Establishment Labs Announces Two-Year Mia Femtech Clinical Results and the Launch of Zen at 8th World Symposium on Ergonomic Implants
13 10월 2023 - 9:00PM
Business Wire
- 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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version on businesswire.com: https://www.businesswire.com/news/home/20231013274160/en/
Investor/Media Contact: Raj Denhoy 415-828-1044
rdenhoy@establishmentlabs.com
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