Form 8-K

8-K — ESTABLISHMENT LABS HOLDINGS INC.

Accession: 0001104659-26-115928

Filed: 2026-10-15

Period: 2026-10-14

CIK: 0001688757

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

Item: Entry into a Material Definitive Agreement

Item: Financial Statements and Exhibits

Documents

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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

October 14, 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

(Commission File No.)

(I.R.S. Employer

incorporation or organization)

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 1.01 Entry into a Material Definitive Agreement.

On October 14, 2026, Establishment Labs Holdings

Inc. (the “Company”), through its wholly owned subsidiary, Establishment Labs, S.A. (“ELSA”), entered into Amendment

No. 3 (“Amendment No. 3”) to the Master Supply Agreement (the “Agreement”), effective January 1,

2027, with NuSil Technology LLC (“NuSil”). Amendment No. 3 extends the end of the initial term of the Agreement from

December 31, 2026, to December 31, 2031, with automatic renewal thereof for successive terms of one (1) year each for up

to five (5) successive renewal terms, unless ELSA or NuSil provides written notice no later than December 31 of the year prior

to the expiration of the initial term or the then-current renewal term. Amendment No. 3 also amends specified provisions of the Agreement

relating to NuSil’s manufacture and sale of medical-grade silicone for use in specified ELSA products as well as payment terms,

business continuity, and certain intellectual property and pricing provisions.

The foregoing description of Amendment No. 3

is qualified in its entirety by reference to the complete text of Amendment No. 3, a copy of which is filed hereto as Exhibit 10.1

and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

No.

Description

10.1+

Amendment No. 3 to Master Supply Agreement, effective as of January 1, 2027, by and between Establishment Labs, S.A., and NuSil Technology LLC.

104

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

+ Certain portions of the exhibit have been redacted in compliance

with Item 601(b)(10) of Regulation S-K.

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:

October 15, 2026

By:

/s/ Cassandra "Sandra" Harris

Name:

Cassandra "Sandra" Harris

Title:

Chief Financial Officer

EX-10.1 — EXHIBIT 10.1

EX-10.1

Filename: tm2627633d1_ex10-1.htm · Sequence: 2

Exhibit 10.1

Certain identified information has been redacted from this exhibit because it is both not material and is the type that the registrant

treats as private or confidential. [***] indicates that information has been redacted.

AMENDMENT NO. 3 TO MASTER SUPPLY AGREEMENT

BETWEEN NUSIL TECHNOLOGY LLC AND ESTABLISHMENT LABS SA

DATED MAY 13, 2022

THIS AMENDMENT NO. 3 (the “Amendment”)

is made effective as of January 1, 2027 (the “Amendment Effective Date”) by and between NuSil Technology LLC,

a Delaware limited liability company with an office at 1050 Cindy Lane, Carpinteria, California 93013 USA (“NuSil”)

and Establishment Labs SA, registered under the laws of Costa Rica and with an office at Zona Franca El Coyol, Calle 0 Edificio

B-25, Alajuela, Costa Rica (“Buyer”). NuSil and Buyer may be referred to herein individually, as a “Party”

and together, as the “Parties”.

WHEREAS, the Parties entered into that

certain Master Supply Agreement dated May 13, 2022, as previously amended by Amendment No. 1 between the Parties dated September 19,

2025, and by Amendment No. 2 between the Parties dated March 31, 2026 (collectively, the “Agreement”); and

WHEREAS, the Parties now desire to further amend the Agreement.

NOW, THEREFORE, in consideration of

the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged,

the Parties agree as follows:

1. Amended Provisions. Effective as of the Amendment Effective Date:

A. The second sentence in Section 2(b) of the Agreement is hereby deleted in its entirety and replaced

with the following:

“Notwithstanding any other provision

in this Agreement, all payments under this Agreement shall be made on a Net 30 EOM basis. Payment is due in full thirty (30) calendar

days following the last day of the calendar month in which the applicable invoice is issued.”

B. Section 5(b) of the Agreement is hereby modified to extend the end of the Initial Term of the

Agreement from December 31, 2026, to December 31, 2031. For the avoidance of doubt, except as expressly modified herein, all

renewal rights set forth in Section 5(b) of the Agreement shall remain unchanged.

C. Section 9 (Intellectual Property) of the Agreement is hereby modified to add the following

sub-section (c), immediately following the end of sub-section (b):

“(c) If the Parties wish

to undertake a project intended to result in jointly owned intellectual property, such project shall be governed by a separate written

agreement signed by an authorized representative of each Party that expressly addresses the ownership and use of any resulting intellectual

property.”

D. Section 11(a) of the Agreement is hereby deleted in its entirety and replaced with the following:

“(a) Subject to the terms

and conditions of this Agreement, during the Term, Buyer shall purchase exclusively from NuSil, and NuSil shall manufacture and sell to

Buyer, all or substantially all of Buyer’s requirements for silicone materials, including, but not limited to, all of Buyer’s requirements of

the Products. As used herein, “substantially all” shall mean [***]. Buyer shall not use, incorporate, mix, or permit the use, incorporation, or mixing of any non-NuSil

silicone materials in any shell or gel for aesthetic and reconstructive implantable medical devices, whether performed by Buyer or by

a third party acting on Buyer’s behalf. To the extent Buyer requires New Material (as defined in Appendix A), the applicable provisions

of Appendix A shall apply.”

NuSil Technology – Establishment Labs Page 1 of 3

E. The second table in Appendix A (Products and Prices; Supply Shortfall) of the Agreement is hereby

deleted in its entirety and replaced with the following table:

[***]

F. The first sentence of the “Exclusive Products” section in Appendix A (Products and Prices;

Supply Shortfall) of the Agreement is hereby modified by deleting the reference to [***] and replacing it with [***].

G. Notwithstanding anything to the contrary in the Agreement, the maximum unsecured credit extended by NuSil

to Buyer at any time shall not exceed [***] (the “Credit Limit”). If

Buyer’s aggregate outstanding accounts receivable balance exceeds the Credit Limit, NuSil may, upon written notice to Buyer, suspend

shipments, require pre-payment, require a letter of credit, require other credit support reasonably acceptable to NuSil, and/or withhold

acceptance of additional Purchase Orders until Buyer’s outstanding balance is reduced below the Credit Limit. NuSil may review the

Credit Limit from time-to-time and may increase or decrease the Credit Limit based upon Buyer’s payment history, financial condition,

and creditworthiness, upon written notice to Buyer. Nothing in this Amendment or the Agreement obligates NuSil to extend credit in excess

of the Credit Limit.

H. NuSil will implement and maintain business continuity and disaster recovery policies and procedures that

it deems commercially reasonable for its operations and industry practices, provided that such policies and procedures are pursuant to,

or comply with, relevant business system security standards (e.g., NIST SP 800-171, ISO/IEC 27001:2022, ISO 22301). NuSil shall

have sole discretion regarding the design, implementation, maintenance, modification, and testing of such policies and procedures. NuSil

shall, upon Buyer's written request, but not more than once per year, provide Buyer with an overview of NuSil’s business continuity

and disaster recovery policies and procedures that relate to the Products, all of which shall be considered Confidential Information under

this Agreement.

I. Last-Time Buy. If (i) NuSil sells, transfers, or otherwise disposes of substantially

all of its assets, or (ii) any person or persons, whether natural or legal, whether acting singly or jointly, become(s) a beneficial

owner, directly or indirectly, of securities of NuSil, representing fifty percent (50%) or more of its combined

voting power (each, a “Change in Control”), then Buyer may, upon written notice to NuSil, make a last-time buy for

such quantities of the Products as Buyer determines is necessary to support its requirements for a period of up to [***]

or the remaining term of this Agreement, whichever is greater, where such requirements are based on Buyer’s prior year’s purchases

of Products, adjusted for Buyer’s anticipated growth rate for the applicable time period; provided, however, that the aggregate

quantity of Products subject to such last-time buy shall not exceed the aggregate quantity of such Products purchased by Buyer from NuSil

during the [***] period immediately preceding Buyer’s notice exercising its last-time buy right. NuSil shall accept

and fulfill such last time buy, in the form of a binding purchase order, at the prices and on the other terms and conditions then applicable

under this Agreement, notwithstanding any assignment, expiration, termination, or other provision of this Agreement. Notwithstanding any

other provision in this Agreement relating to Buyer’s right to make a last time buy, the quantity provided for in this provision,

subject to the foregoing cap, replaces the quantity provided for in such other provisions, including Sections 5(d) and 12(b). If

Buyer exercises such last-time buy right, then Buyer will thereafter be relieved of its obligations under Section 11(a), including

its obligations under the New Material Requests section of Appendix A (Products and Prices; Supply Shortfall).

NuSil Technology – Establishment Labs Page 2 of 3

2. General Provisions. Capitalized terms used in this Amendment, which are not defined herein

and are defined in the Agreement, shall have the identical meanings ascribed to them in the Agreement. Together, the Agreement and this

Amendment constitute the complete agreement between the Parties with respect to the subject matter hereof. In the event of any conflict

or inconsistency between the terms and conditions of this Amendment and those of the Agreement, the terms and conditions of this Amendment

shall govern and control. Except as expressly amended herein, all other terms and conditions of the Agreement shall remain in full force

and effect. This Amendment may be executed in any number of counterparts, each of which will be deemed an original and all of which together

constitute one and the same single document.

IN WITNESS WHEREOF, the Parties hereby

have caused this Amendment to the Agreement to be executed as of the date provided below and effective as of the Amendment Effective Date.

Each person signing below warrants that they are duly authorized to sign for and on behalf of their respective Party.

NuSil Technology LLC

Establishment Labs SA

By:

/s/ Uwe

Winzen

By:

/s/ Sandra

Harris

Name:

Uwe Winzen

Name:

Sandra Harris

Title:

SVP &

General Manager, NuSil

Title:

CFO, Establishment

Labs

Date:

14 October 2026

Date:

14 October 2026

NuSil Technology – Establishment Labs Page 3 of 3

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