What changed in this filing

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Item 9A. Controls and Procedures

2024-02-29 compared with 2023-03-02 · 693 added, 719 removed, 1107 unchanged (56% of the section changed)

and Procedures

Controls and Procedures

of Controls and Procedures

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

public accounting firm pursuant to a permanent exemption of the Commission that permits the Company to provide only management’s

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

report in this Annual Report on Form 10-K.

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

Regarding Foreign Jurisdictions That Prevent Inspections

Executive Officers and Corporate Governance

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

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of Service Commencement

Chief Executive Officer

Financial Officer and Treasurer

Director, Chief Executive Officer

Chief Financial Officer and Treasurer

Francis Duhay

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Glickman, M.D.

Vice President and Chief Medical Officer

Senior Vice President and Chief Medical Officer

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

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

He is an accomplished heart surgeon,

entrepreneur, and corporate executive.

Board certified in general (UCSF) and cardiothoracic surgery (Duke), his seminal work in

minimally invasive cardiac surgery led to 32 patents for surgical devices used in thousands of heart operations.

Dr Duhay left

clinical practice for industry in 2008, where he served as Vice President and General Manager of the nascent transcatheter heart

valve therapy program (Ascendra) at Edwards Lifesciences (“Edwards”), the world’s leading manufacturer of

bioprosthetic heart valves.

With European CE Mark, he oversaw growth in annual 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.

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.

He is an accomplished heart surgeon, entrepreneur,

and corporate executive.

Board certified in general (UCSF) and cardiothoracic surgery (Duke), his seminal work in minimally invasive

cardiac surgery led to 32 patents for surgical devices used in thousands of heart operations.

Dr Duhay left clinical practice for industry

in 2008, where he served as Vice President and General Manager of the nascent transcatheter heart valve therapy program (Ascendra) at

Edwards Lifesciences (“Edwards”), the world’s leading manufacturer of bioprosthetic heart valves.

With European CE

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.

We believe that Dr.

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.

He has been involved in developing,

commercializing, evaluating, and acquiring medical devices for more than 22 years, including serving in leadership positions in

research and development, business development, and marketing at J&J, BTG, plc, Medtronic, Abbott Vascular, and Edwards Life

He is presently serving as the chief executive officer at Innova Vascular, Inc., a medical device company funded largely

via an investment from a publicly traded medical device company.

Prior to this, he co-founded BlackSwan Vascular, Inc., which is a

clinical stage medical device company and where he serves on the board of directors.

He led the strategic alliance for BlackSwan

with Sirtex Medical, which was announced in 2020.

Shrivastava worked on several acquisition and investment deals during his

roles as a senior director, business development at J&J and a vice president, upstream marketing and strategy at BTG, plc, which

had an annual revenue of about $800 million and is now part of Boston Scientific Corporation through an acquisition.

At Medtronic,

Shrivastava was the Director of Global Marketing for the Cardiac and Vascular Group where he helped build the embolization

business, from its initiation to a substantial revenue with a very high CAGR over a period of six years.

Shrivastava was part of

the peripheral vascular business at Abbott Vascular and worked on endovascular and trans-catheter heart valve repair and replacement

products at Edwards Life Sciences.

Shrivastava received his Bachelor of Science in engineering at the Indian Institute of

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

We believe that Dr.

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

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

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

He has been involved in developing, commercializing,

evaluating, and acquiring medical devices for more than 23 years, including serving in leadership positions in research and development,

business development, and marketing at J&J, BTG, plc, Medtronic, Abbott Vascular, and Edwards Life Sciences.

He is presently serving

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

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

including the acquisition deal with Sirtex Medical.

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

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

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

of Boston Scientific Corporation through an acquisition.

At Medtronic, Dr.

Shrivastava was the Director of Global Marketing for the Cardiac

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

over a period of six years.

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

heart valve repair and replacement products at Edwards Life Sciences.

Shrivastava received his Bachelor of Engineering degree at

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

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

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

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

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

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of the Board and Stockholders

board of directors met in person and telephonically five times during 2022 and also acted by unanimous written consent.

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

There were four

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

that was held on November 30, 2022.

that was held on December 5, 2023.

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

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The functions of this committee include, among other things:

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 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;

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

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

auditors and management;

reviewing with our independent

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

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

reviewing our major financial

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

reviewing and evaluating

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

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.

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.

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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any amendments to, or waivers from, any provision of the code.

Trading Policy

Company has adopted an insider trading policy governing the purchase, sale, and/or other dispositions of the Company’s securities

by directors, officers and employees.

The policy is designed to promote compliance with insider trading laws, rules and regulations,

and any listing standards applicable to the Company.

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, 2023 and 2022.

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Chief Executive Officer

7,674,046 (1)

1,340,000 (6)

Chief Financial Officer

2,960,418 (2)

Glickman, M.D.

Chief Medical Officer and Senior Vice President

4,247,442 (3)

Senior Vice President & Chief Technology Officer

2,932,423 (5)

the grant date fair value of 838,000 stock options granted on February 18, 2021, and 349,781 stock options granted on November 30,

2021, computed in accordance with FASB ASC Topic 718.

The February options vest quarterly over a two-year period and the November

options vest quarterly over a three-year period.

the grant date fair value of 324,000 stock options granted on February 18, 2021 and 125,925 stock options granted on November 30,

2021, computed in accordance with FASB ASC Topic 718.

The options vest quarterly over a three-year periods.

the grant date fair value of 406,000 stock options granted on February 18, 2021 and 265,700 stock options granted on November 30,

2021, computed in accordance with FASB ASC Topic 718.

The February options vest quarterly over a two-year period and the November

options vest quarterly over a three-year period.

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

The options vest quarterly over a three-year period.

the grant date fair value of 320,000 stock options granted on February 18, 2021 and 125,925 stock options granted on November 30,

2021, computed in accordance with FASB ASC Topic 718.

The options vest quarterly over a three-year periods.

the grant date fair value of 200,000 shares of restricted stock units granted on November 30, 2021, computed based on the closing

price of the Company’s stock on the grant date.

the grant date fair value of 50,000 shares of restricted stock units granted on November 30, 2021, computed based on the closing

price of the Company’s stock on the grant date.

the grant date fair value of 100,000 shares of restricted stock units granted on November 30, 2021, computed based on the closing

price of the Company’s stock on the grant date.

the grant date fair value of 50,000 shares of restricted stock units granted on November 30, 2021, computed based on the closing

price of the Company’s stock on the grant date.

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

company paid healthcare of $1,155 and 401(k) match of $14,500.

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

company paid healthcare of $651.

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

company paid healthcare of $42,448 and 401(k) match of $14,500.

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

company paid healthcare of $13,274 and 401(k) match of $11,405.

Represents the grant date

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

The options vest

quarterly over a three-year period.

Represents the grant date

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

The options vest

quarterly over a three-year period.

Represents the grant date

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

The options vest

quarterly over a three-year period.

Represents the grant date

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

The options vest

quarterly over a three-year period.

Represents the grant date

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

The options vest

quarterly over a three-year period.