30, 2023.

losses and the uses of cash are primarily due to the Company’s administrative and product research and development activities.

Administrative functions relate to costs to support the Company’s public reporting and investor relations activities, readying for commercial development of its lead product candidate in the event of receiving PMA approval from the

internal administrative functions.

Research and development activities are for continued product development and clinical trials for

our product candidates, currently the VenoValve® and 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.

Although we have discretion in how we use the Company’s

cash resources, we expect to continue these activities for the foreseeable future as we seek to develop and obtain regulatory approval

for our product candidates.

We are not currently generating revenue and do not expect significant revenue until we successfully commercialize

one or more of our product candidates.

cash flows from investing activity consist of maturities and purchases of US Treasury bills from our program to invest excess cash, and

purchases of property and equipment for our lab and offices.

During the nine months ended September 30, 2024 we purchased $33.4 million

of treasury bills and $45.8 million of them matured generating $1.4 million in realized gains and interest income.

We expect to continue

investing as the treasury bills mature and as allowed by the cash requirements of our operations.

In the nine months ended September

30, 2024, our purchases of property and equipment consisting primarily of lab and test equipment, were less than $0.1 million.

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

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

candidates after receiving FDA approval, if ever.

do not currently have material commitments for capital expenditures or other expenditures except for our facility lease commitment of

$0.4 million per year.

However, we expect a modest increase in purchases of property and equipment as we continue SAVVE, plan for commercialization

of the VenoValve and continue development of enVVe.

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

We have historically funded our operations through financing activities.

On September 30, 2024, we closed an offering issuing stock

and warrants and raising approximately $13.6 million net cash proceeds.

Based upon our cash and working capital as of September 30, 2024

we have sufficient capital resources to meet our obligations as they become due for at least one year after the date of this Report and

sustain operations, although we expect to continue incurring losses for the foreseeable future and may need to raise additional capital

to sustain our operations, pursue our product development initiatives and penetrate markets for the sale of our products.

Any inability

to raise additional financing in the foreseeable future would have a material adverse effect on us.

of October 28, 2024, we had cash and investments of $47.1 million.

However, we expect a modest increase in purchases of property and equipment as we continue clinical studies, plan

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.

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

additional capital in the future.

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

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.

Sheet Arrangements

a smaller reporting company, we are not required to provide the information requested by paragraph (a)(5) of this Item.

Accounting Policies and Estimates

a description of our critical accounting policies, see Note 3 – Significant Accounting Policies in Part 1, Item 1 of this Quarterly

Report on Form 10-Q.

Quantitative and Qualitative Disclosure About Market Risk

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Item 2. Management’s Discussion and Analysis