Form 8-K - Current report

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 5, 2024
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)

Buiding 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 8.01 Other Events.

On June 5, 2024, during the 2024 Jefferies Global Healthcare Conference, Establishment Labs (the “Company”) is announcing that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of the Company’s premarket approval application (PMA) for Motiva Implants and has issued a letter to the Company instructing that the PMA is approvable subject to an acceptable FDA inspection of the Company’s manufacturing facilities. The inspection by the FDA has been rescheduled from the previously confirmed dates to take place within the next thirty days.

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:

June 5, 2024

By:

/s/ Rajbir S. Denhoy

Name:

Rajbir S. Denhoy

Title:

Chief Financial Officer

Cover	Jun. 05, 2024
Cover [Abstract]
Document Type	8-K
Document Period End Date	Jun. 05, 2024
Entity Registrant Name	Establishment Labs Holdings Inc.
Entity Incorporation, State or Country Code	D8
Entity File Number	001-38593
Entity Address, Address Line One	Buiding B15 and 25
Entity Address, Address Line Two	Coyol Free Zone
Entity Address, City or Town	Alajuela
Entity Address, Country	CR
Country Region	506
City Area Code	24
Local Phone Number	34 2400
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Shares, No Par Value
Trading Symbol	ESTA
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Entity Central Index Key	0001688757
Amendment Flag	false
Entity Tax Identification Number	98-1436377