PRESS RELEASE

2016.06.23 update

【News】Under the supervision of medical professionals, the manual for proper usage of HAL® for Medical Use (Lower Limb Type) has now been published ~ Commencement of the world’s first insured robotic treatment covered under general public health insurance ~

CYBERDYNE, INC. (the “Company”) has now published the manual for proper usage of HAL® for Medical Use (Lower Limb Type) (hereafter referred as “HAL for Medical Use”), the world’s first robot medical device.

The Company acquired the approval for the manufacture and distribution of HAL for Medical Use as a new medical device in Japan from the Ministry of Health, Labour and Welfare (“MHLW”) on November 25, 2015. Following discussion at the Central Social Insurance Medical Council, which took place on February 10, 2016 and with the explanation by the MHLW regarding the technical fee for treatment using HAL for Medical Use, which took place on April 25, 2016, the world’s first insurance reimbursement price for treatment with robots was decided.

Following this acquisition of approval for manufacture and distribution, a new classification of “Biosignal-responsive motor function improvement device” was established for HAL for Medical Use. For doctors to use such a novel medical device safely and effectively, the Company employed the supervision of medical professionals*1 whose specialty includes the treatment of the device’s target diseases*2 for the drafting and publication of this manual.

With the publication of this manual, medical institutions would be able to check if their facilities meet requirements for installation as well as whether they are using HAL for Medical Use appropriately, allowing for smoother implementation of the device.

<Publication link>
http://www.cyberdyne.jp/products/pdf/HT010911A-U01_R2.pdf

*1 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

*2 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

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