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Smaio signs the first important distribution agreement for its open platform KEOPS-4ME with Highridge Medical in the US

Editor's by Editor's
September 26, 2025
in Spine
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Smaio signs the first important distribution agreement for its open platform KEOPS-4ME with Highridge Medical in the US

Highridge Medical is one of the largest private column companies

The Association represents a key milestone to further expand Smaio’s commercial activity in the United States and promote the adoption of its new open platform for personalized implant solutions

Dallas and Lyon, France, September 24, 2025 -(Business Wire) -Notic regulatory:

Smaio signs the first important distribution agreement for its open platform KEOPS-4ME with Highridge Medical in the US

Smaio (software, adaptive machines and implants in orthopedia-euronext growth paris, ISIN: FR0014005I80 / TICKER: ALSMA), a French-American player specialized in complex column surgery with a global offer that includes the software, adaptive services and related services, today announces the firm of a major society with the spine Companies

Highridge Medical, formed after the acquisition of the business of the Zimvie spine by the investment firm Hig Capital, develops a robust portfolio of screw and plate implants, and fixing systems. With a strong clinical legacy and a commercial scope in the United States, Highridge undertakes to advance in the care of the spine through R&D and innovation.

Within the context of this association, the customers of Highridge surgeons will obtain access to the complete spinal realignment planning capabilities of Smaio and the ability to combine Smaio’s technology with their existing implant systems in a modular and open configuration. This agreement marks a successful launch of the open platform of SMAIO KEOPS-4ME, aimed at providing surgeons throughout the United States with their personalized approach and based on data for complex column surgery, including data analysis, the equilibrium analyzer of 3-D Koeps Analyzer 3D surgery planning and the use of specific K-Rods of the patient.

This strategic collaboration will provide SMAIO access to the US Hospital Network. UU. Highridge, facilitated the implants registration and the broader clinical adoption. With the hospital registration processes and the authorizations of FDA 510 (K) in progress, the two partners hope to start marketing their first joint solutions in early 2026.

Philippe Roussauly, President and CEO of Smaio, declared: “We are delighted to announce this association, which represents another significant milestone in our US growth strategy. UU. And it is the first important association in the construction of our open platform Keops-4me at Smaio Technology Distribution scale throughout the market. A highly qualified commercial network, already active in the first level hospitals.

“As we continue to develop and expand our complex column portfolio, we are very excited about this association with Smaio,” said Rebecca Whitney, CEO of Highridge Medical. “The addition of a 3-D preoperative planning solution with patented algorithms that allow the design of specific spinal rods will be a great benefit for our surgeons and the patients they serve.”

The launch of the Open Platform of Smaio Allana the way for additional associations in the United States, as the company continues to win traction as an innovative trusted partner between key surgical centers.

Upcoming financial events:

Mid -year results 2025 and sales of the third year 2025: Tuesday, October 14, 2025 (after market closure)

About Highridge Medical

Highridge Medical is a global company of medical devices committed to improving column care by associating with the surgeon community to boost innovation. The company has a solid portfolio supported by extensive clinical evidence, including solutions for the complex column, preservation of minimally invasive movement and surgery. For more information, visit www.highridgemedical.com.

About Smaio

A precursor in the use of clinical data and images of the spine, Smaio designs global solutions for column surgery specialists. The company has recognized experience thanks to Kopeops, its Big Data management software that has become a global reference with more than 100,000 cases of documented patients.

Smaio offers column surgeons a comprehensive platform, I-Kontrol, incorporating planning, implants and related services, which allows them to treat spinal pathologies in a safe, effective and lasting way.

Smaio is positioned at the forefront of innovation with the ambition to provide surgeons with the first active robotic solution that allows a high level of performance and repeatability.

Based in Dallas (United States) and Lyon (France), Smaio benefits from the ability and experience of more than 40 highly specialized employees.

For more information, visit our website: www.smaio.com

Listing Market: Euronext Growth Paris
ISIN: FR0014005I80
Ticker: Alsma

Discharge of responsibility

This press release contains non -practical elements, which include, among others, certain statements regarding future results and other future events. These statements are based on the vision and current assumptions of company management. They incorporate known and unknown risks and uncertainties that could lead to significant differences in the results, profitability and expected events. In addition, Smaio, their shareholders and their affiliates, directors, officials, advice and employees have not verified precision and do not make representations or guarantees about statistical information or prognosis information contained in this press release and that originates or derives from third -party sources or industry publications; These statistical data and prognosis information are only used in this press release for information purposes. Finally, this press release can be written in French and English. In case of differences between the two texts, the French version will prevail.

Contacts

Smaio contacts

Smaio
Philippe Roussauly
Executive Director
Renaut Fritsch
Financial Director
investments@smaio.com

Novel
DUSAN ORESSKY/AURÉLIE MANAVARER
Investor relationships
smaio@newcap.eu
Tel.: +33 (0) 1 44 71 94 92

Novel
Arthur Rouillé
Media relationships
smaio@newcap.eu
Tel.: +33 (0) 1 44 71 00 15

Contact Highridge Medical

Media contact
Mark Richards
mark.richards@highridgemedical.com
Tel.: +1 512 913 9572

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