Phantom Neuro, a company developing minimally invasive neural interfaces for intuitive prosthetic control, received approval to conduct its first-in-human early feasibility study, called CYBORG, of the Phantom X system in Australia. This marks a critical stepping stone in the company’s path toward clinical trials and commercialization in the United States, the company said.
The study will evaluate the safety, efficacy, and usability of Phantom X, the company’s proprietary muscle-machine interface designed to enable individuals with limb loss to control prosthetic hands and robotic devices through natural, intuitive movement.
The early feasibility study will enroll up to ten participants with unilateral transradial amputations and will be conducted in Melbourne, Australia, with surgical procedures performed at Cabrini Health and prosthetic care and rehabilitation provided by ProMotion Prosthetics and Enable Rehab.
The Phantom X Control System includes a small, implantable sensor array placed under the skin in the residual limb that interprets neuromuscular activity generated by muscles and translates it into precise robotic limb movement.
Unlike many neural interface approaches that rely on invasive brain or nerve surgery, Phantom Neuro’s approach captures electrical signals without touching the nervous system, enabling intuitive control while avoiding the risks associated with more invasive technologies.
Participants in the study will undergo a single outpatient, same-day implantation procedure, followed by approximately two weeks of recovery before being fitted with a Phantom X compatible prosthetic device. Each participant will then be evaluated over the study period of approximately 20 weeks.
“As Phantom Neuro grows, this study will be the greatest reference point to date for us to fine-tune our technology,” said Vinod Sharma, head of clinical and scientific affairs. “We chose Australia for its efficient early-stage clinical trial pathways, and the results will support our US [Food and Drug Administration investigational device exemption] and a future pivotal trial.”
The study’s primary investigator is Michael Lo, MD, a plastic surgeon at Cabrini Health. Additional study collaborators include Max Ortiz-Catalan, PhD, coordinating principal investigator; David Lee Gow, Dip.App.Sci (P&O), MSc (rehabilitation), director and principal prosthetist, ProMotion Prosthetics; and Abby Hutchison, director and senior occupational therapist, Enable Rehab.
