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Impli, a startup working with innovations from ÌìÃÀ´«Ã½, has been awarded a £1.4 million grant to begin clinical use of a continuous hormone monitoring patch for infertility treatment.

Timing is crucial for in vitro fertilisation (IVF), the most common form of infertility treatment, yet the way most patients are monitored falls far short of what biology demands. Currently, most women on IVF have blood drawn every other day at best. Hormones can shift significantly within hours, and in an ideal world clinicians would want several measurements a day to track those fluctuations accurately. 

This means that critical events such as the hormone surges that determine egg release, dips that cause implantation failure, or early signs of ovarian hyperstimulation syndrome are routinely missed. In a treatment with tragically low success rates, these uncertainties have real consequences for patient outcomes and wellbeing.

Continuous hormone monitoring has the potential to change the landscape of fertility treatment, both in terms of clinical care and patient experience. Sotirios Saravelos Imperial College Healthcare NHS Trust

The solution devised by , based on research by in the Department of Mechanical Engineering at Imperial, involves electrochemical biosensors that sample hormones in the fluid between the cells. These can either be in a subcutaneous implant or, in the Bio-Endocrine Analysis Monitor (BEAM) that Impli is currently testing, microneedles that pierce the skin. 

The biosensors continuously measure the hormones oestradiol, luteinising hormone and progesterone. The data collected is then transmitted wirelessly to a smartphone where AI algorithms convert raw signals into real-time hormone trends.

"Continuous hormone monitoring has the potential to change the landscape of fertility treatment, both in terms of clinical care and patient experience,” says , consultant gynaecologist and reproductive medicine subspecialist at the Wolfson Fertility Centre, part of the . “Rather than snapshots taken at fixed points in time, with Impli we will have access to a live feed of each patient's hormonal response, allowing us to personalise care in a way that has not been possible before.”

Mr Saravelos is part of the research consortium that has won a £1.4 million grant to take Impli’s BEAM device from prototype to its first human clinical validation for IVF.

The project was designed with the help of in the context of a PhD on how AI can support decision making for IVF. This was carried out at the at Imperial, a collaboration between the Department of Computing and the Department of Metabolism, Digestion and Reproduction. Dr Hanassab is now working part-time as Impli’s head of AI.

The grant comes from the National Institute for Health and Care Research Invention for Innovation programme. It will support a 30-month project that brings together Impli, Imperial College Healthcare NHS Trust, the London Institute for Healthcare Engineering at Kings College London and the patient advocacy network Fertility Europe. Specialist medical device manufacturer TTP is also involved.

We are not just building a device, we are building the evidence base to show that continuous hormone monitoring is possible, clinically meaningful and ready for the real world. Anna Luisa Schaffgotsch Founder and chief executive, Impli

BEAM is the first step in Impli's plan to develop a broader platform of fully implantable, long-duration monitoring systems.

“We are not just building a device, we are building the evidence base to show that continuous hormone monitoring is possible, clinically meaningful and ready for the real world,” says Anna Luisa Schaffgotsch, Impli’s founder and chief executive, who was also a biotechnology Master's student at Imperial. “With an exceptional consortium behind us, we now have the funding, the expertise and the clinical pathway to do that properly.”

According to the company, the same core technology has clear expansion potential for conditions such as hormonally driven cancers, polycystic ovary syndrome, endometriosis and menopause.

BEAM's development builds on over 15 years of biosensor research at Imperial, with intellectual property covering the approach to sensing, device architecture and novel data interfaces. To date, Impli has delivered three functional prototypes, completed pre-clinical trials in the laboratory and begun animal trials with positive results. It also has a strategic partnership with Bayer on real-time hormone biosensing, and strong relationships with IVF clinics around the world