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

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.

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Investor/Media Contact:

Raj Denhoy

415 828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.