Establishment Labs Notes Presentation of 5-Year Results from Motiva U.S. IDE Study at The Aesthetic MEET 2025

Rhea-AI Summary

Establishment Labs Holdings Inc. (NASDAQ: ESTA) presented 5-year follow-up data from the Motiva US IDE Study at The Aesthetic MEET 2025. The study, focusing on 451 primary augmentation patients, demonstrated high patient compliance at 88.5% after four years.

Dr. Caroline Glicksman, the Study's Medical Director, highlighted the consistently low complication rates, with no increase in capsular contracture or suspected/confirmed rupture cases since the two-year mark. The company received FDA approval for Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants for primary and revision breast augmentation on September 26, 2024.

Interim CEO Peter Caldini reported strong U.S. market momentum with over 800 accounts and more than 550 placing orders, representing a 20% increase from their previous update three weeks ago.

Positive

• FDA approval received for Motiva breast implants in September 2024
• Strong market adoption with 800+ accounts and 550+ ordering accounts
• 20% growth in accounts over just 3 weeks
• High patient compliance rate of 88.5% at 4 years
• Consistently low complication rates with no increase in issues since 2-year mark

Negative

• None.

Insights

Financial Analyst

Establishment Labs' 5-year clinical data presentation marks a significant milestone in the company's U.S. commercialization journey. The data showing consistently low complication rates with Motiva implants substantiates ESTA's product differentiation claims in the highly competitive breast aesthetics market.

The operational metrics are particularly impressive - over 800 accounts onboarded with more than 550 placing orders, representing 20% growth in just three weeks. This rapid adoption rate signals strong initial market acceptance following the September 2024 FDA approval and suggests the company's U.S. market entry strategy is executing effectively.

What's most notable is the potential for both market share gains and market expansion. The interim CEO's statement that "better technology can improve patient outcomes, take market share, and expand the market" points to a three-pronged growth opportunity. The U.S. breast aesthetics market has seen minimal innovation, creating a competitive vacuum that ESTA appears positioned to capitalize on.

ESTA's comprehensive IP portfolio (200+ patent applications across 20 patent families) and extensive clinical validation (100+ studies/publications) provide significant barriers to entry and sustainable competitive advantages. The company's global manufacturing footprint in Costa Rica with ISO13485:2024 and FDA 21 CFR 820 compliance demonstrates operational readiness to meet increasing demand.

This clinical data presentation, combined with the rapid U.S. market penetration, represents a meaningful inflection point in ESTA's growth trajectory and validates their long-term strategic positioning in the breast aesthetics and reconstruction market.

Medical Device Expert

The 5-year results from Motiva's IDE study represent a critical clinical validation for Establishment Labs' flagship product. The presentation highlights remarkable consistency in safety metrics - particularly noteworthy is the stability in capsular contracture and rupture rates since the 2-year mark, addressing two of the most significant historical complications in breast implant technology.

The 88.5% patient compliance at the four-year follow-up is exceptionally strong for an aesthetic device trial, providing robust statistical power to the findings. This high retention rate itself speaks to patient satisfaction with the technology.

From a technical perspective, Motiva's SmoothSilk surface technology appears to be delivering on its design objectives of reduced inflammatory response and capsule formation. The company's broader technology platform - spanning Femtech applications (Mia), tissue preservation (Preservé), tissue expansion (Flora), and biosensor integration (Zenº) - demonstrates a cohesive innovation strategy rather than isolated product development.

The Motiva Flora tissue expander with integrated RF port technology that remains MRI conditional represents a meaningful advance in reconstruction applications, potentially expanding ESTA's addressable market beyond primary aesthetics into the post-mastectomy reconstruction space.

The company's investment in complementary technologies like the Zensor RFID platform and Zenº biosensor indicates a forward-looking approach to implantable device monitoring and safety. This positions ESTA ahead of potential regulatory requirements for improved implant tracking and monitoring.

The robust clinical data combined with rapid physician adoption suggests that Establishment Labs has successfully addressed both clinical concerns and surgeon preferences with their Motiva technology platform - a rare achievement in the medical device sector.

NEW YORK--(BUSINESS WIRE)-- 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, noted the presentation today of an update on the Motiva US IDE Study. The update will include five-year patient follow-up data for primary augmentation subjects. The Medical Director of the Study, Dr. Caroline Glicksman, who is also an Investigator in the Study, will present the results at The Aesthetic MEET 2025, the annual meeting of The Aesthetic Society, in Austin, Texas.

Dr. Glicksman will present data for the 451 primary augmentation patients enrolled in the study through the five-year follow-up visit. Patient compliance in the primary augmentation cohort of the trial at four years was 88.5%. The five-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	5-year (N=451), 95% CI
Capsular contracture (Baker Grade III/IV)	0.5%
Rupture, suspected or confirmed; MRI cohort1	0.6%
Breast pain	1.2%
Infection	0.9%
Implant removal, with or without replacement	3.1%
Any reoperation2	8.8%
Any complication3	12.0%

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

Commenting on the results, Dr. Glicksman said, “At the mid-point of the ten-year core study, Motiva implants continue to show low rates of complication. The consistency in these clinical results is particularly notable, as we have seen no increase in capsular contracture or in the number of patients with suspected or confirmed rupture since we began reporting at two years. Overall, patient follow-up remains very high, and the rates of complication remain very low. I am proud to be part of this important ongoing study.”

Establishment Labs received approval from the U.S. Food and Drug Administration (FDA) for the use of Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants in primary and revision breast augmentation on September 26, 2024.

“Our momentum in the U.S. continues to exceed expectations,” added Peter Caldini, Establishment Labs’ Interim CEO. “This is driven by differentiated clinical data, along with the complete lack of innovation in this market for years. Our core thesis is proving true: better technology can improve patient outcomes, take market share, and expand the market. We now have over 800 accounts on board with more than 550 placing orders. This is up over 20% from our last update just 3 weeks ago. Our team is in Austin for one of the biggest aesthetic meetings of the year, and the excitement around Motiva is everywhere. We look forward to introducing a new generation of implants to the many surgeons who have not yet had a chance to explore our platform and products.”

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 patents 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.

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 February 28, 2025, which risks and uncertainties may be updated in the future in 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/20250320170725/en/

Investor/Media Contact:

Raj Denhoy

415 828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

What are the key findings from Motiva's 5-year US IDE Study results for ESTA stock?

The study showed consistently low complication rates with 88.5% patient compliance at 4 years, with no increase in capsular contracture or rupture cases since the 2-year mark.

How many medical accounts does ESTA have for Motiva implants in the US market?

ESTA has over 800 accounts with more than 550 placing orders, showing a 20% increase from their update three weeks prior.

When did ESTA receive FDA approval for Motiva breast implants?

ESTA received FDA approval for Motiva SmoothSilk Ergonomix and Round breast implants on September 26, 2024.

What is the patient compliance rate in ESTA's Motiva US IDE Study?

The study showed 88.5% patient compliance in the primary augmentation cohort at the four-year follow-up.