Welcome

"Dear Madam, Dear Sir,
SMAIO delivered a particularly strong performance in 2025, with sales up +67% to €9.2 million. This performance was driven by the excellent momentum of our implant sales in the United States, which rose by +138% to €7.0 million and now account for more than 75% of our activity. The strong ramp-up in the US market, the most profitable spine market in the world, enabled us to achieve a gross margin rate of 83%, up 14 points year-on-year. At the same time, we were able to support this growth with a controlled cost structure, allowing us to continue improving our profitability indicators, including a 36% reduction in our EBITDA loss to €0.8 million, despite an unfavorable exchange rate environment, the introduction of tariffs, increased investment in training new users, and several strategic hires made during the fiscal year, the positive effects of which on the company’s margin will become apparent in the medium term. These achievements demonstrate the relevance of our strategic decisions, which are centered, on the one hand, on the U.S. market—where margins are highest—and, on the other hand, on a strong specialization in complex surgeries performed by a limited number of centers of excellence. In the near future, the strategic partnerships concluded with Highridge Medical and Orthofix for the commercialization of our KEOPS-4ME platform will complement this strategy through a broader deployment of our solutions across several dozen US centers and are expected to become one of SMAIO’s growth drivers in the United States from the second half of 2026 onward. Thanks to the financing transactions completed in 2025, we strengthened our financial structure under very favorable conditions. Our cash position reached €5.9 million as of December 31, 2025, and was further strengthened at the beginning of this year with a €3.6 million fundraising, providing us with the flexibility required to pursue our ambitious growth strategy focused on the North American market and our R&D projects. Building on these structuring milestones and a solid financial position, we now have all the assets needed to continue our growth trajectory and strengthen SMAIO’s position as a leading player in vertebral realignment.”
Philippe ROUSSOULY
Chairman and CEO
Press release
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05/12/2026 - 17:45
SMAIO reported revenue of €2.8 million in Q1 2026