BRAINAURORA-B (06681) has announced that in the evening of October 27, 2026, the company received a Class II Medical Device Registration Certificate for its cognitive function assessment software for depression patients, issued by the Beijing Municipal Medical Products Administration (Beijing Administration). The details are hereby announced as follows: the product is a cognitive function assessment software with the specification model BJHZ-NACT, classified as a Class II medical device, with the registration certificate issued by the Beijing Administration under registration certificate number: Jing Xie Zhu Zhun 20262210410, which the company received in the evening of October 27, 2026.
The product is a standalone software for cognitive function assessment of depression patients, evaluating four major dimensions including memory, attention, executive function, and information processing speed, and producing results to help clinicians understand patients' cognitive conditions and provide safe and effective evidence for subsequent treatment. The clinical trial of the product was initiated in September 2024 and completed in August 2025.
Cognitive symptoms persist throughout the course of depression, affecting the efficacy and cure rate of antidepressant treatment, increasing the risk of relapse, and causing some patients to be unable to restore normal social functioning, resulting in enormous social and economic burdens. This product represents the company's first medical device registration certificate obtained from the Beijing Administration, and is also the first cognitive function assessment medical device registration certificate in the field of depression, marking the company's registration breakthrough in the field of cognitive assessment for mental illness, securing a first-mover position in the market, and further improving the company's digital medical product portfolio for cognitive disorders.
The Board of Directors believes that the above registration achievement helps consolidate the Group's industry position in the field of digital medicine for cognitive disorders and is in the overall interest of the Group and its shareholders.
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