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Item 2. Management’s Discussion and Analysis

2024-07-31 compared with 2024-05-08 · 217 added, 188 removed, 103 unchanged (80% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

following discussion should be read in conjunction with our unaudited condensed financial statements and notes thereto included

In connection with, and because we desire to take advantage of, the “safe harbor” provisions of the Private

Securities Litigation Reform Act of 1995, we caution readers regarding certain forward-looking statements in the following

discussion and elsewhere in this Quarterly Report and in any other statement made by, or on our behalf, whether or not in future

filings with the Securities and Exchange Commission.

Forward-looking statements are statements not based on historical information

and which relate to future operations, strategies, financial results or other developments.

Such forward-looking statements involve

significant risks and uncertainties.

Forward looking statements are necessarily based upon estimates and assumptions that are

inherently subject to significant business, economic and competitive uncertainties and contingencies, many of which are beyond our

control and many of which, with respect to future business decisions, are subject to change.

These uncertainties and contingencies

can affect actual results and could cause actual results to differ materially from those expressed in any forward-looking statements

made by, or on our behalf.

Words such as “anticipate,” “estimate,” “plan,”

“continuing,” “ongoing,” “expect,” “believe,” “intend,”

“may,” “will,” “should,” “could,” and similar expressions are used to identify

forward-looking statements.

Such forward-looking statements also involve other factors which may cause our actual results,

performance or achievements to materially differ from any future results, performance, or achievements expressed or implied by such

forward-looking statements and to vary significantly from reporting period to reporting period.

Although management believes that

the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no assurance that the

underlying assumptions will, in fact, prove to be correct or that actual future results will not be different from the expectations

expressed in this Quarterly Report.

We undertake no obligation to publicly update any forward-looking statements, whether as a

result of new information, future events or otherwise, except as required by applicable law.

following discussion should be read in conjunction with our unaudited condensed financial statements and notes thereto included herein.

In connection with, and because we desire to take advantage of, the “safe harbor” provisions of the Private Securities Litigation

Reform Act of 1995, we caution readers regarding certain forward-looking statements in the following discussion and elsewhere in this

Quarterly Report and in any other statement made by, or on our behalf, whether or not in future filings with the Securities and Exchange

Forward-looking statements are statements not based on historical information and which relate to future operations, strategies,

financial results or other developments.

Such forward-looking statements involve significant risks and uncertainties.

Forward looking

statements are necessarily based upon estimates and assumptions that are inherently subject to significant business, economic and competitive

uncertainties and contingencies, many of which are beyond our control and many of which, with respect to future business decisions, are

subject to change.

These uncertainties and contingencies can affect actual results and could cause actual results to differ materially

from those expressed in any forward-looking statements made by, or on our behalf.

Words such as “anticipate,” “estimate,”

“plan,” “continuing,” “ongoing,” “expect,” “believe,” “intend,”

“may,” “will,” “should,” “could,” and similar expressions are used to identify forward-looking

Such forward-looking statements also involve other factors which may cause our actual results, performance or achievements

to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements and

to vary significantly from reporting period to reporting period.

Although management believes that the assumptions made and expectations

reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove

to be correct or that actual future results will not be different from the expectations expressed in this Quarterly Report.

no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise,

except as required by applicable law.

the context requires otherwise, references in this document to “NVNO”, “we”, “our”, “us”

or the “Company” are to enVVeno Medical Corporation

enVVeno Medical Corporation

is a late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve

the standard of care for the treatment of venous disease.

Chronic Venous Disease (“CVD”) is the world’s most prevalent chronic disease,

impacting approximately 70% of the adult population of the U.S.

Chronic Venous Insufficiency (“CVI”), is a large subset of CVD, which most

often occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling

in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult

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.

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).

To date, patients in our SAVVE trial have

indicated in testimonials to the Company that they have experienced reduced pain and enhanced quality of life as a result of the VenoValve.

Company is also developing a second product called enVVe®, which is a potential first-in-class, non-surgical, transcatheter

based replacement venous valve system consisting of the enVVe valve, the enVVe delivery system, and the delivery system accessories.

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 (the Transcatheter Anti-Thrombotic, Venous Valve Endoprosthesis or TAVVE) in Q2 of 2025.

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

To date, patients

in our SAVVE trial have indicated in testimonials to the Company that they have experienced reduced pain and enhanced quality of life

as a result of the VenoValve.

Company is also developing a second product called enVVe®, which is a potential, non-surgical, transcatheter based

replacement venous valve system consisting of the enVVe valve, the enVVe delivery system, and the delivery system accessories.

is conducting pre-clinical testing on enVVe and currently expects to be ready to file for IDE approval for the enVVe pivotal trial (the

Transcatheter Anti-Thrombotic, Venous Valve Endoprosthesis or TAVVE) in Q2 of 2025.

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”).

We expect the VenoValve to

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

If approved, we expect the VenoValve and enVVe to co-exist,

with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option, although

we cannot provide any assurance that either the VenoValve or enVVe will receive approval from the FDA.

There are currently no devices approved as surgical or non-surgical replacement venous

valves, and there are currently no effective treatments for deep venous CVI caused by incompetent valves.

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

If approved, we expect the VenoValve and enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and

enVVe as a non-surgical replacement venous valve option, although we cannot provide any assurance that either the VenoValve or enVVe

will receive approval from the FDA.

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

and there are currently no effective treatments for deep venous CVI caused by incompetent valves.

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

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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.

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.

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

CVI is 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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has been estimated to exceed $3 billion a year.

VenoValve is a porcine based 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

VenoValve is a porcine based 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.

The VenoValve has been granted

Breakthrough Device designation by the FDA.

Clinical Status

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from the one year first-in-human study were presented at the Charing Cross International Symposium in April of 2021.

eleven (11) patients in the study, revised Venous Clinical Severity Scores (rVCSS) scores improved an average of 6 points, and

patients also experienced significant improvements in pain (measured via visual analog scale (“VAS”) scores), and

quality of life (measured by Veines sym/qol) all at one (1) year when compared to pre-surgery levels.

Revised Venous Clinical

Severity Scoring (rVCSS) is a validated measurement commonly used to objectively assess outcomes in the treatment of venous disease,

and include ten characteristics consisting of physician assessments and patient reported outcomes including pain, inflammation, skin

changes such as pigmentation and induration, the number of active ulcers, and ulcer duration.

The improvement in VCSS scores was

significant and indicates the VenoValve patients who had severe CVI pre-surgery, had mild CVI or the complete absence of disease at

one-year post surgery.

Related safety incidences during the one year first-in-human study for the VenoValve included one (1)

surgical pocket hematoma (anti-coagulation related bleeding outside of the target vein within the surgical cavity), which was

aspirated, intolerance from Coumadin anticoagulation therapy, three (3) minor wound infections (treated with antibiotics), and one

occlusion due to patient non-compliance with anti-coagulation therapy.

the end of the VenoValve first-in-human study, eight (8) study participants agreed to additional monitoring.

In November of 2022, three-year,

positive follow-up data was presented for this cohort of patients at the 49th Annual VEITH Symposium in New York city, showing that patients continued to experience the benefits from the VenoValve

reported at one (1) year.

Among the eleven

(11) patients in the study, revised Venous Clinical Severity Scores (rVCSS) scores improved an average of 6 points, and patients also

experienced significant improvements in pain (measured via visual analog scale (“VAS”) scores), and quality of life (measured

by Veines sym/qol) all at one (1) year when compared to pre-surgery levels.

Revised Venous Clinical Severity Scoring (rVCSS) is a validated

measurement commonly used to objectively assess outcomes in the treatment of venous disease, and include ten characteristics consisting

of physician assessments and patient reported outcomes including pain, inflammation, skin changes such as pigmentation and induration,

the number of active ulcers, and ulcer duration.

The improvement in VCSS scores was significant and indicates the VenoValve patients

who had severe CVI pre-surgery, had mild CVI or the complete absence of disease at one-year post surgery.

Related safety incidences during

the one year first-in-human study for the VenoValve included one (1) surgical pocket hematoma (anti-coagulation related bleeding outside

of the target vein within the surgical cavity), which was aspirated, intolerance from Coumadin anticoagulation therapy, three (3) minor

wound infections (treated with antibiotics), and one occlusion due to patient non-compliance with anti-coagulation therapy.

Three (3) year results from eight (8) first-in-human study participants

who agreed to additional monitoring were presented at the February 2023 annual meeting of the American Venous Forum in San Antonio, Texas.

Patients continued to show significant clinical improvement (average 8 point rVCSS improvement compared to baseline) at three (3) years

post-VenoValve surgery, with no venous ulcer recurrences for C6 patients.

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 at 21 U.S.

endpoints for the SAVVE pivotal study include rVCSS scores, which will be 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

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.

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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

Full enrollment occurred approximately four (4) months earlier than expected due to increased demand for the

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.

Full enrollment occurred approximately four (4) months earlier than expected due to increased demand for

the VenoValve.

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 (8%).

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.

In 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.

The bleeds and wound infections were acute in nature and had no lasting negative impact on patient

health or clinical outcomes.

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

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Meaningful Benefit.

On 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.

patient follow-up was 762 months for the clinical improvement cohort and 582 months for the Clinical Meaningful Benefit cohort.

the FDA indicating that one-year data for all 75 patients will be necessary prior to the filing of the application seeking

pre-market approval (“PMA”) for the VenoValve, the Company expects to file the PMA application seeking approval in Q4 of

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

the FDA indicating that one-year data for all 75 patients will be necessary prior to the filing of the application seeking pre-market

approval (“PMA”) for the VenoValve, the Company expects to file the PMA application seeking approval in Q4 of 2024.

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.

The enVVe system consists of the enVVe replacement venous valve, the

enVVe delivery system, and the delivery system accessories.

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 enVVe system consists of the enVVe replacement venous valve, the enVVe delivery

system, and the delivery system accessories.

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.

bench testing and acute pre-clinical testing for the enVVe valve were very successful.

Adjustments to make it easier to load the

enVVe valve into the enVVe delivery system are being finalized and the Company is currently manufacturing the necessary enVVe valves

and enVVe delivery systems to begin a six-month chronic GLP study, which the Company expects to start in Q3 of 2024.

The GLP study

should be the final step necessary before filing for IDE approval to begin the enVVe pivotal study, which the Company expects to

file in Q2 of 2025.

Adjustments to make it easier to load the enVVe

valve into the enVVe delivery system are being finalized and the Company is currently manufacturing the necessary enVVe valves and enVVe

delivery systems to begin a six-month chronic GLP study, which the Company expects to start in Q4 of 2024.

The GLP study should be the

final step necessary before filing for IDE approval to begin the enVVe pivotal study, which the Company expects to file in Q2 of 2025.

finished 2023 with approximately $46.4 million of cash and investments and had approximately $39.1 million of cash and investments at

March 31, 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.

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.

June 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.

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.

of Operations

of the three months ended March 31, 2024 and 2023

reported net losses of $5.0 million and $6.4 million for the three months ended March 31, 2024 and 2023, respectively, representing a

decrease in net loss of $1.4 million, or 22%, resulting from a decrease in operating expenses and an increase in other income.

of the three months ended June 30, 2024 and 2023

reported net losses of $5.0 million and $6.5 million for the three months ended June 30, 2024 and 2023, respectively, representing a

decrease in net loss of $1.5 million, or 23.1%, resulting from a decrease in operating expenses and an increase in other income, 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

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and Development Expenses

the three months ended March 31, 2024, research and development expenses decreased by $0.5 million or 14%, to $3.1 million from $3.6

million for the three months ended March 31, 2023.

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

SAVVE study as the study was fully enrolled during 2023 resulting in the reduction of outreach and enrollment related activities and

the three months ended June 30, 2024, research and development expenses decreased by $1.4 million or 33.3%, to $2.8 million from $4.2

million for the three months ended June 30, 2023.

This decrease primarily resulted from $1.7 million in lower costs related the SAVVE

study as the study was fully enrolled during 2023 resulting in the reduction of outreach and enrollment related activities and related

costs, partially offset by a $0.3 million increase in personnel costs to support the SAVVE study and enVVe

General and Administrative Expenses

the three months ended June 30, 2024, selling, general and administrative expenses were $2.6 million, flat from the three months ended

June 30, 2023, which was also $2.6 million.

This was due to the net effect of a $0.1 million decrease in share-based compensation,

offset by a $0.1 million increase in legal costs.

For the three months ended June 30, 2024, other income increased $0.1 million

or 25.0% to $0.5 million from $0.4 million for the three months ended June 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 six months ended June 30, 2024 and 2023

We reported net losses of $10.0 million and $12.9 million for the six months

ended June 30, 2024 and 2023, respectively, representing a decrease in net loss of $2.9 million or 22.5%, due to a decrease in operating

expenses of $2.6 million and an increase in other income of $0.3 million.

and Development Expenses

the six months ended June 30, 2024, research and development expenses decreased by $1.9 million or 24.4%, to $5.9 million from $7.8

million for the six months ended June 30, 2023.

This decrease resulted from $2.6 million in lower costs related the SAVVE study as

it was fully enrolled during 2023 resulting in the elimination of costs related to enrolling patients in the study, partially

offset by a $0.6 million increase in personnel costs due to increased payments to additional staff to support ENVVE product development and the SAVVE study, and $0.1 million in higher lab

related costs.

This decrease was offset by a $0.3 million increase in personnel costs to support the SAVVE study and enVVe

development, and $0.2 million in lab costs related to enVVe development.

General and Administrative Expenses

the three months ended March 31, 2024, selling, general and administrative expenses decreased $0.7 million or 22%, to $2.5 million

from $3.2 million for the three months ended March 31, 2023.

The decrease was due to a decrease in share based compensation, which

decreased to $1.2 million in 2024 from $1.9 million in 2023, primarily because of the decrease in the expense associated with grants

made in 2021, which was $0.7 million lower in 2024 than in 2023.

the three months ended March 31, 2024, other income increased $0.1 million or 25% to $0.5 million from $0.4 million for the three months

ended March 31, 2023.

the six months ended June 30, 2024, selling, general and administrative expenses decreased $0.7 million or 12.1%, to $5.1 million from

$5.8 million for the six months ended June 30, 2023.

Of this decrease, $0.9 million was due to share based compensation from grants made

during 2021 because the expense related to portions of grants made during 2021 has been fully amortized and subsequent grants have been

of lower value.

This decrease in stock-based compensation expense was partially offset by a $0.2 million increase in legal costs.

(Income) Expense

the six months ended June 30, 2024, other income increased $0.3 million to $1.0 million from $0.7 million for the six months ended

June 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.

excess cash in U.S.

and Capital Resources

the three-months ended March 31, 2024, the Company incurred losses from operations of $5.5 million and used $3.6 million cash in operating

The net cash used in operating activities during the 2024 period decreased by $1.5 million from $5.1 million for the quarter

ended March 31, 2023.

the six-months ended June 30, 2024, the Company incurred a net loss of $9.9 million and used $7.5 million cash in operating

The net cash used in operating activities during the 2024 period decreased by $2.2 million from $9.7 million for the six

months ended June 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 as well

as 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, and anticipates these

costs will increase, as the Company works to complete

its clinical trials, enhance products, develop new products, bring those products to market, and operate as a public company.

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

product candidates.

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 the SAVVE study,

plan for commercialization of the VenoValve and continue development of enVVe.

Administrative functions relate to costs to support the Company’s public reporting and investor relations activities as well as

internal administrative functions.

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

our product candidates, currently the VenoValve and enVVe.

The Company will continue to incur these costs, and expects costs will increase,

as the Company works to complete its clinical trials, enhance products, develop new products, expand its organization to bring those

products to market, and operate as a public company.

We are not currently generating revenue and do not expect significant revenue until

we successfully commercialize one or more of our product candidates.

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 the SAVVE study, 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 trials

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.

have historically funded our operations through financing activities, such as the capital raise completed in 2023, 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, 2024, we have sufficient capital resources to meet our obligations as they become due

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.

have historically funded our operations through financing activities 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 June 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 Quarterly Report and sustain operations.

5 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