PERTH, WA, Febuary 2024

FDA grants AIRO's High-speed Intelligent Laser Osteotomy (HAiLO™) system 'Breakthrough Device Designation' status

AIRO has been awarded "Breakthrough Device Designation" by the U.S. Food and Drug Administration (FDA), a significant milestone that accelerates the development of its High-speed Intelligent Laser Osteotomy (HAiLO™) system. This advanced technology employs non-contact laser energy at high speeds, seamlessly integrated with surgical robotics and real-time intraoperative digital sensing. This integration enables orthopaedic surgeons the ability to use laser bone shaping technology to achieve unprecedented sub-millimetre accuracy for full and partial knee replacement procedures.

The FDA's Breakthrough Device program facilitates the rapid advancement of technologies that are poised to significantly enhance the treatment of life-threatening or irreversibly debilitating conditions. Through this program, AIRO will receive an expedited review process, and dedicated resources from the FDA to support the device’s pathway to market.

AIRO's co-founder and CEO, Associate Professor Brett Robertson, emphasised the system's unique ability to tailor surgical solutions to individual patient needs. He highlighted the critical role of precision in knee replacement surgeries for the optimal positioning and alignment of implants. "Receiving the Breakthrough Device Designation from the FDA validates the innovative nature of our technology, its commercial potential, and, most importantly, its significant potential benefits to patients worldwide. This achievement streamlines and accelerates the regulatory process in the U.S., ensuring timely access to the clinical and economic advantages of our cutting-edge innovation."

Professor Riaz Khan, Orthopaedic Surgeon, AIRO Chairman and co-founder, firmly believes in the revolutionary impact of the HAiLO™ system on orthopaedic surgery. “The HAiLO system will change the practice of orthopaedics as we know it today.” He elaborated on the transformative capabilities of the system, emphasising the game-changing nature of its real-time digital mapping and non- contact laser bone shaping for knee replacement surgery. This innovation aims to bring us closer to the ideal of a 'forgotten knee'—a knee replacement so successful that the patient no longer experiences discomfort or is significantly aware of the implant during daily activities. Achieving this level of success means that patients can enjoy near-normal knee function, free from the limitations or pain that necessitated the surgery.

Globally, over 1.4 million knee replacement surgeries are performed annually, with a notable percentage of patients remaining dissatisfied with their outcomes. The HAiLO™ system is designed to address the limitations of traditional knee replacement methods, which often result in misalignment, thermal and mechanical bone damage, and the inability to preserve crucial ligaments. AIRO's innovative approach promises to set new benchmarks in orthopaedic care.

"Our vision at AIRO is to restore vitality and movement to the world. In everything we do, we are focused on improving the lives of millions by introducing the HAiLO™ system and accompanying next generation bone and ligament sparing implants that closely replicates and restores near-normal joint function, and in doing so, raise global standards in orthopaedic care" said Associate Professor Brett Robertson.