What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-04-29 compared with 2021-11-12 · 176 added, 169 removed, 59 unchanged (85% of the section changed)

23 unchanged sentences

except as required by applicable law.

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

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

are developing tissue-based solutions that are designed to be life sustaining or life enhancing for patients with deep venous 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.

Our products are being developed 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®.

The VenoValve is currently being evaluated in the

pivotal trial for the purpose of obtaining approval to market and sell the device from the U.S.

Food and Drug Administration

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 currently lease a 14,507 sq.

manufacturing facility

in Irvine, California, where we manufacture medical devices for our clinical trials, and which has capacity for commercial

manufacturing.

September 21, 2021, we announced that we were changing our name from Hancock Jaffe to enVVeno Medical Corporation and that our development

strategy is to focus on the treatment of venous disease.

In addition to the VenoValve, we announced that we have a second product in

the early stages of development called enVVe.

In connection with this change in strategy, we indicated that we are deferring further

development of the CoreoGraft, which is now outside of our primary focus area.

of our products will be required to successfully complete significant clinical trials to demonstrate safety and efficacy before it will

be able to be approved by the FDA.

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

reducing reflux, and lowering venous hypertension, the VenoValve has the potential to reduce or eliminate the symptoms of deep venous,

severe CVI, including venous leg ulcers.

The current version of the VenoValve is designed to be surgically implanted into the femoral

vein of the patient via a 5 to 6 inch incision in the upper thigh.

are presently no FDA approved medical devices to address valvular incompetence, or effective treatments for deep venous CVI.

treatment options include compression garments, or constant leg elevation.

These treatments are generally ineffective, as they attempt

to alleviate the symptoms of CVI without addressing the underlying causes of the disease.

In addition, we believe compliance with

compression garments and leg elevation is extremely low, especially among the elderly.

The premise behind the VenoValve is that by reducing

the underlying causes of CVI, reflux and venous hypertension, the debilitating symptoms of CVI will decrease, resulting in improvement

in the quality of the lives of CVI sufferers.

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®.

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.

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 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.

The current 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.

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

deep venous CVI.

Current treatment options include compression garments, or constant leg elevation, and wound care for venous

These treatments are generally ineffective, as they attempt to alleviate the symptoms of CVI without addressing the underlying

causes of the disease.

In addition, we believe compliance with compression garments and leg elevation is extremely low, especially among

The premise behind the VenoValve is that by reducing the underlying causes of CVI, reflux and venous hypertension, the debilitating

symptoms of CVI will decrease, resulting in improvement in the quality of the lives of CVI sufferers.

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

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

The first-in-human trial 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 procedures for the VenoValve prior to conducting the U.S.

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 include safety (device related adverse events), reflux, measured by doppler, a VCSS

score used by the clinician to measure disease severity, and a VAS score used by the patient to measure pain, and a quality of life

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.

results from the one (1) 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.

Quality of life measured by a VEINES score showed statistically significant improvement.

safety incidences during the one (1) year first-in-human study were minor with no reported device related adverse events.

non-device related adverse safety issues 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

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.

were no device related safety incidences during the one (1) year first-in-human study.

Non-device related safety incidences were minor

and 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.

preparation for the VenoValve U.S.

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a class III medical device.

On April 1, 2021, twenty-seven days after filing the IDE application, we received notification from the FDA

that our IDE application was approved.

We have named the U.S.

pivotal for the VenoValve the SAVVE (Surgical Anti-reflux Veno Valve Endoprosthesis)

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

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

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

We have named

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.

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 trial.

The primary safety endpoint for the pivotal trial is

the absence of material adverse safety events (mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis,

pulmonary embolism) in twenty six percent (26%) or less 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.

VCSS scoring to measure

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

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.

the end of the VenoValve first-in-human study, we asked the study participants if we could continue to monitor them for an additional

one (1) year period.

Eight patients agreed to be monitored and in August of 2021, 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

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

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

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

had been discharged from the hospital.

The surgery was performed by Dr.

Adriana Laser, associate professor of surgery at Albany Medical

College and a vascular surgeon with Albany Med Vascular Surgery.

At the time of the first implantation, we had five (5) clinical sites

that are actively enrolling patients in the SAVVE study and additional sites will become active on a rolling basis over the next several

of the three months ended September 30, 2021 and 2020

reported net losses of $2.4 million and $2.0 million for the three months ended September 30, 2021 and 2020, respectively,

representing an increase in net loss of $0.4 million or 21%, due to an increase in operating expenses of $0.8 million, and a net increase

in other income and expense of $0.4 million.

a developmental stage Company, our revenue, if any, is expected to be diminutive and dependent on our ability to commercialize our product

General and Administrative Expenses

the three months ended September 30, 2021, selling, general and administrative expenses increased by $0.3 million or 27%, to $1.5

million from $1.2 million for the three months ended September 30, 2020.

The net increase reflects increases of $0.2 million in compensation

due to higher share-based compensation in 2021, $0.1 million in outside services related to human resources and information technology

support fees which were higher primarily because of increases in personnel, $0.1 million in higher insurance and other office expense

due to higher D&O insurance premiums, travel, and cleaning, all mainly due to increases in personnel and returning to full time use

of the office in the 2021 period.

These increases were partially offset by lower legal expenses, which were $0.1 million lower in 2021

because of the resolution of a number of legal matters during 2020.

and Development Expenses

the three months ended September 30, 2021, research and development expenses increased by $0.5 million or 62%, to $1.2 million from $0.8

million for the three months ended September 30, 2020.

The increase is primarily due to increases of $0.3 million in compensation and

related costs due to a larger team in 2021, and $0.1 million in higher consulting costs and $0.1 million in lab testing, both related

to preparations for SAVVE.

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.

in Fair Value of Derivative Liability

the quarter ended September 30, 2020, we recorded a loss on the change in fair value of derivative liabilities of $0.1 million.

Our derivative

liabilities were related to warrants issued in connection with our Bridge Offering in February 2020.

There were no similar instruments

outstanding during the quarter ended September 30, 2021.

of the nine months ended September 30, 2021 and 2020

reported net losses of $7.5 million and $4.8 million for the nine months ended September 30, 2021 and 2020, respectively, representing

an increase in net loss of $2.8 million, or 58%, due to an increase in operating expenses of $2.9 million, and an increase in other income

and expense of $0.1 million.

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.

The lack of available clinical personnel both slows enrollment and impacts the speed at

which we can activate 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.

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.

We continue to monitor

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

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 $51.3

million of cash at March 31, 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 March 31, 2022 and 2021

reported net losses of $5.3 million and $2.8 million for the three months ended March 31, 2022 and 2021, respectively, representing an

increase in net loss of $2.5 million, or 89%, resulting from an increase in operating 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.

General and Administrative Expenses

the nine months ended September 30, 2021, selling, general and administrative expenses increased by $1.0 million or 32%, to $4.0 million

from $3.0 million the nine months ended September 30, 2020.

The increase is primarily due to increases of approximately $0.3 million

in stock-based compensation expense, $0.3 million in other compensation primarily from the additional personnel and directors’

cash compensation in 2021, $0.3 million in other administrative expenses due to higher Delaware franchise tax resulting from changes

in the Company’s capital structure, and increases in cleaning and other office related expenses due to returning to full time use

of the office in the 2021 period, $0.1 million in higher insurance due to higher D&O insurance premiums, and $0.1 million increase

in outside services related to the Company’s increased investor outreach in 2021.

These increases were partially offset by lower

legal expenses, which were $0.1 million lower in 2021 because of the resolution of a number of legal matters during 2020.

the three months ended March 31, 2022, selling, general and administrative expenses increased by $2.6 million or 222%, to $3.8 million

from $1.2 million for the three months ended March 31, 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 $2.2 million in 2022 from $0.1 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 higher insurance premiums

related to our D&O, cyber security and product liability insurance coverages.

and Development Expenses

the nine months ended September 30, 2021, research and development expenses increased by $2.0 million or 100%, to $4.0 million from $2.0

million for the nine months ended September 30, 2020.

The increase is due to expanded activity related to SAVVE and includes $0.8 million

in higher compensation from additional personnel, $0.5 million in consulting costs for SAVVE, $0.4 million for testing related to FDA

submissions and SAVVE preparation, and $0.3 million in lab supplies and other related lab costs to support those activities.

in Fair Value of Derivative Liability

the nine months ended September 30, 2020, we recorded a gain on the change in fair value of derivative liabilities of $0.2 million.

derivative liabilities were related to warrants issued in connection with our Bridge Offering in February 2020.

There were no similar

instruments outstanding during the period ended September 30, 2021.

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.

the three months ended March 31, 2022, research and development expenses decreased by $0.1 million or 5%, to $1.5 million from $1.6 million

for the three months ended March 31, 2021.

This decrease primarily resulted from $0.3 million in costs related the Coreograft

product development in 2021, which we did not incur in 2022 due the change in our strategic direction and decision to focus on development

of the VenoValve, partially offset by a $0.2 million increase in lab and personnel costs to support the VenoValve pivotal trial and continued

and Capital Resources

have incurred losses since inception and negative cash flows from operating activities for the nine months ended September 30, 2021.

Since inception, we have funded our operations primarily through our public and private offerings of equity and private placement of

convertible debt securities as well as modest revenues from royalties, contract research and sales of the ProCol Vascular Bioprosthesis.

of November 8, 2021, we had a cash balance of approximately $56,900,000.

measure our liquidity in a variety of ways, including the following:

Working capital

upon our cash and working capital as of September 30, 2021, we have sufficient cash to sustain the Company’s operations at least

one year after the date of this Report.

We have historically funded our operations through public and private issuances of debt and

Our current cash on hand is the result equity issuances completed in February and September of this year.

We expect to use this

cash to fund continued research and trials for our products such as the SAVVE for our VenoValve.

If our trials are successful, we believe

it may be necessary to raise additional capital to take our products to market.

If this is necessary, we believe the Company could have

access to additional capital resources through possible public or private equity offerings, debt financings, corporate collaborations

or other means.

However, there can be no assurance the Company will be able to raise additional capital or obtain new financing when

needed on commercially acceptable terms, if at all.

COVID-19 pandemic has disrupted the global economy and has negatively impacted large populations including people and businesses that

may be directly or indirectly involved with the operation of our Company and the manufacturing, development, and testing of our product

The full scope and economic impact of COVID-19 is still unknown and there are many risks from the COVID-19 that could generally

and negatively impact economies and healthcare providers in the countries where we do business, the medical device industry as a whole,

and development stage, pre-revenue companies such as enVVeno.

the three-months ended March 31, 2022, the Company incurred losses from operations of $5.3 million and used $3.3 million cash in operating

The net cash used in operating activities during the 2022 period decreased by $0.5 from $3.8 million for the quarter ended

March 31, 2021.

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

the VenoValve.

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 lead product candidate.

We are not currently

generating revenue and do not expect significant revenue until we successfully commercialize our lead product candidate.

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

quarter ended March 31, 2022, we purchased $0.1 million of property and equipment consisting primarily of lab and test equipment.

We do not currently have material commitments for capital expenditures or other expenditures with the exception of 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 and plan for commercialization of the VenoValve.

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

the Company raised an aggregate of $57.4 million in net proceeds in private and public placements of its securities.

Our cash balance

as of March 31, 2022, is $51.3 million.

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 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 on us.

upon our cash and working capital as of March 31, 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 April 28, 2022, we had a cash balance of $50.5 million.

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

that may be directly or indirectly involved with the operation of our Company and the manufacturing, development, and testing of our

product candidates.

The 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

Further COVID resurgences put an enormous strain on all hospital resources including clinical staffs.

The lack of available

clinical personnel both slows enrollment and impacts the speed at which we can activate clinical sites.

has also impacted our patient population.