【News】Rentals within Japan of the world’s first robot medical device HAL® for Medical Use (Lower Limb Type) to launch in late August ~the world’s first public health insurance coverage for treatment to delay the progress of slowly progressive rare neuromuscular disease patients~

CYBERDYNE,INC. (the “Company”) will commence the rental service within Japan of HAL® for Medical Use (Lower Limb Type), the world’s first robot medical device in late August, 2016.

HAL® for Medical Use (Lower Limb Type) acquired manufacturing and distribution approval in Japan from the Ministry of Health, Labour and Welfare (“MHLW”), as a new medical device shown to be effective for suppressing the advancement of slowly progressive rare neuromuscular diseases¹ through its treatment on November 25, 2015. Further, on April 25, 2016, HAL became the world’s first robotic treatment device to receive a public insurance reimbursement price for treatment with robots.

In addition, the manual for the proper usage (https://www.jsnt.gr.jp/img/hal.pdf) of HAL® for Medical Use (Lower Limb Type) was published under the supervision of medical professionals^*2 who specialize in the target diseases. With its plan to conduct a device performance survey, which must be conducted to ensure the safety and efficacy of the product in the post-marketing phase, submitted to the Pharmaceuticals and Medical Devices Agency (“PMDA”), the Company decided to launch the rental service of HAL® for Medical Use (Lower Limb Type).

The Company will continue its endeavor to expand the target diseases that can be treated using HAL by accelerating various clinical trials and studies on functional improvement/regeneration treatment of the brain, nerves and muscles for patients suffering from Spinal Cord Injuries and Strokes, in order to propel innovations in the field of medicine and to make contributions to “extending healthy life expectancy.”

Product features

HAL® for Medical Use (Lower Limb Type) 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 diseases¹. 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 (Lower Limb Type). The power units of HAL® for Medical Use (Lower Limb Type) 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 modes³ 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 (Lower Limb Type) for patients with the relevant diseases were recognized by the MLHW, 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 Medical professionals 
・ Clinical trial principal investigator: Dr. Takashi Nakajima (Deputy Director of the Niigata  
       National Hospital)
・ Societies: Japanese Society of Neurology, Japan Society of Neurological Therapeutics,
      Japanese Association of Rehabilitation Medicine

*3 The Robot Suit provides assistance in three control modes depending on wearer’s
      intended use.
・      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 reduce the feeling of
            discomfort. 

(Link: within this site)
HAL for Medical Use (Lower Limb Type) received approval to be manufactured and sold as a medical device by the Ministry of Health, Labour and Welfare
(http://www.cyberdyne.jp/english/company/PressReleases_detail.html?id=3749)

 Central Social Insurance Medical Council: The insurance reimbursement price of the technical fee for the treatment using HAL for Medical Use (Lower Limb Type) was made public in the Points Table of the Medical Fee Schedule Revision Proposal
(http://www.cyberdyne.jp/english/company/PressReleases_detail.html?id=4031)

 Under the supervision of medical professionals, the manual for proper usage of HAL® for Medical Use (Lower Limb Type) has now been published
（http://www.cyberdyne.jp/english/company/PressReleases_detail.html?id=4419）

 Combined Therapy of Spinal Cord Regeneration and HAL® for Medical Use, Leading to Functional Regeneration Treatment
(http://www.cyberdyne.jp/english/company/PressReleases_detail.html?id=4144)