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 today that the first patients in the United States have successfully undergone breast augmentation with Motiva® Implants.
“With the FDA approval last week, we are experiencing high demand for Motiva Implants — both from surgeons and patients,” said Juan José Chacón-Quirós, Founder and Chief Executive Officer of Establishment Labs. “The FDA approval came as we were attending the annual conference of the American Society of Plastic Surgeons. The response was overwhelming, and our team has already talked to more than 400 plastic surgeons post announcement. Since approval, we have already doubled our team to 25 sales reps across the United States, and our story of real innovation, backed by science and data, is resonating strongly. Everything we are seeing suggests that we can be the implant of choice in the United States.”
M. Bradley Calobrace, MD, Kentucky-based board-certified plastic surgeon, and Caroline A. Glicksman, MD, New Jersey-based board-certified plastic surgeon, performed the first surgeries following the U.S. Food and Drug Administration (FDA) approval of Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants in primary and revision breast augmentation.
“I have many patients that have been waiting a long time for Motiva approval, in some cases, for years,” said Dr. Calobrace. “I was delighted to perform one of the first Motiva breast augmentations in the United States. The innovation in these devices not only enhances aesthetics outcomes, but also significantly lowers the rates of the complications we see with other devices. Motiva implants are a game changer.”
Motiva Implants feature the SmoothSilk® surface, which is designed for enhanced biocompatibility and scientifically shown to promote low inflammation. These 6th generation implants are offered in two distinct implant styles. Motiva® SmoothSilk® Ergonomix® is the first breast implant in the world that embodies the science of ergonomics, as it is designed to react, feel, and move like natural breast tissue. Motiva® SmoothSilk® Ergonomix® implants are unique as their shape can adapt as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing up. Motiva® SmoothSilk® Round implants provide increased upper breast fullness and softness while keeping a round full form regardless of 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 U.S. IDE Study and a clinical trial investigator. “Now, we can confidently offer our patients implants that have consistently shown 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 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 20 separate patent families worldwide and over 100 scientific and clinical 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. Please visit our website for additional information at www.establishmentlabs.com.
Forward-Looking Statements
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Contacts
Investor/Media Contact:
Raj Denhoy
415 828-1044
rdenhoy@establishmentlabs.com
