Ushio Medical: Novel Intrinsic Fluorescence Technology Enables 6-Second Precise Detection of Cervical Precancerous Lesions
Current research has confirmed that early screening for cervical cancer can effectively prevent and reverse the disease, with a 100% cure rate for precancerous lesions.The progression from ordinary cervical inflammation to invasive cervical cancer generally takes 10 to 15 years, or even up to 20 years. Timely diagnosis and treatment during this precancerous stage can prevent the lesion from developing into life-threatening invasive cancer.
However, data published by the National Cancer Center in 2019 showed that there were approximately 100,000 new cases of cervical cancer in China in 2015.80% of patients are diagnosed with invasive cancer at the time of confirmation.。
Low awareness of proactive screening for prevention, shortage of specialized diagnostic physicians, and issues with traditional diagnostic technologies such as low automation, prolonged processing time, and high rates of missed and misdiagnoses,Continuously Limiting the Widespread Adoption of Early Screening and Treatment for Cervical Cancer. 2020,Proposed by the 73rd World Health Assembly, developing innovative and cost-effective screening, diagnostic, and therapeutic measures for cervical cancer is a research priority that urgently needs to be strengthened worldwide!
Founded in2016ofUshio Medical Technology (Suzhou) Co., Ltd.(hereinafter referred to as “Niuwei Medical”), located in the Jiangsu Medical Device Technology Industrial Park, is an innovative high-tech medical company integrating independent R&D, manufacturing, sales, after-sales support, and services for cutting-edge medical devices.Novel Intrinsic Fluorescence Technology Developed by the Company, capable ofPrecise Screening and Diagnosis of Cervical Precancerous Lesions and Early-Stage Cervical Cancer, in terms of cost, operation, performance, and potential, all demonstrating superior performance compared to traditional diagnostic techniques.
Leveraging the comprehensive strategic support from its founding shareholder, Ushio Inc., and the cutting-edge research in intrinsic fluorescence technology conducted by Professor Liu Jianhua, a medical R&D advisory expert,Niuwei Medical completed the entire process from technology development, validation, to registration over a three-year period., obtained the registration certificate for its first standard-version product and achieved ISO 13485 quality management system certification in 2019.
Research and application of intrinsic fluorescence technology began as early as 20 years ago.However, constrained by the barriers in excitation light sources and imaging technologies, and has failed to achieve meaningful progress in the clinical stage.
Normal human tissues, precancerous lesions at different stages, and cancerous tissues differ in their molecular structures and metabolic states, resulting in distinct fluorescence spectra and characteristic images upon excitation. Niuwei Medical leverages this principle by varying the wavelength of the excitation light,High-intensity specific wavelengths capable of distinguishing normal tissue, precancerous lesions, and cancerous tissue have been identified.: 340 nm single-wavelength excitation light.
This technique, by exciting the intrinsic fluorescence of cervical tissue and subsequently capturing and resolving the emitted signals,Observation of the Characteristics of Various Intraepithelial Tissue Lesions in Autofluorescence Grayscale Images, thereby completing the detection, with a concordance rate with the gold-standard pathological biopsy reaching98.9%. The test results are saved in image format, which is relatively objective and facilitates quality control as well as remote expert consultation. From photography to imagingJust 6 Seconds, available for immediate examination upon arrival, with instant diagnosis and results.Most importantlyCapable of detecting early-stage lesions from the superficial mucosa to a depth of 2–3 mm into the submucosa. The device features a small footprint, portability, and low environmental requirements, enabling licensed gynecologists toMaster completely within 2-3 days, significantly shortening the training period. For examinees, this examination is non-contact and will not cause any impact on the body.The cost per test is also kept at around 100 yuan.。
This technology can not only be applied in health check-ups and clinical diagnosis, but also helps to precisely guide radical surgery for malignant tumors and achieve accurate biopsy localization., preventing mis-sampling and missed sampling, and improving the hit rate of biopsies, represents a breakthrough advancement in the diagnostic methods for the prevention and control of cervical cancer in women. Its characteristics of high accuracy, ease of operation, and low cost are expected to fundamentallyAchieving a Qualitative Leap in the Capacity Building of Cervical Cancer Diagnostic Professionals and Departments at Primary and Secondary Hospitals, thereby increasing the coverage and detection rates of cervical cancer diagnosis and screening from multiple perspectives, including technical quality, application scenarios, and adoption levels, to achieve a substantial reduction in incidence and mortality rates.
Currently, Niuwei Medical’s core technologies have been filed for patent registration, and academic papers have been published in multiple professional journals, including Nature and the Chinese Journal of Practical Gynecology and Obstetrics.Earned unanimous acclaim from industry experts.
In less than two years since the product launch, under the pressure of recurring pandemic waves, Terumo Corporation stillPromoted the product to over 100 secondary and tertiary hospitals across China.，Achieved a post-marketing clinical validation scale of hundreds of thousands of cases, achievedProduct sales nearing RMB 60 million, and is making a push for orders worth hundreds of millions of yuan.
withSuzhouforR&D and Manufacturing Center, Niuwei Medical is stillNanjingwithBeijingEstablishing Two MajorMarketing Center, with channel coverage across the Chinese market. Located atShenzhenofInternational Marketing CenterIt is also under preparation, with plans to begin strategic expansion into overseas markets next year.
Regarding the current incidence and clinical landscape of cervical cancer in China,Yang Kejian, CEO of Niuwei Medicalused “Extremely Severe、Urgent” to describe, this is also an opportunity that Niuwei Medical needs to actively seize and a responsibility it must proactively assume.
FromTechnical MeansFrom this perspective, China urgently needs innovative technologies to effectively address the current high-cost, low-efficiency clinical screening landscape, and to identify optimal application scenarios and promotion strategies for such technologies. Ushio Medical has already achieved remarkable results in technology development and application promotion.Future, will continue to explore this novel intrinsic fluorescence technologyEarly screening and diagnostic applications for indications such as endometrial cancer, bladder cancer, and colorectal cancer, expected to achieve breakthrough progress in 2024.
YesProduct MarketIn this regard, policy incentives, a market size of RMB 34 billion, and low market penetration all present market expansion opportunities for Ushio Medical. With its current comprehensive product portfolio, the company plans to, over the next three years,Developing Portable Diagnostic ProductsandAI-Enabled Intelligent Diagnostic Assistance SystemR&D registration, continuing to strengthen the in-depth application of this technology in gynecology, health examination institutions, and primary healthcare facilities.
With robust products that meet clinical needs and address technical pain points, and backed by an R&D team mastering core autofluorescence technology,Niuwei Medical is confident in covering over 3,000 healthcare institutions worldwide within the next three years and achieving annual sales exceeding RMB 500 million!