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Form 8-K

sec.gov

8-K — ESTABLISHMENT LABS HOLDINGS INC.

Accession: 0001628280-26-045885

Filed: 2026-06-29

Period: 2026-06-29

CIK: 0001688757

SIC: 3842 (ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES)

Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — esta-20260629.htm (Primary)

EX-99.1 (esta8k62926-ex991bod.htm)

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8-K

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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

June 29, 2026

Date of Report (date of earliest event reported)

Establishment Labs Holdings Inc.

(Exact name of registrant as specified in its charter)

British Virgin Islands 001-38593

98-1436377

(State or other jurisdiction of

incorporation or organization) (Commission File No.)

(I.R.S. Employer

Identification Number)

11401 Century Oaks Terrace

Suite 400

Austin, Texas 78758

(Address of principal executive offices) (Zip Code)

+1 800 924-5072

(Registrant’s telephone number, including area code)

N/A

(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:

☐    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 Name of each exchange on which registered

Common Shares, No Par Value ESTA

The Nasdaq Capital 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.

Appointment of Director; Board Composition Changes

On June 24, 2026, the Board of Directors (the “Board”) of Establishment Labs Holdings Inc. (the “Company”) appointed Taylor Harris to the Board, effective immediately, to serve until the Company’s 2027 annual meeting of shareholders and until his successor is duly elected and qualified. In addition, the Board appointed Mr. Harris as a member of the Audit Committee and the Nominating and Corporate Governance Committee.

In connection with his service as a director, Mr. Harris will receive the Company’s standard non-employee director cash and equity compensation, which is described under the heading “Non-Employee Director Compensation” in the Company’s definitive proxy statement on Schedule 14A filed with the Securities and Exchange Commission (“SEC”) on April 10, 2026. Effective April 24, 2026, the Board updated the non-employee director compensation policy to reflect an initial equity grant of $170,000 for new directors and a non-employee director annual grant of $170,000.

There is no arrangement or understanding between Mr. Harris and any other persons pursuant to which Mr. Harris was appointed as a director, and Mr. Harris has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.

Following the appointment of Mr. Harris to the Audit Committee and the Nominating and Corporate Governance Committee, the composition of the committees are as follows. The Audit Committee shall consist of Ann Custin, Mr. Harris, and Bryan Slotkin, with Ms. Custin serving as chair. The Nominating and Corporate Governance Committee shall consist of Leslie Gillin, Mr. Harris, and Mr. Slotkin, with Ms. Gillin serving as chair. The Board determined that all of the members of the Audit Committee, the Compensation Committee, and the Nominating and Corporate Governance Committee currently satisfy the independence requirements and other established criteria of The Nasdaq Stock Market LLC.

Mr. Harris also executed the Company’s standard form of indemnification agreement, a copy of which has been filed as Exhibit 10.1 to the Company’s Annual Report on Form 10-K filed with the SEC on February 27, 2025.

Item 7.01. Regulation FD Disclosure.

On June 29, 2026, the Company issued a press release announcing the director appointment set forth in Item 5.02 of this Current Report on Form 8-K.

A copy of the press release is furnished as Exhibit 99.1 to this report. This information shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description

99.1

Press Release of Establishment Labs Holdings Inc. dated June 29, 2026.

104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

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.

ESTABLISHMENT LABS HOLDINGS INC.

Dated:

6/29/2026

By:

/s/ Cassandra "Sandra" Harris

Name:

Cassandra "Sandra" Harris

Title:

Chief Financial Officer

EX-99.1

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Document

EXHIBIT 99.1

PRESS RELEASE

Investor/Media Contact:

Malavika William

mwilliam@establishmentlabs.com

Establishment Labs® Appoints Taylor Harris to Board of Directors

NEW YORK, NY, June 29, 2026 -- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction,announced today the appointment of Taylor Harris to its Board of Directors.

Mr. Harris brings more than 25 years of experience in corporate finance, executive leadership and board governance across healthcare, medical technology and life sciences companies. He currently serves on the board of directors of Procept BioRobotics and previously served as a director of Omada Health and Endologix. Most recently, he served as Chief Executive Officer of Cutera, Inc.

Prior to Cutera, Mr. Harris served as Chief Financial Officer of MyoKardia, where he helped guide the company through its acquisition by Bristol Myers Squibb in a transaction valued at $13.1 billion. Earlier in his career, he served as Chief Financial Officer of Zeltiq Aesthetics through its acquisition by Allergan and as Chief Financial Officer of Thoratec Corporation through its acquisition by St. Jude Medical. He also spent more than a decade at JPMorgan Chase & Co. in healthcare equity research and investment banking roles.

“Taylor is a highly regarded and accomplished healthcare executive whose experience will help Establishment Labs through its next phase of growth,” said Nick Lewin, Chairman of the Board of Establishment Labs. “Importantly, he brings deep expertise in the medical aesthetics industry and has helped lead and create substantial value at multiple healthcare companies. His perspective on sustained growth through innovation and focus on shareholder value creation will be a tremendous asset to Establishment Labs as it becomes a true leader in the global aesthetics market.”

“I am honored to join the Board of Establishment Labs at such an exciting time,” said Mr. Harris. “The company has built a reputation for innovation, quality and a strong commitment to improving outcomes for women around the world, and is in a position to become one of the most important companies in aesthetics and healthcare. I look forward to being part of the journey.”

About Establishment Labs

Establishment Labs Holdings Inc. is a global medical device company dedicated to improving women’s health and wellness in breast aesthetics and reconstruction through the power of science, engineering, and technology. The company offers a portfolio of solutions for breast health, breast aesthetics, and breast reconstruction in over 100 countries. With five million Motiva® devices delivered to plastic and reconstructive surgeons since 2010, the company’s products have created a new standard for safety and patient satisfaction. The company’s minimally invasive platform consists of Mia Femtech®, a unique minimally invasive experience for breast harmonization, and Preservé™, a breast tissue preserving and minimally invasive technology for primary breast augmentation and primary mastopexy augmentation. GEM® is a next generation minimally invasive system for gluteal ergonomic modeling currently undergoing an IRB approved pivotal study. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Zensor™ is an RFID technology platform used to safely identify implantable devices from outside the body, and includes the company’s first biosensor Zenº™, currently part of an IRB approved pivotal study to measure core breast temperature. These solutions are supported by over 200 patent applications in 20 separate patent families worldwide and over 100 scientific and clinical studies and publications in peer reviewed journals. Establishment Labs manufactures at two

facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2024 and FDA 21 CFR 820. Please visit our website for additional information at www.establishmentlabs.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “intends to,” “would,” “will,” “may” or other similar expressions in this press release. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, including related product development and commercialization and regulatory approvals, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the company’s performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties, and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results and the timing of events may differ from our expectations, and those differences may be material. Factors, among others, that could cause actual results and events to differ materially from those described in any forward-looking statements include risks and uncertainties relating to: our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product offerings; the rate of adoption of our products by healthcare providers or other customers; the success of our marketing initiatives; the safe and effective use of our products; our ability to protect our intellectual property; our future expansion plans and capital allocation; our ability to expand upon and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid a significant interruption in our supply chains; our ability to attract and retain key personnel; our ability to scale our operations to meet market demands; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. These and other factors that could cause or contribute to actual results differing materially from our expectations include, among others, those risks and uncertainties discussed in the company's annual report on Form 10-K filed on February 27, 2026, which risks and uncertainties may be updated in the future in other filings made by the company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends.

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