- In a 100-patient study of Mia there were no reports of capsular contracture or rupture.
- The new Zensor RFID platform is entirely non-ferromagnetic and adds capability for measurement of temperature and other parameters.
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, announced today both the two-year clinical results of Mia Femtech as well as its launch of Zen, the Company's next generation RFID technology, at the 8th Annual World Symposium on Ergonomic Implants (WSEI) being held this week in Lisbon, Portugal.
The Mia Feasibility Clinical Study is an IRB-approved prospective study that enrolled 100 subjects between December 2020 and April 2021. In the preliminary two-year Kaplan-Meier analysis of key events, there were no reports of capsular contracture (Baker Grade III/IV) and no ruptures (suspected or confirmed). A sub-study of 33 subjects underwent an MRI at 18 months with no ruptures in the cohort. There were also no reports of bleeding, hematoma, or seroma requiring intervention in the study. The follow-up compliance rate at two years was 90%.*
In addition to announcing the Mia study data, Establishment Labs is also launching Zen, which is part of its next generation Zensor RFID platform. All Motiva implants are available with a passive RFID technology, known as Qid®, that provides direct access to device identification information for full compliance as well as for patient peace of mind. Since Qid became available in 2014, approximately two million devices with the technology have been placed in market. The new Zen technology has all the previous benefits of Qid, but is now entirely non-ferromagnetic. Motiva Ergonomix2 Diamond implants used in the Mia Femtech system feature Zen, and it will initially be available in select geographies with Motiva Ergonomix2 Round implants in the Joy program. The Zensor platform has the potential to add additional capabilities in future generations, such as the measurement of temperature and other parameters. Zen with temperature sensing is currently in human trials as part of an IRB-approved study.
"Now in its eighth year, the World Symposium on Ergonomic Implants brings together surgeons, researchers and our commercial partners to share best practices and the latest scientific and clinical data on Motiva implants," said Juan José Chacón-Quirós, Founder and Chief Executive Officer of Establishment Labs. "Over 600 attendees will review the Mia results, which are among the best ever reported at two years, and they will also learn about the launch of our Zen-enabled implantable devices. These advances show that minimally invasive is the future of breast aesthetics and introduce our industry to a whole range of possibilities and health advancements with implantable biosensing."
The World Symposium on Ergonomic Implants is being held October 13-14 in Lisbon, Portugal.
* All data presented is preliminary two-year follow-up data and does not reflect the final study results nor establish the ultimate safety or effectiveness of the 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 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 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 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.
Establishment Labs' Motiva implants and tools are currently not approved for commercial distribution in the United States. The Company's Motiva implants are undergoing clinical investigation pursuant to U.S. FDA regulations for investigational medical devices.
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Contacts:
Investor/Media Contact:
Raj Denhoy
415-828-1044
rdenhoy@establishmentlabs.com
