What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-10-26 compared with 2023-07-31 · 192 added, 202 removed, 125 unchanged (76% 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 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

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

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.

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 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.

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

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.

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 waiting for regulatory approval to begin a first-in-human study

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.

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.

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

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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.

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.

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

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.

In addition to providing safety and efficacy data, 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 SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S.

Endpoints for the VenoValve first-in-human study included safety (device related adverse events), reflux, measured by Duplex Ultrasound,

a rVCSS score used by the clinician to measure disease severity and progress, 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.

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.

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

Among the eleven

(11) patients in the study, reflux 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 commonly used by clinicians in practice and in clinical trials 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.

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

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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.

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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.

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 SAVVE study, a prospective, non-blinded, single

arm, multi-center study of seventy-five (75) CVI patients to be enrolled at up to 20 U.S.

We later received permission from the

FDA to increase the number of clinical sites to up to 30.

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 at the 49th Annual VEITH Symposium in New York city for this cohort of patients.

That data indicated no

recurrences of the severe CVI that was present pre-VenoValve, including no ulcer recurrences for those patients who had venous ulcers

(C6 patients) prior to receiving the VenoValve.

There were no reported safety issues from the end of one (1) year first-in-human study

to the end of the three (3) year reporting period.

In addition, the patients continued to show improvements compared to pre-surgery levels,

reporting 62%, 64%, and 84%, average improvements in reflux, VCSS, and VAS scores, respectively, at an average of three (3) years post

VenoValve surgery.

One deep vein thrombosis (DVT) occurred between year 2 and year 3 due to patient non-compliance with anti-coagulation

In addition to presenting at leading academic and vascular conferences around the world, results from the VenoValve first-in-human

study and following observational period have been published in the Journal of Vascular Surgery Venous and Lymphatic Disorders ,

the Journal of Vascular and Endovascular Surgery , and JAMA Surgery Journal.

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.

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.

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 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

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

mass resignations and continuing turnover of healthcare workers following the COVID-19 pandemic continues to put an enormous strain

on hospital resources, including their clinical staffing and research capabilities These factors impact the rate at which clinical

trials such as SAVVE enroll and progress.

We have taken several steps to help address the hospital staffing shortages, including our

hiring of 4 Clinical Technologists, with extensive and specialized experience in duplex sonography of the deep venous system, to

assist in training site personnel, proctoring Duplex Ultrasound examinations, and providing assistance for the SAVVE

On July 5, 2023 we announced that that we have enrolled 57 subjects in the SAVVE trial and that we expect to achieve

full enrollment (75 subjects) by the end of 2023.

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.

Preliminary bench testing and animal testing for enVVe were completed before our

announcement.

We have filed an application seeking approval to begin an early feasibility study for enVVe.

The trial will be

known as the Transcatheter Anti-reflux, Venous Valve Endoprosthesis early feasibility study (TAVVE-EFS) study.

The initial phase of the TAVVE-EFS

study will seek to enroll 3 to 5 patients across multiple sites.

parameters will be evaluated over the course of the study including safety and technical success of the enVVe venous valve delivery

system, and the safety and clinical performance of the enVVe venous valve.

enVVe is 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 the U.S.

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

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

market for enVVe to be approximately 3.5 million patients.

finished 2022 with approximately $39.1 million of cash and investments and had approximately $25.7 million of cash and investments at

June 30, 2023.

At our existing cash burn rate of approximately $4 - 5 million per quarter, we should have sufficient cash to fund operations

through the end of 2024 and into 2025.

With primary endpoints following full enrollment in the SAVVE pivotal trial of thirty (30) days

for safety, and six (6) months for effectiveness, we expect to have primary endpoint data well in advance of the need to raise additional

of Operations

of the three months ended June 30, 2023 and 2022

reported net losses of $6.5 million and $7.1 million for the three months ended June 30, 2023 and 2022, respectively, representing a

decrease in net loss of $0.6 million, or 8%, 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.

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 June 30, 2023, selling, general and administrative expenses decreased by $1.3 million or 33%, to $2.6 million

from $3.9 million for the three months ended June 30, 2022.

This decrease was due to a $1.2 million decrease in share-based compensation,

and a $0.1 million decrease in professional fees.

Share-based compensation decreased because the expense related to portions of grants

made during 2021 has been fully amortized and subsequent grants have been of smaller value.

remaining $0.1 million decrease results mainly from reductions in legal and accounting fees during the 2023 period.

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

and Development Expenses

the three months ended June 30, 2023, research and development expenses increased by $1.1 million or 35%, to $4.2 million from $3.1 million

for the three months ended June 30, 2022.

This increase primarily resulted from $1.0 million in costs related the SAVVE study, $0.1 million

increase in personnel costs due to additional staff, and $0.1 million in travel costs, both mainly to support the SAVVE, partially offset

by a decrease of $0.1 million in lab costs for VenoValve® continued development.

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 June 30, 2023, other (income) expense increased $0.4 million from $0.1 million in net expense for the three

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

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 June 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 six months ended June 30, 2023 and 2022

reported net losses of $12.9 million and $12.4 million for the six months ended June 30, 2023 and 2022, respectively, representing an

increase in net loss of $0.5 million or 4%, due to an increase in operating expenses of $1.3 million partially offset by an increase

in net other income and expense of $0.8 million.

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.

General and Administrative Expenses

the six months ended June 30, 2023, selling, general and administrative expenses decreased $1.9 million or 25%, to $5.8 million from

$7.7 million for the six months ended June 30, 2022.

Of this decrease, $1.6 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 smaller value.

remaining $0.3 million decrease in expenses is attributable to $0.1 million from lower legal costs mainly related to intellectual property,

$0.1 million from lower Delaware franchise taxes in 2023, and $0.1 million from lower insurance costs related to decreased cost for D&O

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 six months ended June 30, 2023, research and development expenses increased by $3.1 million or 66%, to $7.8 million from $4.7

million for the six months ended June 30, 2022.

This increase primarily resulted from $2.7 million in costs related the SAVVE study,

$0.5 million increase in personnel costs due to additional staff, and $0.1 million in travel costs to support the SAVVE study,

partially offset by $0.2 million lower lab related costs.

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 six months ended June 30, 2023, other (income) expense increased $0.8 million to $0.7 million net other income from $0.1 million

net other expense for the six months ended June 30, 2022.

Other (income) expense is related to interest income and realized and

unrealized (gain)/loss from investments reflecting the Company’s investment activities in US Treasuries and reflects realized

gains, interest income and unrealized gains and losses resulting from changes in market value of the US Treasuries purchased by the

The increase reflects higher yields realized for the six months ended June 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 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.

and Capital Resources

the six-months ended June 30, 2023, the Company incurred a net loss of $12.9 million and used $9.7 million cash in operating

Net cash used in operating activities for the period ended June 30, 2023 period increased by $2.4 million from $7.3

million for the period ended June 30, 2022.

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.

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

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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.

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

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purchases of property and equipment for our lab and offices.

During the six months ended June 30, 2023 we purchased $15.1 million of

treasury bills and $25.0 million of them matured generating $0.3 million in realized gains and interest income.

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 six months ended June 30, 2023,

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.

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of the VenoValve and continue development of enVVe.

Company has historically funded its operations through financing activities such as the capital raises completed in 2021.

investments balances as of June 30, 2023, were $4.7 million and $25.0 million, respectively.

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 to market.

At our existing cash burn rate of approximately $4 - 5 million per quarter, we

should have sufficient cash to fund operations through the end of 2024 and into 2025.

With primary endpoints following full enrollment

in the SAVVE pivotal trial of thirty (30) days for safety, and six (6) months for effectiveness, we expect to have primary endpoint data

well in advance of the need to raise additional capital.

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

upon our cash and working capital as of June 30, 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.

of July 27, 2023, we had a cash and investment balances of $3.5 million and $25.1 million, respectively.

mass resignations and continuing turnover of healthcare workers following the COVID-19 pandemic continues to put an enormous strain

on hospital resources including their clinical staffing and research capabilities.

These factors impact the rate at which clinical

trials such as SAVVE enroll and progress.

We have taken several steps to help address the hospital staffing shortages, including our

hiring of 4 Clinical Technologists, with extensive and specialized experience in duplex sonography of the deep venous system, to

assist in training site personnel, proctoring Duplex Ultrasound examinations, and providing assistance for the SAVVE

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.

Sheet Arrangements

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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