What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-04-28 compared with 2022-10-27 · 243 added, 221 removed, 55 unchanged (89% of the section changed)

25 unchanged sentences

or the “Company” are to enVVeno Medical Corporation

Medical Corporation is a late clinical-stage med-tech company focused on the advancement of innovative bioprosthetic (tissue-based) solutions

to improve the standard of care for the treatment of venous disease.

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 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.

Medical Corporation is a late clinical-stage med-tech company focused on the advancement of innovative bioprosthetic (tissue-based)

solutions to improve the standard of care for the treatment of venous disease.

Chronic Venous Disease (CVD) is the world’s

most prevalent chronic disease, impacting approximately 71% of the adult population of the U.S.

Chronic Venous Insufficiency (CVI),

is a large subset of CVD, which most often occurs when valves inside of the veins of the leg become damaged, resulting in the

backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension)

and in severe cases, venous ulcers that are difficult to heal.

The Company is developing surgical and non-surgical replacement

venous valves for patients suffering from severe CVI of the deep venous system of the leg.

Company’s lead product is the VenoValve®, which is a first-in-class surgical replacement venous valve that is currently being

evaluated in a U.S.

pivotal study.

The Company is also developing a second product called enVVe™, which is a first-in-class, non-surgical,

transcatheter based replacement venous valve.

The Company is currently waiting for regulatory approval to begin a first-in-human study

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

leg, and back to the heart and lungs.

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

Food and Drug Administration (FDA).

We expect the VenoValve to

be eligible for FDA approval first, followed two to three years later by enVVe.

If approved, we expect the VenoValve and enVVe to co-exist,

with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option, although we cannot provide any assurance that either the VenoValve or enVVe will receive approval from the FDA

(see the section entitled “Risk Factors” in our Annual Report on Form 10-K).

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

CVI caused by incompetent valves.

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 replacement venous valve developed at enVVeno Medical to be implanted in the deep venous system of the

leg to treat severe CVI.

leased manufacturing facility in Irvine,

California, which has been ISO 13485-2020 certified for the design, development and manufacturing of tissue based implantable medical

venous disease (“CVD”) is the world’s most prevalent chronic disease.

CVD is generally classified using a standardized

system known as CEAP (clinical, etiological, anatomical, and pathophysiological).

The CEAP system consists of seven clinical classifications

(C0 to C6) with C4, C5 and C6 being the most severe categories of CVD.

Venous Insufficiency (“CVI”) is a large subset of CVD and is generally used to describe patients with C4 to C6 CVD.

a debilitating condition that affects the venous system of the leg causing pain, swelling, edema, skin changes, and ulcerations.

human leg contains three vein systems:

the deep vein system, the superficial vein system, and the perforator vein system which connects

the deep system to the superficial system.

The deep venous system is located below the muscle and facia in the center portion of the

leg and is responsible for approximately 90% of the blood flow.

In order for blood to return to the heart from the foot, ankle, and lower

leg, the calf muscle serves as a pump and pushes the blood up the veins of the leg against gravity and through a series of one-way valves.

Each valve is supposed to open as blood passes through, and then close as blood progresses up the veins of the leg to the next valve.

CVI occurs when the one-way valves in the veins of the leg fail and become incompetent.

When the valves fail, gravity causes the blood

to flow backwards and in the wrong direction (reflux).

As blood pools in the lower leg, pressure inside the veins increases (venous hypertension).

Reflux, and the resulting venous hypertension, causes the leg to swell, resulting in debilitating pain, and in the most severe cases,

venous ulcers.

CVI sufferers experience a significantly reduced quality of life.

Daily activities such as preparing meals, housework, and personal hygiene

(washing and bathing) become difficult due to reduced mobility.

For many severe CVI sufferers, intense pain, which frequently occurs

at night, prevents patients from getting adequate sleep.

Severe CVI sufferers are known to miss approximately 40% more workdays than

the average worker.

A high percentage of venous ulcer patients also experience severe itching, leg swelling, and an odorous discharge.

Wound dressing changes, which occur several times a week, can be extremely painful.

Venous ulcers from deep venous CVI are very difficult

to heal, and a significant percentage of venous ulcers remain unhealed for more than a year.

Even if healed, recurrence rates for venous

ulcers are known to be high (20% to 40%) within the first year and as high as 60% after five years.

Patients with severe CVI often become

housebound and experience social isolation due to difficulty with ambulation.

As a result, studies have shown that patients with active

venous ulcers experience higher rates of anxiety and depression, with reported rates of anxiety of up to 30% and depression up to 40%.

Rates of depression caused by venous ulcers among the elderly are even higher, with 48% of elderly venous ulcer patients having severe

depressive symptoms.

is generally defined as the portion of the population that has a given condition.

Estimates indicate that the prevalence of people in

with severe, deep venous CVI (C4 to C6 disease) with reflux to be approximately 20 million.

Incidence is generally defined as

the number of new cases of an ailment that develop in a given time period.

We estimate that approximately 3.5 million new patients with

severe deep venous CVI are diagnosed each year in the U.S.

including patients that develop venous leg ulcers (C6 patients).

patient seeking treatment of a venous ulcer spends as much as $30,000 a year on wound care, and the total direct medical costs from venous

ulcer sufferers in the U.S.

has been estimated to exceed $3 billion a year.

VenoValve is a porcine based replacement venous valve developed at enVVeno Medical to be surgically implanted in the deep venous system

of the leg to treat severe CVI.

By reducing reflux and lowering pressure (venous hypertension) within the deep venous system of the leg,

the VenoValve has the potential to reduce or eliminate the symptoms of severe deep venous CVI, including the potential to heal

recurring venous leg ulcers.

The VenoValve is implanted into the femoral vein of the patient

in an open surgical procedure via a 5-to-6-inch incision in the upper thigh.

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 ulcers.

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

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.

who would be candidates for the VenoValve.

the VenoValve has the potential to reduce or eliminate the symptoms of severe deep venous CVI, including the potential to heal recurring

venous leg ulcers.

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

in the upper thigh.

As our planned initial entrant to the replacement venous valve market, we estimate that approximately 2.5 million

people with severe deep venous CVI in the U.S.

would be candidates for the VenoValve.

Clinical Status

consultation with the FDA, and as a precursor to the U.S.

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

pivotal trial, in 2020 we conducted a small first-in-human study for the VenoValve

in Colombia which included eleven (11) patients.

Endpoints for the VenoValve first-in-human

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.

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.

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 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

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.

In addition to providing safety and efficacy data, the purpose of the first-in-human

study was to provide proof of concept, and to provide feedback to make any necessary product modifications or adjustments to our surgical

implantation procedure for the VenoValve prior to conducting the SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S.

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

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

of life measurements.

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

Among the eleven

(11) patients in the study, reflux improved an average of 54%, Venous Clinical Severity Scores (“VCSSs”) improved an average

of 56%, and visual analog scale (VAS) scores, which are used by patients to measure pain, improved an average of 76%, all at one (1)

year when compared to pre-surgery levels.

VCSS scores are commonly used by clinicians in practice and in clinical trials to objectively

assess outcomes in the treatment of venous disease, and include ten characteristics including pain, inflammation, skin changes such as

pigmentation and induration, the number of active ulcers, and ulcer duration.

The improvement in VCSS scores is significant and indicates

the VenoValve patients who had severe CVI pre-surgery, had mild CVI or the complete absence of disease at one-year post surgery.

safety incidences during the one year first-in-human study for the VenoValve 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.

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

5 unchanged sentences

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

March 2021, we submitted an IDE application with the FDA and in April 2021, we received notification from the FDA that our IDE application

was approved.

An investigational device exemption or IDE from the FDA is required before a medical device company can proceed with a

pivotal trial for a class III medical device.

This approval allowed us to proceed with our SAVVE study, a prospective, non-blinded, single

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

We later received permission from the

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

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

In 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

had been discharged from the hospital.

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

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.

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

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

In November of 2022, three-year

follow-up data was presented at the 49th Annual VEITH Symposium in New York city for this cohort of patients.

That data indicated no

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

(C6 patients) prior to receiving the VenoValve.

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

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

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

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

VenoValve surgery.

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

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

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

Vascular and Endovascular Surgery , and JAMA Surgery Journal.

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

The FDA had requested that we submit preliminary safety data at thirty (30) days post VenoValve implantation for the first

twenty (20) patients enrolled in the study.

The preliminary safety data included one (1) device related (mild) and two (2) procedure

related (moderate) adverse events.

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

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

their clinical staff.

Hospitals continue to be severely understaffed, which impacts the rate at which clinical trials enroll and progress.

We have taken several steps to help address the hospital staffing shortages, including our hiring of 4 Clinical Technologists, with extensive

and specialized experience in duplex sonography of the deep venous system, to assist in training site personnel, proctoring Duplex Ultrasound

examinations, and providing assistance for the SAVVE study.

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 $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.

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

announcement.

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

The trial will be known

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

The initial phase of the TAVVE-FIH study

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

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

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

enVVe is delivered into the femoral vein of the patient via a minimally

invasive procedure requiring no general anesthesia and no overnight hospital stay.

Due to the minimally invasive nature of the procedure,

we expect to be able to reach patients with less severe CVI or who are otherwise not good candidates for a surgical device, and estimate

market for enVVe to be approximately 3.5 million patients.

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

at March 31, 2023.

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

fund operations through the end of 2024 and into 2025.

With primary endpoints following full enrollment in the SAVVE pivotal trial

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

need to raise additional capital.

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

and sterilization of biologic devices.

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

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

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

We have filed numerous patent applications

for the VenoValve with the U.S.

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

We currently have nineteen (19) patents

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

of Operations

of the three months ended March 31, 2023 and 2022

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

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

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

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

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

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

The remaining

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

and Development Expenses

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, $0.3 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 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.

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

cost related to investor relations and our website update.

and Development Expenses

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, 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.

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

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

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

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

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

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

Other income in 2023 reflects interest,

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

the three months ended March, 31, 2022.

and Capital Resources

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.

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

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

ended March 31, 2022.

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, currently primarily the SAVVE study.

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.

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

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.

Administrative functions relate to costs to support the Company’s public reporting and investor relations activities as well

as internal administrative functions.

Research and development activities are for continued product development and clinical trials

for our product candidates, currently the VenoValve and enVVe.

The Company will continue to incur these costs to complete its

clinical trials, enhance products, develop new products, and operate as a public company.

Although we have discretion in how we use

the Company’s cash resources, we expect to continue these activities for the foreseeable future as we seek to obtain

regulatory approval for our product candidates.

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

we successfully commercialize one or more of our product candidates.

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

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

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

million in realized gains and interest income.

We expect to continue investing as the treasury bills mature and as allowed by the cash

requirements of our operations.

In the quarter ended March 31, 2023,

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

currently have material commitments for capital expenditures or other expenditures except for our facility lease

commitment of $0.4 million per year.

However, we expect a modest increase in purchases of property and equipment as we continue

SAVVE, plan for commercialization of the VenoValve and continue development of enVVe.

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 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

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 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

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

product candidates.

COVID with its variants continues to have both direct and indirect consequences on our clinical trial.

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

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.

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.

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

Our future capital requirements will remain

dependent upon a variety of factors, especially including the success of our clinical trials and related product development costs and

our ability to successfully bring products to market.

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

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

With primary endpoints following full enrollment

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

well in advance of the need to raise additional capital.

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

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

for at least one year after the date of this Report and sustain operations.

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

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

their clinical staff.

Hospitals continue to be severely understaffed, which impacts the rate at which clinical trials enroll and progress.

We have taken several steps to help address the hospital staffing shortages, including our hiring of 4 Clinical Technologists, with extensive

and specialized experience in duplex sonography of the deep venous system, to assist in training site personnel, proctoring Duplex Ultrasound

examinations, and providing assistance for the SAVVE study.

Sheet Arrangements

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What changed 10-Q

Item 2. Management’s Discussion and Analysis