NEW YORK, October 02, 2024–(BUSINESS WIRE)– Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, primarily in breast aesthetics and reconstruction, today announced that the first patients in the United States have successfully undergone breast augmentation with Incentive® Implants.
“With last week’s FDA approval, we are experiencing high demand for Motiva implants — both from surgeons and patients,” said Juan José Chacón-Quirós, Founder and CEO of Establishment Labs. “The FDA approval came as we attended the American Society of Plastic Surgeons annual conference. The response was overwhelming, and our team has already spoken to more than 400 plastic surgeons since the announcement. Since the approval, we have already doubled our team to 25 sales representatives in the United States and our story of real innovation, backed by science and data, resonates strongly Everything we see suggests that we can be the implant of choice in the United States.
M. Bradley Calobrace, MD, a board-certified plastic surgeon based in Kentucky, and Caroline A. Glicksman, MD, a board-certified plastic surgeon based in New Jersey, performed the first surgeries following FDA approval ) Motivation® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants in primary and revision breast augmentation.
“I have many patients who have been waiting a long time for Motiva to be approved, in some cases for years,” said Dr. Kalombrais. “I was delighted to have one of the first Motiva breast augmentations in the United States. The innovation in these devices not only improves aesthetic results, but also significantly lowers the complication rates we see with other devices. Motiva implants are a game changer.”
Motiva implants feature SmoothSilk® surface, which is designed for enhanced biocompatibility and scientifically proven to promote low inflammation. These 6th generation implants are offered in two different implant styles. Motivation® SmoothSilk® Ergonomix® is the world’s first breast implant to incorporate the science of ergonomics as it is designed to react, feel and move like natural breast tissue. Motivation® SmoothSilk® Ergonomix® The implants are unique in that their shape can adjust as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing. Motivation® SmoothSilk® Round implants provide increased fullness and softness of the upper breast while maintaining a round full shape regardless of their position.
“The plastic surgery community has waited more than a decade to offer breast augmentation patients in the United States something truly new,” said Dr. Glicksman, Medical Director of the Motiva US IDE Study and clinical trial investigator. “Now, we can confidently offer our patients implants that consistently show low complication rates and high patient satisfaction.”
More information about Motiva breast implants can be found at motivausa.com.
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 Motivas® devices that Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have set a new standard for patient safety and satisfaction in the more than 85 countries in which they are available. Motiva Flora® The tissue expander is used to improve outcomes in breast reconstruction after breast cancer and is the only regulatory approved expander in the world with an integrated port that uses radio frequency technology that is MRI conditional. Mia Femtech™, Establishment Lab’s unique minimally invasive breast harmony experience, is the Company’s latest breakthrough innovation. These solutions are supported by more than 200 patent applications in 20 separate patent families worldwide and more than 100 scientific and clinical studies and publications in peer-reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica in compliance with all applicable regulatory standards in accordance with ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. Visit our website for more information at www.establishmentlabs.com.
Forward-looking statements
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