Key Highlights

  • Q3 2026 total Revenue of $72.0 million, up 33.9% year over year.
  • U.S. revenue grew 119% to $26.0 million; OUS revenue grew 9.7% to $46.0 million.
  • Achieved first quarter of positive operating and free Cash Flow in company history.
  • Raised full-year 2026 revenue guidance; minimally invasive revenue grew 124% year over year to approximately $9 million.

Revenue Acceleration Led by U.S. Market

Establishment Labs Holdings Inc. (NASDAQ:ESTA), a global medical technology company focused on breast aesthetics and reconstruction, reported Q3 2026 total revenue of $72.0 million, representing 33.9% growth over the $53.8 million reported in Q3 2025. U.S. revenue was the primary growth driver, surging 119.0% to $26.0 million as commercial expansion for the company's Motiva implant system continued to accelerate following FDA clearance.

Outside the United States, revenue increased 9.7% to $46.0 million. The mix shift toward the higher-margin U.S. market and minimally invasive procedures contributed to improving profitability metrics. Minimally invasive revenue—linked to the company's Preservé platform—grew 124% year over year to approximately $9 million, as U.S. commercial adoption continued to expand.

First Positive Operating and Free Cash Flow Quarter

Establishment Labs achieved a significant financial milestone in Q3 2026, reporting its first quarter of positive Operating Cash Flow and positive free cash flow. Adjusted EBITDA grew to $6.4 million, or 8.9% of revenue, compared to $1.2 million, or 2.2% of revenue, in Q3 2025. This improvement reflects the combination of revenue scale and improving cost efficiency as operating expenses declined as a percentage of revenue.

GAAP net loss was $10.7 million, or $(0.35) per share, compared to a net loss of $11.1 million, or $(0.38) per share, in the prior-year period. GAAP operating expenses were $52.3 million, compared to $41.7 million in Q3 2025, reflecting ongoing Investment in the commercial build-out. Adjusted operating expenses were $49.6 million, or 68.8% of revenue, an improvement of 880 basis points from 77.6% a year ago.

Gross Margin and Product Mix Dynamics

GAAP Gross Profit was $49.7 million, representing a gross margin of 69.1%, modestly below the 70.1% in Q3 2025. The decline reflected $1.3 million in inventory charges related to restructuring. Excluding these items, adjusted gross margin was 70.8%, up 70 basis points year over year. The improvement on an adjusted basis was supported by the faster-growing, higher-margin U.S. business, partially offset by a stronger-than-anticipated contribution from OUS distributor sales, which generate incremental revenues at lower margin levels.

The U.S. commercial footprint expanded to more than 2,100 accounts during the quarter, with more than 400 plastic surgeons trained on the Preservé minimally invasive platform. Management received FDA approval for additional smaller Motiva implant sizes and announced larger implant sizes for the minimally invasive platform, broadening the potential patient population and treatment options.

Pipeline and Guidance Update

Establishment Labs announced a new Supply agreement with NuSil to support long-term Manufacturing capacity and future growth. The FDA review of Motiva for breast reconstruction—a significant potential market extension—is progressing in line with management's expectations. Reconstruction applications would substantially expand the addressable market for the company's technology beyond elective aesthetics.

Based on the acceleration in U.S. commercial adoption and the positive cash flow trajectory achieved in Q3, management raised its full-year 2026 revenue guidance. The combination of a broader product offering, expanded surgeon training, and positive free cash flow marks an inflection in the company's operational and financial profile as it scales its U.S. market presence.

Establishment Labs delivered a transformative quarter in Q3 2026, with revenue growing 34% and the company achieving its first quarter of positive operating and free cash flow, underpinned by 119% U.S. revenue growth and 124% growth in minimally invasive revenue. With full-year guidance raised and the FDA review of Motiva for breast reconstruction progressing, the company is building toward sustained profitability on a broadening commercial foundation.

What was Establishment Labs' revenue in Q3 2026?

Establishment Labs reported Q3 2026 total revenue of $72.0 million, up 33.9% from $53.8 million in Q3 2025.

How did U.S. revenue perform for Establishment Labs in Q3 2026?

U.S. revenue grew 119% year over year to $26.0 million in Q3 2026, driven by continued commercial expansion of the Motiva implant system and the Preservé minimally invasive platform.

What cash flow milestone did Establishment Labs achieve in Q3 2026?

Establishment Labs achieved its first quarter of positive operating cash flow and positive free cash flow in Q3 2026, a key financial milestone in the company's trajectory.

What is the status of Motiva's FDA review for breast reconstruction?

The FDA review of Motiva for breast reconstruction is progressing in line with management's expectations as of Q3 2026, per the company's disclosure.