
Establishment Labs Presents Clinical Data On Mia Femtech, Minimally Invasive Breast Augmentation Technology; Launches New RFID Sensor
At the 8th Annual World Symposium on Ergonomic Implants (WSEI) in Lisbon, Portugal, Establishment Labs Holdings Inc. introduced the two-year clinical results of Mia Femtech™, accompanied by the launch of its next-generation RFID technology. The Mia Feasibility Clinical Study enrolled 100 subjects between December 2020 and April 2021. In a preliminary two-year analysis, there were no reports of capsular contracture (Baker Grade III/IV), ruptures, bleeding, hematoma, or seroma requiring intervention. Additionally, a sub-study of 33 subjects who underwent MRI at 18 months showed no ruptures. The two-year follow-up compliance rate was 90%.
Mia Femtech™ is a quick procedure for breast augmentation that offers a discreet breast reshaping in just 15 minutes, utilizing minimally invasive technology. Notably, this procedure requires no general anesthesia, and can increase breast size by one to two cups. Patients are able to return to your daily activities the same day and the technology employs breast tissue preservation techniques to minimize scarring, leaving only small, concealed marks. The technology received CE Mark in May and has also been launched in Japan. The company noted on its earnings call that 47% of the patients who had appointments for the technology were not seeking a breast augmentation prior to learning about Mia
Establishment Labs also launched Zen™ as part of its next-generation Zensor™ RFID platform. All Motiva implants will feature Zen technology, which offers device identification information, full compliance, and patient peace of mind. Zen is entirely non-ferromagnetic and has the potential for future capabilities like temperature measurement which can be used as a biomarker for safety. Zen with temperature sensing is currently in human trials as part of an IRB-approved study.
It has become more common for breast implants to include Radio Frequency Identification (RFID) technology to assess correct implant positioning. RFID technology in breast implants can be a useful tool for visualizing implant positions and diagnosing complications like slight displacements or rotation during magnetic resonance imaging. The Motiva SmoothSilk/SilkSurface® Implants from Establishment Labs were the first to incorporate a radio frequency identification device in 2011.