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2024-05-15 updated

【News】U.S. FDA becomes the world’s first to clear smaller model of Medical HAL and expanded indication for Cerebral Palsy

CYBERDYNE Inc. (Tsukuba, Ibaraki; President & CEO: Yoshiyuki Sankai, the “Company”) announces that the Company obtained marketing clearance from the United States Food and Drug Administration (“US FDA”) on May 7 2024 (U.S. time) for its Medical HAL Lower Limb Type (“Medical HAL”) to expand the indication to cerebral palsy, HTLV-1 Associated Myelopathy (HAM) and Hereditary Spastic Paraplegia. US FDA also cleared the small model of Medical HAL that enables patients above 100 cm to go through Cybernics Treatment.

Important points on US FDA marketing clearance on this occasion

1. In addition to spinal cord injury, stroke and eight types of neuromuscular diseases that have already obtained marketing clearance, US FDA has cleared additional indication for Medical HAL, namely Cerebral Palsy, HTLV-1 Associated Myelopathy (HAM) and Hereditary Spastic Paraplegia. US FDA became the world’s first to acknowledge the safety and efficacy of HAL for cerebral palsy. (The patient who receives treatment for cerebral palsy must be above 12 years old)
2. A small model of Medical HAL also obtained marketing clearance on this occasion, enabling patients with heights from 100cm to 150cm can now receive Cybernics Treatment. US FDA also became the world’s first to acknowledge this small size as a medical device.

Based on the marketing clearance from the US FDA, the Company will further accelerate its business development of Medical HAL in the U.S. and promote this expansion of both indications and sizes of Medical HAL in countries worldwide.

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CYBERDYNE Inc. is a future pioneering company that simultaneously creates innovative technologies, creates new industries, and fosters human resources through these challenges by utilizing Cybernics (*) that fuse “Human” and “Cyber Physical space” (HCPS) to solve various issues facing society. Through these challenges, the Company promotes a virtuous cycle of innovation.