Phantom Neuro has secured approval to initiate its first-in-human trial of the Phantom X system, a minimally invasive muscle-machine interface, in Australia, for prosthesis control.
This development marks an essential phase towards commercialisation and clinical trials in the US.
The early feasibility study (EFS), named CYBORG, aims to assess the efficacy, safety and usability of the system designed to allow individuals with limb loss to operate prosthetic hands and robotic devices through natural movements.
Set to involve up to ten upper-limb, below-the-elbow unilateral amputee subjects, it will take place in Melbourne, Australia, with surgical interventions to be carried out at Cabrini Health.
Prosthetic and rehabilitation services will be provided by ProMotion Prosthetics and Enable Rehab.
Phantom Neuro founder and CEO Connor Glass said: “This approval represents a defining milestone for 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 trial participants will undergo a single outpatient procedure to implant the device, followed by a two-week recovery period before being fitted with a Phantom X-compatible prosthetic. Each participant will then be monitored over a 20-week evaluation period.
The Phantom X Control System features an implantable sensor array placed beneath the skin in the residual limb. This device interprets neuromuscular activity from the muscles and translates it into precise robotic limb movements.
Unlike conventional neural interface methods that require invasive brain or nerve surgery, Phantom Neuro's approach avoids the nervous system, capturing electrical signals to enable intuitive control without the risks associated with more invasive procedures.
The study's primary investigator is Cabrini Health plastic surgeon Michael Lo. Collaborators include coordinating principal investigator Max Ortiz-Catalan, prosthetist and orthotist David Lee Gow, and occupational therapist Abby Hutchison.
