Whether admitted or not, women have played an increasingly important role in the workplace. As the focus of women's lives shifts from family to society, delaying the age of childbearing has become a helpless choice. But the years are not forgiving, and it is relatively difficult to get older. According to statistics, with the increase in the average age of pregnant women, 43% of pregnant families need more than 3 months from preparation to successful pregnancy.
Whether women can conceive is affected by many factors, the most important of which is the level of progesterone. The accuracy of traditional ovulation test strips, thermometers, etc. during use is questionable. For example, ovulation test strips use a fixed hormone threshold to determine ovulation, leading to false positive and false negative results. The thermometer has hysteresis, and the body temperature rises only after ovulation, while the thermometer can only detect half of the six easy-to-pregnancy days.
In addition, when women are pregnant, they can also judge based on progesterone levels. Because the ovulation time per month is not fixed, in other words, women cannot infer ovulation time based on experience. However, normal ovulation is the premise of female pregnancy, and timely control of their own hormone levels is a rigid need for pregnant women.
At present, accurate hormone levels can only be measured in large hospitals in a hospital setting. The hospital channel is difficult to become the first choice for women's pregnancy because of its high cost and low convenience.
Mira product images are provided by respondents
The Mira is a portable, intelligent, real-time diagnostic (POCT) system that is just the size of the palm. Unlike traditional household chemical test strips, which are subjectively judged by the human eye to determine the level of discoloration, Mira uses fluorescence immunoassay, which is the measurement method used by large instruments in hospitals.
In use, Mira will quantitatively determine the biomarker levels of LH, E3G, Progesterone, FSH, hCG, etc. in the urine of the user (covering 5 of the 6 markers in the hospital), thereby making hospital-level accuracy of ovulation time. , easy pregnancy date, ovarian reserve, fetal development, abortion aura, etc., to provide a one-stop solution for women.
Sylvia Kang, the co-founder of Mira, told the arterial network that after 400 clinical samples, the accuracy of Mira was 99%, and there was no significant deviation in common interfering substances in body fluid samples, with sensitivity and specificity up to 98%. And 95% or more.
At the same time, Mira products are all produced by themselves. In Hangzhou, there are more than 1000 square meters of clean workshops with GMP standards. There are more than 40 functional workshops certified by ISO13485 quality system to ensure the quality and stability of the products. It is reported that Mira has high sensitivity to fluorescence signal capture, the detection blank limit is as low as 0.63 mIU/mL, and the average intra-assay coefficient of variation is less than 11%.
Conmanman said that Mira has passed the US FCC, US FDA, European CE certification, and is currently applying for Class II medical device certification to CFDA, which is expected to be approved in the first quarter of next year.
In addition, Mira combines artificial intelligence with medical diagnosis. Through the individualized parameters of physiological indicators, Mira APP presents users with continuous optimization of visual analysis and prediction results, and provides individualized medical advice. It is reported that the Mira App can connect users and doctors, so that users' questions can be answered promptly and accurately by doctors, and doctors can easily obtain continuous and comprehensive data to give specific diagnosis and health advice.
Mira APP image courtesy of respondents
According to Conmanman, Mira's R&D team is located in Silicon Valley, USA and Hangzhou, China, for a total of 36 people. After three years of independent research and development, the Mira team has applied for 18 intellectual property rights, of which 6 have been approved. The Mira team is divided into three departments: immunology, instrument hardware and business. The department of immunology was led by Dr. Chang Xing, the instrument hardware section was led by Dr. Yang Zheng, and the business department was led by Kang Manman. Chang Xing is a postdoctoral fellow at Yale University, a doctoral supervisor at the Chinese Academy of Sciences, and a recipient of the “Young Thousand Talents Program†of the Central Organization Department. Yang Zheng is a postdoctoral fellow at the University of California, San Francisco. He worked for a biotechnology company in the Bay Area for many years, the latter 2014. Acquired by BMS in the year; Conmanman studied and worked in the United States after graduating from high school. He is an MBA from Cornell University and a master of bioengineering from Columbia University. He worked as a business director for Fortune 500 companies and was responsible for 100 million. Global sales of dollars.
According to Conmanman, Mira will be listed in the US, Europe and China from the third quarter of 2018. Mira currently uses content marketing in the United States, deploying social media, search engines, etc., and targeting brands in C-side users. Since its launch in September this year, Mira has achieved high conversion rates in the US market. In addition, based on the mature PBM system in the United States, To B is also an important marketing strategy for Mira in the United States. Mira's B-end users include hospitals, insurance companies, pharmaceutical companies, and large employers. Mira primarily associates with B-side users by providing data.
However, Conmanman emphasized to the arterial network that Mira's strategy in China and Europe will be different. Among them, when Mira enters China, the active community will be the main channel, because the active community can have the e-commerce attribute in China; in Europe, it will focus on the existing channels.
Conmanman said that Mira's final product vision is the home detection platform. As we continue to introduce women's health products, the follow-up will expand to chronic kidney disease and infectious disease detection functions, which will become Mira's main source of sales revenue in the later period. According to her, Mira is currently preparing to extend the test sample to the bloodstream and will be able to detect biomarkers in the blood by means of a micro-bleeding device.
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