SMAIO Receives FDA 510(k) Clearance for Customized Surgery Planning Software Co-Developed with NuVasive

LYON, France, June 8, 2023–(BUSINESS WIRE)–Regulatory Information –

SMAIO (Software, Machines and Adaptative Implants in Orthopaedics – Euronext Development Paris ISIN: FR0014005I80 / Ticker: ALSMA), a French participant specializing in remodeling vertebral fusion with breakthrough innovation, as we speak introduced that it has obtained FDA 510(okay) clearance for the custom-made surgical procedure planning software program co-developed with NuVasive¹.

Acquiring FDA 510(okay) clearance for this custom-made model of the surgical procedure planning software program represents a key milestone within the partnership and licensing settlement signed in Q1 2022 between SMAIO and NuVasive, a worldwide chief in spine know-how innovation. This custom-made surgical procedure planning software program is predicated on SMAIO’s beforehand launched vertebral realignment planning know-how, “Stability Analyzer 3D”.

Philippe ROUSSOULY, CEO of SMAIO, said: “This 510(okay) clearance represents a significant step in direction of the commercialization of our joint planning platform and revolutionary companies to NuVasive clients. We imagine that with our know-how, surgeons will quickly profit from our cutting-edge resolution for planning and performing spine surgical procedure, contemplating particular person morphological specificities and finally, for enhancing affected person outcomes”.

The achievement of this primary milestone, according to the roadmap introduced by SMAIO on the time of its IPO in April 2022, triggers a $3 million fee by NuVasive to SMAIO. As a part of the beforehand introduced partnership, a further milestone fee will likely be triggered after additional integration of the Stability Analyzer 3D into the NuVasive platform, in addition to further technical capabilities.

About SMAIO

A precursor in using scientific information and imaging of the spine, SMAIO designs world options for spine surgical procedure specialists. The Firm has acknowledged experience because of KEOPS, its Massive Information administration software program that has develop into a worldwide reference with greater than 100,000 affected person circumstances documented.

SMAIO affords spine surgeons a complete platform, I-Kontrol, incorporating planning, implants and associated companies, enabling them to deal with spinal pathologies in a protected, efficient and lasting means.

SMAIO is positioned on the forefront of innovation with the ambition of offering surgeons with the primary energetic robotic resolution enabling a excessive degree of efficiency and repeatability to be achieved.

Primarily based in Lyon, France, SMAIO advantages from the ability and experience of greater than 30 extremely specialised employees.

For additional info, please go to our web site: www.smaio.com

Subsequent monetary occasions:

• Annual Common Assembly: June 20, 2023
• H1 2023 gross sales: July 18, 2023 (after market)
• H1 2023 outcomes: October 18, 2023 (after market)

Itemizing market: Euronext Development Paris
ISIN: FR0014005I80
Mnemonic: ALSMA

Disclaimer

This press launch accommodates non-factual parts, together with, however not restricted to, sure statements concerning future outcomes and different future occasions. These statements are primarily based on the present imaginative and prescient and assumptions of the administration of the Firm. They incorporate recognized and unknown dangers and uncertainties that might lead to vital variations in outcomes, profitability and anticipated occasions. As well as, SMAIO, its shareholders and its associates, administrators, officers, counsels and staff haven’t verified the accuracy of, and make no representations or warranties about, statistical info or forecast info contained inside this information launch and that originates or is derived from third social gathering sources or trade publications; these statistical information and forecast info are solely used on this press launch for info functions. Lastly, this press launch could also be drafted in French and in English. Within the occasion of variations between the 2 texts, the French model will prevail.

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¹ On February 9, 2023, Globus Medical, a U.S.-based firm that manufactures and markets a full vary of spinal units and implants, signed an settlement to amass NuVasive in an all-stock transaction valued at roughly $3.1 billion. As of the date of the publication of the annual monetary report and the data out there to SMAIO, NuVasive owns 15.55% of the Firm’s share capital.

Contacts

SMAIO
Philippe Roussouly
Chief Government Officer
Renaut Fritsch
Chief Monetary Officer
traders@smaio.com

NewCap
Dusan Oresansky/Quentin Massé
Investor Relations
smaio@newcap.eu
Tel.: +33 (0)1 44 71 94 92

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