UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 16, 2020
Shockwave
Medical, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001- 38829 | 27-0494101 |
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
5403 Betsy Ross Drive Santa Clara, California |
95054 |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (510) 279-4262
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered |
| Common Stock, par value $0.001 | SWAV | Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 5.02. | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
On July 16, 2020, the Board of Directors (the “Board”) of Shockwave Medical, Inc. (the “Company”), upon the recommendation of the Board’s Nominating and Corporate Governance Committee, appointed Ms. Maria Sainz as a Class I member of the Board, effective July 16, 2020, to fill a vacancy on the Board resulting from an increase in the number of directors constituting the Board, to serve until the Company’s 2023 Annual Meeting of Stockholders and her successor is duly elected and qualified, or until her earlier death, resignation, or removal. Ms. Sainz will serve on the Compensation Committee of the Board.
Ms. Sainz has served as the President and CEO of AEGEA Medical, Inc., since May of 2018. She has over 25 years’ experience in commercial and leadership positions in the medtech industry. Ms. Sainz previously served as the President & CEO of Cardiokinetix, a medical device company pioneering a catheter-based treatment for heart failure. Prior to that, Ms. Sainz was the President & CEO of Concentric Medical, Inc., a developer of minimally invasive products for the treatment of acute ischemic stroke, which was acquired in 2011 by Stryker Corporation. Ms. Sainz began her medtech career at Guidant Corporation where she held positions of increasing responsibility in Europe and the US. At the time of the acquisition of Guidant by Boston Scientific, Ms. Sainz served as President of the Cardiac Surgery division of Guidant Corporation. Ms. Sainz has been intimately involved in several major medtech product launches such as coronary stents or cardiac resynchronization therapy devices. Ms. Sainz also serves as a Director of several public and private medical company boards. She received a M.A in Languages from the University Complutense in Madrid, Spain and a Masters in International Management from the American Graduate School of International Management.
Ms. Sainz will receive compensation in accordance with the Company’s standard compensatory arrangement for non-employee directors in effect from time to time, as most recently described under the caption titled “Director Compensation” in the Company’s proxy statement filed with the Securities and Exchange Commission on April 28, 2020. Ms. Sainz and the Company have entered into the Company’s standard indemnification agreement for directors and executive officers, the form of which was filed as Exhibit 10.7 to the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2020. There are no other material plans, contracts or arrangements in which Ms. Sainz will participate in connection with her appointment.
There are no arrangements or understandings between Ms. Sainz and any other person pursuant to which Ms. Sainz was selected as a director. Ms. Sainz has not been involved in any related person transactions with the Company that would require disclosure under Item 404(a) of Regulation S-K.
On July 20, 2020, the Company posted on its website a press release announcing the appointment of Ms. Sainz to the Board. A copy of that press release is attached hereto as Exhibit 99.1.
| Item 9.01. | Financial Statements and Exhibits. |
Item 9.01(d) – Exhibits
EXHIBIT INDEX
| Exhibit Number |
Description of Exhibit |
| 99.1 | Press release issued by Shockwave Medical, Inc., dated July 20, 2020. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Shockwave Medical, Inc. | |
| Date: July 20, 2020 |
/s/ Hajime Tada |
| Hajime Tada General Counsel |
Exhibit 99.1
SHOCKWAVE APPOINTS MARIA SAINZ TO BOARD OF DIRECTORS
Santa Clara, Calif. — July 20, 2020 — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, announced today that Maria Sainz has joined its Board of Directors and will serve on Shockwave’s Compensation Committee.
“I am delighted to welcome Maria to our Board of Directors,” said Doug Godshall, President and Chief Executive Officer of Shockwave Medical. “Her rich experience in company building and commercialization success within the medical technology sector will make Maria an excellent addition and invaluable strategic resource to Shockwave as we continue to build and grow the company.”
Ms. Sainz, who has over 25 years of experience in leadership and commercial positions in the medical technology industry, currently serves as Chief Executive Officer of Aegea Medical, Inc. Prior to this position, she served as the President and CEO of Cardiokinetix, a medical device company pioneering a catheter-based treatment for heart failure and as the President and CEO of Concentric Medical, Inc., a developer of minimally invasive products for the treatment of acute ischemic stroke, which was acquired in 2011 by Stryker Corporation. Maria began her medical technology career at Guidant Corporation where she held positions of increasing responsibility in Europe and the United States, culminating in her position as President of the Cardiac Surgery division at the time of the acquisition of Guidant Corporation by Boston Scientific. Ms. Sainz has been intimately involved in the launches of several significant medical technology products including coronary stents and cardiac resynchronization therapy devices. She also serves as a member of the board of directors of Orthofix Medical, Inc. and Avanos Medical, Inc. Ms. Sainz received a Master of Arts in Languages from the University Complutense in Madrid, Spain and a Masters in International Management from the American Graduate School of International Management.
“I am honored to join the Shockwave Medical Board of Directors,” said Ms. Sainz. “Shockwave has made tremendous progress transforming the treatment of calcified coronary disease and I am excited to join this esteemed group and to together collaborate with the exceptional management team as Shockwave continues to expand their business, commercial footprint and overall success.”
About Shockwave Medical, Inc.
Shockwave Medical is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. We aim to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through our differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which we refer to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com.
Forward-Looking Statements.
This press release contains statements relating to Shockwave’s expectations, projections, beliefs, and prospects (including statements regarding Shockwave’s product development outlook), which are “forward-looking statements” within the meaning of the federal securities laws and by their nature are uncertain. Words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plans,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: the impact of the COVID-19 pandemic on our operations, financial results, and liquidity and capital resources, including on sales, expenses, supply chain, manufacturing, research and development activities, clinical trials and employees; our ability to design, develop, manufacture and market innovative products to treat patients with challenging medical conditions, particularly in peripheral artery disease, coronary artery disease and aortic stenosis; our expected future growth, including growth in international sales; the size and growth potential of the markets for our products, and our ability to serve those markets; the rate and degree of market acceptance of our products; coverage and reimbursement for procedures performed using our products; the performance of third parties in connection with the development of our products, including third-party suppliers; regulatory developments in the United States and foreign countries; our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines; our plans to research, develop and commercialize our products and any other approved or cleared product; our ability to scale our organizational culture of cooperative product development and commercial execution; the development, regulatory approval, efficacy and commercialization of competing products; the loss of key scientific or management personnel; our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; and our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission (SEC), including in Part I, Item IA - Risk Factors in our most recent Annual Report on Form 10-K filed with the SEC, and in our other periodic and other reports filed with the SEC. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.
Media Contact:
Scott Shadiow
+1.317.432.9210
sshadiow@shockwavemedical.com
Investor Contact:
Debbie Kaster
investors@shockwavemedical.com