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Establishment Labs lifts 2026 revenue guidance after Q3 sales rise to $72.0m on US growth

🇺🇸 Establishment Labs Holdings Inc. (ESTA) · Thu 29 Oct 2026

The breast aesthetics medtech reported US sales up 119% and its first quarter of positive operating and free cash flow, with FDA review of Motiva for reconstruction on track.

Establishment Labs Holdings, a medical technology company focused on breast aesthetics and reconstruction, reported third-quarter 2026 results on 29 October. Revenue reached $72.0 million, up 33.9% on the prior-year period, according to the company's headline.

The US was the main driver, with sales in that market up 119%. The company also reported its first quarter of positive operating cash flow and positive free cash flow.

On the back of the quarter, Establishment Labs raised its 2026 revenue guidance to above $274 million.

On the regulatory side, the company noted that the US Food and Drug Administration (FDA) has approved additional, smaller sizes of its Motiva implants. It also said the FDA's review of Motiva for breast reconstruction remains on track. The summary provided gives no timeline for a decision or detail on the review stage, and the full results text was not available.

What it means for your team

  • Regulatory teams tracking breast implants should note the FDA's approval of further smaller Motiva sizes, which widens the range available in the US.
  • The FDA review of Motiva for breast reconstruction is described by the company as on track; a decision would extend the product's US indications, but no date has been given.
  • Market-access and commercial teams may read the 119% US sales growth and raised guidance as a sign of accelerating US uptake, based on company-reported figures only.

Company's press release (SEC filing): Establishment Labs Holdings Inc. ↗

Article written by VigiEye from the official source (Establishment Labs Holdings Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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