What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-10-27 compared with 2022-08-03 · 142 added, 143 removed, 134 unchanged (68% of the section changed)

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or the “Company” are to EnVVeno Medical Corporation

Medical Corporation is a med-tech company focused on improving the standard of care in the treatment of venous disease.

We are developing

tissue-based solutions that are designed to be life sustaining or life enhancing for patients with Chronic Venous Insufficiency (CVI).

CVI occurs when valves inside of the veins of the leg fail, resulting in insufficient blood being returned to the heart.

We aim to develop

products to address large unmet medical needs by either offering treatments where none currently exist or by substantially increasing

the current standards of care.

Our lead product is a porcine based device to be surgically implanted in the deep venous system of the

leg and is called the VenoValve®.

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.

The Company’s lead product, the VenoValve®, is a first-in-class

surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI).

The Company is

also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe™.

CVI 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 and become chronic.

Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up

the leg, and back to the heart and lungs.

The VenoValve is currently being evaluated in the SAVVE U.S.

pivotal trial for the purpose of obtaining

approval to market and sell the device from the U.S.

Food and Drug Administration (“FDA”).

Our team of officers and directors

has been affiliated with numerous medical devices that have received FDA approval or CE marking and that have been commercially successful.

pivotal study and the company is

currently waiting for regulatory approval to begin the TAVVE first-in-human trial for enVVe.

Our team of officers and directors has been

affiliated with numerous medical devices that have received FDA approval or CE marking and that have been commercially successful.

We develop and manufacture our products in a 14,507 sq.

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13485-2016 certified for the design, development and manufacturing of tissue based implantable medical devices.

VenoValve is a porcine based valve developed at enVVeno Medical to be implanted in the deep venous system of the leg to treat severe

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.

version of the VenoValve is designed to be implanted into the femoral vein of the patient in an open surgical procedure via a 5-to-6-inch

incision in the upper thigh.

VenoValve is a porcine based replacement venous valve developed at enVVeno Medical to be 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.

are presently no FDA approved medical devices to address valvular incompetence in the deep venous system, or effective treatments for

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estimate that there are approximately 2.4 million people in the U.S.

that suffer from deep venous CVI due to valvular incompetence.

who would be candidates for the VenoValve.

Clinical Status

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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 valuable feedback to make any necessary product modifications or adjustments to

our surgical implantation procedure for the VenoValve prior to conducting the U.S.

pivotal trial.

Endpoints for the VenoValve first-in-human

study included safety (device related adverse events), reflux, measured by doppler, a VCSS score used by the clinician to measure disease

severity and progress, a VAS score used by the patient to measure pain, and a quality of life measurement.

study included safety (device related adverse events), reflux, measured by doppler, an rVCCS score, which is used by the clinician to measure disease

regression and progression, a VAS score used by the patient to measure pain, and a quality of life measurement.

results from the one (1) year first-in-human study were presented at the Charing Cross International Symposium in April of 2021.

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

preparation for the VenoValve U.S.

pivotal trial, on March 5, 2021, we submitted an investigational device exemption or IDE application

with the FDA.

IDE from the FDA is required before a medical device company can proceed with a pivotal trial for a class III medical device.

1, 2021, we received notification from the FDA that our IDE application was approved.

We have named the U.S.

pivotal trial for the VenoValve

the SAVVE (Surgical Anti-reflux Veno Valve Endoprosthesis) study.

It is a prospective, non-blinded, single arm, multi-center study of

seventy-five (75) CVI patients to be enrolled at up to twenty (20) U.S.

1, 2021, we received notification from the FDA that our IDE application for the VenoValve U.S.

pivotal trial was approved.

We have named

pivotal trial for the VenoValve the SAVVE ( S urgical A nti-reflux V enous V alve

E ndoprosthesis) study.

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

to be enrolled at up to twenty (20) U.S.

product modifications for the VenoValve were necessary following the first-in-human study and the SAVVE trial is evaluating the same

device that was used in the first-in-human study.

Endpoints for the SAVVE trial mirror those endpoints used for the first-in-human study.

The primary safety endpoint for the pivotal trial is a material adverse safety event (mortality, deep wound infection, major bleeding,

ipsilateral deep vein thrombosis, pulmonary embolism) in no more than twenty six percent (26%) of the patients at one (1) month post

implantation, and the primary effectiveness endpoint for the pivotal trial is improvement in reflux of at least thirty percent (30%),

measured at six (6) months post VenoValve implantation.

In the first-in-human study there were no reported material adverse safety events

at one (1) month post implantation, and reflux improved an average of fifty six percent (56%) at six (6) months post implantation.

scoring to measure disease manifestations, VAS scores to measure pain, and quality of life measurements will also be monitored in the

Endpoints for the SAVVE trial mirror those endpoints used for the first-in-human

The primary safety endpoint for the pivotal trial is a material adverse safety event (mortality, deep wound infection, major

bleeding, ipsilateral deep vein thrombosis, pulmonary embolism) in no more than twenty six percent (26%) of the patients at one (1)

month post implantation, and the primary effectiveness endpoint for the pivotal trial is improvement in reflux of at least thirty

percent (30%), measured at six (6) months post VenoValve implantation in at least fifty five percent (55%) of the patients.

In the first-in-human study there were no reported material

adverse safety events at one (1) month post implantation, and reflux improved an average of fifty six percent (56%) at six (6)

months post implantation.

At least a thirty percent (30%) improvement in reflux occurred in ninety

percent (90%) of the patients.

rVCSS scoring to measure disease manifestations, VAS scores to measure pain, and quality of life

measurements will also be monitored in the study.

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

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

In August of 2021, longer

term follow-up data was presented at the Society of Vascular Surgery Conference in San Diego, for the cohort of eight (8) patients.

data indicated no recurrences of the severe CVI that was present pre-VenoValve, including no ulcer recurrences for those patients whose

venous ulcers had healed following VenoValve surgery.

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

study to the end of the two (2) year reporting period.

In addition, the patients continued to improve, reporting 63%, 60%, and 93%, average

improvements in reflux, VCSS, and VAS scores, respectively, at an average of two (2) years post VenoValve surgery compared to pre-VenoValve

In August of 2021,

longer-term two (2) year follow-up data was presented at the Society of Vascular Surgery Conference in San Diego, for the cohort of

eight (8) patients.

That data indicated no recurrences of the severe CVI that was present pre-VenoValve, including no ulcer

recurrences for those patients whose venous ulcers had healed following VenoValve surgery.

There were no reported safety issues from

the end of one (1) year first-in-human study to the end of the two (2) year reporting period.

In addition, the patients continued to

improve, reporting 63%, 60%, and 93%, average improvements in reflux, VCSS, and VAS scores, respectively, at an average of two (2)

years post VenoValve surgery compared to pre-VenoValve levels.

October of 2021, we announced that the first patient in the SAVVE pivotal trial underwent successful VenoValve implantation surgery and

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During April 2022 our twentieth site in the SAVVE study became active and is eligible to enroll

resurgence of COVID and the Omicron variant had both direct and indirect consequences on our clinical trial.

Several of our clinical

sites put elective surgeries on hold and prohibited potential study subjects from coming to the hospital for screening.

Further, as reported

in the media, COVID resurgences put an enormous strain on all hospital resources including clinical staffs.

In addition to caring for

the influx of COVID patients, hospitals become short staffed due to their own employees’ COVID sicknesses, resulting in clinical

staff being reassigned to cover the shortfall.

This lack of available clinical personnel continues to slow enrollment at

our clinical sites.

COVID impacts our patient population.

Patients with COVID or who have had COVID within ninety (90) days of their screening, are excluded

from our study until after the ninety (90) day period has passed.

continues to have indirect consequences on the SAVVE clinical trial.

in the media, the effects of COVID COVID have resulted in an exodus of health care providers leaving the profession.

These staffing issues continue

to put an enormous strain on all hospital resources including clinical staffs.

This lack of available clinical personnel continues to slow enrollment at our clinical

also impacts our patient population.

Patients with COVID or who are unwilling to get vaccinated, are currently excluded

from our study.

In addition, concerns about getting COVID impact the patients’

willingness to undergo an elective surgical procedure with a one-night hospital stay.

As hospital clinical operations return to more

normal levels, our goal is to fully enroll the SAVVE pivotal trial by the end of 2022 or the beginning of 2023.

Our goal continues to be to fully enroll the SAVVE pivotal trial by the end of the first quarter of 2023.

We continue to monitor

the ongoing overall impact of COVID on the SAVVE clinical trial and will issue updates when appropriate.

patient enrollment and will change our enrollment guidance for SAVVE, if necessary, when we have sufficient information

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 have already been

successfully completed and the Company has filed an application seeking approval to begin first-in-human (FIH) testing in Columbia, which we

expect to receive by the end of 2022.

enVVe first-in-human trial, which will take place in Colombia, will be known as the Transcatheter Anti-reflux, Venous Valve Endoprosthesis

(TAVVE) FIH study.

The initial phase of the TAVVE-FIH study will seek to enroll 3 to 5 patients across multiple sites.

Several 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.

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 estimate the U.S.

market for enVVe to be approximately 3.5 million

February of 2021, we raised $41.4 million of capital in a public offering of our common stock.

In September of 2021, we raised $20 million

dollars of capital in a registered direct offering priced at the market under Nasdaq rules and purchased by a fund managed by Perceptive

Advisors, a leading life sciences investment firm.

We finished 2021 with approximately $55 million of cash and had approximately $9.1

million of cash and $38.1 million of investments at June 30, 2022.

At our existing cash burn rate of approximately $4 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.

of Operations

of the three months ended June 30, 2022 and 2021

We reported net losses of $7.1

million and $2.4 million for the three months ended June 30, 2022 and 2021, respectively, representing an increase in net loss of $4.7

million, or 197%, resulting from an increase in operating expenses and other expenses.

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.

In September of 2021, we raised $20

million dollars of capital in a registered direct offering priced at the market under Nasdaq rules and purchased by a fund managed

by Perceptive Advisors, a leading life sciences investment firm.

We finished 2021 with approximately $55 million of cash and had

approximately $2.9 million of cash and $39.8 million of investments at September 30, 2022.

At our existing cash burn rate of

approximately $4 million per quarter, we should have sufficient cash to fund operations through the end of 2024 and into 2025.

of the three months ended September 30, 2022 and 2021

reported net losses of $6.1 million and $2.4 million for the three months ended September 30, 2022 and 2021, respectively, representing

an increase in net loss of $3.7 million or 154%, due to an increase in operating expenses of $3.4 million, and a net decrease 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

and dependent on our ability to commercialize our product candidates.

General and Administrative Expenses

the three months ended June 30, 2022, selling, general and administrative expenses increased by $2.6 million or 202%, to $3.9 million

from $1.3 million for the three months ended June 30, 2021.

Of this increase, $2.1 million was due to share based compensation from grants

made during 2021, which increased share-based compensation cost to $2.3 million in 2022 from $0.2 million in 2021.

remaining $0.5 million increase reflects $0.2 million from consulting for reimbursement codes for the Company’s product once commercially

approved, $0.1 million from higher Delaware franchise taxes in 2022 which increased due to changes in our capital structure, $0.1 million

from higher information technology and other office expense to support increases in staff, and $0.1 million in compensation due to increased

the three months ended September 30, 2022, selling, general and administrative expenses increased by $2.1 million or 140%, to $3.6 million

from $1.5 million for the three months ended September 30, 2021.

Of this increase, $1.9 million was due to share-based compensation from

grants made during 2021, which increased share-based compensation cost to $2.2 million in 2022 from $0.3 million in 2021.

The remaining

$0.2 million increase reflects higher legal expenses related to building the Company’s patent portfolio.

and Development Expenses

the three months ended June 30, 2022, research and development expenses increased by $2.0 million or 182%, to $3.1 million from $1.1

million for the three months ended June 30, 2021.

the three months ended September 30, 2022, research and development expenses increased by $1.3 million or 108%, to $2.5 million from

$1.2 million for the three months ended September 30, 2021.

This increase primarily resulted from $0.8 million in costs related the SAVVE

study, $0.4 million in lab costs to support the SAVVE study and VenoValve continued development, $0.1 million increase in personnel

costs due to additional staff, and $0.1 million in travel costs mainly to support the SAVVE study.

Other (Income) Expense

For the three months

ended June 30, 2022 other (income) expense increased $0.1 million from nil for the three months ended June 30, 2021.

This change is

primarily related to unrealized loss from investments which reflects changes in market value of the US Treasuries purchased by the

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, 2022 and 2021

We reported net losses of $12.4

million and $5.2 million for the six months ended June 30, 2022 and 2021, respectively, representing an increase in net loss of $7.2 million

or 141%, due to an increase in operating expenses of $7.1 million and an increase in other income and expense of $0.1 million.

study, $0.3 million in lab costs to support the SAVVE study and VenoValve continued development, and $0.2 million increase in personnel

costs due to additional staff.

on Extinguishment of Note Payable

the quarter ended September 30, 2021 the Company recorded a one-time $0.3 million gain on extinguishment of note payable due to the forgiveness

of the loan it had obtained under the PPP program authorized by the CARES act.

of the nine months ended September 30, 2022 and 2021

reported net losses of $18.5 million and $7.5 million for the nine months ended September 30, 2022 and 2021, respectively,

representing an increase in net loss of $11.0 million, or 147%, due to an increase in operating expenses of $10.6 million, and a

decrease in other income and expense of $0.4 million.

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

and dependent on our ability to commercialize our product candidates.

General and Administrative Expenses

the six months ended June 30, 2022, selling, general and administrative expenses increased $5.2 million or 211%, to $7.7 million from

$2.5 million for the six months ended June 30, 2021.

Of this increase, $4.2 million was due to share based compensation from grants made

during 2021, which increased share-based compensation cost to $4.5 million in 2022 from $0.3 million in 2021.

The remaining $1.0 million increase

in expenses is attributable to $0.3 million of consulting costs for reimbursement codes for the Company’s product to be used once

the product is commercially approved, if ever, $0.2 million from higher legal costs mainly related to intellectual property, $0.2 million

from higher Delaware franchise taxes in 2022 which increased due to changes in our capital structure, $0.2 million from higher information

technology and other office expense to support increases in staff and $0.1 million from higher insurance costs related to increased coverages

for cyber risks and higher a D&O insurance premium.

the nine months ended September 30, 2022, selling, general and administrative expenses increased $7.3 million or 183%, to $11.3 million

from $4.0 million for the nine months ended September 30, 2021.

Of this increase, $6.1 million was due to share-based compensation from

grants made during 2021, which increased share-based compensation cost to $6.7 million in 2022 from $0.6 million in 2021.

remaining $1.2 million increase in expenses is attributable to $0.4 million from higher legal costs mainly related to building the Company’s patent portfolio,

$0.3 million of consulting costs for reimbursement codes for the Company’s product to be used once the product is commercially

approved, if ever, $0.3 million from higher information technology and other office expense to support increases in staff, $0.1 million

from higher compensation cost, and $0.1 million from higher insurance costs related to increased coverages for cyber risks and higher

D&O insurance premiums.

and Development Expenses

the six months ended June 30, 2022, research and development expenses increased by $1.9 million or 70%, to $4.6 million from $2.7 million

for the six months ended June 30, 2021.

the nine months ended September 30, 2022, research and development expenses increased by $3.1 million or 78%, to $7.1 million from $4.0

million for the nine months ended September 30, 2021.

increase primarily resulted from $2.8 million in costs related the SAVVE study, $0.2 million in lab costs to support the SAVVE study

and VenoValve continued development, $0.1 million increase in personnel costs due to additional staff, $0.1 million in travel costs to

support the SAVVE study, and $0.1 million in costs for the preparing regulatory submissions related to SAVVE.

Other (Income) Expense

For the six months ended June 30, 2022 other (income) expense increased

$0.1 million from nil for the six months ended June 30, 2021.

This change is primarily related to unrealized loss from investments

which reflects changes in market value of the US Treasuries purchased by the Company.

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 VenoValve continued development, and $0.1 million in travel costs

to support the SAVVE study.

on Extinguishment of Note Payable

the nine months ended September 30, 2021 the Company recorded a $0.3 million gain on extinguishment of note payable due to the forgiveness

of the loan it had obtained under the PPP program authorized by the CARES act.

and Capital Resources

the six-months ended June 30, 2022, the Company incurred losses from operations of $12.4 million and used $7.3 million cash in operating

The net cash used in operating activities during the 2022 period increased by $0.8 from $6.5 million for the six-months ended

June 30, 2021.

the nine-months ended September 30, 2022, the Company incurred losses from operations of $18.5 million and used $11.7 million cash in

operating activities.

The net cash used in operating activities during the 2022 period increased by $3.0 from $8.7 million for the nine-months

ended September 30, 2021.

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

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cash flows from investing activity have historically consisted of purchases of property and equipment for our lab and offices.

during the period ending June 30, 2022, we commenced a program to invest excess cash in US Treasury bills.

In the six months ended June

30, 2022, we purchased $38.3 million of these investments and expect to continue investing as the treasury bills mature and as allowed

by the cash requirements of our operations.

Also, during the six months ending June 30, 2022, we purchased $0.1 million of property and

equipment consisting primarily of lab and test equipment.

during the period ending September 30, 2022, we commenced a program to invest excess cash in US Treasury bills.

In the nine months ended

September 30, 2022, we purchased $42.2 million of these investments and expect to continue investing as the treasury bills mature and

as allowed by the cash requirements of our operations.

Also, during the nine months ending September 30, 2022, we purchased $0.1 million

of property and equipment consisting primarily of lab and test equipment.

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

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Our cash balance

as of June 30, 2022, is $9.1 million.

In addition, we have $38.1 million in investments, for total cash and investments of $47.2 million.

as of September 30, 2022, is $2.9 million.

In addition, we have $39.8 million in investments, for total cash and investments of $42.7

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

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have a material adverse effect on us.

upon our cash and working capital as of June 30, 2022, 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 August 1, 2022,

our cash balance was $5.5 million and our investment balance was $40.7 million.

upon our cash and working capital as of September 30, 2022, 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 October 25, 2022, our cash balance was $2.0 million and our investment balance was $39.9 million.

COVID-19 pandemic continues to disrupt the global economy and has negatively impacted large populations including people and businesses

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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