FDA Events for Establishment Labs (ESTA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Establishment Labs (ESTA).
Over the past two years, Establishment Labs has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Motiva. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Motiva Flora® SmoothSilk® - FDA Regulatory Timeline and Events
Motiva Flora® SmoothSilk® is a drug developed by Establishment Labs for the following indication: Tissue Expander.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Motiva Flora® SmoothSilk®
- Announced Date:
- October 2, 2024
- Indication:
- Tissue Expander.
Announcement
Establishment Labs Holdings Inc. announced that that the first patients in the United States have successfully undergone breast augmentation with Motiva® Implants.
AI Summary
Establishment Labs Holdings Inc. announced a major milestone in the United States as the first patients have successfully undergone breast augmentation with Motiva® Implants. These innovative implants, including the Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round, are designed to improve biocompatibility, lower inflammation, and achieve natural-looking results by adapting to body positions. The procedures were performed by board-certified plastic surgeons, marking a breakthrough in breast aesthetics and reconstruction.
According to the company, Motiva Implants offer a new level of performance in terms of safety and satisfaction. The unique design of these 6th generation implants aims to reduce complications seen with other devices, providing high patient satisfaction. This development highlights Establishment Labs’ commitment to advancing women’s health through science, engineering, and new medical technology in the field of breast augmentation.
Read Announcement- Drug:
- Motiva Flora® SmoothSilk®
- Announced Date:
- September 26, 2024
- Indication:
- Tissue Expander.
Announcement
Establishment Labs Holdings Inc announced it has received approval from the U.S. Food and Drug Administration (FDA) for the use of Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants in primary and revision breast augmentation.
AI Summary
Establishment Labs Holdings Inc. has received U.S. FDA approval for its Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants for use in both primary and revision breast augmentation. This milestone allows U.S. plastic surgeons and their patients to access cutting-edge implant technology that adapts dynamically to body movement and positions, offering a more natural appearance and feel. The Ergonomix® model is uniquely engineered to change shape – appearing round when lying down and more teardrop-like when standing – while the Round model provides consistent fullness and softness. This innovative design features a patented surface that improves biocompatibility and reduces inflammation, which may lead to better clinical outcomes. The FDA decision marks a transformative step in breast aesthetics, providing women with an advanced option that meets both safety and aesthetic needs.
Read Announcement- Drug:
- Motiva Flora® SmoothSilk®
- Announced Date:
- September 26, 2024
- Indication:
- Tissue Expander.
Announcement
Establishment Labs Holdings Inc. announced it has received approval from the U.S. Food and Drug Administration (FDA) for the use of Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants in primary and revision breast augmentation.
AI Summary
Establishment Labs Holdings Inc. has received FDA approval for its Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants, now cleared for use in both primary and revision breast augmentation procedures in the United States. These state-of-the-art implants feature a patented SmoothSilk® surface that enhances biocompatibility and helps reduce inflammation. The Ergonomix model is uniquely designed to adapt to the body’s movements—offering a round shape when lying down and a teardrop shape when standing up—mimicking natural breast tissue. Meanwhile, the Round implant consistently provides increased upper breast fullness and softness regardless of body position. This breakthrough FDA approval marks an important advancement for breast aesthetics, offering women new choices that combine innovative design with proven clinical performance to meet aesthetic goals and improve overall patient satisfaction.
Read Announcement
Establishment Labs FDA Events - Frequently Asked Questions
Yes, Establishment Labs (ESTA) has received FDA approval for Motiva Flora® SmoothSilk®. This page tracks recent and historical FDA regulatory events related to Establishment Labs' drug portfolio.
In the past two years, Establishment Labs (ESTA) has reported FDA regulatory activity for Motiva Flora® SmoothSilk®.
The most recent FDA-related event for Establishment Labs occurred on October 2, 2024, involving Motiva Flora® SmoothSilk®. The update was categorized as "Provided Update," with the company reporting: "Establishment Labs Holdings Inc. announced that that the first patients in the United States have successfully undergone breast augmentation with Motiva® Implants."
Currently, Establishment Labs has one therapy (Motiva Flora® SmoothSilk®) targeting the following condition: Tissue Expander..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ESTA) was last updated on 7/12/2025 by MarketBeat.com Staff
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