
Source:Exploring IVD,IVD Information, In Vitro Diagnostics Network




August 13,An investor asked Biotop Biotech about the company's layout and progress in the brain-computer interface industry.
Biotime Secretary of the Board

The core product of Qingshi Yongjue is a closed-loop modulation system for depression based on invasive brain-computer interface technology, which includes two Class III medical devices, one artificial intelligence diagnosis and treatment software, and a cloud platform for managing the full-course data of patients. The system collects brain electrical signals in real time through implanted electrodes and dynamically adjusts neurostimulation parameters using AI algorithms to achieve closed-loop treatment of "monitoring - analysis - intervention." Notably, its self-developed active implantable device has completed animal experiments with performance meeting design standards. The first scientific research clinical trial showed significant effects, and it has now entered the type inspection phase. According to the plan, registration clinical trials will be conducted at the Second Affiliated Hospital of Zhejiang University in 2027, with commercial application expected by 2030.

Biotest Biotech was founded in 2008. It is a national high-tech enterprise specializing in the research, development, manufacturing, sales, and service of in vitro diagnostic reagents, raw materials, and instruments. Biotest Biotech is committed to providing innovative, instant, and high-quality diagnostic products and solutions to users worldwide to meet unmet medical needs. Currently, Biotest has about a hundred products, with business covering more than 100 countries and regions globally, serving over 3 billion people. The company's product range includes drug abuse testing, infectious disease testing, reproductive health testing, tumor marker testing, cardiac marker testing, and other product series, among which drug abuse testing and infectious disease testing are the leading product lines. The company now possesses over 600 rapid testing products certified by domestic and international institutions. Key performance indicators such as product specificity and sensitivity have reached advanced industry levels. Its business scope extends to many countries and regions worldwide, with overseas sales accounting for approximately 75% of the total.

In the past five years, thanks to its outstanding performance in the global fight against the pandemic, Biotest Biotech's performance has soared, and it was successfully listed on the STAR Market in 2021.


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