Phantom Neuro has secured approval to initiate its first-in-human Early Feasibility Study (EFS), named CYBORG, for the Phantom X system, marking a key milestone in the development of minimally invasive neural interfaces for prosthetic control. The study will be conducted in Australia and represents an early step toward broader clinical validation and eventual regulatory pathways in the United States.
The CYBORG study will assess the safety, efficacy, and usability of Phantom X, a proprietary muscle–machine interface designed to enable individuals with limb loss to control prosthetic devices through intuitive, real-time movement. The trial is expected to enroll up to 10 participants with below-the-elbow upper limb amputations and will take place in Melbourne. Surgical procedures will be conducted at Cabrini Health, with prosthetic care and rehabilitation provided by ProMotion Prosthetics and Enable Rehab.
“This approval represents a defining milestone for Phantom Neuro,” said Connor Glass, Founder and CEO of Phantom Neuro. “For the first time, we're moving from preclinical validation to human implantation. This study is designed to evaluate the safety of our system and begin validating that functional, real-time control of prosthetic devices can be achieved through a minimally invasive muscle interface.”
The Phantom X system consists of a small implantable sensor array placed beneath the skin of the residual limb. The device captures neuromuscular signals generated by muscle activity and translates them into precise control of robotic limbs. Unlike approaches that rely on brain or nerve interfaces, Phantom Neuro’s technology avoids direct interaction with the nervous system, aiming to reduce surgical complexity while maintaining intuitive control.
Participants will undergo a same-day outpatient implantation procedure, followed by an approximate two-week recovery period before being fitted with a compatible prosthetic device. Each participant will then be monitored over a 20-week evaluation period to assess performance and usability outcomes.
“As Phantom Neuro grows, this study will be the greatest reference point to-date for us to fine tune our technology,” said Phantom Neuro's Head of Clinical and Scientific Affairs, Vinod Sharma. “We chose Australia for its efficient early-stage clinical trial pathways, and the results will support our U.S. FDA IDE and a future pivotal trial.”
The study involves collaboration with clinical and rehabilitation experts, including Principal Investigator Michael Lo, M.D., alongside a multidisciplinary team supporting surgical, prosthetic, and therapeutic components.
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