International expansion and market development in the human support industry

「タイにおいては、ＨＡＬ腰タイプを活用した介護予防プログラムの日本での成果等を踏まえ、2026年１月に保健省傘下の老年医学研究所との間でASEANにおける「サイバニクス医療健康イノベーション」の共同推進で合意しており、協業の準備を進めています。」

「In June 2026, the National Neuro-Robotics, Cybernics and Rehabilitation Center, one of the largest integrated medical facilities in Southeast Asia, officially opened. We signed a large-scale deployment agreement with PERKESO and have deployed 50 sets of HAL (65 units) at the facility. PERKESO has also formally announced plans to build a new center as the next project following this center, and we are in discussions regarding the deployment of HAL at the new center.」

「In Ukraine, the company received orders in November 2024 for cybernics products, including the HAL series, for the Ukraine Emergency Recovery and Reconstruction Project implemented by the Japan International Cooperation Agency (JICA), and completed installation at medical facilities in Kyiv, the capital of Ukraine. In addition, the company was selected in October 2025 for a public tender under the Ministry of Economy, Trade and Industry's Ukraine Reconstruction Support and Strengthening Cooperation with Central and Eastern European Countries project, and in December 2025 for a public tender under the United Nations Industrial Development Organization (UNIDO)'s Green Industrial Recovery Project for Ukraine. The company is advancing initiatives to support the social reintegration of war-wounded people and the reconstruction of medical infrastructure.」

「In December 2024, the company signed a large-scale installation agreement with PERKESO for the National Neuro-Robotics, Cybernics and Rehabilitation Centre, one of Southeast Asia's largest integrated healthcare facilities, and completed installation of 50 sets of HAL (65 units) in August 2025.」

「In May 2024, the company held a high-level meeting at its headquarters with Malaysian government officials, including the Minister of Human Resources. The minister expressed an intention to install a large number of cybernics products, including 50 sets of HAL® (65 units), at the National Neuro-Robotics, Cybernics and Rehabilitation Centre, one of Southeast Asia's largest integrated healthcare facilities scheduled to begin operations at the end of 2024. Final contractual adjustments are currently under way.」

「In May 2024, the company obtained from the US FDA the world's first marketing approval for a small model of medical-use HAL® and approval to expand its indications to cerebral palsy, for patients aged 12 and older.」

「As a platform for healthcare services for individuals, the subsidiary RISEヘルスケアグループ (RHG) is expanding its locations in Southern California and entered Northern California in February 2023. As of 31 December 2023, it operated 28 locations, an increase of 12 from the time of acquisition. Combined services using the group's innovative medical technology based on HAL® are currently offered at 4 locations, with a phased transition to full-scale services beginning in January 2023. Cybernics-based treatment is gaining adoption in major countries. Following the introduction of the HAL® series in Turkey in the previous fiscal year, 25 HAL® series units were introduced in May 2023 at Coopselios, a major social cooperative specializing in healthcare and nursing services in Italy.」

「Cyber­nics-based treatment is gaining adoption in major countries. Following the introduction of the HAL® series in Turkey in the previous fiscal year, 25 HAL® series units were introduced in May 2023 at Coopselios, a major social cooperative specializing in healthcare and nursing services in Italy, with further additional installations planned. In Malaysia, business cooperation with the government-linked Social Security Organisation (SOCSO) has been further strengthened. Cybernics-based treatment using HAL® is expanding for SOCSO-insured individuals, with 109 HAL® units leased for consideration at 11 facilities as of the end of September 2023. Construction of the National Neuro-Robotics and Cybernics Centre, one of Southeast Asia's largest integrated healthcare facilities, is progressing, with completion scheduled for around the end of 2024, and a considerable number of HAL® units are also planned for installation.」

「As a platform for healthcare services for individuals, the subsidiary RISEヘルスケアグループ (RHG) is expanding its locations in Southern California and entered Northern California in February 2023. As of 30 June 2023, it operated 27 locations, an increase of 11 from the time of acquisition. Combined services using the group's innovative medical technology based on HAL® are currently offered at 4 locations, with a phased transition to full-scale services beginning in January 2023. Cybernics-based treatment is gaining adoption in major countries. Following the introduction of the HAL® series in Turkey in the previous fiscal year, 25 HAL® series units were introduced in May 2023 at Coopselios, a major social cooperative specializing in healthcare and nursing services in Italy.」

「The healthcare services subsidiary RISEヘルスケアグループ (RHG) operates 26 locations in Southern California, an increase of 10 from the time of acquisition, and plans to expand into Northern California. Combined services using the company's innovative medical technology based on HAL® are currently being trialled at 4 locations, with a phased transition to full-scale services beginning in January 2023.」

「Following the previous fiscal year, cybernics-based treatment is gaining adoption in major countries, with Turkey newly added this fiscal year. In Malaysia, cybernics-based treatment using HAL® for SOCSO-insured individuals continues to expand under the public employee social security program provided by the government-linked Social Security Organisation (SOCSO), the company's business partner, with 98 units leased for consideration at 10 facilities in the country as of the end of September 2022. SOCSO also began construction in June 2022 of the National Neuro-Robotics and Cybernics Centre, Southeast Asia's largest integrated healthcare facility, with completion scheduled for around the end of 2024.」

「The healthcare services subsidiary RISEヘルスケアグループ (RHG) is expanding beyond its current 20 locations, an increase of 4 since the beginning of the year, while conducting trials of combined services using the group's innovative medical technology. In February 2022, the company established CYBERDYNE MALAYSIA as an operating base for APAC and is accelerating the further adoption of cybernics-based treatment. Cybernics-based treatment has also begun at Singapore General Hospital, the largest hospital in Singapore.」

「In the United States, medical-use HAL® lower-limb type received FDA medical device approval for stroke and neuromuscular disorders in October 2020, and the medical-use HAL® single-joint type was registered as a medical device in August 2021. In December 2021, the company acquired RISEフィジカルセラピー, which has 16 locations in Southern California, and is advancing the rollout of its healthcare services business in the United States using its innovative medical technology.」

「In EMEA, meaning Europe and the Middle East, several large projects are under way following new implementations in Spain and France. In the United States, medical-use HAL® lower-limb type received FDA medical device approval for stroke and neuromuscular disorders in October 2020, and the medical-use HAL® single-joint type was registered as a medical device in August 2021. Against this backdrop, the company reached a basic agreement in November 2021 to acquire RISEフィジカルセラピー, which has 16 locations in Southern California, and is advancing initiatives to enter the US healthcare services business through the group.」

「In EMEA, meaning Europe and the Middle East, several large projects are under way following new implementations in Spain and France. In the United States, after obtaining FDA medical device approval for stroke and neuromuscular disorders in October last year, the company is advancing initiatives to promote the adoption of covered and non-covered healthcare services. In major APAC countries, following the medical device approvals and certifications obtained for a broad range of indications in the previous fiscal year, the company will accelerate the further adoption of cybernics-based treatment.」

「Following Malaysia, Thailand and Indonesia, medical device approvals and certifications were obtained in Taiwan, for spinal cord injury only, Australia, Singapore and Turkey for a broad range of indications, including stroke, spinal cord injury and neuromuscular disorders.」

「Following Malaysia, Thailand and Indonesia, medical device approvals have been obtained in Taiwan, for spinal cord injury only, and Australia for a broad range of indications, including stroke, spinal cord injury and neuromuscular disorders. Reviews for medical device approval are also under way in Singapore, Turkey and other markets. In October 2020, the US FDA approved expanded indications for medical-use HAL®, adding stroke and neuromuscular disorders to the existing spinal cord injury indication.」

「Medical device approvals were obtained in Malaysia in October 2019 and in Thailand and Indonesia in April 2020, covering a broad range of indications, including stroke, spinal cord injury, and neuromuscular disorders, as in the EU. Reviews for medical device approval are also under way in Taiwan, Singapore, Turkey and other markets.」

「In October 2019, the company held the first international medical HAL forum in Italy, and in the same month medical HAL® was introduced at Centro Giusti, the second facility in Italy to adopt the product.」

「In October 2019, the company obtained approval in Malaysia. Approval review is currently under way in Thailand, and procedures for filing an approval application have also begun in Taiwan.」

「In APAC (Asia-Pacific), the SOCSO Rehabilitation Center, a medical facility operated by Malaysia's government Social Security Organisation, began operating a total of 24 units of medical HAL® and other HAL® models, including single-joint and lumbar types, in November 2018, and opened the Neuro-Robotics Rehabilitation and Cybernics Center in May 2019. With the cooperation of the Malaysian government and government agencies, the Group is promoting sales of HAL in Asia. In the Philippines, 12 lower-limb HAL® units were introduced at A. Zarate General Hospital in March 2019, and sales activities are under way for other medical institutions. In Thailand, Southeast Asia's largest medical market, medical device approval review is under way, and introduction at several medical institutions has already been informally decided.」

「Introduction is also progressing at medical institutions in the APAC (Asia-Pacific) region. Following the start of operations in November 2018 of 24 units of medical HAL® and other HAL® models, including single-joint and lumbar types, at the SOCSO Rehabilitation Center, a medical facility operated by Malaysia's government Social Security Organisation, operations began in April 2019 at A. Zarate General Hospital in the Philippines with 12 lower-limb units. In Thailand, Southeast Asia's largest medical market, the Thai FDA's medical device approval review is also under way.」

「In Europe, the company continues to operate its treatment services business in Germany and is pursuing various initiatives to extend coverage from public workers' compensation insurance to public health insurance. From a sales perspective, following its introduction at a Polish medical institution in 2017, introduction at the San Girolamo Center, an Italian medical institution specializing in treatment research for neurological diseases, was completed in November 2018. Outside Europe and the United States, discussions are progressing toward introduction at medical institutions in the APAC (Asia-Pacific) region, following the introduction in Saudi Arabia in 2017. In November 2018, the SOCSO Rehabilitation Center, a medical facility operated by Malaysia's government Social Security Organisation, introduced and began operating a total of 24 units of medical HAL® and other HAL® models, including single-joint and lumbar types, the largest number at a single medical institution.」

「From a sales perspective, following the introduction at a Polish medical institution in 2017, the company decided in November 2018 to introduce HAL® at the San Girolamo Center, an Italian medical institution specializing in treatment research for neurological diseases. In October 2018, the SOCSO Rehabilitation Center, a medical facility operated by Malaysia's government Social Security Organisation, decided to introduce a total of 24 units of medical HAL® and other HAL® models, including single-joint and lumbar types. This was the largest number of units introduced at a single medical institution.」

「Outside Germany, medical HAL® has already been introduced at a medical institution in Poland, and discussions are also progressing toward introduction in other EU countries. In the United States, the company obtained FDA (US Food and Drug Administration) marketing approval as a medical device in December 2017, established the joint venture CYBERDYNE & BROOKS, Inc. with Brooks Rehabilitation, one of the leading rehabilitation healthcare groups in the United States, and in March 2018 established the BROOKS CYBERNIC TREATMENT CENTER in Jacksonville, Florida. It began treatment services using medical HAL® and promotional activities throughout the United States, the world's largest medical market. The approval clearly specified that the intended use was to improve patients' walking function itself through treatment with medical HAL®, recognizing its medical therapeutic effect, and the company is holding discussions toward coverage by private workers' compensation insurance and other insurance schemes.」

「Following this approval, the company established the joint venture CYBERDYNE & BROOKS, Inc. with Brooks Rehabilitation, one of the leading rehabilitation healthcare groups in the United States. In March 2018, it established the BROOKS CYBERNIC TREATMENT CENTER in Jacksonville, Florida, began treatment services using medical HAL® and launched promotional activities throughout the United States, the world's largest medical market.」

「In the United States, the company obtained FDA marketing approval as a medical device in December 2017. The approval clearly specified that the intended use was to improve walking function following treatment with medical HAL®, recognizing its medical therapeutic effect. Following this approval, the company is preparing to establish a joint venture with Brooks Rehabilitation, one of the leading rehabilitation healthcare groups in the United States. During the current fiscal year, it plans to establish a cybernics treatment center in Jacksonville, Florida, launch treatment services using medical HAL® and begin promotional activities throughout the United States, the world's largest medical market.」

「In Saudi Arabia, the company obtained marketing approval for medical HAL® from the Saudi Food and Drug Authority (SFDA) in August 2017, and in October 2017 shipped medical HAL® to Abdul Latif Jameel Hospital, a medical institution operated by its business partner, the Abdul Latif Jameel Group.」

「In Poland, private insurance coverage for cybernics treatment using medical HAL® began at a medical institution in July 2017. This was the first case in which a medical institution using medical HAL® entered into an agreement with a private insurance company covering cybernics treatment.」

「In Europe, the company has already obtained medical device certification and operates a treatment services business in Germany. In Germany, treatment using medical HAL® is covered by public workers' compensation insurance, and the company is pursuing various initiatives to extend coverage to public health insurance. In the United States, based on the results of discussions with the FDA (US Food and Drug Administration), the company determined that the FDA had developed a deeper understanding of the innovative nature of functional improvement and functional regeneration treatment for the brain and nervous system using cybernics technology through medical HAL®. On 4 November 2016, it submitted a Pre-submission to the FDA and began procedures for resubmission, seeking approval in a form that would identify the device as a unique and innovative robotic treatment device.」

「In the United States, based on the results of discussions with the FDA (US Food and Drug Administration), the company determined that the FDA had developed a deeper understanding of the innovative nature of functional improvement and functional regeneration treatment for the brain and nervous system using cybernics technology through medical HAL®. On 4 November 2016, it submitted a Pre-submission to the FDA and began procedures for resubmission, seeking approval in a form that would identify the device as a unique and innovative robotic treatment device. In anticipation of FDA medical device approval, the company established CYBERDYNE USA Inc. and began business activities in September 2016.」

「During the second quarter of the current consolidated fiscal year, the company established CYBERDYNE USA Inc. in the United States as a strategic base for its US business and global expansion, in anticipation of FDA (US Food and Drug Administration) approval of medical HAL® as a medical device.」

「In Europe, the company has already obtained medical device certification and operates a treatment services business in Germany. In Germany, treatment using medical HAL® for the lower limbs is covered by public workers' compensation insurance. Seeking to extend coverage to public health insurance, on 27 October 2015 the company submitted an application to InEK (the Institute for the Hospital Remuneration System) concerning reimbursement for the treatment of patients with paraplegia during periods corresponding to the acute and recovery phases.」

「As a leading company in the human support industry, including the robotics and healthcare industries, that supports a healthy and long-lived society, the company is pursuing international business expansion and market development.」