エスタブリッシュメントラボズHDの適時開示・その他

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


May 6, 2025
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)

Building B15 and 25

Coyol Free Zone

Alajuela

Costa Rica

(Address of principal executive offices) (Zip Code)

+506 2434 2400

(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 Filippo "Peter" Caldini as Chief Executive Officer and to the Board of Directors

On May 6, 2025, following an extensive search process for the Company’s permanent Chief Executive Officer role, the Board of Directors (the “Board”) of Establishment Labs Holdings Inc. (the “Company”) appointed the Company’s interim Chief Executive Officer Fillipo “Peter” Caldini to serve as Chief Executive Officer, effective May 7, 2025. The Board also appointed Mr. Caldini as a Class II director of the Company, effective May 24, 2025, with a term of office expiring at the Company’s 2026 Annual General Meeting of Shareholders, filling the vacancy created by the death of director Dennis Condon on January 29, 2025.

There has been no change in Mr. Caldini’s compensation as a result of his appointment to Chief Executive Officer, and Mr. Caldini will not be eligible to receive compensation as a member of the Board as a result of his position as an employee of the Company.

Biographical information for Mr. Caldini can be found under the caption “Executive Officers” in the Company’s Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 10, 2025, which information is incorporated herein by reference.

There are no arrangements or understandings between Mr. Caldini and any other persons pursuant to which he was appointed as Chief Executive Officer of the Company and to serve as a member of the Board. Mr. Caldini has no family relationships with any of the Company’s directors or executive officers, and Mr. Caldini does not have any direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.

Item 7.01. Regulation FD Disclosure.

On May 7 2025, the Company issued a press release announcing Mr. Caldini’s appointment. A copy of the press release is attached to this Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

The information in Item 7.01 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits


Exhibit No.			Description
99.1			Press Release of Establishment Labs Holdings Inc. dated May 7, 2025
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:

May 7, 2025

By:

/s/ Rajbir S. Denhoy

Name:

Rajbir S. Denhoy

Title:

Chief Financial Officer

EX-99.1 2 ex991pressrelease5725.htm EX-99.1 Document



						EXHIBIT 99.1


PRESS RELEASE			Investor/Media Contact: Raj Denhoy 415 828-1044 rdenhoy@establishmentlabs.com

Establishment Labs Appoints Peter Caldini as Chief Executive Officer

NEW YORK, NY, May 7, 2025 -- 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 Peter Caldini as Chief Executive Officer effective May 7, 2025. Mr. Caldini has served as Interim CEO since March 1, 2025, when Establishment Labs’ Founder and previous CEO Juan José Chacón-Quirós retired from the role.

After an extensive search process, it was clear that with his deep operational, commercial, and financial skills, Peter is the ideal person to lead Establishment Labs,” commented Nick Lewin, Chairman of the Board of Establishment Labs. “We have a vision and a mission that is very clear, and execution is paramount to ensure that we accomplish all our goals, including turning EBITDA positive in 2025 and cash flow positive in 2026. Our Founder, Juan José Chacón-Quirós continues as a board member and an integral part of the team, from supporting our continued R&D efforts, to ensuring the adoption of our products and technologies by the plastic surgery community. He will advocate around the world for Establishment Labs and its contributions to women’s health.”

“It is an honor to be leading Establishment Labs,” added Peter Caldini. “Our company has transformed breast aesthetics and reconstruction globally though innovation and science, and it is in a unique position to do so again as we launch in the United States. We are building an incredibly strong moat in a multibillion-dollar market. Our product suite is one of the most differentiated in medtech, and we are working aggressively to take and expand the market. Most exciting to me is what is in front of us: the chance to marry innovation and best-in-class products with operational excellence so that we can deliver to all our stakeholders, including women, plastic surgeons, and investors.”

Fillipo “Peter” Caldini joined Establishment Labs as President in 2024. Previously, he served as the Chief Executive Officer and Director of Acreage Holdings, Inc. from 2020 to 2023 and of Bespoke Capital Acquisition Corp from 2019 to 2020. From 2015 to 2019, Mr. Caldini worked at Pfizer Consumer Healthcare where he was the Regional President for North America and prior to that role, Regional President of EMEA. He worked at Bayer Consumer Healthcare from 2009 to 2014 where he held several roles of increasing responsibility, including Head of Emerging Markets, GM China, and Head of the Nutritionals Strategic Business Unit. Mr. Caldini received his undergraduate degree from Boston University, his MBA from Northeastern University, and a Master’s in International Economics and Management from SDA Bocconi.

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 90 countries. With over four 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 breast augmentation, revision augmentation and 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.

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