ANEUVO Launches U.S. Study of ExaStim, a Non-invasive Spinal Neuromodulation System to Evaluate its Safety and Effectiveness for Paralysis due to Spinal Cord Injury
Los Angeles – January 31, 2023 – Today, ANEUVO®, a platform and therapy development company, has initiated a clinical study of the ExaStim® TSS system, a wirelessly-controlled neuromodulation system designed to deliver transcutaneous spinal cord stimulation (TSS). The ASPIRE™ (Assessing non-invasive spinal Stimulation and PT/OT for motor Improvement Response with ExaStim) study will evaluate the safety and effectiveness of ExaStim in combination with traditional rehabilitation therapy as an adjunct therapy for individuals living with upper extremity paralysis due to spinal cord injury (SCI).
Transcutaneous Spinal Stimulation is an emerging neuromodulation therapy with the potential to help individuals living with spinal cord injury improve motor function. ExaStim therapy delivers stimulation to the spinal cord to modulate neural networks, which enables improvement in motor function. Early research indicates that non-invasive spinal stimulation may help individuals with spinal cord injuries regain lost motor function and improve functional independence.
“Rehabilitation after SCI is complicated and inefficient. Recovery of function is slow and secondary complications can limit progress,” said Dr. Rebecca Martin, the Manager of Clinical Research and Education at the International Center for Spinal Cord Injury (ICSCI) at Kennedy Krieger Institute and an assistant professor at The Johns Hopkins University School of Medicine in the Department of Physical Medicine and Rehabilitation. “TSS via ExaStim has the potential to augment existing therapies, helping patients to restore function and mobility. ExaStim offers a unique multi-electrode array, which allows us to target and control stimulation levels, unlike any device currently on the market. We hope to demonstrate that this novel delivery of TSS will optimize our therapies and yield better outcomes.”
The ASPIRE study is a randomized, prospective, multicenter, sham-controlled clinical study designed to demonstrate the safety and efficacy of the ExaStim TSS system using non-invasive spinal cord stimulation to improve/regain the motor function of individuals with SCI. A maximum of 140 patients will be enrolled at up to 14 sites in the U.S.
“The ExaStim TSS system with a flexible multi-electrode array represents an important advancement in non-invasive spinal cord neuromodulation therapy,” said Dr. Yi-Kai Lo, chief executive officer for ANEUVO. “We are excited to lead the effort through the ASPIRE study to bring this novel device to market, offering physicians and clinicians a new technology to treat patients suffering from spinal cord injury.”
ExaStim is a new non-invasive, non-surgical investigational device. The system is designed to deliver electrical stimulation to the spinal cord through an external electrode array with the flexibility to personalize and tailor therapy to meet the individual needs of patients.
The ASPIRE study is determined to be a non-significant risk (NSR) by the U.S. Food and Drug Administration (FDA). The ExaStim neurostimulator received the FDA Breakthrough Device Designation status for the indication of treating paralysis due to spinal cord injury and is an investigational device limited by the federal government to investigational use.
About Spinal Cord Injury and non-invasive spinal cord stimulation
SCI is defined as damage to the spinal cord that leads to a permanent or temporary neurologic deficit. According to National Spinal Cord Injury Statistical Center, the estimated number of spinal cord injury (SCI) patients in the U.S. in 2021 is approximately 299,000, with an annual incidence of approximately 54 cases per million populations and an estimated lifetime cost of > $1.2M per patient1. Patients with SCI often lose their sensation, mobility, or even autonomic function as the control from the brain to the rest of the body is completely or partially lost at the level of the spinal cord lesion. However, despite SCI interrupts the cerebrospinal pathway, key planning, coordination, and effector centers above and below the injured spinal segment remain intact. This provides the potential opportunity of using non-invasive electrical neuromodulation to enable the neural circuitries residing in the spinal cord to restore motor functions to improve the overall quality of life of individuals with SCI2-3.
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