Establishment Labs Announces First U.S. Commercial Procedure with Motiva Flora Tissue Expander
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, 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.
Forward-Looking Statements
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Contacts
Investor/Media Contact:
Raj Denhoy
415-828-1044
rdenhoy@establishmentlabs.com
