What changed in this filing

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Item 9A. Controls and Procedures

2025-02-28 compared with 2024-02-29 · 758 added, 672 removed, 1128 unchanged (56% of the section changed)

Controls and Procedures

and Procedures

of Controls and Procedures

47 unchanged sentences

Management’s report was not subject to attestation by the Company’s independent registered

public accounting firm pursuant to an exemption from Section 404(b) of the Sarbanes-Oxley Act of 2002 that permits the Company to provide only management’s

report in this Annual Report on Form 10-K.

Accordingly, our management’s assessment of the effectiveness of our internal control

over financial reporting as of December 31, 2023 has not been audited by our auditors, Marcum LLP.

Other Information

Disclosure Regarding Foreign Jurisdictions That

Prevent Inspections

Directors, Executive Officers and Corporate Governance

public accounting firm pursuant to an exemption from Section 404(b) of the Sarbanes-Oxley Act of 2002 that permits the Company to provide

only management’s report in this Annual Report on Form 10-K.

Accordingly, our management’s assessment of the effectiveness

of our internal control over financial reporting as of December 31, 2024 has not been audited by our auditors, Marcum LLP.

Regarding Foreign Jurisdictions That Prevent Inspections

Executive Officers and Corporate Governance

below are the names of the directors and executive officers of the Company, their ages as of the date of this Annual Report, their positions

held and the year they commenced service with the Company.

of Service Commencement

Position(s) Held

Year of Service Commencement

Director, Chief Executive Officer

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Senior Vice President and Chief Medical Officer

Senior Vice President & Chief Technology Officer

Berman Robert Berman has served as our Chief Executive Officer and a member of our Board of Directors since April of 2018.

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He is presently serving

as the chief executive officer at Innova Vascular, Inc., a privately funded medical device company engaged in peripheral venous thrombectomy

Prior to this, he co-founded BlackSwan Vascular, Inc., where he served on its board of directors and led a strategic alliance

including the acquisition deal with Sirtex Medical.

as the chief executive officer at Innova Vascular, Inc., an early commercial stage medical device company engaged in peripheral venous

thrombectomy space.

Prior to this, he co-founded BlackSwan Vascular, Inc., where he served on its board of directors and led a strategic

alliance including the acquisition deal with Sirtex Medical.

Sirtex Medical’s parent company acquired BlackSwan Vascular, Inc.

Shrivastava worked on several acquisition and investment deals during his roles as a senior director, business development at J&J

and a vice president, upstream marketing and strategy at BTG, plc, which had an annual revenue of about $800 million and is now part

of Boston Scientific Corporation through an acquisition.

Shrivastava worked on several acquisition and investment deals during his roles as a senior director, business development

at J&J and a vice president, upstream marketing and strategy at BTG, plc, which had an annual revenue of about $800 million and is

now part of Boston Scientific Corporation through an acquisition.

At Medtronic, Dr.

Shrivastava was the Director of Global Marketing for the Cardiac

and Vascular Group where he helped build the embolization business, from its initiation to a substantial revenue with a very high CAGR

over a period of six years.

Shrivastava was part of the peripheral vascular business at Abbott Vascular and worked on trans-catheter

heart valve repair and replacement products at Edwards Life Sciences.

Shrivastava received his Bachelor of Engineering degree at

the Indian Institute of Technology and a doctorate degree in materials science and engineering from the University of Florida.

Shrivastava is qualified to serve as a member of our board of directors because of having served in Chief Executive Officer

and board of director positions at several medical device start-ups, and leadership positions in research and development, business development,

and marketing at Innova Vascular, Inc., BTG, Medtronic, Abbott Vascular, and Edwards Life Sciences.

Shrivastava was the Director of Global Marketing

for the Cardiac and Vascular Group where he helped build the embolization business, from its initiation to a substantial revenue with

a very high CAGR over a period of six years.

Shrivastava was part of the peripheral vascular business at Abbott Vascular and worked

on trans-catheter heart valve repair and replacement products at Edwards Life Sciences.

Shrivastava received his Bachelor of Engineering

degree at the Indian Institute of Technology and a doctorate degree in materials science and engineering from the University of Florida.

We believe that Dr.

Shrivastava is qualified to serve as a member of our board of directors because of having served in Chief Executive

Officer and board of director positions at several medical device start-ups, and leadership positions in research and development, business

development, and marketing at Innova Vascular, Inc., BTG, Medtronic, Abbott Vascular, and Edwards Life Sciences.

Jenusaitis has served as a member of our board of directors since September 2019.

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Gray has also been self-employed as a strategy and financial consultant.

Gray engaged in Postgraduate

Studies at the University of North Carolina–Chapel Hill and has an undergraduate degree from Bucknell University.

We believe that

Gray is qualified to serve as a member of our board of directors because of his financial and medical reimbursement expertise having

served as the Chief Financial Officer at Highmark, Inc., one of America’s largest health insurance organization.

Gray also currently serves as

Chairman and President of Metropolitan Woodworks, Inc., a manufacturer of custom kitchen cabinetry based in North Carolina.

engaged in Postgraduate Studies at the University of North Carolina–Chapel Hill and has an undergraduate degree from Bucknell University.

We believe that Mr.

Gray is qualified to serve as a member of our board of directors because of his financial and medical reimbursement

expertise having served as the Chief Financial Officer at Highmark, Inc., one of America’s largest health insurance organization.

Glickman, M.D.

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He is a member of the American Institute of CPAs.

Hamed Alavi joined enVVeno Medical as Director, Research, Development and Quality in July 2020 and was promoted to Vice President

of Research, Development and Quality in January 2021.

Prior to joining enVVeno Medical, Dr.

Alavi was the head of engineering at NaviGate

Cardiac Structures Inc., a company which developed tricuspid heart valve replacement and delivery system devices, and held roles at Medtronic

Cardiac and Vascular Group (CVG) and Edwards Lifesciences Center for Advanced Cardiovascular Technology where he used his technical and

leadership skills to drive early-stage medical device technologies from conception to commercialization.

Alavi received his doctorate

in biomedical engineering from the University of California, Irvine where he was trained in one of the most prominent cardiovascular

engineering doctoral programs in the US.

His pioneering work in hybrid tissue and implantable medical devices was broadly recognized

and given accolades by a number of institutions – such as the American Heart Association.

He also holds an M.S.

degree in biomedical

engineering and a B.S.

degree in mechanical engineering.

Relationships

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of the Board and Stockholders

board of directors met in person and telephonically six times during 2023 and also acted by unanimous written consent.

There were four

Audit Committee meetings and three Compensation meetings held in 2023.

Our board of directors had 100% attendance for the Annual Meeting

that was held on December 5, 2023.

board of directors met in person and telephonically five times during 2024 and also acted by unanimous written consent.

four Audit Committee meetings and three Compensation Committee meetings held in 2024.

All of the members of our board of directors

were present during at least 75% of the board of director meetings and all of the members of the respective committees of the board

of directors were present during at least 75% of such committee meetings held other than Matthew Jenusaitis who was present for 67%

of the Compensation Committee meetings.

Our board of directors had 100% attendance for the Annual Meeting that was held on December

It is our policy that all directors must attend all stockholder meetings, barring extenuating circumstances.

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The functions of this committee include, among other things:

evaluating the performance,

independence and qualifications of our independent auditors and determining whether to retain our existing independent auditors or

engage new independent auditors;

reviewing and approving

the engagement of our independent auditors to perform audit services and any permissible non-audit services;

reviewing our annual and

quarterly financial statements and reports, including the disclosures contained under the caption “Management’s Discussion

and Analysis of Financial Condition and Results of Operations,” and discussing the statements and reports with our independent

auditors and management;

reviewing with our independent

auditors and management significant issues that arise regarding accounting principles and financial statement presentation and matters

concerning the scope, adequacy and effectiveness of our financial controls;

reviewing our major financial

risk exposures, including the guidelines and policies to govern the process by which risk assessment and risk management is implemented;

reviewing and evaluating

on an annual basis the performance of the audit committee, including compliance of the audit committee with its charter.

the performance, independence and qualifications of our independent auditors and determining whether to retain our existing independent

auditors or engage new independent auditors;

and approving the engagement of our independent auditors to perform audit services and any permissible non-audit services;

our annual and quarterly consolidated financial statements and reports, including the disclosures contained under the caption

“Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and discussing the

statements and reports with our independent auditors and management;

with our independent auditors and management significant issues that arise regarding accounting principles and financial statement

presentation and matters concerning the scope, adequacy and effectiveness of our financial controls;

our major financial risk exposures, including the guidelines and policies to govern the process by which risk assessment and risk

management is implemented;

our cybersecurity data breach risk and impact, cyber prevention and detection controls, privacy matters, incident response, third-party

cyber risk, cyber trends and events, and other cyber topics;

and evaluating on an annual basis the performance of the audit committee, including compliance of the audit committee with its charter.

board of directors has determined that Mr.

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functions of this committee include, among other things:

reviewing, modifying and

approving (or if it deems appropriate, making recommendations to the full board of directors regarding) our overall compensation

strategy and policies;

reviewing and approving

the compensation, the performance goals and objectives relevant to the compensation, and other terms of employment of our Chief Executive

Officers and our other executive officers;

reviewing and approving

(or if it deems appropriate, making recommendations to the full board of directors regarding) the equity incentive plans, compensation

plans and similar programs advisable for us, as well as modifying, amending or terminating existing plans and programs;

reviewing and approving

the terms of any employment agreements, severance arrangements, change in control protections and any other compensatory arrangements

for our executive officers;

reviewing with management

and approving our disclosures under the caption “Compensation Discussion and Analysis” in our periodic reports or proxy

statements to be filed with the SEC;

preparing the report that

the SEC requires in our annual proxy statement.

modifying and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) our overall

compensation strategy and policies;

and approving the compensation, the performance goals and objectives relevant to the compensation, and other terms of employment

of our Chief Executive Officers and our other executive officers;

and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) the equity incentive

plans, compensation plans and similar programs advisable for us, as well as modifying, amending or terminating existing plans and

and approving the terms of any employment agreements, severance arrangements, change in control protections and any other compensatory

arrangements for our executive officers;

with management and approving our disclosures under the caption “Compensation Discussion and Analysis” in our periodic

reports or proxy statements to be filed with the SEC;

the report that the SEC requires in our annual proxy statement;

advising the board and any other board committees if the clawback provisions

of Rule 10D-1 under the Exchange Act (the “Rule”) are triggered based upon a financial statement restatement or other financial

statement change, with the assistance of management and the audit committee and to the extent that our securities continue to be listed

on an exchange and subject to the Rule.

and Corporate Governance Committee

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The functions of this committee include, among other things:

identifying, reviewing

and evaluating candidates to serve on our board of directors consistent with criteria approved by our board of directors;

evaluating director performance

on our board of directors and applicable committees of our board of directors and determining whether continued service on our board

of directors is appropriate;

evaluating, nominating

and recommending individuals for membership on our board of directors;

evaluating nominations

by stockholders of candidates for election to our board of directors.

reviewing and evaluating candidates to serve on our board of directors consistent with criteria approved by our board of directors;

director performance on our board of directors and applicable committees of our board of directors and determining whether continued

service on our board of directors is appropriate;

nominating and recommending individuals for membership on our board of directors;

nominations by stockholders of candidates for election to our board of directors.

board of directors has adopted a written code of conduct that applies to our directors, officers and employees, including our principal

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and any listing standards applicable to the Company.

A copy of the Company’s insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K

for the fiscal year ended December 31, 2024.

Leadership Structure

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convictions and an adjudication finding that an individual violated federal or state securities laws.

Executive Compensation

following table sets forth total compensation paid to our named executive officers for the years ended December 31, 2024 and 2023.

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Senior Vice President & Chief Technology Officer

Represents the grant date

fair value of 300,000 stock options granted on December 5, 2023, computed in accordance with FASB ASC Topic 718.

The options vest

quarterly over a three-year period.

Represents the grant date

fair value of 75,000 stock options granted on December 5, 2023, computed in accordance with FASB ASC Topic 718.

The options vest

quarterly over a three-year period.

Represents the grant date

fair value of 100,000 stock options granted on December 5, 2023, computed in accordance with FASB ASC Topic 718.

The options vest

quarterly over a three-year period.

Represents the grant date

fair value of 100,000 stock options granted on December 5, 2023, computed in accordance with FASB ASC Topic 718.

The options vest

quarterly over a three-year period.

Represents the grant date

fair value of 100,000 stock options granted on November 30, 2022, computed in accordance with FASB ASC Topic 718.

The options vest

quarterly over a three-year period.

Includes company paid healthcare

of $1,241 and 401(k) match of $15,250.

Includes company paid healthcare

of $1,226 and 401(k) match of $15,250.

Includes company paid healthcare

of $1,241 and 401(k) match of $12,452.

Includes company paid healthcare

of $1,225 and 401(k) match of $2,596.

Includes company paid healthcare

of $35,336 and 401(k) match of $15,250.

Includes company paid healthcare

of $39,723 and 401(k) match of $15,250.

Includes company paid healthcare

of $9,505 and 401(k) match of $14,885.

Includes company paid healthcare

of $9,211 and 401(k) match of $11,755.

the grant date fair value of 200,000 stock options granted on December 18, 2024, computed in accordance with FASB ASC Topic 718.

The options vest quarterly over a three-year period

the grant date fair value of 300,000 stock options granted on December 5, 2023, computed in accordance with FASB ASC Topic 718.

options vest quarterly over a three-year period.

the grant date fair value of 75,000 stock options granted on December 5, 2023, computed in accordance with FASB ASC Topic 718.

options vest quarterly over a three-year period.

the grant date fair value of 75,000 stock options granted on December 18, 2024, computed in accordance with FASB ASC Topic 718.

options vest quarterly over a three-year period.

the grant date fair value of 100,000 stock options granted on December 5, 2023, computed in accordance with FASB ASC Topic 718.

options vest quarterly over a three-year period.

the grant date fair value of 75,000 stock options granted on December 18, 2024, computed in accordance with FASB ASC Topic 718.

options vest quarterly over a three-year period.

the grant date fair value of 100,000 stock options granted on December 5, 2023, computed in accordance with FASB ASC Topic 718.

options vest quarterly over a three-year period.

company paid healthcare of $9,679 and 401(k) match of $18,441.

company paid healthcare of $1,241 and 401(k) match of $15,250.

company paid healthcare of $1,360 and 401(k) match of $12,115.

company paid healthcare of $1,241 and 401(k) match of $12,452.

company paid healthcare of $34,406 and 401(k) match of $17,512.

company paid healthcare of $35,336 and 401(k) match of $15,250.

company paid healthcare of $10,665 and 401(k) match of $14,538.

company paid healthcare of $9,505 and 401(k) match of $14,885.

have entered into various employment agreements with certain of our executive officers.

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For purposes of the following employment agreements:

“Cause” generally

means the executive’s (i) willful misconduct or gross negligence in the performance of his or her duties to us;

failure to perform his or her duties to us or to follow the lawful directives of the Chief Executive Officer (other than as a result

of death or disability);

(iii) indictment for, conviction of or pleading of guilty or nolo contendere to, a felony or any crime involving

moral turpitude:

(iv) repeated failure to cooperate in any audit or investigation of our business or financial practices;

(v) performance

of any material act of theft, embezzlement, fraud, malfeasance, dishonesty or misappropriation of our property;

or (vi) material

breach of his or her employment agreement or any other material agreement with us or a material violation of our code of conduct

or other written policy.

“Good reason”

generally means, subject to certain notice requirements and cure rights, without the executive’s consent, (i) material diminution

in his or her base salary or annual bonus opportunity;

(ii) material diminution in his or her authority or duties (although a change

in title will not constitute “good reason”), other than temporarily while physically or mentally incapacitated, as required

by applicable law;

generally means the executive’s (i) willful misconduct or gross negligence in the performance of his or her duties to us;

willful failure to perform his or her duties to us or to follow the lawful directives of the Chief Executive Officer (other than

as a result of death or disability);

(iii) indictment for, conviction of or pleading of guilty or nolo contendere to, a felony or

any crime involving moral turpitude:

(iv) repeated failure to cooperate in any audit or investigation of our business or financial

(v) performance of any material act of theft, embezzlement, fraud, malfeasance, dishonesty or misappropriation of our

or (vi) material breach of his or her employment agreement or any other material agreement with us or a material violation

of our code of conduct or other written policy.

reason” generally means, subject to certain notice requirements and cure rights, without the executive’s consent, (i)

material diminution in his or her base salary or annual bonus opportunity;

(ii) material diminution in his or her authority or duties

(although a change in title will not constitute “good reason”), other than temporarily while physically or mentally incapacitated,

as required by applicable law;

(iii) relocation of his or her primary work location by more than 25 miles from its then current location;

(iv) a material breach by us of a material term of the employment agreement.

“Change of control”

generally means (i) the acquisition, other than from us, by any individual, entity or group (within the meaning of Section 13(d)(3)

or Section 14(d)(2) of the Exchange Act), other than us or any subsidiary, affiliate (within the meaning of Rule 144 promulgated

under the Securities Act) or employee benefit plan of ours, of beneficial ownership (within the meaning of Rule 13d-3 promulgated

under the Exchange Act) of more than 50% of the combined voting power of our then outstanding voting securities entitled to vote

generally in the election of directors;

(ii) a reorganization, merger, consolidation or recapitalization of us, other than a transaction

in which more than 50% of the combined voting power of the outstanding voting securities of the surviving or resulting entity immediately

following such transaction is held by the persons who, immediately prior to the transaction, were the holders of our voting securities;

or (iv) a material breach by us of a material term of the employment agreement.

of control” generally means (i) the acquisition, other than from us, by any individual, entity or group (within the meaning

of Section 13(d)(3) or Section 14(d)(2) of the Exchange Act), other than us or any subsidiary, affiliate (within the meaning of Rule

144 promulgated under the Securities Act) or employee benefit plan of ours, of beneficial ownership (within the meaning of Rule 13d-3

promulgated under the Exchange Act) of more than 50% of the combined voting power of our then outstanding voting securities entitled

to vote generally in the election of directors;

(ii) a reorganization, merger, consolidation or recapitalization of us, other than

a transaction in which more than 50% of the combined voting power of the outstanding voting securities of the surviving or resulting

entity immediately following such transaction is held by the persons who, immediately prior to the transaction, were the holders

of our voting securities;

or (iii) a complete liquidation or dissolution of us, or a sale of all or substantially all of our assets.

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base salary to $450,000 for 2022 and $500,000 commencing in 2023.

Berman also participates in an annual discretionary bonus pool

where he is eligible for a bonus of up to 60% of his base salary, subject to the achievement of key performance indicators, as

determined by our compensation committee, and may also receive additional discretionary bonuses as determined by our compensation

Berman’s employment agreement may be terminated at any time with or without cause and with or without notice or

for good reason thereunder.

Berman is entitled to participate

in our employee benefit, pension and/or profit sharing plans, and we will pay certain health and dental premiums on his behalf.

employment agreement prohibits him from inducing, soliciting or entertaining any of our employees to leave our employ during the term

of the agreement and for 12 months thereafter.

Pursuant to the terms of his employment

agreement, Mr.

In December 2024 the board of directors increased Mr.

Berman’s base salary to $525,000.

Berman also participates in an annual discretionary bonus pool where he is eligible for

a bonus of up to 60% of his base salary.

The bonus amount actually paid, if any, is subject to the achievement of key performance

indicators established each year by our compensation committee.

Berman may also receive additional discretionary bonuses as determined by our

compensation committee.

Berman’s employment agreement may be terminated at any time with or without cause and with or

without notice or for good reason thereunder.

Berman is entitled to participate in our employee benefit, pension and/or profit sharing plans, and we will pay certain health and dental

premiums on his behalf.

Berman’s employment agreement prohibits him from inducing, soliciting or entertaining any of our employees

to leave our employ during the term of the agreement and for 12 months thereafter.

to the terms of his employment agreement, Mr.

Berman is entitled to severance in the event of certain terminations of employment.

In the event Mr.

Berman’s employment

is terminated by us without cause and other than by reason of disability or he resigns for good reason, subject to his timely executing

a release of claims in our favor and in addition to certain other accrued benefits, he is entitled to receive 12 months of continued base

salary (or 24 months if such termination occurs within 24 months following a change of control).

In connection with his employment, Mr.

Berman received an initial equity grant of an option to

purchase 43,209 shares for $10.00 per share, with 8,642 vesting on the date of his Employment Agreement, March 30, 2018, and the

remaining 80% vested ratably on a monthly basis over the following 24 months.

In February 2021, the board of directors approved an

option grant to Mr.

Berman to purchase 838,000 shares of common stock at an exercise price of $8.20 per shares (the closing price of

the Company’s common stock on February 18, 2021).

The stock option vested in equal quarterly installments over a two-year

In November 2021, the board of directors approved an option grant to Mr.

Berman to purchase 349,781 shares of common stock

at an exercise price of $6.70 per shares (the closing price of the Company’s common stock on November 30, 2021).

option vests in equal quarterly installments over a three-year period.

Also in November 2021, the board of directors granted Mr.

the event Mr.

Berman’s employment is terminated by us without cause and other than by reason of disability or he resigns for good

reason, subject to his timely executing a release of claims in our favor and in addition to certain other accrued benefits, he is entitled

to receive 12 months of continued base salary (or 24 months if such termination occurs within 24 months following a change of control).

connection with his employment, Mr.

Berman received an initial equity grant of an option to purchase 43,209 shares for $10.00 per share,

with 8,642 vesting on the date of his Employment Agreement, March 30, 2018, and the remaining 80% vested ratably on a monthly basis over

the following 24 months.

In February 2021, the board of directors approved an option grant to Mr.

Berman to purchase 838,000 shares of

common stock at an exercise price of $8.20 per share (the closing price of the Company’s common stock on February 18, 2021).

stock option vested in equal quarterly installments over a two-year period.

In November 2021, the board of directors approved an option

Berman to purchase 349,781 shares of common stock at an exercise price of $6.70 per share (the closing price of the Company’s

common stock on November 30, 2021).

The stock option vested in equal quarterly installments over a three-year period.

Also in November

2021, the board of directors granted Mr.

Berman 200,000 restricted stock units.

The restricted stock units were initially subject to milestone-based vesting as follows:

50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being achieved, and (ii) 50% upon the Pre-Market

Approval of the VenoValve.

On December 5, 2023, the Board removed the first vesting condition and conditioned vesting of all 200,000

of the restricted stock units on the Pre-Market Approval of the VenoValve.

In December 2023, the board of directors approved an

option grant to Mr.

Berman to purchase 300,000 shares of common stock at an exercise price of $3.59 per shares (the closing price of

the Company’s common stock on December 4, 2023).

The restricted stock units were initially subject to

milestone-based vesting as follows:

(i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being achieved, and

(ii) 50% upon the Pre-Market Approval of the VenoValve.

On December 5, 2023, the Board removed the first vesting condition and conditioned

vesting of all 200,000 of the restricted stock units on the Pre-Market Approval of the VenoValve.

In December 2023, the board of directors

approved an option grant to Mr.

Berman to purchase 300,000 shares of common stock at an exercise price of $3.59 per share (the closing

price of the Company’s common stock on December 4, 2023).

The stock option vests in equal quarterly installments over a three-year

In December 2024, the board of directors approved an option grant to Mr.

Berman to purchase 200,000 shares of common stock at

an exercise price of $2.57 per share (the closing price of the Company’s common stock on December 18, 2024).

The stock option vests

in equal quarterly installments over a three-year period.

Additionally, the board of directors paid Mr.

Berman a cash

bonus of $500,000 for 2023.

Berman a cash bonus of $232,500

and $500,000 for 2024 and 2023, respectively.

February 19, 2021, the Company entered into an employment agreement with Mr.

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Glynn also participates in an annual

year-end discretionary bonus pool where he is eligible for a bonus of up to 20% of his base salary, subject to the achievement of

key performance indicators, as determined by our compensation committee, and may also receive additional discretionary bonuses as

determined by our compensation committee.

discretionary bonus pool where he is eligible for a bonus of up to 20% of his base salary.

The bonus amount actually paid, if any,

is subject to the achievement of key performance indicators established each year by our compensation committee.

Glynn may also receive

additional discretionary bonuses as determined by our compensation committee.

The board of directors paid Mr.

Glynn a cash bonus of $50,000 for 2023.

employment agreement further provides that Mr.

Glynn is entitled to participate in any employee benefit plans that the Company has

adopted or may adopt.

Glynn a cash bonus of

$38,750 for 2024.

The employment agreement further provides that Mr.

Glynn is entitled to participate in any employee benefit plans

that the Company has adopted or may adopt.

to the terms of the employment agreement, Mr.

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Glynn on the termination date will vest (or terminate) in accordance with the terms of such grant.

In February 2021, the board of directors approved an option grant to Mr.

Glynn to purchase 324,000 shares of common

stock of the Company at an exercise price of $8.20 per shares (the closing price of the Company’s common stock on February 18, 2021).

The stock options vest in equal quarterly installments over a three-year period with a six-month cliff.

In November 2021, the board of

directors approved an option grant to Mr.

Glynn to purchase 125,925 shares of common stock at an exercise price of $6.70 per shares (the

closing price of the Company’s common stock on November 30, 2021).

The stock option vests in equal quarterly installments over a

three-year period.

February 2021, the board of directors approved an option grant to Mr.

Glynn to purchase 324,000 shares of common stock of the Company

at an exercise price of $8.20 per share (the closing price of the Company’s common stock on February 18, 2021).

The stock options

vest in equal quarterly installments over a three-year period with a six-month cliff.

In November 2021, the board of directors approved

an option grant to Mr.

Glynn to purchase 125,925 shares of common stock at an exercise price of $6.70 per share (the closing price of

the Company’s common stock on November 30, 2021).

The stock option vests in equal quarterly installments over a three-year period.

In November 2021, the board of directors granted Mr.

Glynn 50,000 restricted stock units.

The restricted stock units

were initially subject to milestone-based vesting as follows:

(i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints

being achieved, and (ii) 50% upon the Pre-Market Approval of the VenoValve.

On December 5, 2023, the Board removed the first vesting condition

and conditioned vesting of all 50,000 of the restricted stock units on the Pre-Market Approval of the VenoValve.

In December 2023, the

board of directors approved an option grant to Mr.

Glynn to purchase 75,000 shares of common stock at an exercise price of $3.59 per shares

(the closing price of the Company’s common stock on December 4, 2023).

The stock option vests in equal quarterly installments over

a three-year period.

The restricted stock units were initially subject

to milestone-based vesting as follows:

(i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being achieved,

and (ii) 50% upon the Pre-Market Approval of the VenoValve.

On December 5, 2023, the Board removed the first vesting condition and conditioned

vesting of all 50,000 of the restricted stock units on the Pre-Market Approval of the VenoValve.

In December 2023, the board of directors

approved an option grant to Mr.

Glynn to purchase 75,000 shares of common stock at an exercise price of $3.59 per share (the closing

price of the Company’s common stock on December 4, 2023).

The stock option vests in equal quarterly installments over a three-year

Glickman, M.D.

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base salary was $300,000, subject to annual review and adjustment at the discretion of our board of directors.

In connection with his Pre-existing Employment Agreement, Dr.

Glickman received an initial equity

grant of an option to purchase up to 7,380 shares of our common stock with 20% of the shares vesting immediately and 80% vesting on a

monthly basis over 24 months thereafter.

In connection with his

Pre-existing Employment Agreement, Dr.

Glickman received an initial equity grant of an option to purchase up to 7,380 shares of our common

stock with 20% of the shares vesting immediately and 80% vesting on a monthly basis over 24 months thereafter.

The initial term of Dr.

Glickman’s Pre-existing Employment Agreement ended on December

31, 2018 and was automatically extended for an additional three-year term.

Glickman’s Pre-existing Employment Agreement ended on December 31, 2018 and was automatically extended for an additional three-year

July 26, 2019, we entered into an employment agreement with Dr.

Glickman (the “New Employment Agreement”) that supersedes

the terms of the Pre-existing Employment Agreement.

Glickman (the “New Employment Agreement”) that

supersedes the terms of the Pre-existing Employment Agreement.

Pursuant to the terms of the New Employment Agreement, Dr.

Glickman’s base

salary is $350,000 per year, subject to annual review and adjustment at the discretion of the Board.

In December 2022, the board of directors

increased Mr.

Glickman’s base salary is $350,000 per year, subject to annual review and adjustment at the discretion of the Board.

December 2022, the board of directors increased Dr.

Glickman’s base salary to $367,500.

Glickman also participates in an annual year-end discretionary bonus

pool where he is eligible for a bonus of up to 20% of his base salary, subject to the achievement of key performance indicators, as determined

by our compensation committee, and may also receive additional discretionary bonuses as determined by our compensation committee.

In connection with entering into the New Employment Agreement, Dr.

existing seven thousand three hundred and eighty (7,380) options (“Existing Options”) to purchase Company common stock at

two hundred and fifty dollars ($250.00) per share until October 1, 2026, were repriced to fifty dollars ($50.00) per share.

Additionally,

Glickman, in connection with the New Employment Agreement, was granted stock options for the right to purchase seven thousand two

hundred (7,200) common stock at a price equal to fifty dollars ($50.00) per share exercisable until July 26, 2029, which vested quarterly

over a three (3) year period.

Pursuant to the terms of the New

Employment Agreement, Dr.

Glickman is an at-will employee and is entitled to severance in the event of certain terminations of his employment.

Glickman also participates in an

annual year-end discretionary bonus pool where he is eligible for a bonus of up to 20% of his base salary.

The bonus amount actually

paid, if any, is subject to the achievement of key performance indicators established each year by our compensation committee.

may also receive additional discretionary bonuses as determined by our compensation committee.

connection with entering into the New Employment Agreement, Dr.

Glickman’s existing seven thousand three hundred and eighty (7,380)

options (“Existing Options”) to purchase Company common stock at two hundred and fifty dollars ($250.00) per share until

October 1, 2026, were repriced to fifty dollars ($50.00) per share.

Additionally, Dr.

Glickman, in connection with the New Employment

Agreement, was granted stock options for the right to purchase seven thousand two hundred (7,200) common stock at a price equal to fifty

dollars ($50.00) per share exercisable until July 26, 2029, which vested quarterly over a three (3) year period.

to the terms of the New Employment Agreement, Dr.

Glickman is an at-will employee and is entitled to severance in the event of certain

terminations of his employment.

In the event that Dr.

Glickman’s employment is terminated by the Company without Cause (as defined in the New Employment Agreement),

other than by reason of Disability (as defined in the New Employment Agreement), or he resigns for Good Reason (as defined in the New

Employment Agreement), subject to his timely executing a release of claims in favor of the Company and in addition to certain other accrued

benefits, Dr.

Glickman is entitled to receive three months of his base salary for each year that he has been employed by the Company at

the time of termination, up to a total of one year of his base salary.

In February 2021, the board of directors approved an option grant to Dr.

Glickman to purchase 406,000 shares

of common stock at an exercise price of $8.20 per shares (the closing price of the Company’s common stock on February 18, 2021).

The stock option vested in equal quarterly installments over a two-year period.

In November 2021, the board of directors approved an

option grant to Mr.

Glickman to purchase 265,700 shares of common stock at an exercise price of $6.70 per shares (the closing price of

the Company’s common stock on November 30, 2021).

Glickman’s employment is terminated by the Company without Cause (as defined

in the New Employment Agreement), other than by reason of Disability (as defined in the New Employment Agreement), or he resigns for

Good Reason (as defined in the New Employment Agreement), subject to his timely executing a release of claims in favor of the Company

and in addition to certain other accrued benefits, Dr.

Glickman is entitled to receive three months of his base salary for each year

that he has been employed by the Company at the time of termination, up to a total of one year of his base salary.

February 2021, the board of directors approved an option grant to Dr.

Glickman to purchase 406,000 shares of common stock at an exercise

price of $8.20 per shares (the closing price of the Company’s common stock on February 18, 2021).

The stock option vested in equal

quarterly installments over a two-year period.

In November 2021, the board of directors approved an option grant to Mr.

Glickman to purchase

265,700 shares of common stock at an exercise price of $6.70 per share (the closing price of the Company’s common stock on November

The stock option vests in equal quarterly installments over a three-year period.

Also in November 2021, the board of directors granted Mr.

Also in November 2021, the board of directors

Glickman 100,000 restricted stock units.

The restricted stock units were initially

subject to milestone-based vesting as follows:

(i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being

achieved, and (ii) 50% upon the Pre-Market Approval of the VenoValve.

On December 5, 2023, the Board removed the first vesting condition

and conditioned vesting of all 100,000 of the restricted stock units on the Pre-Market Approval of the VenoValve.

In December 2023, the

board of directors approved an option grant to Mr.

The restricted stock units were initially subject to milestone-based vesting as

(i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being achieved, and (ii) 50% upon the Pre-Market

Approval of the VenoValve.

On December 5, 2023, the Board removed the first vesting condition and conditioned vesting of all 100,000

of the restricted stock units on the Pre-Market Approval of the VenoValve.

In December 2023, the board of directors approved an option

Glickman to purchase 100,000 shares of common stock at an exercise price of $3.59 per share (the closing price of the Company’s

common stock on December 4, 2023).

The stock option vests in equal quarterly installments over a three-year period.

In December 2024,

the board of directors approved an option grant to Mr.

Glickman to purchase 75,000 shares of common stock at an exercise price of $2.57

per shares (the closing price of the Company’s common stock on December 4, 2023).

per share (the closing price of the Company’s common stock on December 18, 2024).

The stock option vests in equal quarterly installments

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Additionally, the board of directors paid Mr.

Glickman a cash bonus of $73,500 for 2023.

Glickman a cash bonus of $56,963 and $73,500 for 2024 and 2023,

respectively.

July 29, 2020, we entered into an employment agreement with Dr.

5 unchanged sentences

Alavi also participates in an

annual year-end discretionary bonus pool where he is eligible for a bonus of up to 25% of his base salary, subject to the

achievement of key performance indicators, as determined by our compensation committee, and may also receive additional

discretionary bonuses as determined by our compensation committee.

In November 2021 the board of directors increased Mr.

Alavi’s base salary to $240,000 and, in November 2022, the board of

directors increased Mr.

Alavi’s annual base salary to $300,000.

annual year-end discretionary bonus pool where he is eligible for a bonus of up to 25% of his base salary.

The bonus amount actually

paid, if any, is subject to the achievement of key performance indicators established each year by our compensation committee.

also receive additional discretionary bonuses as determined by our compensation committee.

In November 2021 the board of directors

increased Mr.

Alavi’s base salary to $240,000 and, in November 2022, the board of directors increased Mr.

Alavi’s annual

base salary to $300,000.

Additionally, the board of directors paid Mr.

bonus of $60,000 for 2023.

Pursuant to the terms of the employment

agreement, Mr.

Alavi a cash bonus of $46,500 and $60,000 for 2024 and 2023,

respectively.

to the terms of the employment agreement, Mr.

Alavi’s employment is terminable due to Mr.

Alavi’s disability or death, for “Cause” (as defined

in the employment agreement) or without “Cause” by the Company, and for “Good Reason” (as defined in the employment

agreement) or voluntarily by Mr.

Alavi’s disability or death, for

“Cause” (as defined in the employment agreement) or without “Cause” by the Company, and for “Good Reason”

(as defined in the employment agreement) or voluntarily by Mr.

In the event of Mr.

Alavi’s death or disability, or termination for “Cause”

by the Company or without “Good Reason” by Mr.

Alavi (or his estate) is entitled to receive any unpaid base salary

through the termination date, reimbursement for unreimbursed business expenses, accrued but unused vacation time in accordance with the

Company’s policy and any other payments or benefits that Mr.

Alavi is entitled to in accordance with any Company benefit plans (collectively,

the “Accrued Benefits”).

Upon termination without “Cause” (other than by reason of death or disability) or resignation

for “Good Reason,” Mr.

Alavi will be entitled to three months of severance for each year Mr.

Alavi is employed up to one year

of severance, in addition to all Accrued Benefits.

Any outstanding unvested securities owned by Mr.

Alavi on the termination date will

vest (or terminate) in accordance with the terms of such grant.

In February 2021, the board of directors approved an option grant to Mr.

Alavi to purchase 320,000 shares of common stock of the

Company at an exercise price of $8.20 per shares (the closing price of the Company’s common stock on February 18, 2021).

stock options vest in equal quarterly installments over a three year period with a six month cliff.

In November 2021, the board of

directors approved an option grant to Mr.

Alavi to purchase 125,925 shares of common stock at an exercise price of $6.70 per shares

(the closing price of the Company’s common stock on November 30, 2021).

The stock option vests in equal quarterly installments

over a three year period.

Alavi’s death or disability, or termination

for “Cause” by the Company or without “Good Reason” by Mr.

Alavi (or his estate) is entitled to receive

any unpaid base salary through the termination date, reimbursement for unreimbursed business expenses, accrued but unused vacation time

in accordance with the Company’s policy and any other payments or benefits that Mr.

Alavi is entitled to in accordance with any

Company benefit plans (collectively, the “Accrued Benefits”).

Upon termination without “Cause” (other than by

reason of death or disability) or resignation for “Good Reason,” Mr.

Alavi will be entitled to three months of severance

for each year Mr.

Alavi is employed up to one year of severance, in addition to all Accrued Benefits.

Any outstanding unvested securities

Alavi on the termination date will vest (or terminate) in accordance with the terms of such grant.

The employment agreement

further provides that Mr.

Alavi is entitled to participate in any employee benefit plans that the Company has adopted or may adopt.

February 2021, the board of directors approved an option grant to Mr.

Alavi to purchase 320,000 shares of common stock of the Company

at an exercise price of $8.20 per shares (the closing price of the Company’s common stock on February 18, 2021).

The stock options

vested in equal quarterly installments over a three year period with a six month cliff.

In November 2021, the board of directors approved

an option grant to Mr.

Alavi to purchase 125,925 shares of common stock at an exercise price of $6.70 per shares (the closing price of

the Company’s common stock on November 30, 2021).

The stock option vested in equal quarterly installments over a three year period.

Also in November 2021, the board of directors granted Mr.

Alavi 50,000 restricted stock units.

restricted stock units were initially subject to milestone-based vesting as follows:

(i) 50% upon SAVVE (Surgical Anti-reflux Venous

Valve Endoprosthesis) endpoints being achieved, and (ii) 50% upon the Pre-Market Approval of the VenoValve.

On December 5, 2023, the

Board removed the first vesting condition and conditioned vesting of all 50,000 of the restricted stock units on the Pre-Market

Approval of the VenoValve.

The restricted stock units were initially

subject to milestone-based vesting as follows:

(i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being

achieved, and (ii) 50% upon the Pre-Market Approval of the VenoValve.

On December 5, 2023, the Board removed the first vesting condition

and conditioned vesting of all 50,000 of the restricted stock units on the Pre-Market Approval of the VenoValve.

In December 2023, the

board of directors approved an option grant to Mr.

Alavi to purchase 100,000 shares of common stock at an exercise price of $3.59 per

shares (the closing price of the Company’s common stock on December 4, 2023).

The stock option vests in equal quarterly installments

over a three-year period.

In December 2024, the board of directors approved an option grant to Mr.

Alavi to purchase 100,000 shares

of common stock at an exercise price of $3.59 per shares (the closing price of the Company’s common stock on December 4,

The stock option vests in equal quarterly installments over a three-year period.

The employment agreement further provides

Alavi is entitled to participate in any employee benefit plans that the Company has adopted or may adopt.

Alavi to purchase 75,000 shares of

common stock at an exercise price of $2.57 per shares (the closing price of the Company’s common stock on December 18, 2024).

stock option vests in equal quarterly installments over a three-year period.

Payments Upon Termination or Change-in-Control

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December 2, 2033

February 16, 2034

Glickman, M.D.

7 unchanged sentences

December 2, 2033

February 16, 2034

July 18, 2030

10 unchanged sentences

December 2, 2033

Options were granted on

September 24, 2018, and vested 20% on the date of his Employment Agreement, March 30, 2018, and the remaining 80% vests ratably on

a monthly basis over the 24 months following the date of his Employment Agreement.

Options were granted on

July 18, 2020 and vest ratably on a monthly basis over 36 months.

Options were granted on

February 18, 2021 and vest ratably on a quarterly basis over two years.

Options were granted on

November 30, 2021 and vest ratably on a quarterly basis over three years.

On July 26, 2019, the Company

entered a new employment agreement with Dr.

Glickman that superseded the terms of his existing employment agreement.

In connection

with entering into the new employment agreement, Dr.

Glickman’s existing 7,380 options that were granted on October 1, 2016

were repriced from $250.00 to $50.00 per share.

February 16, 2034

were granted on September 24, 2018, and vested 20% on the date of his Employment Agreement, March 30, 2018, and the remaining 80%

vests ratably on a monthly basis over the 24 months following the date of his Employment Agreement.

were granted on July 18, 2020 and vest ratably on a monthly basis over 36 months.

were granted on February 18, 2021 and vest ratably on a quarterly basis over two years.

were granted on November 30, 2021 and vest ratably on a quarterly basis over three years.

July 26, 2019, the Company entered a new employment agreement with Dr.

Glickman that superseded the terms of his existing employment

In connection with entering into the new employment agreement, Dr.

Glickman’s existing 7,380 options that were granted

on October 1, 2016 were repriced from $250.00 to $50.00 per share.

Additionally, on July 26, 2019, Dr.

Glickman was granted 7,200 options at $50.00

per share vesting quarterly over a three-year period.

Glynn was elevated

to permanent Chief Financial Officer in January 2021.

Options were granted on

July 18, 2020 and vest ratably on a quarterly basis over three years.

Options were granted on

February 18, 2021 and vest ratably on a quarterly basis over three years.

Options were granted on

November 30, 2022 and vest ratably on a quarterly basis over three years.

Options were granted on

December 5, 2023 and vest ratably on a quarterly basis over three years.

Glickman was granted 7,200

options at $50.00 per share vesting quarterly over a three-year period.

Glynn was elevated to permanent Chief Financial Officer in January 2021.

were granted on July 18, 2020 and vest ratably on a quarterly basis over three years.

were granted on February 18, 2021 and vest ratably on a quarterly basis over three years.

were granted on November 30, 2022 and vest ratably on a quarterly basis over three years.

were granted on December 5, 2023 and vest ratably on a quarterly basis over three years.

were granted on December 18, 2024 and vest ratably on a quarterly basis over three years.

that have not

4 unchanged sentences

Hamed Alavi, Senior Vice President and Chief Technology Officer

Determined by multiplying

the number of restricted stock units that have not vested by $5.14, the closing price of NVNO’s common stock on December 30,

2023, the last trading day of 2023.

On November 30, 2021, Mr.

by multiplying the number of restricted stock units that have not vested by $3.02, the closing price of NVNO’s common stock

on December 31, 2024, the last trading day of 2024.

November 30, 2021, Mr.

Berman was granted 200,000 restricted stock units, Dr.

Glickman was granted 100,000 restricted stock units, Mr.

Glynn was granted

50,000 restricted stock units and Mr.

Glickman was granted 100,000 restricted stock units,

Glynn was granted 50,000 restricted stock units and Mr.

Alavi was granted 50,000 restricted stock units.

The restricted stock units were initially

subject to milestone-based vesting as follows:

(i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being

achieved, and (ii) 50% upon the Pre-Market Approval of the VenoValve.

On December 5, 2023, the Board removed the first vesting condition

and conditioned vesting of all of the restricted stock units on the Pre-Market Approval of the VenoValve.

The restricted stock

units were initially subject to milestone-based vesting as follows:

(i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis)

endpoints being achieved, and (ii) 50% upon the Pre-Market Approval of the VenoValve.

On December 5, 2023, the Board removed the

first vesting condition and conditioned vesting of all of the restricted stock units on the Pre-Market Approval of the VenoValve.

Benefit Plans

11 unchanged sentences

filed as an exhibit to this Annual Report on Form 10-K.

Equity Award Grant Timing

We generally grant equity awards to our employees and directors in the fourth quarter each calendar year, except

in the case of equity awards for new hires which are granted at the board meeting following the acceptance of the employment offer.

do not have a written policy regarding the timing of equity awards, but we do not grant equity awards in anticipation of the release of

material nonpublic information, nor do we time the release of material nonpublic information based on equity award grant dates.

currently have reserved 7,150,497 shares of our common stock for issuance under the 2016 Plan, provided, however, if at any time the

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2016 Plan permits the granting of any or all of the following types of awards:

Stock Options .

options entitle the holder to purchase a specified number of shares of common stock at a specified price (the exercise price), subject

to the terms and conditions of the stock option grant.

Our compensation committee may grant either incentive stock options, which

must comply with Code Section 422, or nonqualified stock options.

Our compensation committee sets exercise prices and terms and conditions,

except that stock options must be granted with an exercise price not less than 100% of the fair market value of our common stock

on the date of grant (excluding stock options granted in connection with assuming or substituting stock options in acquisition transactions).

Unless our compensation committee determines otherwise, fair market value means, as of a given date, the closing price of our common

At the time of grant, our compensation committee determines the terms and conditions of stock options, including the quantity,

exercise price, vesting periods, term (which cannot exceed 10 years) and other conditions on exercise.

Stock Appreciation Rights .

Our compensation committee may grant SARs, as a right in tandem with the number of shares underlying stock options granted under

the 2016 Plan or as a freestanding award.

Upon exercise, SARs entitle the holder to receive payment per share in stock or cash, or

in a combination of stock and cash, equal to the excess of the share’s fair market value on the date of exercise over the grant

price of the SAR.

The grant price of a tandem SAR is equal to the exercise price of the related stock option and the grant price

for a freestanding SAR is determined by our compensation committee in accordance with the procedures described above for stock options.

Exercise of a SAR issued in tandem with a stock option will reduce the number of shares underlying the related stock option to the

extent of the SAR exercised.

The term of a freestanding SAR cannot exceed 10 years, and the term of a tandem SAR cannot exceed the

term of the related stock option.

Restricted Stock, Restricted

Stock Units and Other Stock-Based Awards .

Our compensation committee may grant awards of restricted stock, which are shares of

common stock subject to specified restrictions, and restricted stock units, or RSUs, which represent the right to receive shares

of our common stock in the future.

These awards may be made subject to repurchase, forfeiture or vesting restrictions at our compensation

committee’s discretion.

The restrictions may be based on continuous service with us or the attainment of specified performance

goals, as determined by our compensation committee.

Stock units may be paid in stock or cash or a combination of stock and cash,

as determined by our compensation committee.

Our compensation committee may also grant other types of equity or equity-based awards

subject to the terms and conditions of the 2016 Plan and any other terms and conditions determined by our compensation committee.

Performance Awards .

Our compensation committee may grant performance awards, which entitle participants to receive a payment from us, the amount of which

is based on the attainment of performance goals established by our compensation committee over a specified award period.

awards may be denominated in shares of common stock or in cash, and may be paid in stock or cash or a combination of stock and cash,

as determined by our compensation committee.

Stock options entitle the holder to purchase a specified number of shares of common stock at a specified price (the

exercise price), subject to the terms and conditions of the stock option grant.

Our compensation committee may grant either incentive

stock options, which must comply with Code Section 422, or nonqualified stock options.

Our compensation committee sets exercise prices

and terms and conditions, except that stock options must be granted with an exercise price not less than 100% of the fair market

value of our common stock on the date of grant (excluding stock options granted in connection with assuming or substituting stock

options in acquisition transactions).

Unless our compensation committee determines otherwise, fair market value means, as of a given

date, the closing price of our common stock.

At the time of grant, our compensation committee determines the terms and conditions

of stock options, including the quantity, exercise price, vesting periods, term (which cannot exceed 10 years) and other conditions

Appreciation Rights .

Our compensation committee may grant SARs, as a right in tandem with the number of shares underlying stock

options granted under the 2016 Plan or as a freestanding award.

Upon exercise, SARs entitle the holder to receive payment per share

in stock or cash, or in a combination of stock and cash, equal to the excess of the share’s fair market value on the date of

exercise over the grant price of the SAR.

The grant price of a tandem SAR is equal to the exercise price of the related stock option

and the grant price for a freestanding SAR is determined by our compensation committee in accordance with the procedures described

above for stock options.

Exercise of a SAR issued in tandem with a stock option will reduce the number of shares underlying the related

stock option to the extent of the SAR exercised.

The term of a freestanding SAR cannot exceed 10 years, and the term of a tandem

SAR cannot exceed the term of the related stock option.

Stock, Restricted Stock Units and Other Stock-Based Awards .

Our compensation committee may grant awards of restricted stock,

which are shares of common stock subject to specified restrictions, and restricted stock units, or RSUs, which represent the right

to receive shares of our common stock in the future.

These awards may be made subject to repurchase, forfeiture or vesting restrictions

at our compensation committee’s discretion.

The restrictions may be based on continuous service with us or the attainment of

specified performance goals, as determined by our compensation committee.

Stock units may be paid in stock or cash or a combination

of stock and cash, as determined by our compensation committee.

Our compensation committee may also grant other types of equity or

equity-based awards subject to the terms and conditions of the 2016 Plan and any other terms and conditions determined by our compensation

Our compensation committee may grant performance awards, which entitle participants to receive a payment from us, the

amount of which is based on the attainment of performance goals established by our compensation committee over a specified award

Performance awards may be denominated in shares of common stock or in cash, and may be paid in stock or cash or a combination

of stock and cash, as determined by our compensation committee.

Cash-based performance awards include annual incentive awards.

1 unchanged sentence

compensation pursuant to Rule 10D-1 of the Exchange Act, any implementing rules and regulations under such laws, any policies we adopted

to implement such requirements and any other compensation recovery policies as we may adopt from time to time, including our recently adopted clawback policy that was adopted in accordance with Nasdaq rules.

to implement such requirements and any other compensation recovery policies as we may adopt from time to time, including our recently

adopted clawback policy that was adopted in accordance with Nasdaq rules.

the 2016 Plan, in the event of a change in control (as defined in the 2016 Plan), outstanding awards will be treated in accordance with

11 unchanged sentences

of awards will depend on whether the awards are assumed, converted or replaced by the resulting entity.

For awards that are not

assumed, converted or replaced, the awards will vest upon the change in control.

For performance awards, the amount vesting will

be based on the greater of (1) achievement of all performance goals at the “target” level or (2) the actual level of

achievement of performance goals as of our fiscal quarter end preceding the change in control, and will be prorated based on the

portion of the performance period that had been completed through the date of the change in control.

For awards that are assumed,

converted or replaced by the resulting entity, no automatic vesting will occur upon the change in control.

Instead, the awards, as

adjusted in connection with the transaction, will continue to vest in accordance with their terms and conditions.

In addition, the

awards will vest if the award recipient has a separation from service within two years after a change in control by us other than

for “cause” or by the award recipient for “good reason” (each as defined in the applicable award agreement).

For performance awards, the amount vesting will be based on the greater of (1) achievement of all performance goals at the “target”

level or (2) the actual level of achievement of performance goals as of our fiscal quarter end preceding the change in control, and

will be prorated based on the portion of the performance period that had been completed through the date of the separation from service.

awards that are not assumed, converted or replaced, the awards will vest upon the change in control.

For performance awards, the

amount vesting will be based on the greater of (1) achievement of all performance goals at the “target” level or (2)

the actual level of achievement of performance goals as of our fiscal quarter end preceding the change in control, and will be prorated

based on the portion of the performance period that had been completed through the date of the change in control.

awards that are assumed, converted or replaced by the resulting entity, no automatic vesting will occur upon the change in control.

Instead, the awards, as adjusted in connection with the transaction, will continue to vest in accordance with their terms and conditions.

In addition, the awards will vest if the award recipient has a separation from service within two years after a change in control

by us other than for “cause” or by the award recipient for “good reason” (each as defined in the applicable

award agreement).

For performance awards, the amount vesting will be based on the greater of (1) achievement of all performance goals

at the “target” level or (2) the actual level of achievement of performance goals as of our fiscal quarter end preceding

the change in control, and will be prorated based on the portion of the performance period that had been completed through the date

of the separation from service.

and Termination of the 2016 Plan

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monetary damages for breach of their fiduciary duties as directors, except liability for any of the following:

any breach of their duty

of loyalty to us or our stockholders;

acts or omissions not in

good faith or that involve intentional misconduct or a knowing violation of law;

unlawful payments of dividends

or unlawful stock repurchases or redemptions as provided in Section 174 of the DGCL;

any transaction from which

the director derived an improper personal benefit.

breach of their duty of loyalty to us or our stockholders;

or omissions not in good faith or that involve intentional misconduct or a knowing violation of law;

payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the DGCL;

transaction from which the director derived an improper personal benefit.

amended and restated bylaws also provide that we will indemnify our directors and executive officers and may indemnify our other officers

50 unchanged sentences

Shrivastava, Mr.

Jenusaitis were

each granted 8,403 options to purchase shares of our common stock on November 30, 2022, as part of their compensation for the year

ending December 31, 2023, at an exercise price of $6.70 per share.

The options were valued at $4.46 per share as of the date of the

grant and vested in equal quarterly portions starting on March 31, 2023 and through December 31, 2023, such that they were fully

vested at December 31, 2023.

Jenusaitis were each

granted 13,856 options to purchase shares of our common stock on December 5, 2023, as part of their compensation for the year ending

December 31, 2024, at an exercise price of $3.59 per share.

The options were valued at $2.71 per share as of the date of the grant and

will vest in equal quarterly portions starting on March 31, 2024 and through December 31, 2024, such that they were fully vested at December

The grant date value of each grant determined in accordance with FASB ASC Topic 718 was $37,500.

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December 31, 2023, at an exercise price of $6.70 per share.

The options were valued at $5.20 per share as of the date of the grant.

grant date value of each grant determined in accordance with FASB ASC Topic 718 was $37,500.

The options were valued at $4.46 per share as of the date of the grant and

vested in equal quarterly portions starting on March 31, 2023 and through December 31, 2023, such that they were fully vested at December

The grant date value of each grant determined in accordance with FASB ASC Topic 718 was $37,500.

Under the Company’s nonemployee director compensation program, Dr.

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The options were valued at $1.90 per share as of the date of the grant and

will vest in equal quarterly portions starting on March 31, 2024 and through December 31, 2024, such that they will fully vest at December

will vest in equal quarterly portions starting on March 31, 2025 and through December 31, 2025, such that they will fully vest by December

The grant date value of each grant determined in accordance with FASB ASC Topic 718 was $37,500.

Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

following table lists, as of February 27, 2024, the number of shares of common stock of our Company that are beneficially owned by

(i) each person or entity known to our Company to be the beneficial owner of more than 5% of the outstanding common stock;

officer and director of our Company;

following table lists, as of February 26, 2025, the number of shares of common stock of our Company that are beneficially owned by (i)

each person or entity known to our Company to be the beneficial owner of more than 5% of the outstanding common stock;

(ii) each officer

and director of our Company;

and (iii) all officers and directors as a group.

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Perceptive Life Sciences Master Fund Ltd.

Nantahala Capital Management, LLC(3)

Named Executive Officers and Directors

8 unchanged sentences

Represents beneficial ownership of less than 1%.

Except as otherwise noted

below, the address for each person or entity listed in the table is c/o enVVeno Medical Corporation, 70 Doppler, Irvine, California

Based on a Schedule 13G

filed by the Perceptive Live Sciences Master Fund Ltd.

(the “Master Fund”).

The Master Fund directly holds 623,315

shares of common stock and 2,620,227 pre-funded warrants.

The pre-funded warrants may not be exercised if the Master Fund would beneficially

own more than 9.9% of the Company’s outstanding shares of common stock after giving effect to such exercise.

Perceptive Advisors

serves as the investment manager to the Master Fund and may be deemed to beneficially own such shares.

Edelman is the managing

member of Perceptive Advisors and may be deemed to beneficially own such shares.

Includes 1,215,766 shares

of common stock issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February 27, 2024.

Includes 670,596 shares

of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February

Includes 493,679 shares

of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February

Includes 430,499 shares

of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February

Includes 31,151 shares

of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February

Includes 31,151 shares

of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February

Includes 30,351 shares

of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February

Includes 30,351 shares

of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February

as otherwise noted below, the address for each person or entity listed in the table is c/o enVVeno Medical Corporation, 70 Doppler,

Irvine, California 92618.

on a Schedule 13G/A filed with the SEC on November 14, 2024 by (i) Perceptive Advisors LLC(“Perceptive Advisors”), (ii)

Joseph Edelman, and (iii) the Perceptive Life Sciences Master Fund Ltd.

(the “Master Fund”), the Master Fund directly

holds 694,315 shares of common stock and 1,759,035 pre-funded warrants to purchase shares of common stock at an exercise price of

$0.001 per share, (c) 861,192 pre-funded warrants to purchase shares of common stock at an exercise price of $0.0001 per share, (d)

861,192 warrants to purchase shares of common stock at $8.334 per share, and (e) 861,192 warrants to purchase shares of common stock

at $6.945 per share.

The pre-funded warrants and warrants may not be exercised if the Master Fund would beneficially own more than

9.9% of the Company’s outstanding shares of common stock after giving effect to such exercise.

Perceptive Advisors serves as

the investment manager to the Master Fund and may be deemed to beneficially own such shares.

Edelman is the managing member of

Perceptive Advisors and may be deemed to beneficially own such shares.

on a Schedule 13G/A filed with the SEC on November 14, 2024 by (i) Nantahala Capital Management, LLC (“Nantahala”) (ii)

Harkey and (iii) Daniel Mack , Nantahala

directly holds 596,917 shares of common stock and 688,940 warrants.

The warrants may not be exercised if Nantahala would exceed

certain beneficial ownership limitations included therein.

Nantahala may be deemed to beneficially own such shares.

Harkey and Daniel Mack are the managing members of Nantahala, and as the managing members of Nantahala, each of Messrs.

and Mack is a control person in respect of shares beneficially owned by Nantahala and may be deemed to beneficially own such

1,419,878 shares of common stock issuable upon exercise of options that are currently exercisable or exercisable within 60 days of

February 26, 2025.

769,224 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60

days of February 26, 2025.

545,912 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60

days of February 26, 2025.

486,981 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60

days of February 26, 2025.

46,481 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60

days of February 26, 2025.

46,481 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60

days of February 26, 2025.

46,481 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60

days of February 26, 2025.

46,481 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60

days of February 26, 2025.

Relationships and Related Transactions, and Director Independence

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Compensation.”

Life Sciences Master Fund, Ltd.

Perceptive Life Sciences Master

Perceptive Life

Sciences Master Fund, Ltd.

(“Perceptive”), a holder of greater than 5% of our Common Stock based on the Schedule 13G/A

filed by Perceptive on February 14, 2023, participated as an investor in a financing with the Company pursuant to a purchase agreement

that was executed on October 6, 2023.

Pursuant to the purchase agreement, Perceptive purchased pre-funded warrants (the “Pre-Funded

Warrants”) to purchase 861,192 shares of Common Stock, Tranche A Warrants (the “Tranche A Warrants”) to purchase 861,192

shares of Common Stock, and Tranche B Warrants (the “Tranche B Warrants”) to purchase 861,192 shares of Common Stock for

a combined purchase price per Pre-Funded Warrant and accompanying Tranche A Warrant and Tranche B Warrant of $5.8059.

The warrants are

immediately exercisable at an exercise price of $6.945 per share for the Tranche A Warrants, $8.334 per share for the Tranche B Warrants,

and a nominal exercise price of $0.0001 per share for the Pre-Funded Warrants.

The Tranche A Warrants will expire on the date that is

the earlier of (i) 5:00 p.m.

Eastern time on the thirtieth (30th) calendar day following the release by the Company of initial top line

efficacy data including rVCSS data constituting a 3 or more point improvement for the SAVVE clinical trial or (ii) October 11, 2024.

The Tranche B Warrants will expire on the date that is the earlier of (i) 5:00 p.m.

filed by Perceptive on November 14, 2024, participated as an investor in a financing with the Company pursuant to a purchase

agreement that was executed on October 6, 2023.

Pursuant to the purchase agreement, Perceptive purchased pre-funded warrants (the

“Pre-Funded Warrants”) to purchase 861,192 shares of Common Stock, Tranche A Warrants (the “Tranche A

Warrants”) to purchase 861,192 shares of Common Stock, and Tranche B Warrants (the “Tranche B Warrants”) to

purchase 861,192 shares of Common Stock for a combined purchase price per Pre-Funded Warrant and accompanying Tranche A Warrant and

Tranche B Warrant of $5.8059.

The warrants are immediately exercisable at an exercise price of $6.945 per share for the Tranche A

Warrants, $8.334 per share for the Tranche B Warrants, and a nominal exercise price of $0.0001 per share for the Pre-Funded

The Tranche A Warrants expired on April 5, 2024, the thirtieth (30th) calendar day following the release by the Company of

initial top line efficacy data including rVCSS data constituting a 3 or more point improvement for the SAVVE clinical trial.

Tranche B Warrants will expire on the date that is the earlier of (i) 5:00 p.m.

Eastern time on the thirtieth (30th) calendar day

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FDA for the VenoValve or (ii) October 12, 2026.

The Pre-Funded Warrants will terminate when they

are exercised in full.

The Pre-Funded Warrants will terminate when

they are exercised in full.

The offering closed on October 11, 2023.

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Accounting Fees and Services

The aggregate fees billed by Marcum LLP (“ Marcum ”) for professional services rendered for the audit of our

annual financial statements, review of the financial information included in our Forms 10-Q for the respective periods and other required

filings with the SEC for the years ended December 31, 2023 and 2022 totaled $177,000 and $197,000, respectively.

The above amounts are for services rendered in connection with audits and reviews of financial statements and the

issuance of consents in connection with registration statements.

The aggregate fees billed by Marcum LLP (“ Marcum ”) for professional services rendered for the audit of

our annual consolidated financial statements, review of the financial information included in our Forms 10-Q for the respective

periods and other required filings with the SEC for the years ended December 31, 2024 and 2023 totaled $255,000 and $177,000,

respectively.

The above amounts are for services rendered in connection with audits and reviews of consolidated financial statements

and the issuance of consents in connection with registration statements.

For Board of Directors Pre-Approval of Audit and Permissible Non-Audit Services of Independent Auditor

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non-audit related activities incurred during fiscal years 2024 and 2023 were approved by our audit committee in accordance with these

and Financial Statements Schedules

Consolidated Financial

financial statements and the notes thereto, together with the report of our independent registered public accounting firm on those financial

statements, are hereby filed as part of this report beginning on page F-1.

and Consolidated Financial Statement Schedules

Financial Statements

consolidated financial statements and the notes thereto, together with the report of our independent registered public accounting

firm on those consolidated financial statements, are hereby filed as part of this report beginning on page F-1.

Financial Statement Schedules

financial statement schedules have been omitted since the required information is not applicable or is not present in amounts sufficient

to require submission of the schedule, or because the information required is included in the consolidated financial statements and notes

consolidated financial statement schedules have been omitted since the required information is not applicable or is not present in

amounts sufficient to require submission of the schedule, or because the information required is included in the consolidated

financial statements and notes thereto.

following is a complete list of exhibits filed as part of this Form 10-K.

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Description of the Company’s Securities Registered under Section 12 of the Exchange Act (incorporated by reference to Exhibit 4.21 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020)

Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on September 30, 2024).

Form of Underwriter Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on September 30, 2024).

Form of Indemnification Agreement (incorporated by reference to Exhibit 10.30 to the Registrant’s Registration Statement on Form S-1/A (No.

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Code of Conduct (incorporated by reference to Exhibit 14.1 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020).

Insider Trading Policy*

Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2023).

Subsidiaries of the registrant incorporated by reference to Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020).

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Certification of Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act**

Compensation Clawback Policy

Compensation Clawback Policy (incorporated by reference to Exhibit 99.1 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2023).

Inline XBRL Instance Document*

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Presentation Linkbase Document*

Filed herewith.

Furnished and not filed

and not filed herewith.

Form 10-K Summary

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Robert Berman

Chief Executive Officer

(Principal Executive Officer)

Chief Financial Officer

(Principal Financial and

Accounting Officer)

Executive Officer

Executive Officer)

Financial Officer

Financial and Accounting Officer)

MEDICAL CORPORATION

REPORT ON FORM 10-K

TO AUDITED FINANCIAL STATEMENTS

TO AUDITED CONSOLIDATED FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm (PCAOB:

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Statements of Operations for the Years Ended December 31, 2024 and 2023

of Stockholders’ Equity for the Years Ended December 31, 2023 and 2022

Statements of Stockholders’ Equity for the Years Ended December 31, 2024 and 2023

Statements of Cash Flows for the Years Ended December 31, 2024 and 2023

Notes to Financial Statements

to Consolidated Financial Statements

OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

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on the Financial Statements

have audited the accompanying balance sheets of enVVeno Medical Corporation (the “Company”) as of December 31, 2023 and 2022,

the related statements of operations, changes in stockholders’ equity and cash flows for each of the two years in the period ended

December 31, 2023, and the related notes (collectively referred to as the “financial statements”).

In our opinion, the financial

statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the

results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with accounting

principles generally accepted in the United States of America.

have audited the accompanying consolidated balance sheets of enVVeno Medical Corporation (the “Company”) as of December 31,

2024 and 2023, the related consolidated statements of operations, changes in stockholders’ equity and cash flows for each of the

two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”).

In our opinion, based on our audits, the financial statements present fairly, in all material respects, the financial position of the

Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period

ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

financial statements are the responsibility of the Company’s management.

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We determined that there are no critical audit matters.

We have served as the Company’s

auditor since 2015.

February 29, 2024

/s/ Marcum llp

have served as the Company’s auditor since 2015.

MEDICAL CORPORATION

BALANCE SHEETS

(In thousands except par values, unless otherwise indicated)

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Total Liabilities and Stockholders’ Equity

accompanying notes are an integral part of these financial statements.

accompanying notes are an integral part of these consolidated financial statements.

MEDICAL CORPORATION

OF OPERATIONS

STATEMENTS OF OPERATIONS

For the Years Ended

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Realized gain from sales of trading securities

Unrealized gain from trading securities

Unrealized (loss) gain from trading securities

Interest income

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Basic and diluted

accompanying notes are an integral part of these financial statements.

accompanying notes are an integral part of these consolidated financial statements.

MEDICAL CORPORATION

OF CHANGES IN STOCKHOLDERS’ EQUITY

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

thousands, unless otherwise indicated)

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Shared-Based Compensation

Stock Options exercised

Balance at December 31, 2024

$ ( 151,855 )

Stockholders’

Balance at January 1, 2023

$ ( 106,520 )

Common stock and warrants issued in private placement offering

Shared-Based Compensation

Balance at December 31, 2023

accompanying notes are an integral part of these financial statements.

$ ( 130,036 )

accompanying notes are an integral part of these consolidated financial statements.

MEDICAL CORPORATION

OF CASH FLOWS

STATEMENTS OF CASH FLOWS

(In thousands, unless otherwise indicated)

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Amortization of right-of-use assets

Unrealized gain from investments

Unrealized loss (gain) from investments

Changes in operating assets and liabilities:

Prepaid expenses and other current assets

Security deposit and other assets

Accounts payable

Accrued expenses

Accounts payable, accrued expenses and other current liabilities

Operating lease liabilities

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Purchases of property and equipment

Net Cash Used in Investing Activities

Net Cash Provided by (Used in) Investing Activities

Cash Flows from Financing Activities

Proceeds from private placement offering

Proceeds from stock option exercises

Net Cash Provided by Financing Activities

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Cash and cash equivalents - End of year

accompanying notes are an integral part of these financial statements.

accompanying notes are an integral part of these consolidated financial statements.

MEDICAL CORPORATION

TO FINANCIAL STATEMENTS

TO CONSOLIDATED FINANCIAL STATEMENTS

1 – Business Organization and Nature of Operations

Medical Corporation is a late clinical-stage medical device 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 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 surgical replacement venous valve that is currently being

evaluated in a U.S.

Medical Corporation (the “Company”) is a late clinical-stage medical device 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 is developing

surgical and non-surgical replacement venous valves for patients suffering from severe Chronic Venous Insufficiency (“CVI”)

of the deep venous system of the leg.

Company’s lead product is the VenoValve®, which is a potential 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 also developing a second product called enVVe®, which is a potential first-in-class,

non-surgical, transcatheter based replacement venous valve system consisting of the enVVe valve, the enVVe delivery system, and the delivery

system accessories.

The Company is currently conducting pre-clinical testing on enVVe.

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.

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.

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2 – Management’s Liquidity Plan

of December 31, 2023, the Company had a cash balance of $ 3.6

million, investments of $ 42.8

million and working capital of $ 45.6

Although the Company expects to continue incurring losses for the foreseeable future and may need to raise additional

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

Management believes that our capital resources are sufficient to meet our obligations as they become due within one year after the

date of this Annual Report.

of December 31, 2024, the Company had a cash balance of $ 1.8 million, investments of $ 41.4 million and working capital of $ 41.7 million.

Although the Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain

its operations, pursue its product development initiatives and penetrate markets for the sale of its products, Management believes that

our capital resources are sufficient to meet our obligations as they become due within one year after the date of this Annual Report.

3 – Significant Accounting Policies

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Actual results could differ from these estimates.

Significant estimates and assumptions include the valuation allowance related to the

Company’s deferred tax assets, and the valuation of warrants.

consider all highly liquid interest-earning investments with a maturity of three months or less at the date of purchase to be cash equivalents.

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MEDICAL CORPORATION

TO FINANCIAL STATEMENTS

TO CONSOLIDATED FINANCIAL STATEMENTS

Company follows the asset and liability method of accounting for income taxes under ASC 740, “Income Taxes.” Deferred tax

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There were no unrecognized tax benefits and no amounts accrued for interest and penalties as of December 31, 2024

and December 31, 2022.

or December 31, 2023.

The Company is currently not aware of any issues under review that could result in significant payments, accruals

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ASC 820 describes three levels of inputs that may be used to measure

Quoted prices available

in active markets for identical assets or liabilities trading in active markets.

Observable inputs other

than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets;

quoted prices

for identical or similar assets and liabilities in markets that are not active;

or other inputs that are observable or can be corroborated

by observable market data.

Unobservable inputs that

are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

This includes

certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs.

prices available in active markets for identical assets or liabilities trading in active markets.

inputs other than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets;

quoted prices for identical or similar assets and liabilities in markets that are not active;

or other inputs that are observable

or can be corroborated by observable market data.

inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable

instruments, including accounts payable are carried at cost, which management believes approximates fair value due to the short-term

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MEDICAL CORPORATION

TO FINANCIAL STATEMENTS

TO CONSOLIDATED FINANCIAL STATEMENTS

Company has an Equity Incentive Plan under which the Board of Directors may grant restricted stock or stock options to employees and

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and (v) the share options are nontransferable and nonhedgeable.

Company estimated the expected term of the options using the simplified method.

The Company uses its stock’s historical market

5 unchanged sentences

treasury zero-coupon issues with an equivalent remaining expected term.

The dividend yield assumption is based on the Company’s history and expectation of future dividend payouts

on the common stock.

The dividend yield assumption

is based on the Company’s history and expectation of future dividend payouts on the common stock.

option grants without performance conditions, the Company recognizes compensation expense over the requisite service period ratably,

6 unchanged sentences

Contingencies

Company will accrue an estimated loss if information available before the financial statements are issued or are available to be issued

indicates that it is probable that an asset had been impaired or a liability had been incurred at the date of the financial statements

and the amount of loss can be reasonably estimated.

Company will accrue an estimated loss if information available before the consolidated financial statements are issued or are

available to be issued indicates that it is probable that an asset had been impaired or a liability had been incurred at the date of

the consolidated financial statements and the amount of loss can be reasonably estimated.

Adopted Accounting Standards

November 2023, the FASB issued ASU No.

2023-07, Segment Reporting (Topic 280)—Improvements to Reportable Segment Disclosures

(ASU 2023-07).

ASU 2023-07 requires that a public entity that has a single reportable segment, such as the Company, provide all the

disclosures required by the existing segment disclosure requirements in Topic 280, as amended.

segment disclosures include significant segment expenses regularly provided to the chief operating decision maker (CODM) and included

within each reported measure of segment loss, disclosure of other segment items by reportable segment and a description of the segment’s

composition, disclosures about our reportable segment’s profit or loss and assets currently required, disclose the title and position

of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance

and deciding how to allocate resources.

We adopted ASU 2023-07 effective on January 1, 2024, and have retrospectively applied it to all

periods presented.

There was no impact on our financial statements from its adoption.

Accounting Standards

December 2023, the FASB issued ASU No.

2023-09, Income Taxes (Topic 740 – Improvements to Income Tax Disclosures (ASU 2023-09).

ASU 2023-09 is effective for annual periods beginning after December 15, 2024, and requires enhanced disclosures related to the income

tax rate reconciliation and income taxes paid to improve the transparency of income tax disclosures by requiring (1) consistent categories

and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction.

currently evaluating the impact that this guidance will have on our consolidated financial statements.

December 2024, the FASB issued ASU No.

2024-03, Income Statement - Reporting Comprehensive Income- Expense Disaggregation Disclosures

(ASU 2024-03).

ASU 2024-03 requires disclosure of specific information about certain costs and expenses in the notes to its financial

statements for interim and annual reporting periods.

The objective of the disclosure requirements is to provide disaggregated information

to help financial statement users (a) better understand the Company’s performance, (b) better assess the Company’s prospects

for future cash flows, and (c) compare the Company’s performance over time and with that of other entities.

ASU 2024-03 is effective

for annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December

We are currently evaluating the impact that this guidance will have on our consolidated financial statements.

MEDICAL CORPORATION

TO FINANCIAL STATEMENTS

TO CONSOLIDATED FINANCIAL STATEMENTS

4 – Concentrations

6 unchanged sentences

components of investments were as follows at December 31, 2024 and December 31, 2023:

Schedule of Components of Investments

of Components of Investments

December 31, 2024

3 unchanged sentences

Total debt investments

gains of $ 0.5 million

and unrealized losses of $ 0.1 million for the year ended December 31, 2023 and 2022, respectively, from fixed-income securities and primarily

attributable to changes in interest rates.

losses of $ 0.1 million and unrealized gains of $ 0.5 million for the year ended December 31, 2024 and 2023, respectively, from fixed-income

securities are primarily attributable to changes in interest rates.

6 – Property and Equipment

2 unchanged sentences

(In thousands)

Laboratory equipment

4 unchanged sentences

Property and equipment, net

expense was $ 0.2 million and $ 0.2 million for the years ended December 31, 2023 and 2022, respectively.

Depreciation expense is reflected

in general and administrative expenses in the accompanying statements of operations.

expense was $ 0.2 million and $ 0.2 million for both the years ended December 31, 2024 and 2023 and is reflected in general and administrative

expenses in the accompanying statements of operations.

MEDICAL CORPORATION

TO FINANCIAL STATEMENTS

7 – Right-of-Use Assets and Lease Liabilities

November 17, 2021, the Company amended its operating lease for its manufacturing facility in Irvine, California, to extend the term an

additional 60 months from its September 30, 2022 expiration date to a new expiration date of September 30, 2027.

The initial lease rate

at the date of the amendment was $ 30,206 per month with escalating payments.

In connection with the lease, the Company is obligated to

pay $ 7,254 monthly for operating expenses for building repairs and maintenance.

The Company has no other operating or financing leases

with terms greater than 12 months.

Company determined the lease liabilities using the Company’s estimated incremental borrowing rate of 3.95 % to estimate the present

value of the remaining monthly lease payments.

TO CONSOLIDATED FINANCIAL STATEMENTS

7 – Right-of-Use Assets and Liabilities

Company leases its facility in Irvine, California under an operating lease which it amended in November 2021 to extend the lease term

an additional 60 months through September 30, 2027.

The lease rate at the date of the amendment was $ 30,206 per month with escalating

payments adjusting annually.

In connection with the lease, the Company is obligated to pay $ 7,254 monthly for operating expenses for

building repairs and maintenance.

The Company has no other operating or financing leases with terms greater than 12 months.

liabilities were determined using the Company’s estimated incremental borrowing rate of 3.95 % to estimate the present value of

the remaining monthly lease payments.

operating lease cost is as follows (in thousands) :

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Year ended December 31, 2027

Imputed interest

1 unchanged sentence

MEDICAL CORPORATION

TO FINANCIAL STATEMENTS

TO CONSOLIDATED FINANCIAL STATEMENTS

8 – Accounts payable, accrued expenses and other current liabilities

2 unchanged sentences

(In thousands)

Accounts Payable

4 unchanged sentences

of Income Tax Provision (Benefit)

(Dollars in thousands)

For the Years Ended

(Dollars in thousands)

Federal Current

Federal Deferred

State and local:

8 unchanged sentences

of Effective Income Tax Rate Reconciliation

the Years Ended

Tax benefit at federal statutory

For the Years Ended

Tax benefit at federal statutory rate

State taxes, net of federal benefit

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Change in valuation allowance

Effective income tax

Effective income tax rate

MEDICAL CORPORATION

TO FINANCIAL STATEMENTS

TO CONSOLIDATED FINANCIAL STATEMENTS

components of the Company’s deferred tax assets at December 31, 2024 and 2023 are as follows:

1 unchanged sentence

(In thousands)

Deferred tax assets:

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Impairment loss

Property and equipment

Unrealized loss on short-term investments

Total gross deferred tax assets

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740 requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to

the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is

the extent that management assesses that realization is “more likely than not.” Realization of any future tax benefit is

dependent on the Company’s ability to generate sufficient taxable income within the carryforward period.

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allowance increased by $ 5.4 million and $ 5.6 million during the years ended December 31, 2024 and 2023, respectively.

Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally

defined as a greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to

use its pre-change net operating loss, or NOL, carryforwards and other pre-change tax attributes to offset its post-change income taxes

may be limited.

In accordance with Section 382 of the Internal Revenue Code, the usage of the Company’s NOL carry forwards are

subject to annual limitations due to greater than 50 % ownership changes in 2018 and 2021.

December 31, 2023 and 2022, the Company had post-ownership change net operating loss carryforwards for federal income tax purposes of

approximately $ 61.7 million and $ 52.7 million, respectively.

Pre-2018 federal NOLs of approximately $ 12.0 million may be carried forward

for twenty years and begin to expire in 2029.

Based on the 2020 and 2021 ownership changes, the Company expects $ 10.4 million of its

pre-2018 federal NOLs to expire unused.

Under current federal tax law, post-2017 federal NOLs in the aggregate amount of $ 50.3 million

can be carried forward indefinitely although the annual limit of deduction equals 80 % of taxable income.

To the extent the Company utilizes

its NOL carryforwards in the future, the tax years in which the attribute was generated may still be adjusted upon examination by the

Internal Revenue Service or state tax authorities of the future period tax return in which the attribute is utilized.

The Company also

has federal research and development tax credit carryforwards of approximately $ 0.2 million which begin to expire in 2027.

Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change”

(generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period), the

corporation’s ability to use net operating loss (NOL) carryforwards and other pre-change tax attributes to offset its

post-change income taxes may be limited.

Due to various equity transactions, the Company’s ownership changes crossed the 50 %

threshold in 2018, 2020, 2021 and 2024, creating NOL annual use limitations based on the Company’s value

at each of the change dates.

Further, the federal annual limit of NOL use is 80 % of taxable income.

As a result, the maximum amount of

NOL the Company may use in any year is currently 80 % of taxable income for that year, or $ 2.0 million, whichever is less.

December 31, 2024 and 2023, the Company net operating loss carryforwards for federal income tax purposes of approximately $ 72.2

million and $ 61.7

million, respectively.

Of this, pre-2018 federal

NOLs of approximately $ 12.0

million may be carried forward for twenty years

and begin to expire in 2029.

Post 2018 federal NOLs of approximately $ 60.2 million can be carried forward indefinitely.

2020, 2021, and 2024 ownership changes, the Company expects substantially all of its pre-2018 federal NOLs to expire unused.

To the extent

the Company utilizes its NOL carryforwards in the future, the tax years in which the attribute was generated may still be adjusted upon

examination by the Internal Revenue Service or state tax authorities of the future period tax return in which the attribute is utilized.

The Company also has federal research and development tax credit carryforwards of approximately $ 0.2

million which begin to expire in 2027.

of December 31, 2024 and 2023, the Company had net operating loss carryforwards for state income tax purposes of approximately $ 97.7 million

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initiated during 2024 or 2023.

has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s financial

statements as of December 31, 2023 and 2022.

The Company does not expect any significant changes in its unrecognized tax benefits within

twelve months of the reporting date.

The Company’s policy is to classify assessments, if any, for tax related interest as interest

expense and penalties as general and administrative expenses in the statements of operations.

has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s

consolidated financial statements as of December 31, 2024 and 2023.

The Company does not expect any significant changes in its

unrecognized tax benefits within twelve months of the reporting date.

The Company’s policy is to classify assessments, if any,

for tax related interest as interest expense and penalties as general and administrative expenses in the statements of

MEDICAL CORPORATION

TO FINANCIAL STATEMENTS

TO CONSOLIDATED FINANCIAL STATEMENTS

10 – Commitments and Contingencies

3 unchanged sentences

associated with loss contingencies as incurred and accrues for all probable and estimable settlements.

Rankin Complaints

T he Company and its Chief Executive Officer

are parties to civil complaints filed by a former employee, Robert Rankin, who resigned as the Company’s Chief Financial Officer,

Secretary, and Treasurer on March 30, 2020.

Originally filed as two separate complaints, Rankin v.

Hancock Jaffe Laboratories, Inc.

al., Case No.

30-2020-01146555-CU-WR-CJC and Rankin v.

Hancock Jaffe Laboratories, Inc.

et al., Case No.

30-2020-01157857, they have now

been consolidated and will be tried concurrently.

The complaints assert causes of action alleging constructive discharge in violation of public policy, failure to

timely pay Mr.

Rankin’s accrued and unused vacation and three months’ severance under his July 16, 2018 employment agreement,

Retaliation under Labor Code Section 1102.5, unfair competition, defamation, and sex-based discrimination, and seeks damages for back

pay, lost and unpaid wages, emotional and mental distress, consequential damages, punitive damages, compensatory damages and attorney’s

fees and costs.

The Company denies all claims in these matters, is vigorously defending same, and has asserted counterclaims against

Rankin contending that he breached his fiduciary duty and employment agreement with the Company and the Company incurred damages as

The Company continues to believe it has meritorious defenses to these matters, which are currently set for trial on May 13,

of the date of these financial statements, the amount of loss or range of loss associated with these complaints, if any, cannot be reasonably

Accordingly, no amounts related to these complaints are accrued as of December 31, 2023.

MEDICAL CORPORATION

TO CONDENSED FINANCIAL STATEMENTS

TO CONSOLIDATED FINANCIAL STATEMENTS

11 – Stockholders’ Equity

Company entered into a financing transaction in 2023 whereby it raised net proceeds of $ 25.8 million and issued 3.8 million shares of

common stock, 9.6 million warrants subject to performance conditions, 1.0 million prefunded warrants and 0.2 million warrants to the

placement agent.

The weighted average exercise price of the warrants is $ 6.94 .

fees in connection with the capital raise were $ 2.2 million.

the performance conditions are not achieved, 50% of the performance warrants will expire in October 2024 and 50% in October 2026.

the performance conditions are achieved the holder has 30 days to exercise.

warrants have a fair value of $ 19.7 million based on the Black Scholes method and the following weighted average input assumptions:

Company completed equity transactions in each of 2024 and 2023.

The following table provides an overview of those transactions.

of Equity Transactions

Number of shares

Transaction Fees

October 6, 2023

Private Investment in Public Equity (PIPE)

September 30, 2024

Confidentially Marketed Public Offering (CMPO)

2023 transaction included 9.6 million warrants subject to performance conditions, 1.0 million prefunded warrants and 0.2 million warrants

to the placement agent.

The weighted average exercise price of the warrants was $ 6.94 .

The performance condition for 50% of the warrants was met on March 6, 2024,

and the warrants expired.

The performance condition for the remaining 50% of the warrants has not yet been met.

If the performance conditions

for the remaining 50% of these warrants is not met, they will expire in October 2026.

If the performance conditions are achieved the holders

have 30 days to exercise.

2024 transaction included 0.1 million prefunded warrants and 0.3 million warrants to the underwriter.

The weighted average exercise price

of the warrants is $ 4.03 .

warrants issued in 2024 and 2023 have a fair value of $ 1.0 million and $ 19.7 million, respectively, based on the Black Scholes method

and the following weighted average input assumptions:

of Estimated Fair Values and Assumptions

term in years

free interest rate

Contractual life

Risk free interest rate

Dividend yield

summary of warrant activity during the years ended December 31, 2024 and 2023 is presented below:

Schedule of Stock Warrant Activity

of Stock Warrant Activity

(In thousands)

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Outstanding, January 1, 2024

( 4,846,072 )

Outstanding and exercisable, December 31, 2024

MEDICAL CORPORATION

TO FINANCIAL STATEMENTS

TO CONSOLIDATED FINANCIAL STATEMENTS

12 – Share Based Compensation

Incentive Plan

Company issues share-based awards under its Company’s 2016 Omnibus Incentive Plan, which enables the Company to grant stock options,

stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, other share based awards and cash awards to

associates, directors, consultants, and advisors of the Company and its affiliates, and to improve the ability of the Company to attract,

retain, and motivate individuals upon whom the Company’s sustained growth and financial success depend, by providing such persons

with an opportunity to acquire or increase their proprietary interest in the Company.

Stock options granted under the 2016 Plan may be

non-qualified stock options or incentive stock options, within the meaning of Section 422(b) of the Internal Revenue Code of 1986, except

that stock options granted to outside directors and any consultants or advisers providing services to the Company or an affiliate shall

in all cases be non-qualified stock options.

The option price must be at least 100% of the fair market value on the date of grant and

if issued to a 10% or greater shareholder must be 110% of the fair market value on the date of the grant.

Company issues share-based awards under its Company’s 2016 Omnibus Incentive Plan, as amended, which enables the Company to

grant stock options, stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, other share based

awards and cash awards to associates, directors, consultants, and advisors of the Company and its affiliates, and to improve the

ability of the Company to attract, retain, and motivate individuals upon whom the Company’s sustained growth and financial

success depend, by providing such persons with an opportunity to acquire or increase their proprietary interest in the Company.

Stock options granted under the 2016 Plan may be non-qualified stock options or incentive stock options, within the meaning of

Section 422(b) of the Internal Revenue Code of 1986, except that stock options granted to outside directors and any consultants or

advisers providing services to the Company or an affiliate shall in all cases be non-qualified stock options.

option price must be at least 100% of the fair market value on the date of grant and if issued to a 10% or greater shareholder must

be 110% of the fair market value on the date of the grant.

2016 Plan is to be administered by the Board, which has discretion over the awards and grants thereunder.

1 unchanged sentence

November 21, 2026.

Plan was adopted in 2016 and amended in 2018, 2020 and 2021 to increase the number of shares authorized to be awarded under the Plan.

The number of shares subject to the Plan is automatically adjusted from time to time such that shares authorized under the plan shall

always be equal to at least 20 % of the issued and outstanding shares of the Company on a fully diluted basis.

As of December 31, 2023

there are 6,939,796 shares authorized under the Plan which is equal to the 20 % minimum.

number of shares authorized to be issued under the Plan is automatically adjusted from time to time when the Company issues additional

shares of common stock or securities that are convertible or exercisable into shares of common stock (other than pursuant to the Plan)

such that shares authorized under the plan after such issuance shall be equal to at least 20 %

of the issued and outstanding shares of the Company on a fully diluted basis.

As of December 31, 2024 there are approximately

7.2 million shares authorized to be issued under

fair value of each option grant is estimated at the grant date using the Black Scholes method.

8 unchanged sentences

summary of the option activity during the years ended December 31, 2024 and 2023 is presented below:

Schedule of Stock Option Activity

of Stock Option Activity

Outstanding, January 1, 2023

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Outstanding, December 31, 2024

13 – Net Loss Per Share

following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss

per common share as of December, 2024 and 2023:

of Dilutive Net Loss Per Common Share

(In thousands)

Shares of common stock issuable upon exercise of warrants

Shares of common stock issuable upon exercise of options

Potentially dilutive common stock equivalents excluded from diluted net loss per share

14 – Segment Reporting

Company has determined that it currently operates in a single segment, Medical Device development, located in a single geographic location,

the United States.

The accounting policies of the segment are the same as those described in the summary of significant accounting policies.

Since the Company operates in a single segment, the measure of segment total assets and loss from operations is the same as that reported

on the accompanying balance sheets as total assets, and the accompanying statement of operations as loss from operations, respectively.

Company’s chief operating decision maker (“CODM”) is the chief executive officer.

The CODM uses operating expenses to measure performance against

progress in its clinical trials and its product development.

The following table sets forth segment expenses.

of Segment Expenses

(In thousands)

Research and Development:

Employee expense

Total research and development

Selling, general and administrative expense

Employee expense

Professional fees

Total selling, general and administrative expense

Loss from Operations

Adjustments and reconciling Items

Adjustments and reconciling items in the above table consist of interest income and realized and unrealized gains and losses related to

our investments in US Treasury securities.

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-K

Item 9A. Controls and Procedures