What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-05-08 compared with 2023-10-26 · 203 added, 229 removed, 88 unchanged (83% of the section changed)

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

discussion and elsewhere in this 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.

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

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made by, or on our behalf.

Such statements include, without limitation, statements related to the exercise of the warrants issued in

our recent private placement transaction and receipt the proceeds therefrom, our ability to utilize cash on hand (including the

funds from our recent private placement) to fund operations well past several significant milestones, our ability to achieve the

various milestones indicated herein and other statements identified by 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

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

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.

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

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 71% 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 first-in-class surgical replacement venous valve that is currently

being evaluated in a U.S.

pivotal study.

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

first-in-class, non-surgical, transcatheter based replacement venous valve.

The Company is currently conducting pre-clinical testing

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.

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.

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

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

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We expect the VenoValve to

be eligible for FDA approval first, followed two to three years later by enVVe.

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 (see the section entitled “Risk

Factors” in our Annual Report on Form 10-K).

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

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have been commercially successful.

We develop and manufacture our products 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

We develop and manufacture both the VenoValve and EnVVe 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 generally classified using a standardized

CVD is clinically classified using a standardized

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

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

at night, prevents patients from getting adequate sleep.

Severe CVI sufferers are known to miss approximately 40% more workdays than

the average worker.

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.

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

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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 reducing reflux and 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 with severe deep venous CVI in the U.S.

would be candidates for 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

would be candidates for the VenoValve.

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

Clinical Status

consultation with the FDA, and as a precursor to the U.S.

pivotal trial, in 2020 we conducted a small first-in-human study for the

VenoValve in Colombia which included eleven (11) patients.

The purpose of the first-in-human study was to provide proof of concept,

and to provide feedback to make any necessary product modifications or adjustments to our surgical implantation procedure for the

VenoValve prior to conducting the VenoValve pivotal trial.

Endpoints for the VenoValve first-in-human study included safety (device

related adverse events), reflux time, measured by Duplex Ultrasound, rVCSS scoring, which is a measurement created by international vascular societies

and is used by the clinician to measure disease progression and regression a VAS score used by the patient to measure pain, and quality of life measurements.

pivotal trial, in 2020 we conducted a small first-in-human study for the VenoValve

in Colombia which included eleven (11) patients.

The purpose of the first-in-human study was to provide proof of concept, and to provide

feedback to make any necessary product modifications or adjustments to our surgical implantation procedure for the VenoValve prior to

conducting the VenoValve pivotal trial.

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, reflux time improved an average of 54%, Venous Clinical Severity Scores (“VCSSs”)

improved an average of 56%, and visual analog scale (VAS) scores, which are used by patients to measure pain, improved an average of

76%, all at one (1) year when compared to pre-surgery levels.

VCSS scores are a validated measurement commonly used to objectively assess outcomes in the treatment of venous disease, and include

ten characteristics including pain, inflammation, skin changes such as pigmentation and induration, the number of active ulcers, and

ulcer duration.

The improvement in VCSS scores is 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.

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

At the end of the VenoValve first-in-human study, eight (8) study participants

agreed to additional monitoring.

In November of 2022, three-year follow-up data was presented for this cohort of patients at the 49th

Annual VEITH Symposium in New York city.

August 3, 2020, we announced that the FDA granted Breakthrough Device Designation status to the VenoValve.

The FDA’s Breakthrough

Devices Program was established to enable priority review for devices that provide more effective treatment or diagnosis of life threatening

or irreversibly debilitating diseases or conditions.

The goal of the FDA’s Breakthrough Devices Program is to provide patients

and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving

the FDA’s mission to protect and promote public health.

March 2021, we submitted an IDE application with the FDA and in April 2021, we received notification from the FDA that our IDE

application was approved.

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.

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

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VenoValve which is called the SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) clinical study.

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

patients to be enrolled at up to 30 U.S.

Efficacy endpoints for the SAVVE pivotal study include rVCSS scores, which

will be used to provide evidence of clinical 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.

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

events including infection and bleeding.

The first patient in the SAVVE pivotal study was enrolled in October of

Following enrollment of the first patient the SAVVE study was delayed due to COVID-19 restrictions.

November of 2022, we announced we had passed a preliminary safety review by the FDA for the first twenty (20) patients enrolled in the

The FDA had requested that we submit preliminary safety data at thirty (30) days post VenoValve® implantation for the

first twenty (20) patients enrolled in the study.

The preliminary safety data included one (1) device related (mild) and two (2) procedure

related (moderate) adverse events.

After review by the FDA, the study was cleared to continue without modification or interruption.

October 6, 2023, we announced we had achieved full enrollment (75 subjects) in the SAVVE trial, 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.

The Company expects to release initial, topline safety data from the SAVVE study in Q4 of 2023, and initial, topline rVCSS efficacy data

from the SAVVE study in Q2 of 2024.

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

of the application seeking pre-market (PMA) approval for the VenoValve, the Company will be eligible 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.

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

been successfully completed.

October 6, 2023, contemporaneously with the announcement of a Twenty-eight-million-dollar

capital raise, we announced plans to expedite the development of enVVe.

The Company expects to begin

a six (6) month GLP animal study for enVVe in the first quarter of 2024 and to be ready to file for IDE approval for the enVVe pivotal

trial by the end of 2024.

enVVe is delivered into the femoral vein of the patient via a minimally

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

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

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

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.

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.

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

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 not be good candidates for a surgical device, and estimate

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

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.

finished 2023 with approximately $46.4 million of cash and investments and had approximately $42.9 million of cash and investments at

September 30, 2023.

On October 11, 2023, we

closed an offering raising approximately $25.7 million net cash proceeds.

This financing has the potential to fund the Company

through several significant milestones, including the release of initial topline efficacy data from SAVVE, our anticipated FDA

pre-market approval of the VenoValve, the beginning of preparations for VenoValve commercialization, and accelerated plans for the

pivotal trial for enVVe, our transcatheter based replacement venous valve.

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, 2023 and 2022

reported net losses of $5.0 million and $6.1 million for the three months ended September 30, 2023 and 2022, respectively, representing

a decrease in net loss of $1.1 million or 18%, due to a decrease in operating expenses of $0.8 million, and a net increase in other

income and expense of $0.3 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.

General and Administrative Expenses

the three months ended September 30, 2023, selling, general and administrative expenses decreased by $1.1 million or 30%, to $2.6

million from $3.7 million for the three months ended September 30, 2022.

This decrease was due to share-based

compensation reflecting the reduction in expense from grants made during 2021, the cost for portions of which have been fully

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.

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.

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.

and Development Expenses

the three months ended September 30, 2023, research and development expenses increased by $0.3 million or 12%, to $2.8 million from

$2.5 million for the three months ended September 30, 2022.

This increase primarily resulted from $0.2 million in increased

personnel costs to support the SAVVE study, and $0.1 million in lab costs, also to support the SAVVE study and continued product

(Income) Expense

the three months ended September 30, 2023, other (income) expense increased $0.2 million from $0.1 million in net expense for the three

months ended September 30, 2022 to $0.3 million other income for the three months ended September 30, 2023.

Other (income) expense is

primarily related to interest income and realized gains and unrealized (gain)/loss from investments reflecting the Company’s investment

activities in US Treasuries including realized gains, interest income and unrealized gains and losses resulting from changes in market

value of the US Treasuries purchased by the Company.

The increase reflects higher yields realized for the three months ended September

30, 2023 due to changes in interest rates resulting from recent US Federal Reserve actions.

We expect the market value of these investments

to fluctuate somewhat during their term, however all these Treasuries were purchased to provide a positive yield over their term.

of the nine months ended September 30, 2023 and 2022

reported net losses of $17.9 million and $18.5 million for the nine months ended September 30, 2023 and 2022, respectively, representing

a decrease in net loss of $0.6 million, or 3%, due to a decrease in operating expenses of $0.5 million, and an increase in other income

and expense, net, of $1.1 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.

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

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 nine months ended September 30, 2023, selling, general and administrative expenses decreased $3.0 million or 26%, to $8.4

million from $11.4 million for the nine months ended September 30, 2022.

Of this decrease, $2.7 million was due to a reduction in

share-based compensation reflecting the reduction in expense from grants made during 2021, the cost for portions of which have been

fully recognized.

remaining $0.3 million decrease is attributable to $0.2 million from lower patent related legal costs, and $0.1 million from lower insurance costs related to decreased costs for cyber risk and D&O

insurance premiums driven by an improving insurance market.

and Development Expenses

the nine months ended September 30, 2023, research and development expenses increased by $3.5 million or 49%, to $10.6 million from

$7.1 million for the nine months ended September 30, 2022.

increase primarily resulted from $2.5 million in costs related the SAVVE study, $0.8 million higher compensation cost due to

increases in staffing, $0.2 million in travel cost and $0.1 million in lab costs, both to support the SAVVE study and VenoValve continued

(Income) Expense

the nine months ended September 30, 2023, other (income) expense increased $1.1 million from less than $0.1 million in other

(income) expense for the nine months ended September 30, 2022 to $1.1 million other income for the nine months ended

September 30, 2023.

Other (income) expense is primarily related to interest income and realized gains and unrealized (gain)/loss

from investments reflecting the Company’s investment activities in US Treasuries including realized gains, interest income and

unrealized gains and losses resulting from changes in market value of the US Treasuries purchased by the Company.

reflects higher yields realized for the nine months ended September 30, 2023 due to changes in interest rates resulting from recent

US Federal Reserve actions.

We expect the market value of these investments to fluctuate somewhat during their term, however all

these Treasuries were purchased to provide a positive yield over their term.

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.

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

excess cash in US Treasury bills.

and Capital Resources

the nine-months ended September 30, 2023, the Company incurred a net loss of $17.9 million and used $13.9 million cash in operating activities.

Net cash used in operating activities for the period ended September 30, 2023 increased by $2.1 million from $11.8 million for

the period ended September 30, 2022.

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.

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 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 obtain regulatory approval for our product

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, 2023 we purchased $24.3 million

of treasury bills and $38.6 million of them matured generating $0.5 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, 2023, our purchases of property and equipment consisting primarily of lab and test equipment, were less than $0.1 million.

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

Company has historically funded its operations through financing activities.

On October 11, 2023, we closed an offering issuing

stock and warrants and raising approximately $25.7 million net cash proceeds.

Based upon our cash and working capital as of

September 30, 2023, and after considering the transaction closed on October 11, 2023, 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.

As of October 23, 2023, we had

a cash and investment balances of $1.9 million and $48.6 million, respectively.

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.

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

and related product development costs and our ability to successfully bring products to market.

We anticipate that our cash burn rate

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

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

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

2 unchanged sentences

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What changed 10-Q

Item 2. Management’s Discussion and Analysis