PRESS RELEASE

2016.09.30 update

【News】Commencement of investigator-initiated clinical trial of stroke patients using HAL® for Medical Use (Single-Leg Model) ~Step towards the medical device approval and expansion of Cybernic treatment~

The double-leg model of HAL® for Medical Use already obtained the manufacturing and distribution approval under Japan’s Pharmaceutical and Medical Device Law (“PMDL”) as a medical device for neuromuscular disease patients (see our news on November 25, 2015). From September 30, an investigator-initiated clinical trial of the single-leg model of HAL® for Medical Use as a medical device for stroke patients to recover walking ability commenced to take necessary procedures to obtain the manufacturing and distribution approval under PMDL in the University of Tsukuba Hospital and the Ibaraki Prefectural University of Health Sciences Hospital.

Today, the both university hospitals made announcements, which could be found in the following links.

(Links: In Japanese only)
News release by University of Tsukuba Hospital
News release by Ibaraki Prefectural University of Health Sciences Hospital

Excerpts from the press release
[This is an only trial translation of external organizations’ press release, done by CYBERDYNE INC. (“the Company”). The Company is not responsible for the content of it.]

September 30, 2016

University of Tsukuba Hospital
 Prefectural University of Health Sciences Hospital

Start of investigator-initiated clinical trial of HAL® for Medical Use (Single-Leg Model) aiming at recovery of walking ability of stroke patients

~Step towards the medical device approval and new dimension of Cybernics treatment~

University of Tsukuba Hospital as well as Ibaraki Prefectural University of Health Sciences Hospital commenced their investigator-initiated clinical trial for Single-Leg Model of HAL® for Medical Use*1, in order to acquire manufacturing and distribution approval as a medical device built for the purpose of recovering walking ability of stroke patients. 

Together with CYBERDYNE, INC., the two university hospitals have been conducting clinical researches to explore new treatment method for stroke patients with gait disorder since 2013. Based on the accumulated research results, this new clinical trial, aims at obtaining manufacturing and distribution approval for HAL® for Medical Use (Single-Leg Model, clinical trial identification code “HAL-TS01”). This clinical trial is supported by the Japan Agency for Medical Research and Development (AMED) and Advanced Research & Development Programs for Medical Innovation. University of Tsukuba Hospital will lead the clinical trial and it will be conducted in 7 facilities including Ibaraki Prefectural University of Health Sciences Hospital. 

Backgrounds

There are number of treatment methods tried on stroke patients to recover their walking ability. However, depending on the level of their disorder, there are limits on recovery of their walking ability. This makes it difficult for considerable population of those patients to return to the society. Our clinical research found out that HAL® for Medical Use may enable those patients to recover walking ability beyond the limit of other treatment methods (a submitted essay which covers this finding has already been accepted). 

This clinical trial will investigate how much further the treatment conducted by HAL® for Medical Use (Single-Leg Model) can add to the recovery of walking ability with other treatment methods. Institutional Review Board of University of Tsukuba Hospital approved this initiative to conduct the clinical trial and clinical trial plan was submitted to the Pharmaceutical and Medical Devices Agency (“PMDA”) in August 31, 2016. 

HAL for Medical Use (Double-Leg Model) has already obtained the manufacturing and distribution approval under Japan’s Pharmaceutical and Medical Device Law (“PMDL”) as a innovative medical device to delay the progress of slowly progressive neuromuscular disease patients such as Amyotrophic Lateral Sclerosis and Muscular Dystrophy. “Stroke”, the targeted disease for this clinical trial is known to be a disease with vast numbers of 1,179 thousand patients and the medical fee required to treat these patients is said to be JPY 1 trillion and 773 billion, fee large enough to compress the national medical budget. It is also known to be the number 1 cause of paraplegic aftereffects, forcing patients to use care support. If we succeed on realizing Cybernic treatment for stroke patients, utilizing HAL for Medical Use, introduction of these robotic treatment devices to medical facilities is anticipated to accelerate, making contribution to solve one of the social problem that this country faces. 

Explanation of terminology

*1 HAL for Medical Use ® (Hybrid Assistive Limb ®)
Innovative Cyborg-type robotic treatment device developed by Dr. Yoshiyuki Sankai, professor at the Graduate School of Systems and Information Engineering, University of Tsukuba as well as Director at the Center for Cybernics Research, University of Tsukuba. This device uses faint bio-electrical signals (BES), a signal generated when the brain initiates a movement, to control and using this, HAL improves and regenerates the physical functions. Basic research of HAL was conducted in University of Tsukuba and developed and distributed as a medical device by CYBERDYNE, INC. Joint-research between University of Tsukuba and CYBERDYNE, INC. remains to be active. In this clinical trial, Single-Leg Model (trial indication code “HAL-TS01”), another variation of the HAL for Medical Use (Double-Leg Model) that obtained the medical approval as medical device for delaying the progress of the slowly progressive neuromuscular disease will be used. 

*2 Investigator-initiated clinical trial
Clinical trial led by a doctor in charge of investigation and it is often conducted by the two following reasons.
a: if the product is intended for rare diseases and it is thought to be difficult for companies to develop
b: when researchers such as doctors intends to make their research project into practical application.
In this case, it is because of the second reason.

*3 Cybernic treatment
Innovative function improvement, regeneration treatment utilizing a new academic field of  “Cybernics: the fusion and combination of humans, machines and information systems” 

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