【News】HAL for Medical Use (Lower Limb Type) treats first patient after acquisition of medical device approval at Niigata National Hospital and other medical institutions ~The start of treatments covered by public medical insurance for patients with rare neuromuscular diseases~

On September 2, 2016, the National Hospital Organization Niigata National Hospital and the National Hospital Organization Tokushima Hospital will provide treatment to patients with slowly progressive rare neuromuscular diseases*¹ using HAL for Medical Use (Lower Limb Type) (hereafter referred as “HAL for Medical Use”), the world’s first robotic treatment device built for delaying the advancement of such diseases. This is the first time the treatment will be administered since the device obtained its manufacturing and distribution approval in November 25, 2015.

Hereafter, HAL for Medical Use will be installed in multiple medical facilities that meet the necessary requirements and will be used regularly as a treatment covered by public health insurance. As a reference, the reimbursement price for this device’s technology was decided on April 25, 2016, at which point HAL for Medical Use became the first instance of robotic treatment covered by public health insurance in the world.

The patients who will receive treatment at the Niigata National Hospital include a female patient in her teens with Charcot-Marie-Tooth disease, which causes muscle atrophy and loss of sensitivity in the lower limbs and feet, a male patient in his 50’s with Spinal Bulbar Muscular Atrophy, which causes muscle weakness, muscle atrophy, and bulbar palsy, and several other patients. Niigata National Hospital will administer their treatment with HAL for Medical Use rented from CYBERDYNE, INC. (the “Company”). According to Neurologist and Deputy Director of the Niigata National Hospital, Dr. Takashi Nakajima, who provided this treatment, “Until now, there were no treatment methods for patients with these rare neuromuscular diseases, but this break-through technology gives us a new avenue for treatment. I want to continue advancing efforts to expand the target diseases, so that patients with other diseases can benefit from HAL.”

Currently as of September 2, 2016, the Company has received unofficial notices of interest from more than 25 hospitals looking to install HAL for Medical Use and many other inquiries about implementation. The Company will proceed to make core hospitals the base of each region, and expects to expand steadily.

(Reference) Features of HAL for Medical Use HAL for Medical Use is a robot that obtained manufacturing and distribution approval under the Pharmaceuticals and Medical Devices Act of Japan as a new medical device under a new classification of “Biosignal-responsive motor function improvement device,” for the purpose of treating patients suffering from slowly progressive rare neuromuscular diseases*¹. When a wearer intends to move its body, various signals are sent from the brain to the muscles through nerves but impairments disturb the motion of musculoskeletal system Those signals, however, leak onto the skin surface as bio-electric signals (“BES”) which are read by HAL for Medical Use. The power units of HAL for Medical Use are activated according to this BES and other information obtained from its many sensors, allowing the device to realize the movements of the lower limbs as intended by the user. There are three control modes*² installed into this device and the modes can be adjusted at each joint, in various combinations that can be customized according to the wearer’s condition. The medical effects of treatment with HAL for Medical Use for patients with the relevant diseases were recognized by the Ministry of Health, Labour and Welfare, leading to coverage by public health insurance.

*1 Target diseases Slowly progressive rare neuromuscular diseases stated below:
・ Spinal Muscular Atrophy (SMA)
・ Spinobulbar Muscular Atrophy (SBMA)
・ Amyotrophic Lateral Sclerosis (ALS)
・ Charcot-Marie-Tooth disease (CMT)
・ Distal Myopathy
・ Inclusion Body Myositis (IBM)
・ Congenital Myopathy
・ Muscular Dystrophy

*2 The Robot Suit provides assistance in three control modes depending on the wearer’s intended purpose.
・ Cybernic Voluntary Control Mode:
      The assistance provided at the corresponding joint is based on the BES and posture.
・ Cybernic Autonomous Control Mode:
      The assistance provided at the corresponding joint is based on pre-programmed leg    
      trajectories. Several trajectories for standing up and walking are installed in the Robot  
      Suit.
・ Cybernic Impedance Control Mode:
      The power unit at the corresponding joint exerts just enough torque to compensate for
      frictional resistance and reduces the feeling of discomfort.