Establishment Labs Announces Three-Year Mia Femtech Clinical Results at 9th World Symposium on Ergonomic Implants
Establishment Labs Holdings (NASDAQ: ESTA) presented three-year clinical results for Mia Femtech™ at the 9th World Symposium on Ergonomic Implants in Barcelona. The clinical study, involving 100 subjects enrolled between December 2020 and April 2021, showed remarkable safety outcomes with no reports of major complications including capsular contracture, ruptures, infections, hematoma, or changes in sensation. The study maintained a 93% follow-up compliance rate. The data demonstrates some of the best breast implant results reported at three years, positioning minimally invasive procedures as the future of breast aesthetics.
Establishment Labs Holdings (NASDAQ: ESTA) ha presentato i risultati clinici triennali per Mia Femtech™ al 9° Simposio Mondiale sugli Impianti Ergonomici a Barcellona. Lo studio clinico, che ha coinvolto 100 soggetti arruolati tra dicembre 2020 e aprile 2021, ha mostrato risultati di sicurezza notevoli senza segnalazioni di complicazioni maggiori come contrattura capsulare, rotture, infezioni, ematomi o variazioni nella sensibilità. Lo studio ha mantenuto un tasso di compliance al follow-up del 93%. I dati dimostrano alcuni dei migliori risultati degli impianti mammari riportati a tre anni, posizionando le procedure minimamente invasive come il futuro dell'estetica mammaria.
Establishment Labs Holdings (NASDAQ: ESTA) presentó los resultados clínicos de tres años para Mia Femtech™ en el 9° Simposio Mundial sobre Implantes Ergonómicos en Barcelona. El estudio clínico, que involucró a 100 sujetos inscritos entre diciembre de 2020 y abril de 2021, mostró resultados de seguridad notables sin informes de complicaciones mayores, incluyendo contractura capsular, rupturas, infecciones, hematomas o cambios en la sensibilidad. El estudio mantuvo una tasa de cumplimiento de seguimiento del 93%. Los datos demuestran algunos de los mejores resultados de implantes mamarios reportados a tres años, posicionando los procedimientos mínimamente invasivos como el futuro de la estética mamaria.
Establishment Labs Holdings (NASDAQ: ESTA)는 바르셀로나에서 열린 제9회 인체 공학적 임플란트 세계 심포지엄에서 Mia Femtech™의 3년 임상 결과를 발표했습니다. 임상 연구는 2020년 12월과 2021년 4월 사이에 등록된 100명을 포함하며 놀라운 안전성 결과를 보여주었으며, 심각한 합병증에 대한 보고는 없었습니다. 여기에는 피막 구축, 파열, 감염, 혈종 또는 감각 변화가 포함됩니다. 이 연구는 93%의 추적 관찰 준수율을 유지했습니다. 데이터는 3년 동안 보고된 가장 좋은 유방 임플란트 결과 중 일부를 보여주며, 최소 침습적 절차를 유방 미용의 미래로 자리잡게 합니다.
Establishment Labs Holdings (NASDAQ: ESTA) a présenté les résultats cliniques sur trois ans de Mia Femtech™ lors du 9ème Symposium Mondial sur les Implants Ergonomiques à Barcelone. L'étude clinique, impliquant 100 sujets inscrits entre décembre 2020 et avril 2021, a montré des résultats de sécurité remarquables sans rapports de complications majeures, y compris la contracture capsulaire, les ruptures, les infections, les hématomes ou les changements de sensation. L'étude a maintenu un taux de conformité au suivi de 93%. Les données démontrent certains des meilleurs résultats d’implants mammaires rapportés à trois ans, positionnant les procédures peu invasives comme l'avenir de l'esthétique mammaire.
Establishment Labs Holdings (NASDAQ: ESTA) präsentierte beim 9. Welt-Symposium für Ergonomische Implantate in Barcelona die dreijährigen klinischen Ergebnisse für Mia Femtech™. Die klinische Studie, in die 100 Probanden eingeschlossen wurden, die zwischen Dezember 2020 und April 2021 registriert wurden, zeigte bemerkenswerte Sicherheitsaus outcomes ohne Berichte über schwerwiegende Komplikationen wie Kapselfibrose, Risse, Infektionen, Hämatome oder Empfindungsänderungen. Die Studie wies eine 93%ige Folge-Compliance-Rate auf. Die Daten zeigen einige der besten Ergebnisse von Brustimplantaten, die nach drei Jahren berichtet wurden, und ordnen minimalinvasive Verfahren als die Zukunft der Brustästhetik ein.
- Zero major complications reported in three-year clinical data
- High follow-up compliance rate of 93%
- Growing market demand in current territories
- Recent FDA approval of Motiva implants enables US market entry
- 1% reoperation rate reported
- 1% malposition/displacement rate observed
Insights
The three-year clinical data for Mia Femtech™ demonstrates exceptional safety outcomes with
The study's preliminary results, while promising, are from a relatively small cohort of 100 subjects. The minimal reoperation rate of
The clinical results strengthen Establishment Labs' competitive position in the breast aesthetics market. With over 4 million Motiva devices delivered across 85+ countries, the company has established a robust market presence. The expansion potential into the U.S. market following FDA approval represents a significant growth catalyst.
The WSEI symposium attendance of 500+ plastic surgeons indicates strong professional interest in the technology. The zero-complication rates could drive surgeon adoption and patient preference, potentially accelerating market penetration. The company's extensive IP portfolio of 200+ patent applications provides strong market protection and positions them well for sustained growth in the femtech sector.
The Mia Femtech Clinical Study is an IRB-approved prospective study that enrolled 100 subjects between December 2020 and April 2021. In the preliminary three-year analysis of key complications, there were no reports of capsular contracture (Baker Grade III/IV) and no ruptures (suspected or confirmed). There were also no reports of infection, hematoma, or seroma requiring intervention in the study and no reports of changes in nipple or breast sensation. The follow-up compliance rate at three years was
“The 9th Annual World Symposium on Ergonomic Implants will bring together over 500 plastic surgeons, researchers and commercial partners to share best practices and the latest scientific and clinical data on Establishment Labs’ growing portfolio of technologies, focusing this year on breast tissue preservation,” said Juan José Chacón-Quirós, Founder and Chief Executive Officer of Establishment Labs. “The Mia results being shown this week are among the best breast implant data reported at three years and prove again that minimally invasive is the future of breast aesthetics. Demand for Mia in our current markets, from both women and clinic partners that launched over the past year, is reaching an inflection point and with the recent FDA approval of Motiva implants, we have already begun the process to bring this revolutionary technology to the United States.”
The World Symposium on Ergonomic Implants is being held October 31 to November 2 in
Primary Augmentation & Primary Congenital |
3-year (N=100), |
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Capsular contracture (Baker Grade III/IV) |
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Rupture, suspected or confirmed* |
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Infection |
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Seroma |
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Hematoma |
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Changes in Nipple Sensation |
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Changes in Breast Sensation |
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Malposition/Displacement** |
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Inferior malposition |
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Any reoperation |
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*Includes overall and MRI cohort (33 subjects/ 66 implants) combined
** One patient had an implant malposition and underwent implant reposition; no implant exchange
All data presented is preliminary follow-up data and does not reflect the complete study results nor establish the ultimate safety or effectiveness of the Mia Femtech procedure.
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 nearly four 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 over 85 countries in which they are available. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and it is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. 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 patent 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20241031705128/en/
Investor/Media Contact:
Raj Denhoy
415 828-1044
rdenhoy@establishmentlabs.com
Source: Establishment Labs Holdings Inc.
FAQ
What were the key findings of ESTA's three-year Mia Femtech clinical results?
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What was the reoperation rate in ESTA's Mia Femtech three-year study?
