Establishment Labs (ESTA) Wins FDA Approval for Motiva Implants

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to women’s health and wellness, has received U.S. FDA approval for its Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants. The company is currently leading the PRISM Women’s Health Index, with shares trading up 13%.

Highlights:

• Advanced Breast Implants: Motiva® SmoothSilk® Ergonomix® implants are designed to adapt to the body’s movement, maintaining a round shape when lying down and a teardrop shape when standing. Motiva® SmoothSilk® Round implants provide increased upper breast fullness while keeping a round form regardless of position.
• Clinical Trial Success: The Motiva U.S. IDE Study, the most rigorous breast implant clinical trial performed under FDA guidelines, showed exceptional results. The study reported less than 1% rates of capsular contracture and rupture, indicating the implants’ safety and effectiveness.
• Improved Patient Outcomes: Three-year Kaplan-Meier risk rates in the primary augmentation cohort showed low complications:
  • Capsular Contracture: 0.5%
  • Rupture: 0.6%
  • Breast Pain: 0.7%
  • Infection: 0.9%
  • Overall complication rate, including reoperations, was 8.4%.
• Widespread Use: Since 2010, nearly four million Motiva® devices have been used by surgeons in over 85 countries, creating a new standard for safety and patient satisfaction.
• First New Approval Since 2013: This is the first new breast implant PMA approved by the U.S. FDA since 2013, highlighting the innovation gap Motiva is filling in the U.S. breast implant market.

Establishment Labs is recognized for its focus on developing products tailored to women’s lifestyles, supported by over 200 patent applications and 100 clinical studies.