What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-11-12 compared with 2021-08-11 · 160 added, 194 removed, 68 unchanged (84% of the section changed)

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except as required by applicable law.

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

or the “Company” are to Hancock Jaffe Laboratories, Inc.

Jaffe Laboratories, Inc.

is a medical device company developing tissue-based devices that are designed to be life sustaining or life

enhancing for patients with cardiovascular disease, and peripheral arterial and venous disease.

The Company’s 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 products which we are developing include:

the VenoValve®, a porcine based device to be surgically

implanted in the deep venous system of the leg to treat a debilitating condition called chronic venous insufficiency (“CVI”);

and the CoreoGraft®, a bovine based conduit to be used to revascularize the heart during coronary artery bypass graft (“CABG”)

Both of these products are currently being developed for approval by the U.S.

Food and Drug Administration (“FDA”).

Our current senior management team has been affiliated with more than 50 products that have received FDA approval or CE marking.

lease a 14,507 sq.

manufacturing facility in Irvine, California, where we manufacture products for our clinical trials and which

has previously been FDA certified for commercial manufacturing of devices.

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

before it will be able to be approved by the FDA.

are in the process of developing the following bioprosthetic implantable devices for peripheral vascular and cardiovascular disease:

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

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 patient via a

5 to 6 inch incision in the upper thigh.

the context requires otherwise, references in this document to “enVVeno” “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.

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

In addition, we believe that compliance with

In addition, we believe compliance with

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

Valve transplants from other parts of the body

have been attempted, but with very-poor results.

Many attempts to create substitute valves have also failed, usually resulting in early

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.

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 Colombian trial included 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.

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.

pivotal trial.

In December of 2018,

we received regulatory approval from Instituto Nacional de Vigilancia de Medicamentos y Alimentos (“INVIMA”), the Colombian

equivalent of the FDA.

On February 19, 2019, we announced that the first VenoValve was successfully implanted in a patient in Colombia.

Between April of 2019 and December of 2019, we successfully implanted VenoValves in 10 additional patients, completing the implantations

for the Colombian first-in-human study.

Overall, VenoValves have been implanted in all 11 patients.

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 measurement.

results from the first-in-human study were released in December of 2020.

Among the 11 patients, 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%, when compared to pre-surgery levels.

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

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

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

2 unchanged sentences

The improvement in VCSS

scores is significant and indicates that almost all of the VenoValve patients who had severe CVI pre-surgery, had mild CVI or the complete

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 were minor with no reported device related adverse events.

Minor 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 therapy.

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

preparation for the VenoValve U.S.

pivotal trial, we submitted a Pre-IDE filing with the FDA in October of 2020 and had a pre IDE meeting

with the FDA on January 11, 2021.

Topics presented at the meeting included the background and clinical need for the VenoValve, proposed

pivotal study design, patient monitoring protocols for safety and efficacy, bench testing protocols used to develop the device,

and the VenoValve first-in-human results.

We received valuable feedback from the FDA in several areas during the Pre-IDE meeting and

believe we reached consensus on many important issues.

pivotal trial, on March 5, 2021, we submitted an IDE application with the FDA.

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.

On March 5, 2021 we filed an IDE application with the FDA for the VenoValve U.S.

pivotal trial.

1, 2021, twenty-seven days after filing the IDE application, we received notification from the FDA that our IDE application was approved.

pivotal for the VenoValve will be known at the SAVVE (Surgical Anti-reflux Veno Valve Endoprosthesis) study and is a prospective,

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

for the SAVVE trial mirror those endpoints used for the first-in-human trial, and include the absence of material adverse safety events

(mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis, pulmonary embolism) at thirty (30) days post implantation,

reductions of reflux at one hundred and eighty days (180) days post VenoValve implantation, VCSS scoring to measure disease manifestations,

VAS scores to measure pain, and quality of life measurements.

We have significant interest from key opinion leaders and several of the

top vascular clinicians in the U.S.

who would like to participate in the VenoValve U.S.

pivotal trial.

We are in the process of qualifying

the sites, seeking investigational review board (“IRB”) and other necessary approvals, negotiating clinical trial agreements,

and preparing for site training and initiations.

At this point we expect the first implantation for the SAVVE study to occur during

the third quarter of 2021.

On August 3, 2020, we announced

that the FDA granted Breakthrough Device Designation status to the VenoValve.

The FDA’s Breakthrough Devices Program was established

to enable priority review for devices that provide more effective treatment or diagnosis of life threatening or irreversibly debilitating

diseases or conditions.

The goal of the FDA’s Breakthrough Devices Program is to provide patients and health care providers with

timely access to medical devices by speeding up their development, assessment, and review, while preserving the FDA’s mission to protect

and promote public health.

CoreoGraft is a bovine based off the shelf conduit that could potentially be used to revascularize the heart, instead of harvesting the

saphenous vein from the patient’s leg.

In addition to avoiding the invasive and painful SVG harvest process, HJLI’s CoreoGraft

closely matches the size of the coronary arteries, eliminating graft failures that occur due to size mismatch.

In addition, with no graft

harvest needed, the CoreoGraft could also reduce or eliminate the inner thickening that burdens and leads to failure of the SVGs.

addition to providing a potential alternative to SVGs, the CoreoGraft could be used when making grafts from the patients’ own arteries

and veins is not an option.

For example, patients with significant arterial and vascular disease often do not have suitable vessels to

be used as grafts.

For other patients, such as women who have undergone radiation treatment for breast cancer and have a higher incidence

of heart disease, using the LIMA may not be an option if it was damaged by the radiation.

Another example are patients undergoing a second

CABG surgery.

Due in large part to early SVG failures, patients may need a second CABG surgery.

If the SVG was used for the first CABG

surgery, the patient may have insufficient veins to harvest.

While the CoreoGraft may start out as a product for patients with no other

options, if the CoreoGraft establishes good short term and long term patency rates, it could become the graft of choice for all CABG

patients in addition to the LIMA.

Clinical Status

January of 2020, we announced the results of a six-month, nine sheep, animal feasibility study for the CoreoGraft.

Bypasses were accomplished

by attaching the CoreoGrafts from the ascending aorta to the left anterior descending artery, and surgeries were preformed both on-pump

and off-pump.

Partners for the feasibility study included the Texas Heart Institute, and American Preclinical Services.

subjects were evaluated via angiograms and flow monitors during the study, and a full pathology examination of the CoreoGrafts and the

surrounding tissue was performed post necropsy.

results from the feasibility study demonstrated that the CoreoGrafts remained patent (open) and fully functional at 30, 90, and 180 day

intervals after implantation.

In addition, pathology examinations of the grafts and surrounding tissue at the conclusion of the study

showed no signs of thrombosis, infection, aneurysmal degeneration, changes in the lumen, or other problems that are known to plague and

lead to failure of SVGs.

addition to exceptional patency, pathology examinations indicated full endothelialization for grafts implanted for 180 days both throughout

the CoreoGrafts and into the left anterior descending arteries.

Endothelium is a layer of cells that naturally exist throughout healthy

veins and arteries and that act as a barrier between blood and the surrounding tissue, which helps promote the smooth passage of blood.

Endothelium are known to produce a variety anti-clotting and other positive characteristics that are essential to healthy veins and arteries.

The presence of full endothelialization within the longer term CoreoGrafts indicates that the graft is being accepted and assimilated

in a manner similar to natural healthy veins and arteries that exist throughout the vascular system and is an indication of long-term

biocompatibility.

May of 2020, we announced that we had received approval from the Superintendent of Health of the National Health Counsel for the Republic

of Paraguay to conduct a first-in-human, feasibility trial for the CoreoGraft.

Up to 5 patients that need coronary artery bypass graft

surgery were to receive CoreoGraft implants as part of the first-in-human study.

In July of 2020, we announced that we had received permission

to proceed with the first-in-human study, which had been put on hold due to the COVID-19 pandemic, and in August of 2020 we announced

that the first two patients had been enrolled for the first-in-human CoreoGraft trial.

Heart bypass surgeries for the first two patients

to receive CoreoGraft implants as part of our first-in-human trial were successfully completed in October of 2020.

A third bypass surgery

using the CoreoGraft was successfully completed in November of 2020 and another surgery was completed in December of 2020.

Two CoreoGraft

surgical patients have expired due to non-device related adverse events, one in October and one in November of 2020.

As a result of these

deaths, the feasibility study was put on hold, pending a review by an ethics committee that oversees the feasibility trial.

the committee has given approval to resume with the feasibility study, due to the recent resurgence of COVID-19 in South America (including

in Paraguay), the first-in-human CoreoGraft feasibility trial remains on hold.

At this time we have no further information as to when

the study might resume.

of the three months ended June 30, 2021 and 2020

reported net losses of $2.4 million and $1.6 million for the three months ended June 30, 2021 and 2020, respectively, representing an

increase in net loss of $0.8 million or 50%, due to an increase in operating expenses of $0.9 million, and a decrease in other income

and expense of $0.1 million.

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

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.

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

The FDA’s Breakthrough

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

or irreversibly debilitating diseases or conditions.

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

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

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

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

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 June 30, 2021, selling, general and administrative expenses increased by $0.5 million or 54%, to $1.3 million

from $0.8 million for the three months ended June 30, 2020.

The increase is primarily due to $0.3 million in higher compensation costs

due mainly from share based compensation, $0.1 million in higher Delaware franchise taxes, which increased due to changes in

our capital structure, $0.1 million in higher outside services due to recruiting fees and $0.1 million in higher D&O insurance premiums,

partially offset by $0.1 million in lower legal fees.

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 June 30, 2021, research and development expenses increased by $0.4 million or 54%, to $1.1 million from $0.7 million

for the three months ended June 30, 2020.

This increase results from our efforts to apply and prepare for the IDE submission and pivotal

trial of the VenoValve, and related lab and personnel costs to support those activities, and is primarily due to $0.3 million in compensation

due to a larger team, and $0.1 million in other lab costs to support preparation for our pivotal trial.

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 June 30, 2020, we recorded a gain on the change in fair value of derivative liabilities of $0.1 million.

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 February 25, 2020 private placement.

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

There were no similar instruments

outstanding during the quarter ending June 30, 2021.

of the six months ended June 30, 2021 and 2020

reported net losses of $5.2 million and $2.8 million for the six months ended June 30, 2021 and 2020, respectively, representing an increase

in net loss of $2.4 million or 85%, due to an increase in operating expenses of $2.2 million, and a decrease in other income and expense

of $0.2 million.

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.

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 six months ended June 30, 2021, selling, general and administrative expenses increased $0.7 million or 35%, to $2.5 million from

$1.8 million for the six months ended June 30, 2020.

The increase is primarily due to $0.3 million in higher compensation cost $0.2 million

in higher Delaware franchise taxes, which increased due to changes in our capital structure, $0.1 million in higher D&O insurance

premiums, and $0.1 million in higher outside services due to recruiting fees.

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.

and Development Expenses

the six months ended June 30, 2021, research and development expenses increased by $1.5 million or 124%, to $2.7 million from $1.2 million

for the six months ended June 30, 2020.

This increase results from our efforts to apply and prepare for the IDE submission and pivotal

trial of the VenoValve, and related lab and personnel costs to support those activities, and is primarily due to $0.5 million in compensation

due to a larger team, $0.7 million in costs related to the preparing for VenoValve pivotal trial including regulatory submissions other

preparatory work, $0.2 million in costs related to product testing and production, and $0.1 million in other lab costs to support preparation

for our pivotal trial.

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 six months ended June 30, 2020, we recorded a gain on the change in fair value of derivative liabilities of $0.3 million.

Our derivative

liabilities were related to warrants issued in connection with our February 25, 2020 private placement.

There were no similar instruments

outstanding during the period ending June 30, 2021.

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.

and Capital Resources

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

inception, we have funded our operations primarily through our IPO, private and public 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 August 6, 2021, we had a cash balance of $40.1 million.

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:

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

year after the date of this Report.

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

2 unchanged sentences

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 HJLI.

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

Sheet Arrangements

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What changed 10-Q

Item 2. Management’s Discussion and Analysis