Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura) and MELTIN MMI (Head Office: Chuo-ku, Tokyo, Japan; CEO: Mark Kasuya; hereinafter “MELTIN”) announced today that they have concluded an agreement regarding marketing alliance in Japan for the MELTz® Hand Rehabilitation System (hereafter “MELTz®”; generic name: active extension / bending and stretching rotation exercise equipment), which the two companies jointly developed and for which MELTIN has obtained medical device certification as manufacturer and distributor.
Receiving exclusive supplies of MELTz® from MELTIN, Sumitomo Pharma will begin marketing MELTz® to mainly rehabilitation wards for convalescent period patients in September 30, 2022 as the company’s first frontier business product.
MELTz® is a medical device that takes advantage of bio-signal processing and biomimetic robot technology. Its intended use is to maintain, develop, or restore muscle strength in the upper limbs of patients undergoing rehabilitation of hand/finger paralysis due to stroke or other causes. This device is designed to support rehabilitation of hand/finger motor function by connecting algorithms that recognize hand/finger movement signals from myoelectricity (bio-signals) with a robot system that provides motor assistance according to the intended movements of the user. MELTz® has the following features.
<Features of MELTz®>
|General name||Active extension / bending and stretching rotation exercise equipment|
|Commercial name||MELTz® Hand Rehabilitation System|
|Classification||Class II controlled medical device (controlled medical device requiring special maintenance)|
|Medical device certification No.||304AIBZX00014000|
|Purpose of use, indications||To be used to maintain, develop, or restore muscle strength in upper limbs|
|Classification of medical devices for specified medical fee calculation||Device to increase the amount of physical activity|
|Launch date||September 30, 2022|
|Manufacturer/distributor||MELTIN MMI Co., Ltd.|
|Distributor||Sumitomo Pharma Co., Ltd.|
Sumitomo Pharma will provide information to medical institutions, etc. and supply MELTz® to them through Kuribara Medical Instruments and others as the distribution and marketing agents in the market.
Sumitomo Pharma and MELTIN plan to conduct clinical researches using MELTz® and make improvements to the device based on evidence obtained from the studies. In the future, the partners will conduct clinical studies using an improved product, aiming to obtain approval for new or improved medical devices.
About Development of MELTz® Hand Rehabilitation System (MELTz®)
Sumitomo Pharma and MELTIN signed in 2018 a joint research and development agreement for medical devices using MELTIN’s excellent bio-signal processing and robotics. The two companies have since been engaged in the development of neurorehabilitation devices. MELTIN applied for approval of MELTz® as an active extension / bending and stretching rotation exercise equipment (generic name) in February 2022 and obtained medical device certification in May of the same year. Subsequently in July 2022, MELTz® was covered by insurance as a device to increase the amount of physical activity.
About Medical Device Certification
For manufacturing/marketing highly controlled medical devices and controlled medical devices designated by the Minister of Health, Labor and Welfare based on its standards, such products need to obtain certification (third-party certification) by item from organizations registered with the Minister of Health, Labor and Welfare (third-party certification bodies).
About Sumitomo Pharma
Sumitomo Pharma defines its corporate mission as “To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide.” By channeling our efforts into the research and development of new drugs, Sumitomo Pharma aims to realize our corporate mission and provide innovative and effective pharmaceutical solutions not only to people in Japan but also around the world. Sumitomo Pharma’s goal is to create innovative pharmaceutical products in the research focus areas with high unmet medical needs of Psychiatry & Neurology, Oncology, and Regenerative Medicine / Cell Therapy. In business fields other than pharmaceuticals, too, Sumitomo Pharma is working on research and development and commercialization of innovative healthcare solutions under the framework of a frontier business, which goes beyond the traditional boundaries of a pharmaceutical company, with the aim of contributing to “wide-ranging well-being.” For more information, please visit https://www.sumitomo-pharma.com.
MELTIN is a venture company that utilizes the two core technologies of proprietary bio-signal processing and bio-inspired robotics in order to realize cyborg technology that can maximize human creativity by implementing medical devices and avatars in society.
Kasuya, CEO of MELTIN, states, “the MELTz® to be marketed this time is the first practical product that uses cyborg technology. We hope it will become a new rehabilitation option for patients. We would like to continue to grow so that we can realize a society where cyborg technology will provide all individuals, regardless of age or physical ability, with options to live their lives to the full without feeling any inconvenience.” For more information, please visit https://www.meltin.jp/en/.
About Kuribara Medical Instruments Corporation
Kuribara Medical Instruments Corporation is a comprehensive medical equipment wholesale company that operates mainly in the Kanto and Shinetsu areas with the management philosophy of “Contributing local medicine.”
Pursuing the satisfaction of healthcare providers, we aim to contribute to the advancement of medical care and nursing care qualities and improving the QOL by stable supply of medical equipment and services to medical institutions.
Sumitomo Pharma Co., Ltd.
TEL: +81-6-6203-1407 (Osaka); +81-3-5205-3725 (Tokyo)
MELTIN MMI Co., Ltd.
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