10161762Feasibility Study of an Intermittent Hormone Monitoring device - a groundbreaking, minimally invasive wearable biosensor allowing at-home monitoring of hormones.ActiveFeasibility StudiesInnovate UK**Hormones regulate almost every physiological process in the body**. For women, they are particularly volatile and complex, underlying critical stages and conditions such as puberty, fertility, PCOS, and menopause. Yet hormone monitoring remains outdated, reliant on venous blood draws, a clinic-bound, invasive method that captures only static snapshots and often misses the fluctuations that matter most. This limitation affects millions of women, yet clinical protocols remain rudimentary, often based on symptoms alone. PCOS, which impacts 1 in 10 globally, is characterised by irregular and imbalanced hormone levels. In the UK, PCOS-related care costs the NHS an estimated **£400 million annually**, driven by diagnostic delays and long-term complications. Menopause, experienced by over **13 million UK women,** is still typically managed without regular hormone monitoring, due to the difficulties of frequent blood draws, leading to under-treatment, misdiagnosis, and NHS costs £100Ms. This is especially problematic in fertility treatments like IVF and egg freezing, where hormone levels shift rapidly and must be tracked precisely. Patients typically need blood tests every 1--3 days, **involving clinic visits, long waits, and discomfort**. Results take 12--36 hours, **delaying key decisions like dose adjustments or procedure timing**. This lag **increases the risk** of mistimed interventions, potentially lowering success rates despite cycle costs of £5,000--£8,000\. For clinics, repeated visits **strain lab capacity, staff time, and patient capacity**. Level Zero Health is developing a groundbreaking wearable biosensor that delivers **real-time, clinical-grade hormone data through a minimally invasive patch**. By sampling interstitial fluid, which mirrors blood, and using highly specific aptamers, it provides lab-quality results without the need for blood draws enabling comfortable and remote monitoring. This feasibility R&D project will validate our technology in women, assessing correlation with blood assays, accuracy, specificity, and the ability to track hormonal peaks and troughs. Results will guide refinement, regulatory planning, supporting commercialisation. The most **critical step** now is to demonstrate technical feasibility in women, marking the first milestone towards a new minimally invasive standard for hormone monitoring We will start with IVF, where integration into clinical workflows can deliver immediate impact for both clinicians and patients. However, **the long-term potential is far, far greater**. For PCOS, menopause, and a wide range of hormone-related conditions, this technology will finally **generate the data needed to drive a step-change in women's health research and care.** This is the kind of innovation the field needs: a foundational platform to revolutionise how hormones are understood, monitored, and managed.