What SMAIO does

SMAIO (legal name S.M.A.I.O SA) is a French-American medical technology company specializing in software and implantable devices for complex spine surgery. Founded in 2010 and headquartered in Saint-Priest, near Lyon, France, the company is listed on Euronext Growth Paris (ticker ALSMA) and operates within the Otsuka Group ecosystem based in Japan. Its product portfolio is anchored by the i-Kontrol platform (launched 2021), a four-module system — i-PLAN for surgical planning, i-PERFORM for intra-operative execution support, i-CHECK for post-operative outcomes monitoring, and i-LEARN for surgeon training and education — built on top of the KEOPS patient database software that has been a recognized reference for spine surgery clinical data and imaging since 2010.

Complementary hardware includes the KHEIRON spinal fixation implant system (available with both CE Mark and FDA clearance), K-ROD patient-specific rod implants engineered for compatibility with multiple third-party fixation systems (NuVasive Reline, Orthofix Mariner/Virata, DePuy Synthes Expedium/TriALTIS, Highridge Vital), the K-BA3D 3D surgical planning software, and K-BALL instruments. Revenue is generated primarily through hardware sales (KHEIRON implants and K-ROD rods) supplemented by enterprise software licensing and services tied to the i-Kontrol platform. Go-to-market combines direct enterprise sales to spine surgeons and hospital procurement teams (currently ~15 US medical centers) with strategic distribution partnerships, most recently with Highridge Medical and Orthofix for US K-ROD rollout starting Q2 2026. FY 2025 sales reached €9.2 million (+67% YoY), with US implant sales of €7.0 million (+138% YoY) representing over 75% of activity, and gross margin of 83% (up 14pp).

Name

SMAIO

Legal name

S.M.A.I.O SA

Website

https://smaio.com

Company type

Public

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Short description

SMAIO is a French-American medical technology company that provides spine surgeons with an integrated platform (i-Kontrol) combining 3D surgical planning software, patient-specific and standard spinal implants (KHEIRON, K-ROD), and post-operative outcome tracking. Listed on Euronext Growth Paris, it generates the majority of revenue from US hospital and surgical center customers.

Ownership category

akta.pro rank

Product category

Spinal Implant Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Spine Implants & Motion Preservation (Fusion/Disc/Interspinous) (HLAHAEAC)

akta.pro secondary industries

Surgical Navigation, Robotics & Patient-Matched Instrumentation (Ortho/Spine) (HLAHAEAL), 3D-Printed & Patient-Specific Implants (Custom Ortho/Spine/Cranial) (HLAHAEAJ)

Keywords

• Spinal implant devices
• Spine surgery software
• Surgical planning tools
• Patient-specific implants
• Spinal fixation systems

Headquarters

HQ city

Saint Priest

HQ country

France

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Technology or R&D, Personnel, Marketing or Sales, Infrastructure

Revenue model

1. US Implant Sales: Primary revenue driver with 138% growth to €7.0 million in 2025, representing over 75% of total company activity. Includes KHEIRON implant system and K-ROD patient-specific implants.
2. Software and Services: KEOPS database software and i-Kontrol platform services including surgical planning, execution support, and outcome tracking.
3. K-BA3D Software Licenses: Pre-operative planning software distributed with IFU documentation across EU and US markets.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels1 record

Core offering

SMAIO designs, manufactures, and sells spinal implant devices and software for spine surgery. The company offers the KHEIRON spinal fixation system, K-ROD patient-specific implants, and K-BALL surgical instruments, supported by the i-Kontrol platform which integrates K-BA3D surgical planning software (evolved from the KEOPS patient database) with intra-operative execution and post-operative outcome tracking for spine surgeons.

Product overview

SMAIO is a French-American medical technology company specializing in complex spine surgery, offering a comprehensive ecosystem combining software solutions, implantable devices, and services. The company's i-Kontrol platform, launched in 2021, provides spine surgeons a holistic solution consisting of four integrated modules: i-PLAN for surgical planning, i-PERFORM for surgical execution, i-CHECK for post-operative outcomes monitoring, and i-LEARN for training and education. The platform is powered by KEOPS, the company's patient database software launched in 2010 that has become a global reference for clinical data and imaging. SMAIO's product portfolio includes the KHEIRON Spinal Fixation System (implants and instruments), K-ROD patient-specific implants compatible with multiple third-party spinal systems (NuVasive, Orthofix, DePuy Synthes, Highridge), K-BA3D 3D surgical planning software, and K-BALL instruments. FY 2025 sales reached €9.2 million with 67% growth, driven by 138% US implant sales growth.

Differentiator

Problem solved

Functional benefit

Brands

• i-Kontrol: Holistic platform providing surgeons control over surgical planning, execution, outcomes, and education programs. Includes i-PLAN, i-PERFORM, i-CHECK, and i-LEARN modules.
• KHEIRON
• KEOPS-4ME
• K-BALL
• K-BA3D

Products and services

• i-Kontrol Platform
• KHEIRON Spinal Fixation System (Implants)
• KHEIRON Instruments
• K-ROD Patient-Specific Implants
• K-BA3D Surgical Planning Software
• K-BALL Surgical Instruments

Quantifiable outcome

• 326 spinal procedures performed in 2025 versus 180 in 2024 (81% increase)
• +3 more outcomes

Named customers1 record

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

AI capability2 records

Feature7 records

Partnerships

Two partnerships are on record, tiered core.

• Highridge MedicalcoreChannel Partner/ Reseller/ Distributor · 1 January 2025Strategic distribution partnership for KEOPS-4ME platform in the United States. Enables rollout of patient-specific K-Rods starting Q2 2026, expanding SMAIO's reach in the US spinal surgery market.
• OrthofixcoreChannel Partner/ Reseller/ Distributor · 1 January 2025Strategic distribution partnership for KEOPS-4ME platform in the United States. Major spine surgery company partnership enabling patient-specific K-Rod distribution and US market expansion.

Scale indicators11 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Globus Medical: Major pure-play spine medical device company following the NuVasive acquisition, offering spinal fixation implants, surgical planning software, and enabling technology. Directly comparable to SMAIO's combined software + implant + patient-specific rod strategy in the US spine market.
• Orthofix Medical: Spine and orthopedics medical device company with fixation systems (Mariner, Virata) that are explicitly compatible with SMAIO's K-ROD patient-specific implants. Functions as both a direct competitor and a strategic distribution partner, making it the most operationally comparable peer.
• Highridge Medical: Spine hardware company whose Vital fixation system is compatible with SMAIO's K-ROD implants and which signed a strategic US distribution agreement for the KEOPS-4ME platform. Closely overlaps with SMAIO in patient-specific and deformity-correction spine solutions.
• Alphatec Holdings (ATEC): Growth-stage spine medical device company focused on procedurally integrated solutions for complex deformity and degenerative spine surgery. Comparable in product scope (fixation + enabling technology) and in mid-stage commercial scaling profile similar to SMAIO's US trajectory.
• NuVasive (a Globus Medical company): Spine-focused medical device pioneer (now part of Globus Medical) whose Reline fixation system is compatible with SMAIO K-ROD implants. Highly comparable in complex spine surgery focus and surgeon-driven GTM motion.

Emerging players

• Carlsmed: Emerging US company commercializing patient-specific spine implants using proprietary planning software and 3D-printed technology. Direct conceptual comparator for SMAIO's K-ROD patient-specific strategy and a key emerging competitive threat.
• SI-BONE: Public emerging-growth spine device company specializing in minimally invasive surgical solutions for the sacropelvic anatomy. Comparable as a small-cap, single-segment spine medtech that has scaled procedure volume via focused surgeon adoption — analogous to SMAIO's current growth-stage trajectory.

Broad incumbents

• Stryker (Spine division): Large diversified medical device conglomerate with a substantial spine portfolio including fixation, interbody, and surgical navigation products. Represents the broad incumbent competitive backdrop against which SMAIO's niche patient-specific offering must scale.
• Medtronic (Spine & Biologics): Global medical device leader with one of the largest spine surgery businesses (post-Medicrea acquisition). Sets the standard for integrated spinal hardware, biologics, and surgical planning at scale that SMAIO's i-Kontrol platform aims to compete against.
• DePuy Synthes (Johnson & Johnson): Spine division of J&J offering Expedium and TriALTIS fixation systems, both of which are explicitly compatible with SMAIO K-ROD implants. Represents the largest incumbent competitor and a critical compatibility partner for SMAIO's patient-specific strategy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds4 records

Investors5 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SMAIO