What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-07-31 compared with 2023-04-28 · 134 added, 105 removed, 193 unchanged (55% of the section changed)

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or the “Company” are to enVVeno Medical Corporation.

Medical Corporation is a late clinical-stage med-tech 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.

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

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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).

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

CVI caused by incompetent valves.

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).

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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VenoValve surgery.

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

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.

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.

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

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

widely reported in the media, the lasting impact from the COVID-19 pandemic has put an enormous strain on hospital resources including

their clinical staff.

Hospitals continue to be severely understaffed, which impacts the rate at which clinical trials 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 study.

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.

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

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announcement.

We also filed an application seeking approval to begin a first-in-human (FIH) trial in Columbia.

The trial will be known

as the Transcatheter Anti-reflux, Venous Valve Endoprosthesis first-in-human (TAVVE-FIH) study.

The initial phase of the TAVVE-FIH 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 are otherwise not good candidates for a surgical device, and estimate

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.

market for enVVe to be approximately 3.5 million patients.

finished 2022 with approximately $39.1 million of cash and investments and had approximately $34.2 million of cash and investments

at March 31, 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 capital.

possess an extensive proprietary processing and manufacturing methodology specifically applicable to the design, processing, manufacturing

and sterilization of biologic devices.

This includes FDA compliant quality control and assurance programs, proprietary tissue processing

technologies demonstrated to eliminate recipient immune responses, trusted relationship with abattoir suppliers, and a combination of

tissue preservation and gamma irradiation that enhances device functions and guarantees sterility.

We have filed numerous patent applications

for the VenoValve with the U.S.

Patent and Trademark Office (USPTO) and throughout the world.

We currently have nineteen (19) patents

granted from agencies around the world including five (5) from the USPTO.

finished 2022 with approximately $39.1 million of cash and investments and had approximately $29.8 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 March 31, 2023 and 2022

reported net losses of $6.4 million and $5.3 million for the three months ended March 31, 2023 and 2022, respectively, representing an

increase in net loss of $1.1 million, or 21%, resulting from an increase in operating expenses.

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

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General and Administrative Expenses

the three months ended March 31, 2023, selling, general and administrative expenses decreased by $0.6 million or 16%, to $3.2 million

from $3.8 million for the three months ended March 31, 2022.

Of this decrease, $0.4 million was due to share based compensation, which

decreased to $1.8 million in 2023 from $2.2 million in 2022, primarily because of the timing of vesting of grants made in 2021.

The remaining

$0.2 million decrease reflects $0.1 million from lower Delaware franchise taxes in 2023, and $0.1 million from lower outside services

cost related to investor relations and our website update.

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.

and Development Expenses

the three months ended March 31, 2023, research and development expenses increased by $2.0 million or 125%, to $3.6 million from

$1.6 million for the three months ended March 31, 2022.

This increase primarily resulted from $1.6 million in costs related the

SAVVE study, $0.3 million increase in lab and personnel costs to support the VenoValve pivotal trial and enVVe development, and $0.1

million in travel costs, also related to the SAVVE study.

the three months ended March 31, 2023, other income was $0.4 million compared to nil in 2022.

Other income in 2023 reflects interest,

realized gains and unrealized gains from our program to invest excess cash in US Treasury bills, which we had not yet commenced during

the three months ended March, 31, 2022.

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.

(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.

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.

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

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.

(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.

and Capital Resources

the three-months ended March 31, 2023, the Company incurred losses from operations of $6.8 million and used $5.1 million cash in operating

The net cash used in operating activities during the 2023 period increased by $1.8 million from $3.3 million for the quarter

ended March 31, 2022.

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.

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 candidates.

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

we successfully commercialize one or more of our product candidates.

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

and purchases of property and equipment for our lab and offices.

During the quarter ended March 31, 2023 we purchased $8.6 million of treasury bills and $11.5 million of them matured generating $0.1

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 quarter ended March 31, 2023,

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 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.

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,

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

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.

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.

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

investments balances as of March 31, 2023, were $2.3 million and $31.9 million, respectively.

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

Our future capital requirements will remain

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

upon our cash and working capital as of March 31, 2023, we have sufficient capital resources to meet our obligations as they become due

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 April 26, 2023, we had a cash and investment balances of $2.8 million and $31.0 million, respectively.

The lasting impact from the COVID-19 pandemic has put an enormous strain on hospital resources including

their clinical staff.

Hospitals continue to be severely understaffed, which impacts the rate at which clinical trials 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 study.

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