Canary Medical Inc.

Canary’s technology platform integrates three existing, FDA-approved and validated technologies: ultra-low power Micro Electro-Mechanical Systems (MEMS), pacemaker batteries, and wireless data transmission (telemetry). The resulting Canary Health Implantable Reporting Processor (CHIRP) sensor is sufficiently modular that it can be cost-effectively customized and embedded in the tibial extension segment of a commercial knee prostheses. Using gyroscopes, accelerometers, and a pedometer, the CHIRP generates clinically relevant data on device function, range of motion (ROM), gait characteristics, patient behaviour, and early signs of loosening/infection/failure. As a measure of patient activity during recovery, the device will count virtually every step taken for the first year and periodically thereafter. Knee function will be assessed through detailed gait analysis (such as stride length, cadence, walking speed), ROM (knee and tibial), and stability (medial-lateral, anterior-posterior and rotational) over the lifespan of the device. Potential complications such as infection and loosening will be predicted based on data analytics and machine learning. The power management algorithm, the battery technology, and the radio/antenna design, allow the TKA-CHIRP to passively transmit useful data for up to twenty years. The CHIRPs modular design allows it to be customized for a wide range of orthopaedic devices in the future, including TKA devices form other manufacturers, total hip arthroplasties, total shoulder arthroplasties and fracture fixation devices. A program is under development for vascular devices such as stents, stent grafts and heart valves. The design has been tested and validated in orthopaedic models and human cadaver studies, the FDA has confirmed a De Novo 510K regulatory pathway, and regulatory submission for approval will occur in Q1 2020.