UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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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.
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Item 7.01 Regulation FD Disclosure.
On April 20, 2023, Establishment Labs Holdings Inc. (the “Company”) issued a press release announcing the presentation of interim study data in connection with its Motiva US IDE Study at The Aesthetic Meeting 2023.
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 April 20, 2023. |
| 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: | April 20, 2023 | By: | /s/ Rajbir S. Denhoy |
| Name: | Rajbir S. Denhoy | ||
| Title: | Chief Financial Officer | ||
Exhibit 99.1
Establishment Labs Notes Presentation of 3-Year Results from Motiva U.S. IDE Study at The Aesthetic Meeting 2023
New York, NY, April 20, 2023 -- 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, today noted the presentation of a study update on the Motiva US IDE Study. The update included three-year patient follow-up data for primary augmentation subjects. The Medical Director of the Study, Dr. Caroline Glicksman, who is also a Principal Investigator in the Study, presented the results today at Aesthetic Surgery Education and Research Foundation (ASERF) Premier Global Hot Topics session as part of The Aesthetic Meeting 2023 in Miami, Florida.
Dr. Glicksman presented data for the 451 primary augmentation patients enrolled in the study through the three-year follow-up visit. Patient compliance in the primary augmentation cohort of the trial at three years was 92.4%. The three-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort were as follows:
| Primary Augmentation | 3-year (N=451), 95% CI |
| Capsular contracture (Baker Grade III/IV) | 0.5% |
| Rupture, suspected or confirmed; MRI cohort1 | 0.6% |
| Breast pain | 0.7% |
| Infection | 0.9% |
| Implant removal, with or without replacement | 1.6% |
| Any reoperation2 | 6.1% |
| Any complication3 | 8.4% |
1. MRI cohort N=176
2. Any surgery on the breast or chest area, device or non-device related, including size change
3. Any device or non-device related event, including reoperation
“The Motiva US IDE study is still in follow-up, but the consistency in clinical outcomes from year two to year three are notable, with no increase in capsular contracture or the number of patients with suspected or confirmed rupture, including in the MRI cohort. The preliminary results and the continued high rates of patient follow-up remain encouraging,” said Dr. Glicksman. “These results are the latest evidence of the performance of Motiva implants, adding to data collected over twelve years and from over three million implants placed in markets globally. The clinical results presented today have been submitted to the FDA as part of the final module of the PMA, and we look forward to this new standard in breast implants being made available to women in the United States.”
The Motiva Core pivotal study is an ongoing US clinical trial of an investigational medical device under an FDA-approved Investigational Device Exemption. The Motiva device has not been approved by the Food and Drug Administration and is not commercially available in the United States. This interim report describes preliminary data available to date and does not necessarily reflect final clinical results nor demonstrate the investigational device’s safety and effectiveness for the United States trial. Accordingly, no conclusions should be drawn based on the information presented.
About Establishment Labs
Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness through the power of science, engineering, and technology. The Company offers a portfolio of Femtech solutions for breast health, breast aesthetics and breast reconstruction. The over three million Motiva® devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the 85 countries in which they are available. The Motiva Flora® tissue expander is the only regulatory-approved expander in the world with an integrated port that is MRI conditional and is used to improve outcomes in breast reconstruction following breast cancer. Mia Femtech™, Establishment Lab’s unique minimally invasive experience for breast harmony, is the Company’s most recent breakthrough innovation. These solutions are supported by over 200 patents and patent applications in 25 separate patent families worldwide and over 50 scientific studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. In 2018, the Company received an investigational device exemption (IDE) from the FDA for Motiva Implants® and began a clinical trial to support regulatory approval in the United States. 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 quarterly report and annual reports, and 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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Cover |
Apr. 20, 2023 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Apr. 20, 2023 |
| Entity File Number | 001-38593 |
| Entity Registrant Name | Establishment Labs Holdings Inc. |
| Entity Central Index Key | 0001688757 |
| Entity Incorporation, State or Country Code | D8 |
| Entity Address, Address Line One | Building 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 |
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