Milestone Medical Announces Expected Q1 2026 Launch of First Brain-Computer Interface Medical Device Certification and Commercialization Plan

China Securities News (Reporter Wang Luo) – On the evening of December 24, the investor relations activity record form disclosed by Medlander Medical Technology Inc. showed that from December 22 to 23, 50 representatives from 48 institutions, including TF Securities, Bosera Funds, China Asset Management, and CITIC Securities, conducted online research on the company. The institutions focused on core issues such as the technical barriers, registration progress, commercialization pathway, and data compliance of the company's brain-computer interface business.

Clarify Evidence Nodes: Brain-Computer Interface Commercialization Accelerates Across the Board

In terms of registration progress, the company has clarified the key time nodes and expects to obtain the first medical device registration certificate for brain-computer interface in the first quarter of 2026, corresponding to the product of a brain-computer interface transcranial magnetic stimulation instrument. After the first certificate is obtained, this technology will be quickly integrated into the company's existing soft hand function training system, pelvic floor rehabilitation equipment, and other product lines, achieving large-scale application of technological achievements.

In terms of technical cooperation, Medlander has reached an exclusive strategic partnership with Rongnao Technology on the medical front. Rongnao Technology will provide core technical support, and both parties will work together to advance the clinical transformation and product implementation of brain-computer interface technology, laying a solid technical foundation for subsequent commercialization plans.

The company emphasized that its brain-computer interface (BCI) business complements its traditional core operations deeply. Taking the field of pelvic floor rehabilitation as an example, for patients suffering from chronic pelvic pain and urinary incontinence, who often experience accompanying psychological issues such as anxiety and depression, the integration of BCI technology enables "simultaneous treatment of mind and body." This not only enriches existing treatment options but also further enhances customer loyalty and treatment value. In the future, while consolidating its traditional business foundation, the company will steadily advance the registration and market launch of BCI products, continuously expand its multi-product line and multi-indication layout, and propel the new business from the market introduction phase into a period of rapid growth.

The policy end also provides strong support, with the country continuously increasing its backing for cutting-edge technologies such as brain-computer interfaces. Several provinces have clearly introduced the "non-invasive brain-computer interface adaptation fee" charging item, and the access channel for medical insurance is gradually widening, creating a favorable policy environment for the commercialization of products.

Multimodal Technology Builds Barriers: Three Major Application Pathways Focus on Rehabilitation Needs

Medlander Expounds on the Unique Value of Its Multimodal Brain-Computer Interface Technology, Highlighting Core Technical Advantages. This technology achieves complementary advantages of two types of signals—EEG with high temporal resolution and fNIRS with precise spatial localization—by simultaneously collecting EEG and fNIRS optical signals. The fusion of these signals enables a more three-dimensional and accurate analysis of real-time brain states, such as patient focus, emotional tension levels, and activation levels in specific brain regions.

Compared with traditional EEG detection, this technology is more practical in clinical applications: Near-infrared light detection is not affected by factors such as hair and sweating, simplifying the operation process, improving the patient experience, and making brain-computer interface technology truly adaptable to daily clinical work scenarios. Currently, there are few companies in the industry that can stably integrate the two systems into wearable medical devices and complete strict registration verification, forming a significant technical barrier; In the future, the company will further consolidate its competitive advantage by accumulating high-quality clinical data and iterating algorithm models.

Based on this core technology advantage, Medlander has planned three clear application pathways, which are being advanced in an orderly manner according to the level of clinical implementation difficulty and market maturity:First, prioritize the layout in the field of mental and psychosomatic disease regulation, targeting intervention needs for depression, anxiety, insomnia, and other disorders. Enhance the precision and efficacy of physical treatments through closed-loop neuromodulation systems, and rapidly achieve market penetration by leveraging existing psychiatric and neurological channels.Secondly, focus on the rehabilitation of motor dysfunction, targeting scenarios such as hand function training post-stroke. Leverage the company's existing product foundation and market network to enhance active rehabilitation outcomes, with a current emphasis on consolidating applications in the field of gross motor rehabilitation.Thirdly,布局 cognitive function障碍 intervention赛道, targeting the cognitive intervention needs of aging-related diseases such as Alzheimer's disease and Parkinson's disease. Commercialization is expected to commence in 2027 after the completion of relevant research and development.

In response to the data compliance concerns of institutions, Medlander has clearly adopted the core principle of "data never leaves the hospital." By collaborating with hospitals on scientific research and jointly developing clinical solutions, it ensures that data is securely used for analysis and model optimization within the hospital's firewall, with intellectual property shared by both parties. At the same time, it actively participates in the formulation of industry data standards, promoting the establishment of a standardized data management and protection system.