Establishment Labs Submits to FDA for Approval of Motiva Implants in Breast Reconstruction
Establishment Labs Holdings Inc. - Common Shares (ESTA)
Last establishment labs holdings inc. - common shares earnings: 11/12 07:00 am
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Source: Business Wire
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, today announced that it has submitted Motiva® implants for approval in primary and revision breast reconstruction to the U.S. Food and Drug Administration (FDA). The products were previously approved by the FDA for use in breast augmentation on September 27, 2024.“Expanding our FDA approval from breast augmentation to reconstruction is an important step forward for women’s health,” said Jeff Ehrhardt, Senior Vice President and Establishment Labs’ General Manager of North America. “Breast reconstruction has seen little innovation for more than a decade, despite these patients often needing improved and more advanced technology. This milestone brings us closer to offering the benefits of Motiva to women after mastectomy, providing the same proven technology that has see
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ESTA
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ESTA
Earnings
- 11/5/25 - Beat
ESTA
Sec Filings
- 1/14/26 - Form 8-K
- 1/12/26 - Form 8-K
- 1/9/26 - Form 4
- ESTA's page on the SEC website