【News】HAL Lower Limb Type obtained medical device approval for Taiwan

CYBERDYNE Inc. [Tsukuba, Ibaraki, CEO: Yoshiyuki Sankai (the “Company”)] obtained a medical device approval for HAL for Medical Use Lower Limb Type (“Medical HAL”, a device designed to induce improvement of the physical function of the wearer from the Taiwan Food and Drugs Administration (TFDA). In addition to Japan, the U.S. and the EU, the Company is promoting the development of Medical HAL in the Asia Pacific (APAC) region, receiving approvals in Malaysia, Thailand, Indonesia and recently in Australia (announced on October 15th).

Following the TFDA approval on this occasion, the Company will work with its partner, CHC Healthcare Group (承業生醫企業集團), a major medical device trading company in Taiwan, to start Cybernics Treatment in the groups hospital called Yee Zen General Hospital. The groups subsidiary, Chiu Ho Medical System Company(久和醫療儀器公司) will act as the Company’s agent to conduct sales activity of HAL in Taiwan.

Yee Zen General Hospital(怡仁綜合醫院)

Cybernics Treatment Center

From October 2019, The Company announced the coordination with CHC Group and started to operate HAL Lumbar Type for Well-being from November 2019 while making application to TFDA for Medical HAL. The TFDA approval on this occasion is only for spinal cord injury. However, as the Company succeeded on expanding the US FDA approval on October 2, the Company is working to expand the covered disease with the TFDA towards wide range of other disease such as stroke and progressive neuromuscular diseases as soon as possible.

The Company plans to coordinate with its partners in Taiwan to offer Cybernics Treatment, an innovative medical technology originated in Japan, to Taiwan with the aim of realizing a healthy and longevity society in which all people can enjoy healthy and prosperous lives.

*CHC Group
CHC Healthcare Group was established in 1977 and the group has grown into a holding company of 20 subsidiaries around Taiwan and surrounding region (stock code in the Taiwanese Stock Exchange: 4164). As a major trading company of medical device, CHC Healthcare Group handles variety of medical technology from diagnostic imaging to products for neuroscience. CHC Healthcare Group operates Yee Zen General Hospital as an international institute to educate personnel with cutting-edge medical technologies. The hospital known to be the base in Taiwan for training Taiwanese medical professionals and enhancing quality of medical services.

Link)
October 28, 2019 HAL is now available in Taiwan
https://www.cyberdyne.jp/wp_uploads/2019/10/20191014_PR_Taiwan_Eng1.pdf

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