HAL Medical Exoskeleton Approved for Treatment of HAM and Hereditary Spastic Paraplegia in Japan Medical Exoskeleton Report

CYBERDYNE, not the company behind the evil AI in science fiction, but the maker of human-empowering robotic technology, announced this month that Medical HAL is now approved for two new treatments. Specifically, the lower body medical exoskeleton can now be used to treat hereditary spastic paraplegia and HTLV-1-related myelopathy (HAM). At this point, the approval only covers Japan and the HAL (Hybrid Assistive Limb [HAL]-HN01) exoskeleton is mainly used in clinics and medical centers with trained operators who assist the user when attached to a winch.

• HTLV-1 associated myelopathy (HAM) is “a chronic, slowly progressive disease of the spinal cord seen in some people infected with the HTLV-1 virus, which results in painful stiffness and weakness in the legs.” – National MS Society
• Hereditary spastic paraplegia a group of inherited disorders characterized by progressive weakness and spasticity (stiffness) of the legs. -NIH

The Medical HAL is intended to improve gait in patience, reduce disease progression and even regenerate certain neural functions at a faster rate than conventional walking therapy.

Medical Evidence for Treatment Approvals:

The approval for the treatment of HAM and hereditary spastic paraplegia is based on a recently completed clinical trial by Dr. Takashi Nakajima, Director of Niigata National Hospital, titled “Investigator Initiated Clinical Study of Robot wearable assist for lower limbs voluntarily controlled by bioelectrical signals etc. (Hybrid Assist Limb [HAL]-HN01) as a New Medical Device to Delay the Progression of Refractory Rare Neuromuscular Diseases – A Multicenter Randomized Controlled Parallel Group Study to Evaluate the Short-Term Gait Enhancement Effect on Ambulatory Disability Caused by Paraplegia spastic such as HTLV-1 (HAM) associated myelopathy, etc.-(STUDY NCY-2001R).

With the inclusion of HAM and hereditary spastic paraplegia, Medical HAL is now approved as a medical device for the treatment of a total of ten neuromuscular diseases in Japan. The other eight are spinal muscular atrophy (SMA), spherospinal muscular atrophy (SBMA), amyotrophic lateral sclerosis (ALS), Charcot-Marie-Tooth disease, distal myopathy, inclusion body myositis, myopathy congenital, muscular dystrophy.

In the near future, CYBERDYNE aims to obtain insurance coverage so that medical reimbursement can be calculated by each hospital when treating patients with HAM and hereditary spastic paraplegia with medical HAL in Japan.

References:

• Press release: Treatment of HAM and hereditary spastic paraplegia approved for medical HAL, 2022-10-28, CYBERDYNE, link
• Register of support studies: link