Establishment Labs Announces First U.S. Commercial Procedure with Motiva Flora Tissue Expander
02 Janeiro 2024 - 10:00AM
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,
announced that the Motiva Flora® SmoothSilk® Tissue Expander was
used for the first time in the United States at the University of
Texas MD Anderson Cancer Center in Houston by Mark Clemens, MD MBA
FACS, Professor of Plastic Surgery. The recent FDA clearance and
first procedure mark significant developments in the field of
plastic and reconstructive surgery.
"This Flora device is a new resource in our toolkit for breast
cancer reconstruction,” Dr. Clemens noted. “It introduces features
such as being MR conditional and also reduces interference during
radiation therapy. It's essential for patients to have access to
innovative solutions that may improve their treatment outcomes and
facilitate their journey of restoration."
The Flora® Tissue Expander includes several proprietary
innovations, including Establishment Labs’ patented SmoothSilk®
surface technology and an RFID-enabled, non-magnetic port, labeled
as MR Conditional by the FDA. SmoothSilk® has been shown to produce
the least amount of inflammation and foreign body response compared
to other device surfaces1. By being magnet-free, Flora avoids the
interference that magnets cause during MRI and may improve the
precision of radiation oncology treatment. All other commercially
available breast tissue expanders include magnets.
“We are so pleased to enter the United States, the largest
market in the world for breast reconstruction,” added Juan José
Chacón-Quirós, Founder and Chief Executive Officer of Establishment
Labs. “Our company is grounded in the core principle of improving
women’s health and wellness, and the U.S. deserves the highest
standard of care. Real innovation leads to better patient outcomes,
and Flora is setting a new standard in breast reconstruction.”
- Doloff, J.C., Veiseh, O., de Mezerville, R. et al. The surface
topography of silicone breast implants mediates the foreign body
response in mice, rabbits and humans. Nat Biomed Eng 5, 1115–1130
(2021). https://doi.org/10.1038/s41551-021-00739-4
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 MR
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 silicone gel-filled implants are
currently not approved for commercial distribution in the United
States. The Company’s implants are undergoing PMA 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/20240102192117/en/
Investor/Media Contact: Raj Denhoy 415-828-1044
rdenhoy@establishmentlabs.com
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