⏰ TL;DR (Too Long; Didn't Read)

💡The Idea

• Every year there are over 170 million cases of femur or tibia fractures globally, 45% of which result in surgery (source). Surgical treatment of bone fractures is one of the most frequent surgical procedures in the orthopedic field
• However, surgery for bone fractures is challenging, requiring a high level of anatomical understanding and guesswork, and involves a significant amount of manual work
• AIRS has developed a unique AI-based, surgical platform that includes three major components:
1. Precision Robotic Surgery Fixation Device - enables precise bone positioning with zero manual labor as well as pin positioning
2. Surgical Navigation System - Real-time visualization and tracking of bone fragments
3. Bone fixation pins - Uni-cortical screw-less pins with a robot connection

🥇Benefits

• Improved surgical outcomes - 10x accuracy, lower error rates, faster postoperative recuperation, fewer re-surgeries
• Labor and cost reduction -fewer people needed to perform surgery. Faster surgery times
• Safer surgeries - minimal radiation exposure, 12x less on average

💵 Business Model

• One-time sale of a robotic system - $600,000 per unit
• Ongoing sales of disposable - $1,000 per surgery set with an expected 150 cases per year per system

🌎Market data

The global orthopedic surgical robots market was valued at $6.4 billion in 2021 and is expected to reach $24.22 billion by 2029, growing annually by 18.1% in the period leading to 2029. (source)

🚀Status

• 5 patents granted in Korea and US
• Development concluded. Ready for mass production.
• Pilot in a local Korean hospital in progress, sales to initiate by end of year 2023

📋Regulation

• Status
• KFDA for fixation pin is complete
• KFDA for positioning system to be ready by August 2023
• Future strategy and plan
• Clinical trials for FDA in process. Expected to conclude in mid-2024