【News】US FDA posted the details of the clearance on its database

As it was announced in the news release of October 6, 2020, the Company obtained additional clearance on its product, HAL for Medical Use Lower Limb Type from the U.S. Food and Drug Administration (“FDA”) on October 2, 2020 (US timezone) to expand the coverage to treatment of stroke and neuromuscular disease. FDA published the detail of the clearance on its database, as stated below.

Database of FDA : 510(k) Premarket Notification
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201559

*excerpts on the medical effect of Medical HAL

1) Stroke：
Once gait function ceased to improve from conventional rehabilitation, subjects started the comparative intervention, and results after a 5 week treatment program (5 sessions per week) were compared to show significant differences between the two groups. The group that used the HAL showed great additional improvement (greater than the MCID) whereas the group that continued conventional gait rehabilitation did not show much change. The results of the control group indirectly proves that the criteria used to identify the “end” of natural recovery & rehabilitation was valid, which in turn suggests that the treatment with HAL provides additional improvements for patients in this population.

２）Neuromuscular disease：
Patients with progressive neuromuscular disease are not the typical population to use this type of medical device. However a GCP clinical trial and post market survey in Japan shows temporary effects for this population. Although the speed of disease progression greatly depends on the type of disease and the progression phase, as a group, treatment with the HAL helped patients maintain their physical function (distance walked in 2 minutes) above the baseline level before starting treatment for over 1.5 years. Also noteworthy was the finding that CK (Creatine Kinase) levels did not elevate after treatment and instead showed a slight tendency to decrease, which suggests that treatment with HAL does not lead to overuse or excessively burden the muscles when used for patients in this population.

Link）news release on October 6, 2020
https://www.cyberdyne.jp/english/company/PressReleases_detail.html?id=9822