SMAIO Reports First-Half 2026 Results and Sales for the Third Quarter of 2026

Philippe Roussouly, Chairman and CEO of SMAIO

“In the third quarter of 2026, our sales totaled €2.0 million, remaining stable compared to last year. For the first nine months of the year, sales reached €7.2 million up 2%, with nearly 80% generated in the United States. In dollars, our North American sales rose 4% to $6.4 million; converted to euros, they remained stable at €5.5 million, as unfavorable exchange rate movements had a negative impact of €0.2 million over the period. This moderate growth masks a profound transformation in our U.S. customer base. Four long-standing partner surgeons, who represented more than half of our U.S. sales in the first nine months of 2025 ($3.5 million), reduced their activity in 2026 ($2.2 million): three of them due to their move to new centers at the beginning of the year, and the fourth for personal reasons that affected his surgical practice beyond SMAIO. To date, we are seeing a gradual resumption of surgeries following the registrations completed at two of the three new centers where the aforementioned surgeons have recently set up practice, and we hope to obtain registration for the third center in early 2027. We anticipate that the fourth surgeon mentioned will be unable to perform surgeries in the coming months, leading to a corresponding increase in the workload for the other SMAIO-affiliated surgeons working at the same center. At the same time, our U.S. customer base has expanded significantly over the past nine months: - About thirty surgeons have used our custom-made rods, either through our open platform in collaboration with our industrial partners or in combination with other compatible systems, for more than 80 procedures (more than $260,000, compared to approximately $100,000 in 2025). - About ten new surgeons have signed up for our comprehensive package (over $0.9 million). - Our existing customers' activity across our entire product portfolio increased by nearly 27% ($3.0 million compared with $2.4 million). This momentum is expected to gain further traction thanks to our industry partnerships. Following Orthofix, with the first billings for patient-specific rods K-ROD on the KEOPS-4ME open platform, and Highridge, the signing in early October of a distribution agreement with DePuy Synthes, one of the world's leading orthopedic companies, marks a major milestone. This third partnership with a leading player confirms the appeal of our open platform, which has the potential to become a powerful driver of adoption for our technologies in the United States. Sales volumes with Orthofix and Highridge are also expected to grow as the listings initiated since the beginning of the year in targeted centers take effect. At the same time, we are increasing our R&D investments, both in our software, particularly our artificial intelligence applications designed for automated image processing and predictive analysis of patient data, and in our implants. We have made significant progress on our cobalt-chrome rod, which is highly anticipated by North American open-platform surgeons, as well as on the multi-axial version of our pedicle screw, which will offer our customers greater versatility in treating a growing number of patients. Finally, we continue to raise awareness among the international surgical community about the concept of spinal alignment, following the recent success of our Sagittal Alignment Contest in Sydney, which drew about 40 participants, and the 5th edition of our Sagittal Alignment Think Tank, scheduled to take place in New York in December. With cash and cash equivalents of €7.0 million at June 30, 2026, a range of innovative solutions, and a growing presence in U.S. centers of excellence, we are approaching the coming months with an unwavering commitment to making SMAIO the international leader in spinal alignment.”