Press Release: April 24, 2020
Mira Fertility is launching the first FDA and CE registered numeric estrogen and Luteinizing hormone test
New at-home tracking solution detects full fertile window with >99% Accuracy
April 13, 2020 – The hormone estrogen is a key component in understanding reproductive health and an integral part of the fertility process. Tracking both Luteinizing hormone and estrogen allows the detection of a full fertile window and ovulation. These hormone levels are related to IVF, menopause, as well as hormone imbalances such as PCOS, and other conditions. Bay Area-based company Mira offers the first at-home solution that gives an actual number of both hormones, which is important for millions of women with variable cycles and hormones imbalance.
Mira Fertility Plus the second product released from Mira Fertility. This personalized ovulation monitoring system helps couples conceive using a highly accurate Fluorescent-based test of the hormones. Since the launch in January 2018, thousands of women have used Mira to get pregnant or avoid pregnancy. New Mira Plus Wands works with the original Mira analyzer. It makes this Analyzer a one-stop solution for a complete picture of the reproductive cycle and health. Later this year Mira plans to expand the line to measuring progesterone, hCG, FSH as well as analysis for ovarian reserve, fetal health and miscarriage, menopause and hormone imbalances.
During this uncertain time, Mira’s mission to empower women to have a better understanding of their own health is even more important. Many fertility treatments were canceled and postponed. Having a solution like Mira that shows the full fertile window by tracking actual hormone levels can increase chances to get pregnant naturally almost twice according to a recent study. Mira provides insights into how our body works and helps with making decisions in the comfort of your own home vs. going to the doctors, with comparable lab-grade accuracy.
Emerging FemTech companies like Mira are trying to help women track, understand, and act on their personal data. FemTech is still a largely underserved market with huge opportunities for growth. By some estimates, FemTech could become a $50 billion industry by 2025. At-home solutions for tracking hormones with greater accuracy enables more opportunities for preventative medicine and diagnosis as virtual care and telemedicine are skyrocketing adoption. Hormones are in tight connection with our immune system and body. They deliver messages to organs and tell them what to do. Even small hormonal imbalances can lead to noticeable changes.
“It is important to know a woman’s cycle is more than just ovulation. The hormone regularity, profile and trend are strongly related to a woman’s health in general,” Said Sylvia Kang, co-founder, and CEO of Mira. “We want to arm women to know their bodies, become aware of any issues early, and ease the process of getting pregnant or avoiding pregnancy. Knowledge is power and being able to run analytics on your own health helps to make the right decisions and be proactive, which is a much needed complementary to mainstream medicine.
ABOUT MIRA FERTILITY
FDA and CE-registered, Mira’s first product, Mira Fertility, is the first at-home Fluorescent Immunoassay test for women, detecting the Luteinizing hormone (LH) peak, which indicates the beginning of ovulation. The Mira Fertility Analyzer and disposable test wands leverage the power of a high-precision fluorescent-based test to provide accurate and reliable fertility tracking, delivered right to the Mira App.
Currently, all hormone-based fertility trackers on the market estimate ovulation based on a fixed hormone threshold. Mira is the only personalized ovulation monitoring system that measures the numeric hormone concentration of each woman, just like how it is done in a hospital lab. Because every woman is unique, the quantitative hormone data that Mira provides is extremely useful for people with irregular cycles, PCOS, and hormone imbalances. Regular Ovulation Prediction Kits (OPK) detect ovulation based on a static LH value, which causes many false results and missed ovulation peaks. This means Mira shows the actual hormone levels and the hormone curve, while OPK determines ovulation based on the population average.
By combining hormonal concentration and menstrual pattern tracking with machine learning algorithms powered by artificial intelligence, Mira Fertility has the capability to personalize cycle prediction, health data interpretation, and behavior guidance to each woman based on the individualized analysis. Only 2.6 inches in width, the Mira Analyzer provides personalized, lab-grade accuracy in a palm-sized device.
Mira Fertility was created through years of research in direct response to the increased challenge of getting pregnant due to women’s professional development and delayed maternal age. 43% of women take several months to conceive, and there is currently a lack of accurate and reliable at-home aid. After completing clinical trials involving more than 400 patient samples, Mira Fertility achieved >99% accuracy rate in detecting hormone concentrations when compared with hospital-grade lab equipment and provided the $24B women’s health and chronic disease monitoring market with a hospital leveled technology for safe, at-home use.
Mira Fertility is available for purchase worldwide. Consumers can purchase the Mira Fertility Starter Kit at $199 which includes the Mira Analyzer and 10 Fertility Test Wands. Additional Fertility Test Wands are available for purchase in packs 20.
ABOUT MIRA FERTILITY PLUS
The Mira Fertility Plus wands measure both numeric estrogen and LH hormones. New Mira Plus Wands work with the same Analyzer that Mira has. The Mira Fertility Plus consists of Mira Fertility Plus Wands that sample urine, a palm-sized and USB-charged Mira Analyzer device, and a smartphone app that uses cloud-based AI to personalize fertility cycle analysis. Users simply insert one of the disposable Mira Fertility Wands, after sampling a urine sample, into the Mira Analyzer’s test slot. Users will use approximately 10-15 Mira Wands per cycle.
The Mira Analyzer reads the fertility hormone level and displays on the analyzer’s display screen the numeric hormone concentrations. It then sends the user’s personal quantitative hormone levels to the accompanying app, which analyzes the data by the AI on the cloud and automatically tracks and predicts the individual’s cycle health.
THE FUTURE OF MIRA SYSTEM
As the next step, Mira is launching Progesterone tests later this year, which will expand the product line. By combining Estrogen and Progesterone tests with the already existing LH test, these hormones together provide more insightful data into the users’ fertile window, cycle phases, and deeper health insights.
Aside from championing a comprehensive women’s health home monitoring platform, Mira plans to expand the systems’ AI-powered analysis and tracking capabilities into chronic disease testing including infectious disease, kidney health, thyroid hormones, gout, and general wellness monitoring such as weight loss and stress management.
For more information on Mira and to receive updates on the future of Mira System, please visit miracare.com.
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