What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-10-31 compared with 2024-07-31 · 128 added, 136 removed, 184 unchanged (59% of the section changed)

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pivotal study called the SAVVE trial (Surgical Anti-reflux Venous Valve Endoprosthesis).

To date, patients

in our SAVVE trial have indicated in testimonials to the Company that they have experienced reduced pain and enhanced quality of life

as a result of the VenoValve.

Company is also developing a second product called enVVe®, which is a potential, non-surgical, transcatheter based

replacement venous valve system consisting of the enVVe valve, the enVVe delivery system, and the delivery system accessories.

is conducting pre-clinical testing on enVVe and currently expects to be ready to file for IDE approval for the enVVe pivotal trial (the

Transcatheter Anti-Thrombotic, Venous Valve Endoprosthesis or TAVVE) in Q2 of 2025.

Definitive one year data from SAVVE is expected to be released in the fourth quarter of 2024.

Company is also developing the next generation replacement venous valve called enVVe®, which will be delivered via transcatheter

as opposed to an open surgery.

The Company is conducting pre-clinical testing on enVVe and currently expects to be ready to file for

IDE approval for the enVVe pivotal trial in mid

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

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Food and Drug Administration (“FDA”).

to be eligible to file for FDA approval of the VenoValve in the fourth quarter of 2024 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.

There are currently no devices approved as surgical or non-surgical replacement venous valves,

and there are currently no effective treatments for deep venous CVI caused by incompetent valves.

be eligible to file for FDA approval of the VenoValve in the fourth quarter of 2024 followed approximately three years later by enVVe.

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

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

treatments for deep venous CVI caused by incompetent valves.

team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and that

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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 them 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.

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.

Daily activities such as preparing meals, housework, dressing, 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 them 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.

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

Patients with severe CVI often become housebound and experience social isolation due to difficulty with ambulation.

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.

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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

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

of the leg to treat severe CVI caused by valvular incompetence.

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Clinical Status

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

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

in Colombia which included eleven (11) patients.

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 VenoValve pivotal trial.

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, revised Venous Clinical Severity Scores (rVCSS) scores improved an average of 6 points, and patients also

experienced significant improvements in pain (measured via visual analog scale (“VAS”) scores), and quality of life (measured

by Veines sym/qol) all at one (1) year when compared to pre-surgery levels.

Revised Venous Clinical Severity Scoring (rVCSS) is a validated

measurement commonly used to objectively assess outcomes in the treatment of venous disease, and include ten characteristics consisting

of physician assessments and patient reported outcomes including pain, inflammation, skin changes such as pigmentation and induration,

the number of active ulcers, and ulcer duration.

The improvement in VCSS scores was 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.

Related safety incidences during

the one year first-in-human study for the VenoValve included one (1) surgical pocket hematoma (anti-coagulation related bleeding outside

of the target vein within the surgical cavity), 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.

Three (3) year results from eight (8) first-in-human study participants

who agreed to additional monitoring were presented at the February 2023 annual meeting of the American Venous Forum in San Antonio, Texas.

Patients continued to show significant clinical improvement (average 8 point rVCSS improvement compared to baseline) at three (3) years

post-VenoValve surgery, with no venous ulcer recurrences for C6 patients.

March of 2021 we received IDE approval from the FDA to begin the VenoValve pivotal study.

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two (2) months of the study.

Full enrollment occurred approximately four (4) months earlier than expected due to increased demand for

the VenoValve.

November 16, 2023, we presented preliminary device related thirty-day Device Related Material Adverse Event (“MAE”) data

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In addition, none of the patients with a fully healed venous ulcer had experienced an ulcer

the FDA indicating that one-year data for all 75 patients will be necessary prior to the filing of the application seeking pre-market

approval (“PMA”) for the VenoValve, the Company expects to file the PMA application seeking approval in Q4 of 2024.

FDA has indicated that one-year data on all patients will be necessary prior to completing the application seeking

pre-market approval (“PMA”) for the VenoValve.

On August 14, 2024, the Company announced it had filed and the FDA had approved four of the required five modules

of its PMA application.

The Company expects to file the fifth and final module of its PMA application in Q4 of

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.

The enVVe system consists of the enVVe replacement venous valve, the enVVe delivery

system, and the delivery system accessories.

enVVe is designed to be delivered into the femoral vein of the patient via a minimally invasive

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market for enVVe to be approximately 3.5 million patients.

bench testing and acute pre-clinical testing for the enVVe valve were very successful.

Adjustments to make it easier to load the enVVe

valve into the enVVe delivery system are being finalized and the Company is currently manufacturing the necessary enVVe valves and enVVe

delivery systems to begin a six-month chronic GLP study, which the Company expects to start in Q4 of 2024.

The GLP study should be the

final step necessary before filing for IDE approval to begin the enVVe pivotal study, which the Company expects to file in Q2 of 2025.

On October 28,

2024, we announced the successful start to a six-month pre-clinical GLP study for enVVe.

The first wave of implants, for the

long-term subjects, was successfully completed, with the final wave for the shorter-term subjects scheduled for December.

study is a prerequisite to seeking IDE approval from the FDA to begin the enVVe U.S.

pivotal study.

The Company expects to file for IDE approval for the enVVe pivotal study in mid 2025.

finished 2023 with approximately $46.4 million of cash and investments and had approximately $48.4 million of cash and investments at

June 30, 2024.

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

clinical trials, related product development costs, and our ability to successfully bring products to market.

We anticipate that our

cash burn rate will increase from current levels of approximately $4 million to $5 million per quarter as we conduct our clinical trials

and work toward bringing our product candidates to market.

of Operations

of the three months ended June 30, 2024 and 2023

reported net losses of $5.0 million and $6.5 million for the three months ended June 30, 2024 and 2023, respectively, representing a

decrease in net loss of $1.5 million, or 23.1%, resulting from a decrease in operating expenses and an increase in other income, as described in further detail below.

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.

September 30, 2024.

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

of our clinical trials, related product development costs, and our ability to successfully bring products to market.

We anticipate that

our cash burn rate will increase from current levels of approximately $4 million to $5 million per quarter as we conduct our clinical

trials and work toward bringing our product candidates to market.

September 30, 2024, we closed a public offering raising approximately $13.6 million net cash proceeds.

Based on management’s

current expectations, this capital has the potential to fund the Company through several significant milestones, including the anticipated FDA pre-market approval of the VenoValve, the beginning of preparations for

VenoValve commercialization, and the initial stages of the pivotal trial for enVVe.

Although we expect our quarterly cash burn rate will increase over time to support these milestones, after the additional

proceeds from our offering, we believe we have sufficient cash to fund operations past what we expect will be regulatory approval of

the VenoValve and the start of the enVVe pivotal trial.

of the three months ended September 30, 2024 and 2023

reported net losses of $5.6 million and $5.0 million for the three months ended September 30, 2024 and 2023, respectively, representing

an increase in net loss of $0.6 million or 12%, due to an increase in operating expenses of $0.8 million, and an increase in other income

of $0.2 million.

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

the near future and dependent on our ability to commercialize our product candidates.

and Development Expenses

the three months ended June 30, 2024, research and development expenses decreased by $1.4 million or 33.3%, to $2.8 million from $4.2

million for the three months ended June 30, 2023.

This decrease primarily resulted from $1.7 million in lower costs related the SAVVE

study as the study was fully enrolled during 2023 resulting in the reduction of outreach and enrollment related activities and related

costs, partially offset by a $0.3 million increase in personnel costs to support the SAVVE study and enVVe

the three months ended September 30, 2024, research and development expenses increased by $0.1 million or 2%, to $2.9 million from $2.8

million for the three months ended September 30, 2023.

This increase primarily resulted from $0.2 million in increased personnel costs

to support the SAVVE study and enVVe development, partially offset by a $0.1 million decrease in lab costs.

General and Administrative Expenses

the three months ended June 30, 2024, selling, general and administrative expenses were $2.6 million, flat from the three months ended

June 30, 2023, which was also $2.6 million.

This was due to the net effect of a $0.1 million decrease in share-based compensation,

offset by a $0.1 million increase in legal costs.

For the three months ended June 30, 2024, other income increased $0.1 million

or 25.0% to $0.5 million from $0.4 million for the three months ended June 30, 2023.

Other income in both periods reflects realized gains,

interest, and unrealized gains from our program to invest excess cash in US Treasury bills.

of the six months ended June 30, 2024 and 2023

We reported net losses of $10.0 million and $12.9 million for the six months

ended June 30, 2024 and 2023, respectively, representing a decrease in net loss of $2.9 million or 22.5%, due to a decrease in operating

expenses of $2.6 million and an increase in other income of $0.3 million.

the three months ended September 30, 2024, selling, general and administrative expenses increased by $0.7 million or 27%, to $3.3

million from $2.6 million for the three months ended September 30, 2023.

This increase was due to a $0.2 million increase in

consulting expense related to market research for the Company’s products, and a $0.7 million increase in legal costs,

partially offset by a $0.1 million decrease in share-based compensation, and a $0.1 million decrease in travel expenses due to full

enrollment of the SAVVE study during 2023 resulting in less travel to study sites in 2024.

the three months ended September 30, 2024, other income increased $0.2 million or 52.0% to $0.5 million from $0.3 million for the three

months ended September 30, 2023.

Other income in both periods reflects realized gains, interest, and unrealized gains from our program

to invest excess cash in US Treasury bills.

of the nine months ended September 30, 2024 and 2023

reported net losses of $15.6 million and $17.9 million for the nine months ended September 30, 2024 and 2023, respectively, representing

a decrease in net loss of $2.3 million, or 13%, due to a decrease in operating expenses of $1.8 million, and an increase in other income

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 in

the near future and dependent on our ability to commercialize our product candidates.

and Development Expenses

the six months ended June 30, 2024, research and development expenses decreased by $1.9 million or 24.4%, to $5.9 million from $7.8

million for the six months ended June 30, 2023.

This decrease resulted from $2.6 million in lower costs related the SAVVE study as

it was fully enrolled during 2023 resulting in the elimination of costs related to enrolling patients in the study, partially

offset by a $0.6 million increase in personnel costs due to increased payments to additional staff to support ENVVE product development and the SAVVE study, and $0.1 million in higher lab

related costs.

the nine months ended September 30, 2024, research and development expenses decreased by $1.9 million or 18%, to $8.7 million from $10.6

million for the nine months ended September 30, 2023.

decrease resulted from a $2.7 million reduction in costs related the SAVVE study as it reached full enrollment during the 2023 period

requiring less study related enrollment activity during the 2024 period, partially offset by $0.8 million higher compensation cost due

to increases in staffing.

General and Administrative Expenses

the six months ended June 30, 2024, selling, general and administrative expenses decreased $0.7 million or 12.1%, to $5.1 million from

$5.8 million for the six months ended June 30, 2023.

Of this decrease, $0.9 million was due to share based compensation from grants made

during 2021 because the expense related to portions of grants made during 2021 has been fully amortized and subsequent grants have been

of lower value.

This decrease in stock-based compensation expense was partially offset by a $0.2 million increase in legal costs.

(Income) Expense

the six months ended June 30, 2024, other income increased $0.3 million to $1.0 million from $0.7 million for the six months ended

June 30, 2023.

Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest

excess cash in U.S.

the nine months ended September 30, 2024, selling, general and administrative expenses of $8.4 million

were flat when compared to the nine months ended September 30, 2023.

This is due to $1.0 million in lower share-based compensation

from the reduction in expense from grants made during 2021, the cost for portions of which have been fully recognized, a $0.1 million

decrease in travel expenses due to full enrollment of the SAVVE study during 2023 resulting in less travel to study sites in 2024, partially

offset by $0.8 million in higher legal cost and a $0.3 million increase in consulting expense related to market research for the Company’s

the nine months ended September 30, 2024, other income increased $0.4 million to $1.5 million from $1.1 million for the nine months ended

September 30, 2023.

Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess

and Capital Resources

the six-months ended June 30, 2024, the Company incurred a net loss of $9.9 million and used $7.5 million cash in operating

The net cash used in operating activities during the 2024 period decreased by $2.2 million from $9.7 million for the six

months ended June 30, 2023.

the nine-months ended September 30, 2024, the Company incurred a net loss of $15.6 million and used $11.7 million cash in operating activities.

Net cash used in operating activities for the period ended September 30, 2024 decreased by $2.2 million from $13.9 million for the period

ended September 30, 2023.

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

Administrative functions relate to costs to support the Company’s public reporting and investor relations activities, readying for commercial development of its lead product candidate in the event of receiving PMA approval from the

internal administrative functions.

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our product candidates, currently the VenoValve® and enVVe®.

The Company will continue to incur these costs, and expects costs will increase,

as the Company works to complete its clinical trials, enhance products, develop new products, expand its organization to bring those

products to market, and operate as a public company.

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

we successfully commercialize one or more of our product candidates.

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 develop and 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 nine months ended September 30, 2024 we purchased $33.4 million

of treasury bills and $45.8 million of them matured generating $1.4 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 nine months ended September

30, 2024, our purchases of property and equipment consisting primarily of lab and test equipment, were less than $0.1 million.

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

$0.4 million per year.

However, we expect a modest increase in purchases of property and equipment as we continue the SAVVE study, plan

for commercialization of the VenoValve and continue development of enVVe.

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.

We anticipate that our cash burn rate

will increase from current levels of approximately $4 million to $5 million per quarter as we conduct our clinical trials and work toward

bringing our product candidates to market.

have historically funded our operations through financing activities and will need to raise additional capital in the future.

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.

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

We have historically funded our operations through financing activities.

On September 30, 2024, we closed an offering issuing stock

and warrants and raising approximately $13.6 million net cash proceeds.

Based upon our cash and working capital as of September 30, 2024

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, although we expect to continue incurring losses for the foreseeable future and may need to raise additional capital

to sustain our operations, pursue our product development initiatives and penetrate markets for the sale of our products.

Any inability

to raise additional financing would have a material adverse effect on us.

on our cash and working capital as of June 30, 2024, we have sufficient capital resources to meet our obligations as they become due

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

to raise additional financing in the foreseeable future would have a material adverse effect on us.

of October 28, 2024, we had cash and investments of $47.1 million.

Sheet Arrangements

a smaller reporting company, we are not required to provide the information requested by paragraph (a)(5) of this Item.

Accounting Policies and Estimates

a description of our critical accounting policies, see Note 3 – Significant Accounting Policies in Part 1, Item 1 of this Quarterly

Report on Form 10-Q.

Quantitative and Qualitative Disclosure About Market Risk

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis