SMAIO (ALSMA) Investor presentation summary

Integrated spine surgery platform

• i-Kontrol links pre-op planning, patient-specific execution, outcome monitoring and surgeon training.

• KEOPS contains 100,000 patient cases; 3D Balance Analyzer uses clinical and imaging data to plan procedures.

• KHEIRON combines customized rods, 90° translation screws and K-guides for precise positioning and progressive deformity reduction.

• More than 1,400 surgeries were performed across six countries since June 2019, with reported high clinical outcomes and surgeon and patient satisfaction.

• SPIDER roadmap targets a passive robot version by 2025 and an active version by 2026.

Market and competitive position

• Global spine market was $10bn in 2019, including a $3bn spinal fusion market; more than 1m instrumented surgeries are performed annually.

• The spinal fusion market is forecast to grow at a 5% CAGR through 2025, with demand spanning planning, patient-specific implants, robotics and outcome monitoring.

• Six US companies hold 84% of the spinal fusion market; more than 400 manufacturers offer similar poly-axial tulip pedicle screws.

• Intellectual property includes four robotics patents, one realignment algorithm patent and five implant design patents.

Commercial and strategic expansion

• Sales reached €2.1m in 2021, up 73% YoY; expansion was driven mainly by the US.

• NuVasive partnership includes a $10m equity investment: $5m at IPO and $5m tied to milestones; US software co-exclusivity lasts three years from platform integration.

• NuVasive milestones include $3m after FDA approval of customized 3D Balance Analyzer software and $2m after platform integration.

• Roadmap targets more than €12m annual sales by 2025 and around 200 surgeries per month in 2024.

• Factory construction is planned for 2024, with operations targeted for early 2026; capacity target is around 20 surgeries daily and manufacturing costs are targeted to fall from 50% to 20% of sales.