SMAIO Reported Revenue of €2.8 Million in the First Quarter of 2026, an Increase of 11%

• Revenue in the United States reached a record quarterly high of €2.3 million (+21%), or $2.6 million (+35%)¹ excluding currency effects
• The United States accounts for nearly 80% of the Group's total sales

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Regulatory News:

SMAIO (Software, Machines and Adaptive Implants in Orthopaedics Euronext Growth Paris, ISIN Code: FR0014005I80 Ticker: ALSMA), a French-American company specialized in complex spine surgery and offering an integrated pre-, intra- and postoperative solution based on 3D planning software, adaptive implants and related services, today announced its revenue for the first quarter of 2026.

Philippe ROUSSOULY, Chairman and CEO of SMAIO, stated: "Sales for the first quarter of 2026 reflect our strong foothold in North America, where we achieved record quarterly sales of €2.3 million, representing a 21% increase. Excluding the unfavorable currency effect linked to the weak dollar, the 35% increase in sales to $2.6 million clearly demonstrates the growing adoption of our solutions by spinal surgeons in this strategic market.

At the same time, we are continuing to prepare for the commercial rollout of our patient-specific rods K-ROD via our open KEOPS-4ME platform, with the first partnerships signed in late 2025 expected to begin contributing to revenue starting in the second half of fiscal year 2026.

We remain fully focused on our long-term growth drivers commercial execution in the United States and innovation to continue our path of sustainable growth."

Q1 2026 sales

In €m*	Q1 2026	Q1 2025	Change
Sales of implants**	2.8	2.5	+12%
of which the US	2.3	1.9	+21%
of which rest of the world (outside France)	0.3	0.4	-23%
of which France	0.3	0.3	n.s.
Other			n.s.
Total Group sales	2.8	2.6	+11%
* Unaudited figures; ** Including patient-specific rods K-ROD

The SMAIO Group's sales for the first quarter of 2026 reached €2.8 million, compared with €2.6 million in the first quarter of 2025, representing an increase of 11%.

Implant sales, which now account for nearly all of revenue, rose by 12%, driven by strong sales dynamics in the United States.

Revenue in North America rose by 21% to €2.3 million, confirming SMAIO's growing commercial momentum in its priority market, despite an unfavorable impact from the euro/dollar exchange rate of approximately €0.25 million for the quarter. The United States accounted for nearly 80% of the Group's business activity during the period.

In the rest of the world, excluding France, revenue amounted to €0.3 million, compared to €0.4 million in the first quarter of 2025, due to a temporary decline in business in Denmark linked to local restrictions, beyond SMAIO's control, imposed by a hospital administration. Activity there is expected to return to normal in September 2026. In France, activity remained stable at €0.3 million.

Upcoming financial event:

• Annual General Meeting: Tuesday, June 16, 2026
• Half-year 2026 sales: Thursday, July 16, 2026 (after market close)

About SMAIO

A precursor in the use of clinical data and imaging of the spine, SMAIO designs global solutions for spine surgery specialists. The Company has recognized expertise thanks to its big data database, which has become a global reference with more than 100,000 patient cases documented. SMAIO offers spine surgeons a comprehensive platform, i-Kontrol, incorporating planning, implantable devices and related services, enabling them to treat spinal pathologies in a safe, effective and lasting way. The open platform deployed by the Company in the United States, KEOPS-4ME, is designed to offer a personalized and data-driven approach for complex spine surgeries, enabling SMAIO to enter into commercial partnerships with major US surgical companies and to provide their surgeon customers with patientspecific implants. Based in Dallas (United States) and Lyon (France), SMAIO benefits from the skill and expertise of more than 40 highly specialized employees.

For further information, please visit: www.smaio.com

Listing market: Euronext Growth Paris
ISIN : FR0014005I80
Ticker: ALSMA

Disclaimer

This press release contains non-factual elements, including, but not limited to, certain statements regarding future results and other future events. These statements are based on the current vision and assumptions of the management of the Company. They incorporate known and unknown risks and uncertainties that could result in significant differences in results, profitability and expected events. In addition, SMAIO, its shareholders and affiliates, directors, officers, advisors and employees have not verified the accuracy of, and make no representations or warranties about, the statistical information or forecast information contained in this press release that originates from or is derived from third-party sources or industry publications. Such statistical data and forecast information are used in this press release for information purposes only.

¹Revenue of $2.0 million generated in the United States in Q1 2025

View source version on businesswire.com: https://www.businesswire.com/news/home/20260512998596/en/

Contacts:

SMAIO
Philippe Roussouly
Chairman CEO
Renaut Fritsch
Chief Financial Officer
[e-mail]

NewCap
Dusan Oresansky/Thomas Cozzolino
Investor Relations
[e-mail]
T.: 01 44 71 94 92