EP Mediate Co., Ltd.

GNI Group Ltd. (Chuo-ku, Tokyo; Director, Representative Executive Officer, President and CEO: Ying Luo) and EPS Holdings Inc. (Shinjuku-ku, Tokyo; Representative Director: Hao Yan; hereinafter “EPSHD”) has signed an agreement to acquire 60% of the outstanding shares of Micren Healthcare Co., Ltd. (Headquarters: Shinjuku-ku, Tokyo; President and Representative Director: Michiharu Miyahara; “Micren Healthcare”) with EPSHD’s subsidiary, EP Mediate Co., Ltd. (Headquarters: Shinjuku-ku, Tokyo; President and Representative Director: Masanori Tanji; “EP Mediate”), who currently owns Micren Healthcare, and formed as a joint venture. Micren Healthcare holds a Type I Medical Device Marketing Authorization Holder license and provides professional and independent Designated Marketing Authorization Holder (DMAH) and In-Country Caretaker (ICC) for clinical trial services for medical devices. Micren Healthcare have handled novel medical devices, e.g., genetic testing sytem, SaMD with AI and deep learning technology which most often require clinical data in support of obtaining device approvals in Japan and have seen increase of foreign prospective clients. Medical device industry in the world is expected to expand in the future, especially in China and Asian market. Forming Micren Healthcare as a joint venture, it is a small but first significant step for GNI to establish an operating presence in Japan and we will strengthen the support system for introducing foreign medical device in Japan market with GNI’s strong presence in the US and China.

Micren Healthcare Co., Ltd., has been acquired by EP Mediate Co., Ltd., which is a subsidiary of the leading Japanese CRO, EPS Holdings, Inc. Micren Healthcare provides professional and independent Designated Marketing Authorization Holder (DMAH) and In-Country Caretaker (ICC) for clinical trial services for medical devices and holds a Type I Medical Device Marketing Authorization Holder license. “We have seen an increase in clients of novel medical devices including in genetic testing, SaMD with AI and deep learning technology which most often require clinical data in support of obtaining device approvals in Japan”, said Michiharu Miyahara, President of Micren Healthcare. “Combining EP Mediate and Micren Healthcare capabilities will allow for a broader service offering to our DMAH clients in particular in the area of clinical studies and investigation.”. EP Mediate provides CRO services, including clinical studies and investigation, post-market clinical studies and regulatory consulting to predominantly Japanese medical device companies and subsidiaries of foreign medical device companies located in Japan.　“With the acquisition of Micren Healthcare we will bring in more in-depth expertise and experience working with international companies and will increase our inhouse global regulatory capabilities by offering assistance with clinical investigation, regulatory device submissions, insurance reimbursement strategy and submission, and post approval services such as importation, release judgment, vigilance works and reporting.” said Masanori Tanji, President and Representative Director of EP Mediate. The stock purchase agreement was made on June 18, 2021 and the completions of this acquisition has been set for June 30, 2021.