Regulatory Pathway Neuraura aims to launch an over-the-counter device under an FDA 510(k) pathway with a pelvic pain application as the initial use, presenting a clear entry point for early adopters and payer conversations while planning broader PCOS and insulin resistance indications.

Underserved Market PCOS affects over 10% of women and is a leading cause of infertility and premature diabetes; the market is under-researched and under-funded, indicating strong unmet needs and potential for rapid uptake once an effective, affordable device is available.

Product Strategy Initial non-prescription, affordable device to augment natural body processes, followed by targeted clinical studies and user data to broaden claims to insulin resistance and other PCOS aspects, creating a staged value proposition for upsell and premium devices.

Strategic Partnerships Small-scale clinical work and real-world user data collection create opportunities to partner with clinics, wellness providers, and payers for reimbursement pathways as claims expand, accelerating market access and credibility.

Growth Readiness Lean team with external scalability potential aligns with staged product launches and potential premium device development for pre-diabetes/diabetes, offering clear upsell paths and cross-sell opportunities within women's health tech.