Impli wins £1.4m for hormone patch

Impli has secured a £1.4m grant to begin clinical use of a real-time hormone patch for infertility treatment.

The startup, which is working with innovations from Imperial College London, is developing a continuous hormone monitoring system for use in in vitro fertilisation, known as IVF.

IVF is a fertility treatment in which eggs are fertilised outside the body before an embryo is transferred to the womb.

Timing is critical in IVF, the most common form of infertility treatment, but most patients are still monitored through blood tests taken every other day at best.

Hormone levels can change within hours, meaning important shifts may be missed.

These can include hormone surges linked to egg release, dips that may contribute to implantation failure and early signs of ovarian hyperstimulation syndrome.

Ovarian hyperstimulation syndrome is a potentially serious reaction to fertility medicines, where the ovaries over-respond and become swollen.

In a treatment with low success rates, these uncertainties can affect patient outcomes and wellbeing.

Impli’s system is based on research by Dr Salzitsa Anastasova in the department of mechanical engineering at Imperial.

The technology uses electrochemical biosensors to sample hormones in the fluid between cells.

These can be used in a subcutaneous implant, meaning one placed under the skin, or in Impli’s Bio-Endocrine Analysis Monitor, known as BEAM, which uses microneedles that pierce the skin.

Microneedles are tiny needles designed to enter the upper layers of the skin with minimal discomfort.

The biosensors continuously measure oestradiol, luteinising hormone and progesterone, which are hormones involved in the menstrual cycle and fertility treatment.

Data is transmitted wirelessly to a smartphone, where AI software converts raw signals into real-time hormone trends.

Sotirios Saravelos, consultant gynaecologist and reproductive medicine subspecialist at the Wolfson Fertility Centre, part of Imperial College Healthcare NHS Trust, said:

“Continuous hormone monitoring has the potential to change the landscape of fertility treatment, both in terms of clinical care and patient experience. 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.”

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

The project was designed with support from Dr Simon Hanassab as part of a PhD on how AI can support decision making for IVF.

The work was carried out at the UKRI Centre for Doctoral Training in AI for Healthcare at Imperial, a collaboration between the department of computing and the department of metabolism, digestion and reproduction.

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 bringing together Impli, Imperial College Healthcare NHS Trust, the London Institute for Healthcare Engineering at King’s College London and the patient advocacy network Fertility Europe.

Specialist medical device manufacturer TTP is also involved.

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

Anna Luisa Schaffgotsch, founder and chief executive of Impli, said:

“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. 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 could later have applications in hormonally driven cancers, polycystic ovary syndrome, endometriosis and menopause.

Polycystic ovary syndrome is a common hormonal condition that can affect periods, fertility and metabolism.

Endometriosis is a condition where tissue similar to the lining of the womb grows outside the uterus, often causing pain.

BEAM’s development builds on more than 15 years of biosensor research at Imperial, with intellectual property covering the sensing approach, device architecture and data interfaces.

Impli has so far delivered three functional prototypes, completed pre-clinical laboratory trials and begun animal trials, which the company said have shown positive results.

It also has a strategic partnership with Bayer on real-time hormone biosensing and relationships with IVF clinics internationally.