NaiXin Technologies Files Prospectus for AI-Driven, Multimodal Mental Health Diagnostic and Therapeutic Platform

On a Monday in April this year, long queues formed both inside and outside the gates of a renowned mental health center, with nearly 1,200 residents seeking prescription refills. This microcosm of societal reality has drawn attention to persistent challenges in the field of mental health and psychiatry, including rising prevalence rates, suboptimal clinical efficacy, and inadequacies in current diagnostic and treatment models and modalities.

Over the past decade, several international research teams have found in their preliminary studies thatIndividuals at high risk for psychiatric disorders exhibit distinct biological markers, which not only facilitate early identification but also allow for improved cure rates through early intervention. Consequently, the clinical focus has shifted from treatment to prevention. Therefore, establishing effective technologies and standards for early risk identification is crucial to enable primary prevention in patients and deliver precise interventions for high-risk populations, with optimizing the timing of intervention being paramount to achieving the best therapeutic outcomes.

In this regard, NIACIN TECH (hereinafter referred to as “NIACIN TECH”) shares the same understanding.NIACIN TECH believes that the mental health industry is in a stage of evolution towards intelligence. Building a product matrix of “screening + diagnosis + treatment + prevention” through multimodal and software-hardware integration, combining medical devices with intelligent technologies, is an effective approach to bridging the gap in diagnostic and therapeutic methods for mental disorders.. By targeting this currently untapped market, NIACIN TECH’s comprehensive product portfolio can effectively bridge the significant supply-demand gap in this field, thereby enhancing diagnostic and therapeutic efficiency and gaining market recognition.

Unlike the traditional diagnostic and treatment approach that relied on physicians’ subjective experience-based judgments and primarily focused on symptomatic treatment in later stages,NIACIN TECH shifts the focus of disease diagnosis and treatment to the early risk stage through objective biomarkers, and builds a product system addressing early screening, early diagnosis, and early intervention from three aspects: inflammatory metabolic pathways, brain functional structure, and cognitive behavior.

NIACIN TECH recognizes that the current development of the mental health industry lacks relevant database infrastructure. If massive amounts of patient data cannot be collected and utilized effectively and scientifically, diagnostic methods will inevitably fail to achieve comprehensive improvement, thereby hindering the industry’s ability to meet the demands of the rapidly growing mental health market.

The founding team member participated in building the world’s largest single-center cohort of individuals at risk for mental disorders, characterized by the most comprehensive biomarker profile, highest homogeneity, and a follow-up period exceeding 12 years, to provide robust, real-time data support for disease diagnosis. This cohort serves as a critical foundation for the precise screening, diagnosis, and treatment of psychiatric and psychological disorders, as well as for the development of NIACIN TECH’s solutions.

The company has currently builtIntelligent Navigation Fully Automated Physical Modulation System (TMS), Niacin Skin Response Analyzer, Intelligent Eye Movement Analyzer, and Online Cognitive Behavioral Therapy Digital Therapeutics, forming a multimodal product matrix that integrates software and hardware to realize a new diagnostic and therapeutic model of “early screening, early diagnosis, and early intervention.”

“The pathogenesis of mental disorders is complex, and biological markers are not well-defined. Without reliance on instrumental equipment and biochemical testing, it is nearly impossible to achieve precise diagnosis of mental disorders.”Only through multidimensional diagnostic tools based on big data and algorithms can disease diagnosis and treatment be effectively guided.“said the founder of NIACIN TECH.”

It is reported that this system does not rely on clinicians’ empirical judgment to identify stimulation sites; instead, it delivers physically modulated interventions based on individual patients’ imaging features. All physical intervention procedures performed on the patient—including localization, navigation, and stimulation—as well as subsequent adjustments to treatment protocols, are driven by intelligent algorithms and automatically adjusted by the system. This device can significantly reduce clinicians’ time costs, enable precise diagnosis and treatment of psychiatric and psychological disorders, and improve both clinical treatment efficiency and therapeutic effectiveness.

A substantial body of experimental data has now demonstrated that an abnormal niacin response can serve as one of the endophenotypic characteristics of the niacin-blunted subtype in various mental disorders. The detection principle involves assessing cerebral phospholipid metabolism to determine whether inflammatory processes are occurring in neural pathways, thereby enabling rapid screening of brain health status. Currently, the novel technology of ultra-early metabolomic diagnosis based on the niacin-induced skin flushing response has been validated as an early biomarker.

Currently, the company employs a neural network-based quantitative prediction model built on machine learning algorithms to achieve a quantitative assessment of skin flushing severity by acquiring parameters such as the area of the skin flushing reaction region and characteristics of skin color distribution.Eliminating the influence of subjective factors inherent in existing manual observational assessments, it achieves consistency in the quantitative results of skin erythema reaction severity.Improved the accuracy and reliability of subsequent predictions of patients' disease probability. It has set a benchmark for the product's scientific rigor and medical mechanism, while also securing a leading window of opportunity for its future official market launch.

Furthermore, the company has been granted an invention patent by the China National Intellectual Property Administration (CNIPA) related to the quantification of skin flushing responses. The high degree of consistency between the Niacin Skin Response Analyzer and the visual assessment method in terms of testing procedures, materials, and evaluation criteria demonstrates that the analyzer can effectively replace the scoring process of traditional visual assessment. The introduction of this product not only contributes to reducing the assessment workload for doctors and nurses but also promotes, to a certain extent, the transition of psychiatric medical devices from the era of manual operation to the era of automation.

The Intelligent Eye Movement Analyzer, developed by NIACIN TECH based on its proprietary eye-tracking hardware and software combined with artificial intelligence technology, precisely records and analyzes the spatiotemporal trajectories of eye movements, providing objective and quantitative evaluation metrics for the diagnosis and assessment of mental disorders. Leveraging clinical big data research, the device introduces four original clinical diagnostic paradigms. The diagnostic reports not only indicate the presence of abnormalities but also expand the range of applicable indications, including anxiety, depression, bipolar disorder, and schizophrenia.

In addition to developing biological diagnostic solutions, NIACIN TECH has also created a digital therapeutic platform for online cognitive behavioral therapy (CBT). The company aims to reduce the side effects associated with pharmacological treatments, standardize and modularize the psychotherapy process, shorten the training cycle for psychotherapists, and minimize repetitive tasks for therapists. These efforts are designed to address the long-standing issue of supply-demand imbalance in the mental health sector.

In addition to improving physicians’ work efficiency, this digital therapeutic can enhance treatment outcomes by providing real-time reminders and tracking patients’ daily homework completion, as well as monitoring the progress and status of behavioral interventions. Physicians can prescribe different treatment modules tailored to individual patients’ symptoms, thereby enabling precision medicine. For patients, the product allows 24-hour feedback on their psychological state and treatment progress, facilitating collaboration with physicians to optimize homework adherence and therapeutic efficacy. Moreover, it has virtually no treatment side effects and offers greater accessibility.

Addressing the critical pain point of the significant disparity between supply and demand, the emergence of this digital therapeutic is bound to enhance the accessibility of psychiatric and psychological diagnosis and treatment to a certain extent.

Through the product pipeline established by NIACIN TECH, it can be seen thatLeveraging the world’s largest cohort of individuals at risk for disease, and building on intelligent medical devices, the company employs multiple biological diagnostic methods to assist clinical diagnosis. This approach shifts the window for disease screening, diagnosis, treatment, and prevention earlier in the care continuum, while enhancing the accuracy and efficiency of diagnosing mental health disorders.

Not only that,The company continues to optimize its digital analytics system to enable automated, intelligent, and personalized diagnosis and treatment of diseases through non-pharmacological interventions, thereby refining the end-to-end workflow of “screening, diagnosis, treatment, and prevention” for mental disorders and further addressing the supply–demand imbalance in the mental health sector.

The company has filed over ten intellectual property applications to date, with four innovative products finalized and launched in the market. Its product promotion model simultaneously covers both in-hospital and out-of-hospital channels, creating a closed commercial loop and offering broad market prospects.

For in-hospital scenarios, NIACIN TECH provides quantitative and intelligent tools covering the entire spectrum of “screening, diagnosis, treatment, and prevention” for mental disorders. This solution meets the needs for full-cycle, end-to-end management of high-risk populations for mental disorders across diverse settings, including nearly 6,000 mental health service institutions, the psychology departments of nearly 20,000 Grade A tertiary hospitals, hundreds of thousands of community healthcare facilities, and psychological clinics throughout China.

For out-of-hospital settings, the company has established an integrated service workflow encompassing patient navigation, diagnosis, and intervention for key populations. Through multi-party collaborations, its products and services reach at-risk groups across various sectors, offering risk assessment services, psychological counseling for mild cases, nutritional intervention for moderate cases, and referral of severe cases to medical institutions for further diagnosis and treatment. This model currently covers enterprises and public institutions, health examination centers, and third-party imaging centers.

In March this year, the Ministry of Finance issued the "Notice on Organizing the Declaration of Demonstration Projects for Public Hospital Reform and High-Quality Development Supported by the Central Financial Budget," to support the implementation of demonstration projects for public hospital reform and high-quality development. Among them, the item "Focusing on Enhancing the Diagnostic and Treatment Capabilities of Municipal and County-Level Public Hospitals" specifically points out that key support will be provided for the construction of clinical specialties such as infectious diseases, psychiatry, emergency care, critical care medicine, cardiovascular and cerebrovascular diseases, obstetrics and gynecology, and pediatrics in municipal and county-level public hospitals, as well as promoting the construction of "three-in-one" smart hospitals encompassing electronic medical records, intelligent services, and intelligent management, along with the standardization of hospital information systems.

This policy explicitly supports the development of psychiatric specialties. The strengthening of diagnostic and treatment capabilities in psychiatry, the enhancement of related medical services, and the disbursement of national subsidy funds will inevitably drive updates to diagnostic and treatment models as well as related medical equipment, thereby promoting the development of the medical equipment industry and injecting greater momentum into its growth. The mental health sector will thus enter a period of developmental opportunity, with enhanced capabilities for product commercialization.

In the future, NIACIN TECH will strengthen its coverage of the entire population of patients with mental and psychological disorders through an integrated solution for out-of-hospital psychological assessment and effective intervention, as well as an in-hospital model for medical diagnosis and treatment. For in-hospital scenarios, solutions such as the niacin skin reaction analyzer, intelligent eye-tracking analyzer, and intelligent TMS system can significantly reduce labor costs and precisely improve treatment efficiency. These solutions align with national policy requirements, such as medical insurance cost containment, feature a highly viable business model, and demonstrate a clear growth trajectory. Out-of-hospital scenario solutions can effectively enhance patient stickiness and compliance, expand the product’s reach, and facilitate the referral of high-risk populations to hospitals.

As in-hospital and out-of-hospital scenarios become increasingly integrated, the diagnostic and therapeutic concept of “early screening, early diagnosis, and early intervention” for mental and psychological disorders will accelerate its adoption in China. NIACIN TECH will further advance the industrialization of its products and services.

As the government progressively incorporates mental health initiatives into national policy, the treatment of mental and psychological disorders is poised for widespread adoption. Given the large patient population with psychiatric conditions in China and the abundance of real-world data on mental health, this presents an optimal window for the development of AI-based medical devices, which will further advance personalized treatment approaches.

Amidst this surge of interest, a large number of industry practitioners have emerged in recent years to explore innovative solutions. Although companies adopt varying strategies, it is evident that traditional diagnostic methods alone are no longer sufficient to significantly improve the accuracy of diagnosis and treatment. Only by leveraging various instruments to conduct multidimensional biomarker assessments of the brain during the critical pre-symptomatic window, thereby gaining a thorough understanding of the pathogenesis, can we further enhance the precision of diagnosis and therapy.

Meanwhile, the shift in psychiatric diagnosis from clinical medicine to preventive medicine represents a major trend. To meet this challenge, the industry requires close collaboration between enterprises and institutions that possess high-quality clinical cohort data characterized by large sample sizes, comprehensive biomarkers, and high homogeneity. Such partnerships will facilitate the translation and application of AI-driven mental health technology products independently developed in China.

NIACIN TECH has assembled an interdisciplinary team comprising psychiatric clinical experts, artificial intelligence specialists, and engineering professionals. Led by senior psychiatric clinicians and scientists, this cohesive team integrates cross-disciplinary expertise to merge clinical practice with AI technology, delivering innovative solutions. Moving forward, the company will continue to contribute more innovative solutions to the field, driving industry development.