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PRESS RELEASE

2022-08-17 updated

【News】 Capital and business alliance with Hirosaki Lifescience Innovation, Inc., developer of regenerative medicine products using autologous cell culture

CYBERDYNE Inc. (Tsukuba, Ibaraki, Japan, President & CEO: Yoshiyuki Sankai; from now on, referred to as the “Company”) and Hirosaki Lifescience Innovation, Inc. (Hirosaki, Aomori, Japan, President & CEO: Yoichiro Machida; from now on referred to as “Hirosaki LI”) a bio-venture company that develops regenerative medicine products using autologous cell culture based on advanced cell culture and collagen processing technologies, announced to form a capital and business alliance (CYBERDYNE’s investment in Hirosaki LI). Furthermore, the Cybernics Excellence Japan Fund 1 Investment Limited Partnership (CEJ Fund), operated by the Company’s subsidiary, will also invest in Hirosaki LI.

(1) Human (autologous) oral mucosa-derived epithelial cell sheet “Sacracy” using human amniotic membrane substrate
Sacracy, developed by Hirosaki LI, received manufacturing and marketing approval on January 20, 2022*1 as a regenerative medicine product for reducing ocular surface adhesions in corneal epithelial stem cell exhaustion and is scheduled to be covered by Japanese insurance on September 1, 2022*2. This is the first and only case in which an independent, unlisted company not part of a domestic or international group of listed companies has successfully obtained approval for a regenerative medicine product.

(2) Autologous chondrocyte processed products (development name: IK-01)
IK-01, developed by Hirosaki LI, is a regenerative medicine product that uses a patient’s autologous cartilage cells to repair damaged cartilage in the knee joint by transplanting them into the patient’s damaged area after manufacturing at a culture facility. Hirosaki LI is currently conducting a Phase 3 validation study in traumatic cartilage injury and is preparing for an additional Phase 2 study in osteoarthritis of the knee.

Through this alliance, the Company aims to provide a curative treatment for knee osteoarthritis patients by combining the IK-01 developed by Hirosaki LI with CYBERDYNE’s Wearable Cyborg HAL. In addition, in preparation for future demand from the expanded application of IK-01 to osteoarthritis of the knee by Hirosaki LI, the Company will support the realization of a stable supply system for IK-01 using our automated cell culture technology at the Cybernics Medical Innovation Base that is being established in Tonomachi King Sky Front in Kawasaki City, Japan.

(Comment from CYBERDYNE CEO Yoshiyuki Sankai)
Osteoarthritis of the knee requires artificial joints in many patients as symptoms progress. We believe that combining HAL and regenerative medicine for osteoarthritis of the knee will create a combined treatment method of HAL and regenerative medicine for osteoarthritis of the knee, which can be deployed as a new treatment method in Japan and abroad. Through this alliance, we will also fully utilize our “Cybernics Medical Innovation Base Building A,” located at the King Skyfront (Kawasaki City). Together, we will advance to a new stage in the development and manufacture of regenerative medicine products.
We look forward to future business development.

■ News release by Hirosaki Lifescience Innovation, Inc. (available in Japanese only)
https://prtimes.jp/main/html/rd/p/000000001.000106391.html

Reference link from the website of Hirosaki Lifescience Innovation, Inc.
*1 Obtained manufacturing and marketing approval (Jan 20, 2022) (only in Japanese)
http://hirosaki-li.co.jp/newspdf/news20220120.pdf
*2 Listed on public health insurance (Aug 4, 2022) (only in Japanese)
http://hirosaki-li.co.jp/newspdf/news20220804.pdf

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