Phantom Neuro Receives Approval for First-In-Human Clinical Study

Study to Evaluate Safety and Function of Phantom X, Minimally Invasive Muscle–Machine Interface for Prosthesis Control

AUSTIN, Texas, April 15, 2026 /PRNewswire/ -- Phantom Neuro, a company developing minimally invasive neural interfaces for intuitive prosthetic control, today announced that it has received approval to conduct its first-in-human Early Feasibility Study (EFS), called CYBORG, of the Phantom X system in Australia. This marks a critical stepping stone in the company's path toward U.S. clinical trials and commercialization.

The study will evaluate the safety, efficacy, and usability of Phantom X, Phantom Neuro'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 10 upper limb, below the elbow unilateral, amputee participants 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.

"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."

About the Phantom X Control System

• The Phantom X Control System includes a small, implantable sensor array placed under the skin in 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.

About the Clinical Trial

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 an approximately 20-week study period.

"As Phantom Neuro grows, this study will be the greatest reference point to-date for us to fine tune our technology," says 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's Primary Investigator is Michael Lo, M.D., a leading plastic surgeon at Cabrini Health. Additional study collaborators include Max Ortiz-Catalan, PhD, coordinating principal investigator, David Lee Gow, prosthetist and orthotist, and Abby Hutchison, occupational therapist.

About Phantom Neuro

Phantom Neuro is a neurotechnology company developing a minimally invasive interface that enables intuitive control of prosthetic limbs and robotic exoskeletons. Originally developed at the Johns Hopkins University School of Medicine, Phantom Neuro has received funding from investors including Ottobock, Blackrock Neurotech, Breakout Ventures, Draper Associates, LionBird Ventures, and Time BioVentures. Headquartered in Austin, Texas, Phantom Neuro is backed by a globally recognized advisory board of experts from CTRL-Labs, DARPA, Johns Hopkins University, and Precision Neuro. Learn more at www.phantomneuro.com.

CONTACT
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SOURCE Phantom Neuro Inc.