What changed in this filing

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Item 9A. Controls and Procedures

2026-03-26 compared with 2025-02-28 · 1004 added, 872 removed, 1014 unchanged (65% of the section changed)

and Procedures

Controls and Procedures

of Controls and Procedures

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were no changes in our internal control over financial reporting identified in connection with the evaluation required by Exchange Act

Rule 13a-15(d) during the quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect,

our internal control over financial reporting.

Management, including the principal executive officer and principal financial officer,

does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all

error and all fraud.

Controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving

their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and

Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that

all control issues and instances of fraud, if any, within the Company have been detected.

These inherent limitations include the realities

that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake.

Additionally, controls

can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls.

The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there

can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

Over time, controls

may become inadequate because of changes in conditions, or deterioration in the degree of compliance with the policies or procedures.

Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting

and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles.

Rule 13a-15(d) during the quarter or year ended December 31, 2025 that have materially affected, or are reasonably likely to materially

affect, our internal control over financial reporting.

Management, including the principal executive officer and principal financial

officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or

detect all error and all fraud.

Controls and procedures, no matter how well designed and operated, can provide only reasonable assurance

of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible

controls and procedures.

Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance

that all control issues and instances of fraud, if any, within the Company have been detected.

These inherent limitations include the

realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake.

Additionally,

controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of

the controls.

The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events,

and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

time, controls may become inadequate because of changes in conditions, or deterioration in the degree of compliance with the policies

or procedures.

Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur

and not be detected.

Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability

of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted

accounting principles.

the supervision and with the participation of our management, including the principal executive officer and principal financial officer,

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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

of our internal control over financial reporting as of December 31, 2025 has not been audited by our auditors, CBIZ CPAs P.C.

Other Information

Disclosure Regarding Foreign Jurisdictions That

Prevent Inspections

Directors, 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.

Position(s) Held

Year of Service Commencement

of Service Commencement

Director, Chief Executive Officer

Chief Financial Officer and Treasurer

Jennifer Bright

Chief Financial Officer

Francis Duhay

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marketing, compliance, turnarounds, and the development and licensing of emerging technologies.

Bright has served as our Chief Financial Officer since May 2025.

Bright is a certified public accountant with more than 25

years of professional accounting and finance experience.

Bright was the Chief Financial Officer of BIOLASE, Inc., until November

2024 when the company sold substantially all assets to MegaGen Implant Co., LTD.

From June 2020 to December 2020, she was consulting

as Interim Director of Accounting at Spectrum Pharmaceuticals and was the Corporate Controller at Kellermeyer Bergensons Services from

November 2018 to April 2020.

Previously, Ms.

Bright held senior accounting director and controller positions at Advantage Solutions,

Inc., Crunch Holdings, LLC, Apria Healthcare Group, Inc., and Richmond American Homes, and was a Supervising Senior Auditor at the accounting

firm of PricewaterhouseCoopers LLP.

Bright holds a B.A.

degree in Business Administration from the University of Washington.

Francis Duhay has served as member of our board of directors since October 2018.

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Mark, he oversaw growth in sales of transcatheter heart valves from $3M to over $250M within the first four years of commercial launch.

Promoted to Vice President of Global Medical & Clinical Affairs, he led planning and execution of four US FDA pivotal clinical trials.

He was eventually promoted to Chief Medical Officer, where, in addition to overseeing Global Medical & Clinical Affairs, he supported

other areas within Edwards including Health Economics & Reimbursement in its successful application for a procedure code, payment,

and coverage of transcatheter aortic valve replacement (TAVR), and Regulatory Affairs, as an industry representative and clinical expert

on the ISO 5840:2014 and 5910:2018 cardiac valve working groups.

After departing Edwards, he co-founded and led Koa Accel, a major medical

device accelerator in the Orange County, CA, ecosystem.

This bore three medical device startups – Makani Science (selected into

the 2021 cohort of the prestigious Y-Combinator), Kino Discovery (selected into the 2021 cohort of MedTech Innovator), and Kahala Biosciences.

Most recently, Dr Duhay served as Senior Vice President of Global Medical & Clinical Affairs for Olympus Corporation, the world’s

leading manufacturer of colonoscopes, duodenoscopes, bronchoscopes, and cystoscopes.

Promoted to Vice President of Global Medical & Clinical Affairs, he led planning and execution of four U.S.

FDA pivotal clinical

He was eventually promoted to Chief Medical Officer, where, in addition to overseeing Global Medical & Clinical Affairs,

he supported other areas within Edwards including Health Economics & Reimbursement in its successful application for a procedure

code, payment, and coverage of transcatheter aortic valve replacement (TAVR), and Regulatory Affairs, as an industry representative and

clinical expert on the ISO 5840:2014 and 5910:2018 cardiac valve working groups.

After departing Edwards, he co-founded and led Koa Accel,

a major medical device accelerator in the Orange County, CA, ecosystem.

This bore three medical device startups – Makani Science

(selected into the 2021 cohort of the prestigious Y-Combinator), Kino Discovery (selected into the 2021 cohort of MedTech Innovator),

and Kahala Biosciences.

Most recently, Dr Duhay served as Senior Vice President of Global Medical & Clinical Affairs for Olympus

Corporation, the world’s leading manufacturer of colonoscopes, duodenoscopes, bronchoscopes, and cystoscopes.

We believe that Dr.

Duhay is qualified to serve

as a member of our board of directors because he is a trained cardiac and thoracic surgeon and former Chief Medical Officer at Edwards

Life Sciences.

Duhay is qualified to serve as a member of our board of directors because he is a trained cardiac and thoracic surgeon and former Chief

Medical Officer at Edwards Life Sciences.

Sanjay Shrivastava has served as a member of our board of directors since October 2018.

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a very high CAGR over a period of six (6) 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 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

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.

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

He had a 20-year career at Highmark, Inc., one

of America’s largest health insurance organizations, which serves over 20 million subscribers, and includes Highmark Blue Cross

Blue Shield Pennsylvania, Highmark Blue Cross Blue Shield Delaware, and Highmark Blue Cross Blue Shield West Virginia, which he retired

from in 2008.

He had a twenty (20) year career at Highmark,

Inc., one of America’s largest health insurance organizations, which serves over 20 million subscribers, and includes Highmark

Blue Cross Blue Shield Pennsylvania, Highmark Blue Cross Blue Shield Delaware, and Highmark Blue Cross Blue Shield West Virginia, which

he retired from in 2008.

While at Highmark, Mr.

Gray helped increase revenues to $12.3 billion from $6.9 billion, and helped generate an operating

gain of $375 million from an operating loss of $91 million.

In addition to being the board chairman, Chief Executive Officer, and President

of several of Highmark’s subsidiaries and affiliated companies, Mr.

Gray was the Chief Financial Officer of Highmark’s parent

company and was the primary contact to Highmark’s board of directors for Highmark’s audit, investment and compensation (incentive

plans) committees.

Gray helped increase revenues to $12.3 billion from $6.9 billion, and helped generate

an operating gain of $375 million from an operating loss of $91 million.

In addition to being the board chairman, Chief Executive Officer,

and President of several of Highmark’s subsidiaries and affiliated companies, Mr.

Gray was the Chief Financial Officer of Highmark’s

parent company and was the primary contact to Highmark’s board of directors for Highmark’s audit, investment and compensation

(incentive plans) committees.

His many responsibilities at Highmark included rate setting and reimbursement negotiations.

Following Highmark, Mr.

Following Highmark,

Gray co-founded U.S.

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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.

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

Glickman, M.D.

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Medical, Cohesion Technologies, Thoratec, GraftCath, Inc., TVA medical, Austin, Texas.

Glynn was hired as our interim Chief Financial Officer in April 2020 and has subsequently been elevated to our fulltime Chief

Financial Officer effective January 2021.

Glynn has more than thirty-nine years of experience providing financial services to a variety

of public and private companies, including in the role as Chief Financial Officer.

Glynn founded Edward Thomas Associates,

a firm that provides public and private companies with accounting and finance services, including chief financial officer services.

Glynn has been a Managing Director of Edward Thomas Associates since 2012.

Glynn has a proven record of success managing the financial

aspects of dynamic organizations either as a member of the management team or in a consulting capacity.

He started his career as an auditor

with Deloitte and went on to be the CFO and Controller of several technology, manufacturing, and distribution companies.

his BS and MS degrees in Accounting from California State University Northridge.

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

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II Directors (serving until the 2028 Annual Meeting of Stockholders, or until their earlier death, disability, resignation or removal) :

Jenusaitis*, Robert A.

Jenusaitis* and Robert A.

III Director (serving until the 2026 Annual Meeting of Stockholders, or until his earlier death, disability, resignation or removal) :

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of the Board and Stockholders

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.

board of directors met in person and telephonically six (6) times during 2025 and also acted by unanimous written consent.

four (4) Audit Committee meetings and two (2) Compensation Committee meetings held in 2025.

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.

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 Dr.

Shrivastava who was present for 50% of the

Audit Committee meetings.

Our board of directors had 100% attendance for the Annual Meeting that was held on December 11, 2025.

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

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

board of directors has established three standing committees—audit, compensation, and nominating and corporate governance—each

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The functions of this committee include, among other things:

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.

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 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;

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 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;

reviewing 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:

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.

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;

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:

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.

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.

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.

A copy of the Company’s insider trading policy is filed as Exhibit 19.1 to

this Annual Report on Form 10-K.

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, 2025 and 2024.

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during the fiscal year ended December 31, 2025.

Name and Principal Position

Incentive Plan

Chief Executive Officer

Jennifer Bright,

Chief Financial Officer

Former Chief Financial Officer

Glickman, M.D.

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Senior Vice President & Chief Technology Officer

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.

Represents the grant date

fair value of 5,714 stock options granted on December 18, 2024, computed in accordance with FASB ASC Topic 718.

The options vest

quarterly over a three (3) year period.

Represents the grant date

fair value of 10,000 stock options granted on May 19, 2025, computed in accordance with FASB ASC Topic 718.

The options vest quarterly

over a three (3) year period with a one (1) year cliff.

Represents the grant date

fair value of 2,142 stock options granted on December 18, 2024, computed in accordance with FASB ASC Topic 718.

The options vest

quarterly over a three (3) year period.

Represents the grant date

fair value of 2,142 stock options granted on December 18, 2024, computed in accordance with FASB ASC Topic 718.

The options vest

quarterly over a three (3) year period.

Includes company paid healthcare

of $38,104, 401(k) match of $17,094 and employer paid life insurance policy premium of $3,564.

Includes company paid healthcare

of $9,679 and 401(k) match of $18,440.

Includes company paid healthcare

of $22,457, 401(k) match of $3,708 and employer paid life insurance policy premium of $669.

Includes company paid healthcare

of $777, 401(k) match of $5,673 and employer paid life insurance policy premium of $1,782.

Includes company paid healthcare

of $1,360 and 401(k) match of $12,116.

Includes company paid healthcare

of $26,734, 401(k) match of $14,848 and employer paid life insurance policy premium of $4,944.

Includes company paid healthcare

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

Includes company paid healthcare

of $13,371, 401(k) match of $13,286 and employer paid life insurance policy premium of $540.

Includes company paid healthcare

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

On May 19, 2025, Ms.

was appointed as Chief Financial Officer.

Excludes severance of $136,298

and $20,192 of accrued vacation.

On May 19, 2025, Mr.

Glynn resigned as Chief Financial Officer of the Company.

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

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For purposes of the following employment agreements:

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;

“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;

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

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;

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

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Berman, our current Chief Executive Officer and director.

Pursuant to the terms of his employment agreement, Mr.

Berman’s base salary was initially $400,000, subject to annual review

and adjustment at the discretion of our compensation committee.

to the terms of his employment agreement, Mr.

Berman’s base salary was initially $400,000, subject to annual review and adjustment

at the discretion of our compensation committee.

In November 2021 the board of directors increased Mr.

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

In December 2024 the board of directors increased Mr.

Berman’s base salary to

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.

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

In December 2024, the board of directors increased Mr.

Berman’s base salary

Berman also participates in an annual discretionary bonus pool where he is eligible for a bonus of up to 60% of his

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

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

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the following 24 months.

In July 2020, the board of directors approved an option grant to Mr.

Berman to purchase 1,142 shares of common

stock at an exercise price of $350.00 per share.

The stock options vested ratably on a monthly basis over the following three (3) years.

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.

Berman to purchase 23,942 shares of common stock at an exercise

price of $287.00 per share (the closing price of the Company’s common stock on February 18, 2021).

The stock options vested in

equal quarterly installments over a two (2) year period.

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

to purchase 9,993 shares of common stock at an exercise price of $234.50 per share (the closing price of the Company’s common stock

on November 30, 2021).

The stock options vested in equal quarterly installments over a three (3) year period.

Also in November 2021,

1 unchanged sentence

Berman 5,714 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 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

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 5,714 of the restricted stock units on the Pre-Market Approval of the VenoValve.

In December 2025, the vesting conditions were

not achieved, and the restricted stock units were cancelled.

In December 2023, 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.

Berman to purchase 8,571 shares of common stock at an exercise price of $125.65 per share (the closing price of the Company’s common

stock on December 4, 2023).

The stock options vest in equal quarterly installments over a three (3) year period.

In December 2024, the

board of directors approved an option grant to Mr.

Berman to purchase 5,714 shares of common stock at an exercise price of $89.95 per

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

The stock options vest in equal quarterly installments

over a three (3) year period.

Additionally, the board of directors paid Mr.

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.

Glynn, in connection with Mr.

Glynn’s elevation

to full time Chief Financial Officer, treasurer and secretary of the Company.

Pursuant to the employment agreement, Mr.

provided for an initial salary of $225,000 per year, subject to annual review and adjustment at the discretion of the Board.

November 2024 the board of directors increased Mr.

Glynn’s base salary to $262,500.

Glynn also participates in an annual

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

$38,750 for 2024.

The employment agreement further provides that Mr.

Glynn is entitled to participate in any employee benefit plans

Berman a cash bonus of $232,500 for 2024.

May 19, 2025, the Company entered into an employment agreement with Ms.

Pursuant to the employment agreement, Ms.

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

annual year-end discretionary bonus pool where she is eligible for a bonus of up to forty percent (40%) of her annual salary.

was initially awarded 10,000 stock options pursuant to the 2016 Plan at an exercise price of $126.70 per share.

Such stock options will

vest quarterly over a three (3) year period with a one (1) year cliff, subject to Ms.

Bright’s continued employment through each

such vesting date.

The Employment Agreement further provides that Ms.

Bright 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.

Glynn’s employment is terminable due to Mr.

Glynn’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.

Glynn’s death or disability, or termination

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

Glynn (or his estate) is entitled to receive

to the terms of the employment agreement, Ms.

Bright’s employment is terminable due to Ms.

Bright’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 Ms.

In the event of Ms.

Bright’s death or disability, or termination

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

Bright (or her 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.

Glynn is entitled to in accordance with any

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

Bright 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.

Glynn will be entitled to three months of severance

for each year Mr.

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

Any outstanding unvested securities

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

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 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

Upon termination without “Cause” (other than by reason

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

Bright will be entitled to three months of severance for each

Bright is employed by the Company, up to a total of one year of severance, in addition to all Accrued Benefits.

Any outstanding

unvested securities owned by Ms.

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

Glickman, M.D.

9 unchanged sentences

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

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

(3) year term.

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.

December 2022, the board of directors increased 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 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.

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.

In December 2024, the board of directors increased Dr.

Glickman’s base

salary to $385,875.

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.

Glickman may also receive additional discretionary bonuses as determined by our compensation

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.

Glickman’s existing two hundred and ten (210) options (“Existing

Options”) to purchase Company common stock at eight thousand seven hundred and fifty dollars ($8,750.00) per share until October

1, 2026, were repriced to one thousand seven hundred and fifty dollars ($1,750.00) per share.

Additionally, in connection with his New

Employment Agreement, Dr.

Glickman was granted stock options for the right to purchase two hundred and five (205) common stock at a price

equal to one thousand seven hundred and fifty dollars ($1,750.00) 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.

8 unchanged sentences

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

July 2020, the board of directors approved an option grant to Dr.

Glickman to purchase 1,142 shares of common stock at an exercise price

of $350.00 per share.

The stock options vested ratably on a monthly basis over the following three (3) years.

In February 2021, the board

of directors approved an option grant to Dr.

Glickman to purchase 11,600 shares of common stock at an exercise price of $287.00 per share

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

The stock options vested in equal quarterly installments

over a two (2) year period.

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

Glickman to purchase 7,591 shares

of common stock at an exercise price of $234.50 per share (the closing price of the Company’s common stock on November 30, 2021).

The stock options vest in equal quarterly installments over a three (3) year period.

Also in November 2021, the board of directors granted

Glickman 2,857 restricted stock units.

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 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.

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

respectively.

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 2,857 of the restricted

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

In December 2025, the vesting conditions were not achieved, and the restricted

stock units were cancelled.

In December 2023, the board of directors approved an option grant to Dr.

Glickman to purchase 2,857 shares

of common stock at an exercise price of $125.65 per share (the closing price of the Company’s common stock on December 4, 2023).

The stock options vest in equal quarterly installments over a three (3) year period.

In December 2024, the board of directors approved

an option grant to Dr.

Glickman to purchase 2,142 shares of common stock at an exercise price of $89.95 per share (the closing price

of the Company’s common stock on December 18, 2024).

The stock options vest in equal quarterly installments over a three (3) year

Additionally, the board of directors paid Dr.

Glickman a cash bonus $56,963 for 2024.

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

Hamed Alavi, our Senior Vice President and Chief Technology Officer

(the “Employment Agreement”).

Hamed Alavi, our Senior Vice President and Chief Technology Officer (the

“Employment Agreement”).

Pursuant to the terms of the Employment Agreement, Mr.

Alavi’s base salary was

$190,000, subject to annual review and adjustment at the discretion of our board of directors.

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.

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.

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

respectively.

Alavi’s base salary was $190,000, subject

to annual review and adjustment at the discretion of our board of directors.

Alavi 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.

Alavi may also receive additional

discretionary bonuses as determined by our compensation committee.

In November 2021 the board of directors increased Mr.

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

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

December 2024, the board of directors increased Mr.

Alavi’s base salary to $315,000.

Additionally, the board of directors paid

Alavi a cash bonus of $46,500 for 2024.

to the terms of the employment agreement, Mr.

21 unchanged sentences

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.

July 2020, the board of directors approved an option grant to Mr.

Alavi to purchase 228 shares of common stock at an exercise price of

$350.00 per share.

The stock options vested ratably on a monthly basis over the following three (3) years.

In February 2021, the board

of directors approved an option grant to Mr.

Alavi to purchase 9,142 shares of common stock of the Company at an exercise price of $287.00

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

The stock options vested in equal quarterly installments

over a three (3) year period with a six (6) month cliff.

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

to purchase 3,597 shares of common stock at an exercise price of $234.50 per share (the closing price of the Company’s common stock

on November 30, 2021).

The stock options vested in equal quarterly installments over a three (3) year period.

Also in November 2021,

the board of directors granted Mr.

Alavi 1,428 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.

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.

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 1,428 of the restricted stock units on the Pre-Market Approval of the VenoValve.

In December 2025, the vesting conditions were

not achieved, and the restricted stock units were cancelled.

In November 2022, the board of directors approved an option grant to Mr.

Alavi to purchase 2,857 shares of common stock at an exercise price of $234.50 per share.

The stock options vested in equal quarterly

installments over the following three (3) years.

In December 2023, the board of directors approved an option grant to Mr.

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.

Alavi to purchase

2,857 shares of common stock at an exercise price of $125.65 per share (the closing price of the Company’s common stock on December

The stock options vest in equal quarterly installments over a three (3) year period.

In December 2024, the board of directors

approved an option grant to Mr.

Alavi to purchase 2,142 shares of common stock at an exercise price of $89.95 per share (the closing

price of the Company’s common stock on December 18, 2024).

The stock options vest in equal quarterly installments over a three

(3) year period.

Payments Upon Termination or Change-in-Control

25 unchanged sentences

February 16, 2034

July 18, 2030

Jennifer Bright,

Chief Financial Officer (6)

February 18, 2031

November 30, 2031

December 2, 2033

July 18, 2030

6 unchanged sentences

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.

Options were granted on

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

on a monthly basis over the twenty-four (24) months following the date of his Employment Agreement.

Options were granted on

July 18, 2020 and vested ratably on a monthly basis over thirty-six (36) months.

Options were granted on

February 18, 2021 and vested ratably on a quarterly basis over two (2) years.

Options were granted on

November 30, 2021 and vested ratably on a quarterly basis over three (3) 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 210 options that were granted on October 1, 2016 were

repriced from $8,750.00 to $1,750.00 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.

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

Berman, Chief Executive Officer

Glickman, M.D., Chief Medical Officer and Senior Vice President

Craig Glynn, Chief Financial Officer

Hamed Alavi, Senior Vice President and Chief Technology Officer

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,

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.

Glickman was granted 205 options at $1,750.00

per share and vested quarterly over a three (3) year period.

Bright was appointed

as Chief Financial Officer in May 2025.

Options were granted on

July 18, 2020 and vested ratably on a quarterly basis over three (3) years.

Options were granted on

February 18, 2021 and vested ratably on a quarterly basis over three (3) years.

Options were granted on

November 30, 2022 and vested ratably on a quarterly basis over three (3) years.

Options were granted on

December 5, 2023 and vest ratably on a quarterly basis over three (3) years.

Options were granted on

December 18, 2024 and vest ratably on a quarterly basis over three (3) years.

Options were granted on

May 19, 2025 and vest ratably on a quarterly basis over three (3) years, with a one (1) year cliff.

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

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) then the number of shares authorized to be awarded under the Plan shall increase to an amount equal to no

less than 20% of the issued and outstanding shares of common stock of the Company on a fully diluted basis.

Such increase, if any, shall

occur automatically upon each applicable issuance of securities by the Company.

All shares available for issuance under the Plan may

be granted as incentive stock options under Code Section 422.

The shares of common stock issuable under the 2016 Plan will consist of

authorized and unissued shares, treasury shares or shares purchased on the open market or otherwise, all as determined by our company

from time to time.

Award Grant Timing

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.

We 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 220,150 shares of our common stock for issuance under the 2016 Plan, provided, however, if at any time 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) then the number of shares authorized to be awarded under the Plan shall increase to an amount equal to no less than 20%

of the issued and outstanding shares of common stock of the Company on a fully diluted basis.

Such increase, if any, shall occur automatically

upon each applicable issuance of securities by the Company.

All shares available for issuance under the Plan may be granted as incentive

stock options under Code Section 422.

The shares of common stock issuable under the 2016 Plan will consist of authorized and unissued

shares, treasury shares or shares purchased on the open market or otherwise, all as determined by our company from time to time.

any award is cancelled, terminates, expires or lapses for any reason prior to the issuance of shares or if shares are issued under the

20 unchanged sentences

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

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.

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.

Cash-based performance awards include annual incentive awards.

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

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.

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.

and Termination of the 2016 Plan

earlier terminated by our board of directors, the 2016 Plan will terminate, and no further awards may be granted, 10 years after October

earlier terminated by our board of directors, the 2016 Plan will terminate, and no further awards may be granted, 10 years after April

26, 2018, the date on which it was approved by our stockholders.

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

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.

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.

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

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table below shows the compensation paid to our non-employee directors during 2025 and 2024.

Fees earned or paid in cash

Stock awards ($)

Option awards

Non-equity incentive plan compensation ($)

Nonqualified deferred compensation earnings

All other compensation

Francis Duhay, M.D.

Francis Duhay

Sanjay Shrivastava

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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

granted 564 options to purchase shares of our common stock on December 18, 2024, as part of their compensation for the year ending December

31, 2024, at an exercise price of $89.95 per share.

The options were valued at $66.45 per share as of the date of the grant and will

vest in equal quarterly portions starting on March 31, 2025 and through December 31, 2025, such that they were fully vested as of December

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

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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

granted 395 options to purchase shares of our common stock on December 5, 2023, as part of their compensation for the year ending December

31, 2023, at an exercise price of $125.65 per share.

The options were valued at $94.72 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 as of December

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

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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 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;

Security Ownership of

Certain Beneficial Owners and Management and Related Stockholder Matters

following table lists, as of March 24, 2026, 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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shares of common stock subject to options or warrants held by that person that are currently exercisable or exercisable within 60 days

of February 26, 2025.

We did not deem such shares outstanding, however, for the purpose of computing the percentage ownership of any

other person.

of March 24, 2026.

We did not deem such shares outstanding, however, for the purpose of computing the percentage ownership of any other

Except as indicated by the footnotes below, we believe, based on the information furnished to us, that the beneficial owners

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Perceptive Life Sciences Master Fund Ltd.

Nantahala Capital Management, LLC(3)

Satterfield, Jr.

Kingdon Capital Management, L.L.C.

Braeden Lichti (5)

Named Executive Officers and Directors

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Hamed Alavi (8)

Craig Glynn (7)

Francis Duhay, M.D.

Jennifer Bright (9)

Francis Duhay (10)

Sanjay Shrivastava (10)

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Represents beneficial ownership of less than 1%.

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

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/A

filed by the Perceptive Life Sciences Master Fund Ltd.

(the “Master Fund”) and Company records.

As of February 17, 2026,

the Master Fund directly holds 58,520 shares of common stock as adjusted for the reverse stock split.

Perceptive Advisors serves

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

Joseph Edelman is the managing

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

Based on a Schedule 13G

filed by Thomas A.

Satterfield, Jr.

filed on November 19, 2025.

Satterfield directly holds 52,071 shares of common stock as adjusted

for the reverse stock split.

Based on a Schedule 13G

filed by Kingdon Capital Management, L.L.C.

As of September 9, 2025, Kingdon directly holds 38,836 shares

of common stock or securities as adjusted for the reverse stock split that are exercisable into shares of common stock within 60

days of September 9, 2025.

Based on a Schedule 13G

filed by Braeden Lichti and Northstrive Fund II LP (“Northstrive”) on February 10, 2026.

Lichti and Northstrive directly

hold 31,151 shares of common stock.

Lichti is the manager of Northstrive and may be deemed to beneficially own such shares.

Includes 45,120 shares

of common stock issuable upon exercise of options that are currently exercisable or exercisable within 60 days of March 24, 2026.

Includes 23,782 shares

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

Includes 18,620 shares

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

Includes 3,333 shares of

common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of March 24,

Includes 2,719 shares of

common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of March 24,

Certain Relationships

and Related Transactions, and Director Independence

following is a description of transactions since January 1, 2024 to which we were a party in which (i) the amount involved exceeded or

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Compensation.”

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 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

following the PMA Approval by the U.S.

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

The Pre-Funded Warrants will terminate when

they are exercised in full.

The offering closed on October 11, 2023.

Indemnification

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information provided in Item 10, under the subheading “Director Independence” is incorporated herein.

Accounting Fees and Services

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.

Principal Accounting

Fees and Services

The aggregate fees billed by CBIZ CPAs P.C.

(“CBIZ”) 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 year ended December 31, 2025 totaled $249,000.

The aggregate

fees billed by Marcum LLP (“Marcum”) for professional services rendered for the review of the financial information included

in our Forms 10-Q for the respective periods and other required filings with the SEC for the year ended December 31, 2024 totaled $226,000.

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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or relationship between us and our independent registered public accounting firm.

Our engagement of Marcum to conduct all audit and permissible

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

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.

Our engagement of CBIZ and Marcum to conduct all audit

and permissible non-audit related activities incurred during fiscal years 2025 and 2024 were approved by our audit committee in accordance

with these procedures.

Exhibits and Consolidated

Financial Statement Schedules

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.

Consolidated Financial

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.

Consolidated Financial

Statement Schedules

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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Fifth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed on September 16, 2020).

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed on June 6, 2018).

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on November 20, 2025).

Certificate of Amendment to the Fifth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on December 2, 2020).

Specimen common stock certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1 (No.

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Form of Warrant Agent Agreement, inclusive of Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on July 21, 2020).

Form of Private Placement Warrant (incorporated by reference to Exhibit 4.18 to the Registrant’s Registration Statement on Form S-1/A (No.

of Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.18 to the Registrant’s Registration Statement on

Form S-1/A (No.

333-239658) filed on July 16, 2020).

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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 8, 2021).

Form of Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on September 8, 2021).

of Placement Agent Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on

September 8, 2021).

Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K filed on October 12, 2023).

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(incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on August 1, 2019).

Employment Agreement, dated as of February 19, 2021, by and between enVVeno Medical Corporation and Craig Glynn (incorporated by reference to Exhibit 10.18 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020).

Employment Agreement, dated as of July 29, 2020, by and between enVVeno Medical Corporation and Hamed Alavi.

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Form of Registration Rights Agreement, dated October 6, 2023 (incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed on October 12, 2023).

Employment Agreement, dated as of May 16, 2025, by and between enVVeno Medical Corporation and Jennifer Bright (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025).

At The Market Offering Agreement, dated October 30, 2025, by and between enVVeno Medical Corporation and Ladenburg Thalmann & Co.

(incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on October 30, 2025).

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

Insider Trading Policy *

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).

Consent of Marcum LLP, independent registered public accounting firm*

Consent of CBIZ CPAs P.C., independent registered public accounting firm*

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

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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, 2024).

Inline XBRL Instance Document*

Inline XBRL Taxonomy Extension

Schema Document*

Inline XBRL Taxonomy Extension

Calculation Linkbase Document*

Inline XBRL Taxonomy Extension

Definition Linkbase Document*

Inline XBRL Taxonomy Extension

Label Linkbase Document*

Inline XBRL Taxonomy Extension

Presentation Linkbase Document*

and not filed herewith.

XBRL Instance Document*

XBRL Taxonomy Extension Schema Document*

XBRL Taxonomy Extension Calculation Linkbase Document*

XBRL Taxonomy Extension Definition Linkbase Document*

XBRL Taxonomy Extension Label Linkbase Document*

XBRL Taxonomy Extension Presentation Linkbase Document*

Filed herewith.

Furnished and not filed

Form 10-K Summary

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its behalf by the undersigned, thereunto duly authorized.

February 27, 2025

March 26, 2026

MEDICAL CORPORATION

Robert Berman

Executive Officer

Executive Officer)

Financial Officer

Financial and Accounting Officer)

Robert Berman

Chief Executive Officer

(Principal Executive Officer)

Jennifer Bright

Chief Financial Officer

(Principal Financial and

Accounting Officer)

MEDICAL CORPORATION

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TO AUDITED CONSOLIDATED FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm (PCAOB:

Balance Sheets as of December 31, 2024 and 2023

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

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

to Consolidated Financial Statements

Reports of Independent Registered Public Accounting Firms (PCAOB:

0199 and 688 )

Consolidated Balance Sheets as of December 31, 2025 and 2024

Consolidated Statements of Operations for the Years Ended December 31, 2025 and 2024

Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2025 and 2024

Consolidated Statements of Cash Flows for the Years Ended December 31, 2025 and 2024

Notes to Consolidated Financial Statements

OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

the Shareholders and Board of Directors of

Medical Corporation

on the Financial Statements

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.

Our responsibility is to express an opinion on the Company’s

financial statements based on our audits.

We are a public accounting firm registered with the Public Company Accounting Oversight Board

(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.

securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

conducted our audits in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audits to obtain

reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.

is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.

As part of our audits

we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion

on the effectiveness of the Company’s internal control over financial reporting.

To the Stockholders and Board of Directors of

enVVeno Medical Corporation

Opinion on the Financial Statements

We have audited the accompanying consolidated

balance sheet of enVVeno Medical Corporation (the “Company”) as of December 31, 2025, the related consolidated statements

of operations, changes in stockholders’ equity and cash flows for the year ended December 31, 2025 and the related notes (collectively

referred to as the “financial statements”).

In our opinion, based on our audit, the financial statements present fairly, in

all material respects, the financial position of the Company as of December 31, 2025 and the results of its operations and its cash flows

for the year ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America .

We also have audited the adjustment to the 2024

consolidated financial statements for the reverse stock split described in Note 1.

In our opinion, such adjustments are appropriate and

have been properly applied.

We were not engaged to audit, review, or apply any procedures to the 2024 consolidated financial statements

of the Company other than with respect to the reverse stock split and, accordingly, we do not express an opinion or any other form of

assurance on the 2024 financial statements taken as a whole.

Basis for Opinion

These financial statements are the responsibility

of the Company’s management.

Our responsibility is to express an opinion on the Company’s financial statements based on our audit.

are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are

required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and

regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the

standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial

statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged

to perform, an audit of its internal control over financial reporting.

As part of our audit we are required to obtain an understanding

of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal

control over financial reporting.

Accordingly, we express no such opinion.

audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error

or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding

the amounts and disclosures in the financial statements.

Our audits also included evaluating the accounting principles used and significant

estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that our audits

provide a reasonable basis for our opinion.

Audit Matters

audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be

communicated to the audit committee and that:

(1) relate to accounts or disclosures that are material to the financial statements and

(2) involved our especially challenging, subjective, or complex judgments.

Our audit included performing procedures to assess

the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond

to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.

Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating

the overall presentation of the financial statements.

We believe that our audit provide s a reasonable basis for our opinion.

Critical Audit Matters

Critical audit matters are matters arising from

the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and

(1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,

subjective, or complex judgments.

We determined that there are no critical audit matters.

/s/ Marcum llp

have served as the Company’s auditor since 2015.

/s/ CBIZ CPAs P.C.

CBIZ CPAs P.C.

We have served as the Company’s auditor since 2015 (such date

takes into account the acquisition of the attest business of Marcum LLP by CBIZ CPAs P.C.

effective November 1, 2024).

March 26, 2026

OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

the Stockholders and Board of Directors of

Medical Corporation

on the Financial Statements

We have audited, before the effects of the retrospective adjustments for the impact of the reverse stock split

as discussed in Note 1 to the consolidated financial statements (the “Reverse Stock Split Adjustments”), the accompanying

consolidated balance sheet of enVVeno Medical Corporation (the

“Company”) as of December 31, 2024, the related consolidated statements of operations, changes in stockholders’ equity

and cash flows for the year ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”)

(the 2024 financial statements before the effects of the Reverse Stock Split Adjustments).

In our opinion, based on our audit, the financial

statements, before the effects of the Reverse Stock Split Adjustments, present fairly, in all material respects, the financial position

of the Company as of December 31, 2024, and the results of its operations and its cash flows for the year ended December 31, 2024, in

conformity with accounting principles generally accepted in the United States of America.

We were not engaged to audit, review, or apply any procedures to the Reverse Stock Split Adjustments and, accordingly,

we do not express an opinion or any other form of assurance about whether such adjustments are appropriate and have been properly applied.

Those retrospective adjustments were audited by CBIZ CPAs P.C.

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

Our responsibility is to express

an opinion on the Company’s financial statements based on our audit.

We are a public accounting firm registered with the Public Company

Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance

with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and

perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due

to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial

As part of our audit we are required to obtain an understanding of internal control over financial reporting but not for the

purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.

Accordingly, we express

no such opinion.

Our audit included performing procedures to assess the risks of material misstatement of the financial statements,

whether due to error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis,

evidence regarding the amounts and disclosures in the financial statements.

Our audit also included evaluating the accounting principles

used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.

that our audit provides a reasonable basis for our opinion.

We served as the Company’s auditor from 2015 to 2025.

February 27, 2025

MEDICAL CORPORATION

BALANCE SHEETS

(In thousands except par values, unless otherwise indicated)

thousands except par values, unless otherwise indicated)

Current assets:

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Total liabilities

Commitments and Contingencies

Commitments and Contingencies – Note 10

Stockholders’ Equity:

6 unchanged sentences

Total liabilities and stockholders’ equity

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

accompanying notes to consolidated financial statements.

MEDICAL CORPORATION

STATEMENTS OF OPERATIONS

thousands except per share data)

For the Years Ended

(In thousands except per share data)

Operating expenses:

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Realized gain from sales of trading securities

Unrealized (loss) gain from trading securities

Unrealized loss from trading securities

Interest income

3 unchanged sentences

Basic and diluted

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

accompanying notes to consolidated financial statements.

MEDICAL CORPORATION

2 unchanged sentences

Stockholders’

Balance at January 1, 2024

Balance, January 1, 2025

$ ( 151,855 )

Common stock and warrants issued in private placement offering

Shared-Based Compensation

Stock Options exercised

Balance at December 31, 2024

Issuance of common stock from At-the-Market offering (ATM), net of fees

Exercise of common stock warrants

Stock-based compensation

Balance, December 31, 2025

$ ( 171,327 )

Stockholders’

Balance at January 1, 2023

Balance, January 1, 2024

$ ( 130,036 )

Common stock and warrants issued in private placement offering

Shared-Based Compensation

Balance at December 31, 2023

Issuance of common stock and pre-funded warrants in public offering, net of fees

Stock-based compensation

Options exercised

Balance, December 31, 2024

$ ( 151,855 )

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

accompanying notes to consolidated financial statements.

MEDICAL CORPORATION

STATEMENTS OF CASH FLOWS

(In thousands, unless otherwise indicated)

thousands, unless otherwise indicated)

For the Years Ended

(In thousands, unless otherwise indicated)

Cash Flows from Operating Activities

Adjustments to reconcile net loss to net cash used in operating activities:

Share-based compensation

Stock-based compensation

Depreciation and amortization

Amortization of right-of-use assets

Unrealized loss (gain) from investments

Unrealized loss from investments

Changes in operating assets and liabilities:

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Purchases of property and equipment

Net Cash Provided by (Used in) Investing Activities

Net cash provided by investing activities

Cash Flows from Financing Activities

Proceeds from private placement offering

Proceeds from stock option exercises

Proceeds from the sale of common stock and pre-funded warrants in public offering, net of fees

Proceeds from sale of common stock in At-the-Market offering, net of fees

Proceeds from exercise of warrants

Proceeds from exercise of stock options

Net cash provided by financing activities

Net Decrease in Cash and Cash Equivalents

Net increase (decrease) in cash and cash equivalents

Cash and cash equivalents, beginning of year

Cash and cash equivalents, end of year

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

accompanying notes to consolidated financial statements.

MEDICAL CORPORATION

1 unchanged sentence

1 – Business Organization and Nature of Operations

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 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.

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

Food and Drug Administration (FDA).

We expect the VenoValve to

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

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

with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option.

Medical Corporation (the “Company”) is a 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 a replacement venous valve for patients suffering from severe

Chronic Venous Insufficiency (“CVI”) of the deep venous system of the leg.

Company first developed the VenoValve®, which was a potential first-in-class surgical replacement venous valve (the Company received

a not-approvable letter from the U.S.

Food and Drug Administration (“FDA”) in response to its PMA application for the VenoValve

in August 2025).

The Company is now focused on its next-generation, non-surgical venous valve product, called the enVVe® system.

The enVVe System consists of the enVVe Valve, enVVe Delivery System, enVVe Nose Cone, the enVVe Delivery System Accessories, and the

enVVe Crimping System.

The enVVe Valve is a first-in-class, non-surgical, transcatheter based replacement venous valve being developed

for the treatment of severe CVI.

The enVVe Valve is designed to act as a one-way valve, to help assist in propelling blood up the veins

of the leg, and back to the heart and lungs.

The Company has completed pre-clinical testing on the enVVe System and has begun discussions

with the FDA regarding the enVVe pivotal trial, which it expects to begin in 2026.

enVVe System is being developed for approval by the FDA.

Reverse Stock Split

the annual meeting of the Company’s stockholders held on December 11, 2025 (the “2025 Annual Meeting”), the Company’s

stockholders approved an amendment to the Company’s Restated Certificate of Incorporation, as amended (the “Restated Certificate

of Incorporation”), to effect a reverse stock split of our common stock, at a ratio between one-for-five (1:5) and one-for-thirty-five

January 2, 2026, the Company’s board of directors (the “Board”) approved a one-for-thirty-five (1:35) reverse stock

split of the outstanding shares of our common stock (the “Reverse Stock Split”).

On January 16, 2026, the Company filed an

amendment to the Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to effect the Reverse Stock

Split, which became effective on January 20, 2026.

The amendment did not change the number of authorized shares of our common stock.

as the context otherwise requires, all common stock share numbers, share price amounts (including exercise prices, conversion prices,

and closing market prices) and shares issued upon the exercise of warrants contained in the audited consolidated financial statements

and notes thereto have been retroactively adjusted to reflect the Reverse Stock Split.

2 – Management’s Liquidity Plan

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use of the asset and its eventual disposition are less than its carrying amount.

MEDICAL CORPORATION

TO CONSOLIDATED FINANCIAL STATEMENTS

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

26 unchanged sentences

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

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

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.

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

6 unchanged sentences

would have been anti-dilutive.

MEDICAL CORPORATION

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

nonemployees.

The accounting treatment for share-based payments to employees and non-employees is substantially equivalent.

The accounting treatment for stock-based payments to employees and non-employees is substantially equivalent.

compensation cost is recorded for all option grants and awards of non-vested stock based on the grant date fair value of the award, and

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

The Company uses its stock’s historical market

information to calculate volatility used in estimating fair value of options granted.

The volatility assumption is based on the historical

volatility of the Company’s common stock with an equivalent remaining expected term.

The risk-free interest rate is based on the

implied yield available on U.S.

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.

Company uses its stock’s historical market information to calculate volatility used in estimating fair value of options granted.

The volatility assumption is based on the historical volatility of the Company’s common stock with an equivalent remaining expected

The risk-free interest rate is based on the implied yield available on U.S.

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.

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 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.

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

ASU 2023-09 was effective for annual periods beginning after December 15, 2024, and required 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.

ASU 2023-09 effective on January 1, 2025, and have prospectively applied it to all periods presented.

Accounting Standards

December 2024, the FASB issued ASU No.

9 unchanged sentences

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

MEDICAL CORPORATION

TO CONSOLIDATED FINANCIAL STATEMENTS

4 – Concentrations

5 unchanged sentences

5 – Investments

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

of Components of Investments

components of investments were as follows:

Schedule of Components of Investments

December 31, 2025

December 31, 2024

(In thousands)

Fair Value Level 1

1 unchanged sentence

Total debt investments

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.

losses of $ 0.4 million and $ 22,000 for the year ended December 31, 2025 and 2024, respectively, from fixed-income securities are primarily

attributable to changes in interest rates.

6 – Property and Equipment

of December 31, 2024, and 2023, property and equipment consist of the following:

and equipment consist of the following:

of Property and Equipment

(In thousands)

Laboratory equipment

3 unchanged sentences

accumulated depreciation

Property and equipment, net

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 CONSOLIDATED FINANCIAL STATEMENTS

Total property and equipment, net

expense was $ 0.1 million and $ 0.2 million for the years ended December 31, 2025 and 2024, respectively, and is reflected in general and

administrative expenses in the accompanying statements of operations.

7 – Right-of-Use Assets and Liabilities

1 unchanged sentence

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.

The lease rate at the date of the amendment was approximately $ 30,000 per month with

escalating payments adjusting annually.

In connection with the lease, the Company is obligated to pay approximately $ 7,000 monthly for

operating expenses for building repairs and maintenance.

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

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) :

operating lease cost is as follows:

of Operating Lease Cost

For the Year Ended

December 31, 2024

(In thousands)

Operating lease cost

1 unchanged sentence

of Supplemental Cash Flow Information Related to Operating Lease

(Dollars in thousands)

For the Year Ended

December 31, 2024

(In thousands)

Operating cash flow information:

2 unchanged sentences

of Operating Remaining Lease Term and Discount Rate

December 31, 2024

Remaining lease term

5 unchanged sentences

Year ended December 31, 2027

Total lease liability

Imputed interest

Present value of our lease liability

MEDICAL CORPORATION

TO CONSOLIDATED FINANCIAL STATEMENTS

8 – Accounts payable, accrued expenses and other current liabilities

of December 31, 2024 and 2023, accounts payable, accrued expenses and other current liabilities consist of the following:

payable, accrued expenses and other current liabilities consist of the following:

of Accounts Payable, Accrued Expenses and Other Current Liabilities

(In thousands)

Accounts Payable

Accrued compensation costs

Accrued expenses

Accrued clinical costs

Accrued severance

Other accrued expenses

Total accounts payable, accrued expenses and other current liabilities

9 – Income Taxes

domestic and foreign components of net loss before income taxes are as follows:

Schedule of Domestic and Foreign Components of Net Loss Before Income Taxes

the Years Ended

Net loss before income

following summarizes the Company’s income tax provision (benefit):

of Income Tax Provision (Benefit)

(Dollars in thousands)

For the Years Ended

(Dollars in thousands)

(In thousands)

Federal Current

6 unchanged sentences

Income tax provision (benefit)

December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures.

This guidance is intended

to enhance the transparency and decision-usefulness of income tax disclosures by requiring more granular disaggregation in the effective

tax rate (“ETR”) reconciliation and providing expanded information regarding income taxes paid, categorized by jurisdiction.

The Company adopted the provisions of ASU 2023-09 on a prospective basis effective January 1, 2025.

accordance with this guidance, the following table provides a disaggregated reconciliation of the Company’s effective income tax rate

statutory federal income tax rate:

Schedule of Effective Income Tax Rate Reconciliation

(In thousands)

For the Year Ended

December 31, 2025

(In thousands)

Tax benefit at federal statutory rate

State taxes, net of federal benefit

Foreign tax effects

Effects of changes in tax laws or rates enacted

Effect of cross-border tax laws

Research and development costs

Changes in valuation allowance

Nontaxable or nondeductible items:

Stock-based compensation

Changes in unrecognized tax benefits

Other adjustments:

Stock-based compensation true-up

Other adjustments

Effective income tax

reconciliation between the U.S.

statutory federal income tax rate and the Company’s effective tax rate for the year’s ended

December 31, 2024 and 2023 is as follows:

of Effective Income Tax Rate Reconciliation

For the Years Ended

statutory federal income tax rate and the Company’s effective tax rate for the year ended December

31, 2024 is as follows in accordance with the guidance prior to adoption of ASU 2023-09:

For the Year Ended

Tax benefit at federal statutory rate

5 unchanged sentences

Effective income tax rate

MEDICAL CORPORATION

TO CONSOLIDATED FINANCIAL STATEMENTS

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

The Company’s state and

local income tax expense is primarily driven by its operations in California.

For the year ended December 31, 2025, California represents

greater than 50% of the state and local income tax component of the effective tax rate reconciliation.

No other individual state or local

jurisdiction accounted for more than 50% of the aggregate state and local tax effect for the year ended December 31, 2025.

components of the Company’s deferred tax assets are as follows:

of Deferred Tax Assets and Liabilities

(In thousands)

For the Years Ended

(In thousands)

16 unchanged sentences

valuation allowance

Total deferred tax assets

July 4, 2025 the One Big Beautiful Bill Act, or OBBBA, was enacted.

The legislation includes several changes to the U.S.

federal corporate

income tax law, among other things, reinstating 100 % bonus depreciation on qualified fixed assets, immediate expensing of domestic research

and development expenditures, and favorable rules for determining the limitation on business interest expense.

These changes were retroactively

enacted for tax years beginning after December 31, 2024 with certain provisions effective after January 19, 2025 and were reflected in

the income tax provision for the year ended December 31, 2025.

The provisions of the OBBBA did not have a material impact on the effective

income tax rate.

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

6 unchanged sentences

allowance increased by $ 4.2 million and $ 5.4 million during the years ended December 31, 2025 and 2024, 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 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

of December 31, 2025 and 2024, the Company net operating loss carryforwards for federal income tax purposes of approximately $ 95.6 million

and $ 72.2 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

and $ 61.1 million, respectively, which can be carried forward for twenty years and begin to expire in 2029.

The remaining post 2018 federal NOLs of approximately $ 83.6 million can be carried forward indefinitely

and could be used to offset up to 80 % of taxable income in all the future years.

of December 31, 2025 and 2024, the Company had net operating loss carryforwards for state income tax purposes of approximately $ 114.0

million and $ 97.7 million, respectively, which can be carried forward for twenty years and begin to expire in 2029.

the extent the Company utilizes its NOL carryforward 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

utilization of the Company’s net operating loss carryforwards and research tax credit carryovers could be subject to annual limitations

under Section 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), due to ownership change limitations

that may have occurred previously or that could occur in the future.

These ownership changes limit the amount of net operating loss carryforwards

and other deferred tax assets that can be utilized to offset future taxable income and tax, respectively.

In general, an ownership change,

as defined by Section 382 and 383 of the Code, results from transactions increasing ownership of certain stockholders or public groups

in the stock of the corporation by more than 50 percent points over a three-year period.

The Company has not completed an analysis of

an ownership change under Section 382 of the Code.

To the extent that a study is completed and an ownership change is deemed to occur,

the Company’s net operating losses and tax credits could be limited.

Company files income tax returns in the U.S.

1 unchanged sentence

by those taxing authorities.

The Company’s federal income taxes for the years beginning in 2020 remain subject to examination.

The Company’s state and local income tax returns for the years beginning in 2021 remain subject to examination.

No tax audits were

initiated during 2024 or 2023.

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 CONSOLIDATED FINANCIAL STATEMENTS

The statute of limitations for assessment by the IRS and state tax authorities is open for tax years ending

December 31, 2025, 2024, 2023, 2022 and 2021, although carryforward attributes that were generated for tax years prior to 2021 may still

be adjusted upon examination by the IRS or state tax authorities if they either have been, or will be, used in future period.

audits were initiated during 2025 or 2024.

For the fiscal year ended December 31, 2025, the Company did not make any

payments for federal or state income taxes, net of refunds received.

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, 2025 and 2024.

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.

10 – Commitments and Contingencies

3 unchanged sentences

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

MEDICAL CORPORATION

TO CONSOLIDATED FINANCIAL STATEMENTS

11 – Stockholders’ Equity

Company completed equity transactions in each of 2024 and 2023.

The following table provides an overview of those transactions.

Company completed equity transactions during the years ended December 31, 2025 and 2024.

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

November 4 through December 19

At-the-Market Offering (ATM)

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:

2025 transaction is a result of the sale the common stock under an At-the-Market Agreement (“ATM”), entered into on October

30, 2025 to create an at-the-market equity program under which the Company may sell up to $ 50 million of shares of its common stock from

time to time.

2024 transaction included approximately 2,000 pre-funded warrants and approximately 9,000 warrants to the underwriter with a weighted

average exercise price of the warrants is $ 140.88 and a fair value of $ 1.0 million based on the Black Scholes method and the following

weighted average input assumptions:

of Estimated Fair Values and Assumptions

2 unchanged sentences

Dividend yield

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

summary of warrant activity is presented below:

of Stock Warrant Activity

(In thousands)

Outstanding, January 1, 2023

(In thousands)

Outstanding, January 1, 2024

( 4,846,072 )

Outstanding, December 31, 2024

Outstanding and exercisable, December 31, 2025

MEDICAL CORPORATION

TO CONSOLIDATED FINANCIAL STATEMENTS

12 – Share Based Compensation

12 – Stock-based Compensation

Incentive Plan

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.

Company issues stock-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 stock-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.

2016 Plan is to be administered by the Board, which has discretion over the awards and grants thereunder.

No awards may be issued after

November 21, 2026.

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 %

April 26, 2028.

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

As of December 31, 2025 there are 220,150

shares authorized to be issued and 33,678 remaining available for future issuance under the Plan.

fair value of each option grant is estimated at the grant date using the Black Scholes method.

7 unchanged sentences

Dividend yield

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

summary of the option activity is presented below:

of Stock Option Activity

(In thousands)

Outstanding, January 1, 2024

2 unchanged sentences

Exercisable, December 31, 2025

Company includes share-based compensation expense in selling, general and administrative expenses, and recognized $ 4.1 million and $ 5.2

Company includes stock-based compensation expense in selling, general and administrative expenses, and recognized $ 3.4 million and $ 4.1

million during the years ended December 31, 2025 and 2024, respectively.

of December 31, 2024, there was $ 4.9 million of unrecognized share-based compensation expense related to outstanding stock options and

restricted stock units that will be recognized over the weighted average remaining vesting period of 1.7 years.

of December 31, 2025, there was $ 3.2 million of unrecognized stock-based compensation expense related to outstanding stock options that

will be recognized over the weighted average remaining vesting period of 1.6 years.

Company also issues restricted shares and restricted stock units under the 2016 Plan.

A summary of the restricted share and restricted

stock units activity during the years ended December 31, 2023 and 2022 is presented below:

of Restricted Stock Units

Restricted Shares

Outstanding, January 1, 2023

Shares vested

Outstanding, December 31, 2023

Shares Vested

Outstanding, December 31, 2024

As of December 31, 2024, there were 11,428 restricted

stock units issued and outstanding.

As of December 31, 2025, vesting conditions required for the restricted stock units was not achieved

and the restricted stock units were cancelled.

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:

per common share:

of Dilutive Net Loss Per Common Share

(In thousands)

Shares of common stock issuable upon exercise of warrants

2 unchanged sentences

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 has determined that it currently operates in a 1 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 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)

the Years Ended

(In thousands)

1 unchanged sentence

Employee expense

Total research and development

research and development

Selling, general and administrative expense

1 unchanged sentence

Professional fees

Total selling, general and administrative expense

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.

and reconciling items

and reconciling items in the above table consist of interest income and realized and unrealized gains and losses related to our investments

Treasury securities.

15 – Subsequent Events

Reverse Stock Split

December 11, 2025, the Company completed its 2025 Annual Meeting of Stockholders (the “Annual Meeting”).

At the Annual Meeting,

the Company’s stockholders, among other things, granted authority to the Company’s Board of Directors to effectuate a reverse

stock split of the Company’s common stock at a ratio of between one-for-five and one-for-thirty-five , with such ratio to be determined

at the sole discretion of the Company’s Board of Directors (the “Board”) and with such reverse stock split to be effected

at such time and date, if at all, as determined by the Board in its sole discretion.

January 20, 2026, the Company effected a one-for-thirty-five (1:35) reverse stock split (the “Reverse Stock Split”) of the

shares of the Company’s common stock, par value $ 0.00001 per share (the “Common Stock”).

As a result of the Reverse

Stock Split, every thirty-five (35) shares of issued and outstanding Common Stock was automatically combined into one (1) issued and

outstanding share of Common Stock, without any change in the par value per share.

No fractional shares were issued as a result of the

Reverse Stock Split and any fractional shares resulting from the Reverse Stock Split were rounded down to the nearest whole share and

remitted cash payments in lieu of fractional shares.

Following the Reverse Stock Split, the number of shares of Common Stock outstanding

was reduced from 22,946,223 shares to 655,606 shares.

to their terms, proportional adjustments were also made to the Company’s outstanding stock options and warrants such that the number

of shares of Common Stock underlying such securities were reduced by a factor of 35 and the exercise prices of such securities were increased

by a factor of 35 (by way of example, if prior to the Reverse Stock Split there was an outstanding warrant to purchase 3,500 shares of

Common Stock at an exercise price of $ 0.30 per share, such warrant has now been adjusted following the Reverse Stock Split and is now

a warrant to purchase 100 shares of Common Stock at an exercise price of $10.50) .

The number of authorized shares of Common Stock under

the Certificate of Incorporation will remain unchanged at 250,000,000 shares.

Minimum Price Bid Compliance

February 4, 2026, the Company announced that it has received formal notice from the Listings Qualifications staff of The Nasdaq Stock

Market LLC (“Nasdaq”) that the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum

bid price of $ 1.00 per share.

Nasdaq confirmed that for the 10 consecutive business days, from January 20, 2026 through February 2, 2026,

the closing bid price of the Company’s common stock was at or above $1.00, and as a result, the matter was closed.

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