Highridge Medical is one of the world’s largest privately held spine companies

The partnership represents a key milestone in further expanding SMAIO’s business activity in the U.S. and driving adoption of its new open platform for customized implant solutions

DALLAS & LYON, France--(BUSINESS WIRE)--

Regulatory News:

SMAIO , a French-American player specialized in complex spine surgery with a global offer comprising software, adaptative implants and related services, today announces the signing of a major partnership with Highridge Medical (Westminster, Colorado), one of the world’s largest privately held spine companies.

Highridge Medical, formed following the acquisition of ZimVie’s spine business by investment firm H.I.G. Capital, develops a robust portfolio of screw and plate implants, and fixation systems. With a strong clinical legacy and commercial reach across the United States, Highridge is committed to advancing spine care through R&D and innovation.

Within the context of this partnership, Highridge’s surgeon customers will gain access to SMAIO’s full spinal realignment planning capabilities 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 SMAIO’s open platform KEOPS-4ME, aimed at providing surgeons across the U.S. with its personalized and data-driven approach to complex spine surgery, including data analysis, 3-D surgery planning KEOPS balance Analyzer 3D and use of the patient-specific K-Rods.

This strategic collaboration will provide SMAIO with access to Highridge’s U.S hospital network, facilitated implant registration and broader clinical adoption. With hospital registration processes and FDA 510(k) clearances underway, the two partners expect to begin marketing their first joint solutions in early 2026.

Philippe ROUSSOULY, Chairman and CEO of SMAIO, stated: “We are thrilled to announce this partnership, which represents another significant milestone in our U.S. growth strategy and is the first major partnership in building our open platform KEOPS-4ME to scale SMAIO technology distribution across the US market. It confirms the relevance of our approach based on combining implants with software and data analysis for the benefit of spinal surgery. Working with Highridge Medical gives us immediate access to a highly qualified commercial network, already active in top-tier hospitals. It is a powerful accelerator for the adoption of our technology in this key market.”

“As we continue to develop and expand our complex spine portfolio, we are very excited about this partnership with SMAIO,” said Rebecca Whitney, CEO of Highridge Medical. “The addition of a 3-D pre-operative planning solution with proprietary algorithms that enable the design of patient-specific spinal rods will be a great benefit to our surgeon customers and the patients they serve.”

The launch of SMAIO’s open platform paves the way for additional partnerships in the United States, as the Company continues to gain traction as a trusted innovative partner among key surgical centers.

Upcoming financial events:

Half-year 2025 results and Q3 2025 sales: Tuesday, October 14, 2025 (after market close)

About Highridge Medical

Highridge Medical is a global medical device company committed to improving spine care by partnering with the surgeon community to drive innovation. The company has a strong portfolio supported by extensive clinical evidence, including solutions for complex spine, motion preservation, and minimally invasive surgery. For further information, please visit www.highridgemedical.com.

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 KEOPS, its Big Data management software that has become a global reference with more than 100,000 patient cases documented.

SMAIO offers spine surgeons a comprehensive platform, I-Kontrol, incorporating planning, implants and related services, enabling them to treat spinal pathologies in a safe, effective and lasting way.

SMAIO is positioned at the forefront of innovation with the ambition of providing surgeons with the first active robotic solution enabling a high level of performance and repeatability to be achieved.

Based in Dallas (United States) and Lyon (France), SMAIO benefits from the skill and expertise of more than 40 highly specialized staff.

For further information, please visit our website: 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 its affiliates, directors, officers, counsels and employees have not verified the accuracy of, and make no representations or warranties about, statistical information or forecast information contained within this news release and that originates or is derived from third party sources or industry publications; these statistical data and forecast information are only used in this press release for information purposes. Finally, this press release may be drafted in French and in English. In the event of differences between the two texts, the French version will prevail.

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Source: SMAIO