Establishment Labs Notes Presentation of 2-Year Results from Motiva US IDE Study at The Aesthetic Meeting 2022

Rhea-AI Summary

Establishment Labs Holdings Inc. (NASDAQ: ESTA) presented interim data from its Motiva US IDE Study at The Aesthetic Meeting 2022 in San Diego. This includes two-year follow-up data for 451 primary augmentation patients, showing a 94.9% compliance rate. Notable findings include low complication rates, with capsular contracture at 0.5% and rupture at 0.3%. Dr. Caroline Glicksman emphasized the significance of these preliminary results, contributing to the clinical understanding of Motiva Implants. The Motiva device remains investigational and not yet FDA-approved for commercial use in the U.S.

Positive

• Two-year patient follow-up data shows 94.9% compliance rate.
• Low rates of complications: 0.5% capsular contracture and 0.3% rupture.
• Ongoing clinical study contributes to a decade-long data foundation on Motiva Implants.

Negative

• Motiva device is still investigational and not FDA-approved for commercial use.

SANTA BARBARA, Calif.--(BUSINESS WIRE)-- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today noted the presentation of interim study data from the augmentation cohort of its Motiva US IDE Study. This Study Update includes two-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, is presenting the results today at The Aesthetic Meeting 2022 in San Diego, California.

Dr. Glicksman will present data for the 451 primary augmentation patients enrolled in the study through the two-year follow-up visit. Patient compliance in the primary augmentation cohort of the trial at two years was 94.9%. The two-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	2-year (N=451), 95% CI
Capsular contracture (Baker Grade III/IV)	0.5%
Rupture, suspected or confirmed	0.3%
Breast pain	0.5%
Infection	0.9%
Implant removal, with or without replacement	1.6%
Any reoperation1	5.7%
Any complication2	7.5%
1. Any surgery on the breast or chest area, device or non-device related, including size change
2. Any device or non-device related event, including reoperation

Commenting on the results, Dr. Glicksman said, “The Motiva IDE study is still in its follow-up phase, but the high rate of patient follow-up and preliminary clinical results are encouraging. The clinical study data we will present today adds to a foundation of science and clinical data on Motiva Implants going back eleven years and encompassing over two-million implants. As a study investigator on this rigorous PMA Study, I am proud to be a part of providing women in the United States access to a new class of options in breast implants.”

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. The company’s initial focus is breast health, principally breast aesthetics and reconstruction. Establishment Labs offers a portfolio of advanced silicone gel-filled breast implants, branded as Motiva Implants^® that include a number of innovative and patented features designed to deliver improved aesthetic and clinical outcomes. Since commercial launch in 2010, approximately 2.0 million Motiva Implants^® have been delivered to plastic surgeons in over 80 countries. The company also offers or has under development a number of related products and technologies, including the Motiva Flora^® tissue expander and Motiva MIA®, the company’s minimally invasive breast enhancement procedure. In 2018, Establishment Labs received an investigational device exemption (IDE) from the FDA for the Motiva Implant® and began a clinical trial to support regulatory approval in the United States. Motiva Implants^® are manufactured at the company’s two facilities in Costa Rica, which are compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. 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 March 1, 2022, quarterly reports on Form 10-Q, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220420006239/en/

Investor/Media Contact:

Raj Denhoy

415-828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

What were the results of the interim study for Establishment Labs (ESTA)?

The interim study showed a 94.9% compliance rate with low complication rates, including 0.5% capsular contracture and 0.3% rupture.

When was the Motiva US IDE Study data presented by ESTA?

The data was presented at The Aesthetic Meeting 2022 in San Diego.

What is the significance of the Motiva study results for ESTA?

The results contribute to the understanding of Motiva Implants, though the device remains investigational and not approved by the FDA.

What is the status of the Motiva device for Establishment Labs (ESTA)?

The Motiva device is currently investigational and has not been commercially approved in the United States.