Domestic and international clinical trials to expand the indications

「For stroke, based on the results of the investigator-initiated clinical trial of the medical HAL lower-limb type (single-leg model), the latest patient profiles and clinical needs, we are preparing to submit notification of a clinical trial for a new medical HAL lower-limb model (two-leg model). For the HAL lumbar type, favorable results were obtained in a pilot study showing improved motor function in patients with Parkinson’s disease, and we are preparing to conduct a clinical trial to obtain medical device approval.」

「For stroke, the company is preparing for a clinical trial using a new dual-leg model, based on the results of the physician-initiated clinical trial of the medical-use HAL Lower Limb Type (single-leg model), the HIT2016 trial, and current clinical needs.」

「For stroke, based on the results of the physician-initiated clinical trial of the medical-use HAL® Lower Limb Type (single-leg model), the HIT2016 trial, the company is preparing, in consultation with the authorities, to conduct an additional clinical trial addressing current patient profiles and clinical needs. In addition, since January 2022, a physician-initiated clinical trial aimed at improving gross motor function in pediatric patients presenting with motor and postural impairments associated with cerebral palsy and other conditions has been conducted mainly at the University of Tsukuba Hospital.」

「In May 2024, the company obtained, ahead of any other country, marketing approval from the U.S. Food and Drug Administration (FDA) for the smaller model of the medical-use HAL® and approval to expand its indication to cerebral palsy in patients aged 12 and older. Approval of the smaller model as a medical device enables treatment with the medical-use HAL® for patients measuring 100 cm to 150 cm in height, for whom use of the existing model, intended for patients at least 150 cm tall, had been difficult.」

「For spinal cord diseases, the company obtained approval in October 2022 to add two indications, viral HTLV-1-associated myelopathy (HAM) and hereditary spastic paraplegia, and in October 2023 the Ministry of Health, Labour and Welfare issued notification of insurance coverage. For spinal cord injury, a traumatic spinal cord disease, the company is discussing with the authorities an application to add the indication. For stroke, based on the results of the physician-initiated clinical trial of the medical-use HAL® Lower Limb Type (single-leg model), the HIT2016 trial, the company is preparing, in consultation with the authorities, to conduct an additional clinical trial addressing current patient profiles and clinical needs. A physician-initiated clinical trial aimed at improving gross motor function in pediatric patients presenting with motor and postural impairments associated with cerebral palsy and other conditions has been underway mainly at the University of Tsukuba Hospital since January 2022. In addition, the company developed a product equivalent to the trial device as a smaller model of the medical-use HAL® for shorter patients and, in June 2023, submitted an application to PMDA (Pharmaceuticals and Medical Devices Agency) for marketing approval as a medical device for the already approved indications.」

「For spinal cord injury, a traumatic spinal cord disease, the company is discussing with the authorities an application to add the indication.」

「For stroke, the company is considering conducting an additional clinical trial to address current patient profiles and clinical needs, based on discussions with the authorities regarding the clinical significance and statistical significance of differences in the primary endpoint in the physician-initiated clinical trial of the medical-use HAL® Lower Limb Type (single-leg model), the HIT2016 trial. In addition, the company developed a product equivalent to the trial device as a smaller model of the medical-use HAL® for shorter patients and, in June 2023, submitted an application to PMDA (Pharmaceuticals and Medical Devices Agency) for marketing approval as a medical device for the already approved indications.」

「In addition, since January 2022, a physician-initiated clinical trial has been underway, mainly at the University of Tsukuba Hospital, to improve gross motor function in pediatric patients presenting with motor and postural impairments associated with cerebral palsy and other conditions.」

「On 27 October 2022, approval was granted to add HTLV-1-associated myelopathy (HAM) and hereditary spastic paraplegia to the already approved 8 progressive neuromuscular intractable diseases. The Company will proceed with the procedures related to coverage under the medical fee reimbursement system.」

「For the investigator-initiated clinical trial of the medical HAL® lower-limb type single-leg model in stroke patients with hemiplegia, the Company is consulting with the authorities, together with the trial coordinating physician and statistical experts, regarding the clinical significance, considered the most important evaluation point of this trial, and the statistical significance of the primary endpoint. The Company believes that the results of the efficacy and safety evaluations from this trial will also provide useful data for applications for health insurance coverage for stroke patients in other countries.」

「In January 2022, an investigator-initiated clinical trial began, centered on Tsukuba University Hospital, to improve gross motor function in children with motor and postural disorders associated with pediatric cerebral palsy and other conditions.」

「For the investigator-initiated clinical trial seeking medical device approval for the medical HAL® lower-limb type single-leg model to improve motor function, including walking ability, in stroke patients with hemiplegia, the Company will consult with the authorities (PMDA) based on the analysis of the trial data and proceed with preparations for a marketing authorization application.」

「The investigator-initiated clinical trial to expand the indication of medical HAL® lower-limb type to stroke patients in Japan was completed in December 2020. Based on the trial results, the Company plans to file a medical device application to expand the indication.」

「For medical HAL® lower-limb type, an investigator-initiated clinical trial has been under way since September 2016 to expand the indication to approximately 8 million stroke patients in Japan and the United States. The number of participants has already reached the target number of cases, and the trial is scheduled for completion in December 2020.」

「For medical HAL® lower-limb type, an investigator-initiated clinical trial is under way to expand the indication to approximately 8 million stroke patients in Japan and the United States and is scheduled for completion by December 2020.」

「For stroke, an investigator-initiated clinical trial for medical device approval using the medical HAL® lower-limb type single-leg model has been under way since September 2016 and is scheduled for completion in December 2020.」

「For the medical HAL® lower-limb type, a multicenter investigator-initiated clinical trial of the HAL® medical lower-limb single-leg model is under way to expand the indication to approximately 8 million stroke patients in Japan and the United States, with completion expected around the middle of fiscal 2020.」

「In Saudi Arabia, where the product was introduced in 2017, clinical trials for patients with spinal cord injuries were completed at multiple public medical institutions, including the country's largest hospital, under the leadership of the Saudi Ministry of Health (MOH) beginning in March 2019. The clinical results showed substantial improvements in patients' walking ability.」

「For the medical HAL® lower-limb type, a multicenter investigator-initiated clinical trial of the medical HAL® lower-limb single-leg model is under way at 15 medical institutions in Japan to expand the indication to approximately 8 million stroke patients in Japan and the United States, and is expected to be completed in the first half of fiscal 2020.」

「To expand the indication to approximately 8 million stroke patients in Japan and the United States, a multicenter investigator-initiated clinical trial of the medical HAL® lower-limb single-leg model is under way at 15 medical institutions in Japan and is expected to be completed during the current fiscal year.」

「To expand the indication to approximately 8 million stroke patients in Japan and the United States, a multicenter investigator-initiated clinical trial of the medical HAL® lower-limb single-leg model is under way at 15 medical institutions in Japan. To expand the applicable height range, the Company is developing a 2S size and holding discussions with PMDA toward medical device approval. In addition, preparations are under way for an investigator-initiated clinical trial of the ultra-lightweight and compact HAL® single-joint type, which supports the elbow and knee joints, for the treatment of acute-phase stroke, with Kyoto University Hospital serving as the lead research and development institution.」

「In parallel, an investigator-initiated clinical trial for medical device approval of the medical HAL® lower-limb single-leg model is under way to expand the indication to stroke.」

「The Group will continue to establish core medical centers for neuromuscular intractable diseases and accelerate clinical trials and investigator-initiated clinical trials for other diseases, including stroke and spinal disorders, to expand the applications of cybernics treatment.」

「In October 2017, the HAL® single-joint type, which is ultra-lightweight and compact and supports the elbow and knee joints, was selected for an AMED-funded project involving an investigator-initiated clinical trial for acute-phase stroke treatment, with Kyoto University Hospital serving as the lead research and development institution. The Company will proceed toward making it a medical device following the investigator-initiated clinical trial.」

「To expand the indications to stroke, an investigator-initiated clinical trial for medical device approval of the medical HAL® single-leg model has continued since September 2016.」

「Medical HAL® is undergoing clinical trials in Japan and overseas to expand its indications, and deployment at domestic medical institutions has begun under the world's first public health insurance coverage for the treatment. As of the end of March 2017, 188 units, including those used in clinical trials, were in operation in Japan and overseas, of which 38 were rented in Japan.」

「The Company will accelerate clinical trials and investigator-initiated clinical trials in collaboration with medical institutions in Japan and overseas to expand the indications to other diseases, including stroke and spinal cord injury. For stroke, an investigator-initiated clinical trial for medical device approval using the medical HAL® single-leg model to improve and restore function has already been under way since 30 September 2016.」

「For medical HAL® (single-leg model), an investigator-initiated clinical trial for medical device approval began on 30 September 2016 to improve and restore function in stroke patients.」

「Medical HAL® (lower-limb type) is undergoing clinical trials in Japan and overseas to expand its indications. As of the end of June 2016, 145 units, including those used in clinical trials, were in operation in Japan and overseas, and the Company will begin full-scale deployment at domestic medical institutions against the backdrop of coverage under public health insurance.」

「Medical HAL® (lower-limb type) is undergoing clinical trials in Japan and overseas to expand its indications, and as of the end of March 2016, 140 units, including those used in clinical trials, were in operation in Japan and overseas.」