Medical Press Release

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

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

CYBERDYNE, not the company behind evil AI in science fiction but the manufacturer of human-empowering robotics 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 used primarily in clinics and medical centers with trained operators assisting the user while they are attached to a hoist.

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

The Medical HAL is meant to improve the gait in patients, reduce the progression of the diseases, and even regenerate some neural function at a faster rate than conventional walking therapy.

Medical Evidence for the 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 National Hospital Organization Niigata Hospital, titled “Investigator-Initiated Clinical Study of Wearable Assistive Robot for Lower Limbs Controlled Voluntarily by Bioelectric Signals etc., (Hybrid Assistive Limb [HAL]-HN01) as a New Medical Device to Delay Progression of Intractable Rare Neuromuscular Diseases – A Multicenter Randomized Controlled Parallel-Group Study to Evaluate the Short-Term Gait Improvement Effect on Ambulation Disability Caused by Spastic Paraplegia such as HTLV-1-Associated Myelopathy (HAM), 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 for a total of ten neuromuscular diseases in Japan. The remaining eight are Spinal muscular atrophy (SMA), Spherospinal muscular atrophy (SBMA), Amyotrophic lateral sclerosis (ALS), Charcot-Marie-Tooth disease, Distal myopathy, Inclusion body myositis, Congenital myopathy, Muscular dystrophy.

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

References:

  • Press Release: Treatment of HAM and Hereditary Spastic Paraplegia approved for Medical HAL, 2022-10-28, CYBERDYNE, link
  • Supporting Study Registry: link

 

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