[News] HAL for Medical Use’s Pre-Submission as a medical device that provides the unique innovative Cybernic treatment submitted to the US FDA ~ Continued discussions with the FDA has led to a deeper understanding of the HAL for Medical Use, and the process toward medical device approval of this innovative treatment device that is unlike any other has begun ~

CYBERDYNE,INC. (the “Company”) has found that the United States Food and Drug Administration’s (“FDA”) understanding of HAL for Medical Use’s*1 (“Medical HAL”) innovation to use Cybernic technology to provide functional improvement/regeneration treatment of the brain and nervous system has deepened as a result of continued discussions, and the Company has begun its reapplication process toward obtaining medical device approval in a format that allows for Medical HAL to be identified as a new and unique robot treatment device.

Until now, the Company had proceeded with the 510(k) application process with the FDA (submitted on June 22, 2015 EST) for the Medical HAL’s approval as a Class II medical device. Though Medical HAL’s purpose is to provide treatment for functional improvement and regeneration through active and voluntary movement using signals from the brain and nervous system, for reasons that include the fact that it is a device worn on the lower limbs, Medical HAL was being reviewed at the FDA under the same medical device category as other powered orthoses that have fundamentally different purposes of use, such as the passive transportation of patients.

However, anticipating the business developments after obtaining medical device approval in the US, the Company has continued to clarify and explain the uniqueness of Medical HAL’s innovations (the robotic treatment device attempts to actively improve and regenerate nerve connectivity by detecting and processing signals that carry the users intent to move from the brain and nervous system to the muscles (Bio-Electrical Signals), and feeding back somatosensory and proprioceptive information through voluntary movements realized by Medical HAL’s assistance from the peripherals to the Central Nervous System) to the FDA. The Company is confident that the FDA’s understanding of the uniqueness of the device has deepened, and on November 4, 2016 EST, the Company has submitted a Pre-Submission*2 to start its process toward obtaining medical device approval in a format that allows for Medical HAL to be identified as a new robot treatment device unlike any other.

As of November 2016, Medical HAL is certified and approved as a medical device in Japan and Europe. The treatment is covered by public worker’s compensation insurance in Germany, public health insurance in Japan, and the device is used in medical facilities across Japan and Europe. Furthermore, in Germany the process for approval for coverage by public health insurance is underway, and in Japan, clinical trials to expand target diseases, clinical trials for medical device approval of the single-leg version for treatment of stroke patients, and clinical research on new medical technologies involving the device’s combined use with regenerative medicine and/or pharmaceuticals have begun. In addition, because Medical HAL is able to collect and evaluate information of both the brain/nervous system and the musculoskeletal system while treating the patient, its potential to become a new medical technology platform is highly promising.

【*1 HAL for Medical Use】
In 2013, HAL for Medical Use obtained conformity certification (CE marking) from a European accreditation organization (Notified Body) and became the first robotic treatment device for patients suffering from brain, nerve and muscular diseases. In Germany, patients are able to claim the entire fee for treatment of spinal cord injuries using HAL for Medical Use with public workers’ compensation insurance. In Japan, an investigator-led clinical trial for the treatment of slowly progressing rare neuromuscular diseases (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 and Muscular Dystrophy) using HAL for Medical Use was conducted, leading to the manufacturing and distribution approval as a new medical device under the Pharmaceuticals and Medical Devices Act of Japan in November 2011 and the determination of public medical insurance pricing in April 2016.

【Features of HAL for Medical Use】
The cyborg-type robot, HAL is an innovative Cybernic System developed for the purpose of regenerating and improving patients’ brain-neuro-physical functions especially in the medical field. HAL is equipped with the Cybernic Treatment Control System, which includes the Cybernic Voluntary Control, a function based on the patient’s bio-electrical signals derived from the brain and nervous system that reflect the patient’s intended movement; the Cybernic Autonomous Control, a function based on processing information on the wearer’s movement such as posture and balance by artificial intelligence; the Cybernic Impedance Control, a function that adjusts to the wearer’s individual characteristics; and a Cybernic Hybrid Control System, which combines all three of these functions.

When a wearer intends to move their body, various signals are sent from the brain to the muscles through the nervous system, and these signals leak onto the skin surface as bio-electric signals (“BES”). By using this BES, HAL for Medical Use is able to realize the wearer’s intended movement, and simultaneously feedback somatosensory and proprioceptive signals to the brain through this voluntary movement. By acting as the bridge between the brain and nervous system and the body, HAL for Medical Use establishes an interactive Bio Feedback (iBF) system, promoting the brain and nervous system to adapt and relearn, leading to the improvement and regeneration of physical functions.

【*2 Pre-Submission】
A Pre-Submission is defined as a formal written request from an applicant/sponsor for feedback from FDA to be provided in the form of a formal written response or, if the manufacturer chooses, a meeting or teleconference in which the feedback is documented in meeting minutes. A Pre-Submission is appropriate when FDA’s feedback on specific questions is necessary.