Phantom Neuro receives approval for first-in-human CYBORG clinical study in Melbourne, Australia

Phantom Neuro/Phantom X

Phantom Neuro announced regulatory approval to conduct the CYBORG (Control Through your Optimized Resistive Bionic Output Gesture) first-in-human early feasibility study in Melbourne. The trial will enroll up to 10 below-elbow amputees and evaluate the Phantom X system's safety and performance.

• Up to 10 participants with below-elbow amputation will enroll in Melbourne
• Surgical implantation at Cabrini Health; prosthetic care by ProMotion Prosthetics
• ~20-week evaluation period per participant; results to support future FDA Investigational Device Exemption
• Australia's efficient regulatory pathway chosen to accelerate U.S. clinical progression