Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced that it has sold more than five million Motiva breast implant devices worldwide, a milestone that underscores the company’s swift expansion into the U.S. market following FDA approval on September 27 2024. The figure represents the first time a new breast implant brand has reached this volume since the industry’s last major product launch in 2013.
The milestone builds on the company’s strong revenue trajectory. In the third quarter of 2025, ESTAs revenue rose 33.8% to $53.8 million, driven largely by Motiva sales in the United States, which accounted for $11.9 million of that total. Full‑year 2025 revenue guidance of $210.5‑$211.5 million reflected a 27% increase over 2024, and the company’s cash balance of $70.6 million positioned it to fund continued growth.
Motiva’s U.S. launch has captured roughly 20% of the primary and revision breast‑augmentation market by the end of 2025, according to CEO Peter Caldini. The company’s two ISO13485:2024‑certified manufacturing sites in Costa Rica and its compliance with FDA 21 CFR 820 standards support the rapid scale of production and distribution.
While the company remains unprofitable, its financials show a clear path to profitability. Net loss for Q3 2025 was $11.1 million, an improvement from $16.7 million a year earlier, and the company is targeting adjusted EBITDA positive every quarter in 2026. Gross margin expanded to 70.5% in Q4 2025 from 70.1% in Q3 2025, driven by higher average selling prices for Motiva and the minimally invasive Preservé platform.
Management highlighted that the five‑million‑device milestone is a tangible indicator of market acceptance and a foundation for future growth. “Surpassing five million Motiva devices is another milestone for our company, and a clear reflection that our investment in bringing better technology and procedures to market is rewarded by strong consumer adoption,” said Caldini. The company’s guidance for 2026 projects revenue of $264‑$266 million, a 25% increase over 2025, and a continued focus on expanding the U.S. sales force.
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