iFluid Biotech Files IPO Prospectus: Pioneering 'Biological Computers' to Empower Primary Healthcare Diagnostics and Intelligent Health Data Management

Since its inception, Shenzhen iFLUID BIOTECH Co., Ltd. (hereinafter referred to as “iFLUID”) has targeted the primary healthcare market, aiming to facilitate the automation and intelligent upgrading of laboratory testing at the grassroots level.

Zhang Yicong, Founder & CEO of iFLUID BIOTECH, stated that the primary reasons for focusing on the primary healthcare market are—

On one hand, the Report to the 20th National Congress of the Communist Party of China pointed out the need to deepen reforms in the medical and health system and promote the coordinated development and governance of medical insurance, healthcare services, and pharmaceuticals. Meanwhile, in recent years, the state has continued to advance healthcare reforms, improving and implementing measures such as tiered diagnosis and treatment and initial consultations at primary care facilities. This indicates that, at the national level, enhancing the capacity of primary healthcare services has received significant attention. On the other hand, the accelerating pace of population aging and the increasingly large population of patients with chronic diseases have made it even more “urgent” to strengthen primary healthcare service capabilities.

In initiatives to enhance the capacity of primary healthcare services, strengthening laboratory testing capabilities is of paramount importance.

However, primary healthcare institutions currently face challenges such as low diagnostic and treatment standards, staff shortages, and outdated medical equipment, making them unable to fully meet the needs for primary care diagnosis and treatment. For instance, most laboratory equipment in these institutions remains semi-automated, with "old, scarce, and backward" being their main characteristics. This directly leads to prolonged turnaround times for test reports, failing to meet clinical demands in a timely manner, and indirectly extends the cycle of diagnosis and treatment. Therefore, against the backdrop of lacking essential "tools" for clinical diagnosis and treatment, the operations of most primary healthcare institutions struggle to develop and remain in a precarious situation. Consequently, a more intelligent and integrated diagnostic solution will become the key to helping primary healthcare institutions "break free" from their predicament.

Furthermore, in the fight against COVID-19, the importance of primary healthcare, particularly primary diagnosis, has been highlighted once again, with primary care capabilities facing severe tests. This sends a clear signal to the outside world that enhancing primary diagnostic capabilities is urgent. Almost simultaneously, in 2020, iFLUID BIOTECH decisively entered the primary medical testing market, aiming to contribute to improving primary healthcare service capabilities.

Founder & CEO Zhang Yicong pointed out that iFLUID BIOTECH's greatest advantage lies in product R&D and design.

When introducing iFLUID BIOTECH’s product philosophy, he noted that the company regards its self-developed instruments and equipment as “biological computers.” Unlike conventional computers that read data from disks, iFLUID BIOTECH’s devices “read” human health data stored in blood samples, such as biomarkers and genetic material. Through these “biological computer” instruments, iFLUID BIOTECH aims to help users quantify their physical health status during clinical diagnosis or health management processes.

The product philosophy of creating a “biological computer” has also clarified the fundamental requirements for instrument and equipment R&D at iFLUID BIOTECH:

On one hand, "full automation" is the most fundamental requirement for iFLUID BIOTECH’s product development. It can significantly reduce the workload of medical technicians in primary care laboratories and lower the probability of errors caused by manual operations. On the other hand, considering the limited financial resources of primary healthcare institutions, iFLUID BIOTECH adopts a highly integrated design in its products to reduce equipment costs. Furthermore, to minimize equipment failure rates and simplify after-sales maintenance, all iFLUID BIOTECH testing devices feature a liquid-free design. The introduction of iFLUID BIOTECH’s testing equipment helps promote business development in primary healthcare institutions and enhances their self-sustaining revenue-generating capabilities.

Guided by the aforementioned design principles, iFLUID BIOTECH has progressively built its product pipeline, which includes small-scale intelligent laboratory automation solutions tailored for small and medium-sized medical institutions, a POCT product line designed to meet the routine testing needs of primary healthcare facilities, and a home-testing product line currently in the pre-research phase.

Recently, iFLUID BIOTECH’s fully automated three-part differential hematology, biochemistry, and immunoassay integrated analyzer; fully automated five-part differential hematology, biochemistry, and immunoassay integrated analyzer; fully automated multiplex homogeneous chemiluminescence analyzer; and fully automated liquid bead-based POCT system will be exhibited from May 28 to 30 at the 20th China Association of Clinical Laboratory Practice (CACLP) Expo and the 3rd China International IVD Upstream Raw Material Manufacturing and Distribution Supply Chain Expo (CISCE) (Booth: A4-2120).

In primary healthcare laboratory testing, complete blood count (CBC) is the most frequently performed test. However, there is currently a “mismatch” between available CBC testing equipment on the market and the actual needs and capabilities of primary healthcare institutions: first, some instruments are priced too high, exceeding the purchasing capacity of these institutions; second, primary healthcare institutions handle relatively small sample volumes, whereas the currently prevalent large-pack reagents inevitably lead to resource waste; third, common equipment adopts liquid-path designs, which result in higher failure rates.

Based on the aforementioned insights into the testing needs of primary healthcare institutions, iFLUID BIOTECH has launched a fully automated integrated analyzer for complete blood count (with three-part or five-part differential), biochemistry, and immunoassays. Featuring a fully automated design with simple and convenient operation, the device enables automatic sample loading. It also adopts a liquid-path-free design to reduce equipment failure rates, while offering a lower cost.

Moreover, the device is compatible with single-test reagents, thereby meeting the low-volume testing needs of primary healthcare facilities. In addition to complete blood count (CBC) analysis, this all-in-one system largely fulfills the routine clinical laboratory requirements of primary medical institutions. Furthermore, due to its compact size and ease of operation, it is suitable for diverse settings, including clinics, community health service stations, village health rooms, enterprise and school infirmaries, hospital wards, nursing homes, ambulances, and field environments.

Regarding after-sales service for this device, iFLUID BIOTECH commits to providing free replacements in the event of quality issues, thereby alleviating concerns about after-sales support among primary healthcare institutions.

Compared with traditional chemiluminescence technology, homogeneous chemiluminescence not only simplifies the magnetic bead washing steps but also eliminates the need for expensive substrates or luminescence-initiating reagents. Meanwhile, homogeneous chemiluminescence technology features high sensitivity, a wide dynamic range, and excellent precision.

Moreover, the iFLUID BIOTECH fully automated multiplex homogeneous chemiluminescence analyzer is highly competitive in enhancing efficiency—it can complete combined testing for four biomarkers within 10 minutes, helping primary healthcare institutions reduce costs and improve operational efficiency.

In addition, Zhang Yicong added, “The reduction in testing steps and the simplification of instrument structure can also improve CV control.”

iFLUID BIOTECH’s fully automated liquid-phase chip POCT adopts flow cytometry-based fluorescence detection technology. This technology represents a new generation of high-throughput, multi-analyte combined testing platforms. Exploration of flow cytometry-based fluorescence detection has also become one of the hot tracks in the field of in vitro diagnostics. The reason lies in its ability to achieve high-throughput, rapid, and simultaneous detection of various indicators, including tumor markers, autoimmune diagnostic markers, diabetes-related hormones, endocrine markers, cardiovascular disease-related factors, and pathogens, thereby fully meeting the clinical demand for high-throughput testing.

Among these, fluorescently encoded microspheres are the core of the fluorescence detection system. iFLUID BIOTECH’s self-developed quantum dot-encoded microspheres offer advantages over other encoded microspheres, including no spectral overlap and high coding accuracy. Furthermore, by employing innovative microfluidic chip technology, iFLUID BIOTECH integrates sample pretreatment and the sheath flow chamber onto a single-use chip, enabling the instrument to achieve a liquid-path-free design. “This is the first fully automated liquid-phase chip POCT device adopting a liquid-path-free design,” emphasized Zhang Yicong.

In addition to the POCT devices to be showcased at CACLP, iFLUID BIOTECH has launched a compact intelligent laboratory automation line to address the urgent need for automated solutions in the clinical laboratories of small and medium-sized medical institutions that cannot afford the high costs.

According to Zhang Yicong, iFLUID BIOTECH’s fully automated integrated hematology, biochemistry, and immunoassay analyzer is scheduled to obtain medical device registration certification by the end of the year. At this stage, iFLUID BIOTECH will actively seek collaboration opportunities with upstream and downstream partners in the industry chain to jointly provide high-quality equipment for primary healthcare institutions, thereby enhancing primary medical services and diagnostic capabilities.

It is undeniable that iFLUID BIOTECH boasts strong product capabilities. This strength stems from its assembly of a robust R&D team with diverse disciplinary backgrounds.

Take Founder & CEO Zhang Yicong as an example: he holds a master’s degree in Biotechnology from the University of Queensland and has extensive experience in reagent R&D. The team members are all PhDs and master’s graduates from top universities and technology companies worldwide. After three years of development, iFLUID BIOTECH has gradually integrated and built a multidisciplinary R&D team with diverse backgrounds spanning chemistry, biology, medicine, optics, automation, and artificial intelligence.

From an outside perspective, iFLUID BIOTECH, a startup founded just three years ago, has already achieved phased milestones. But in the view of Zhang Yicong, it is only just beginning—

“On one hand, most industries have already entered the era of intelligence and digitalization, while the testing sector remains in the early stages of automation adoption. However, the state’s vigorous promotion of tiered diagnosis and treatment policies, coupled with the urgent demand for automated equipment from primary healthcare institutions, clearly indicates a need for high-quality automated laboratory testing equipment and solutions at the grassroots level. In this context, iFLUID BIOTECH will maintain its strategic positioning, leverage its technological advantages, and do its utmost to meet the needs of both the nation and healthcare institutions for automated testing equipment and solutions. On the other hand, in recent years, continuous reforms in the pharmaceutical and healthcare system have shifted the focus of health endeavors from ‘disease-centered’ to ‘people’s health-centered.’ Greater emphasis is now being placed on disease prevention by various stakeholders, suggesting significant growth potential in the out-of-hospital market. In response, iFLUID BIOTECH will align with market trends by deploying home-based testing devices, aspiring to ‘soar like the Roc, riding the wind to ascend ninety thousand li.’” added Zhang Yicong, Founder and CEO of iFLUID BIOTECH.