PCOS affects more than 10% of women, is the leading cause of female infertility, and leads to diabetes in more than half of sufferers before the age of 40. It is one of the most under-researched, under-served, and under-funded women’s health conditions. Neuraura is bringing to market the first effective, widely accessible treatment for PCOS as an over-the-counter, affordable device that augments the body's natural processes rather than just masking the symptoms. We are entering the market through an initial application in pelvic pain leveraging a predicate regulatory code (NUH) under an FDA 510(k) pathway. Once in market, we will escalate the device claims to the treatment of insulin resistance and other aspects of PCOS, leveraging targeted small-scale clinical studies as well as user data. Longer term, we will develop a premium, reimbursed device for the treatment of pre-diabetes and diabetes.
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