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.

Vipoglanstat has reached the halfway point for patient recruitment in a phase 2 endometriosis trial.

Gesynta Pharma said 50 per cent of the target of 190 patients have been randomised in the NOVA trial.

The study is evaluating vipoglanstat, described by the company as a novel, non-hormonal, non-opioid drug candidate for the treatment of endometriosis.

Endometriosis is a chronic inflammatory condition where tissue similar to the lining of the womb grows outside the uterus, often causing severe pain and, in some cases, infertility.

The condition affects more than 10 per cent of women of reproductive age.

Top-line results from the study are expected in 2027.

The NOVA trial is a randomised, double-blind, placebo-controlled phase 2 proof-of-concept study evaluating vipoglanstat in women with endometriosis across Europe.

This means patients are assigned to treatment groups by chance, neither participants nor researchers know who receives the drug or placebo during the study, and the results are intended to show whether the treatment has enough evidence to move into later testing.

The trial is assessing the efficacy and safety of two dose levels of vipoglanstat and will provide information for the design of a subsequent phase 3 programme.

Eva Johnsson, chief medical officer and vice president of clinical development at Gesynta Pharma, said:

“Reaching the halfway point in patient recruitment marks a major milestone for our Phase 2 clinical trial in endometriosis. Achieved well ahead of schedule, the rapid progress reflects strong participation from clinical sites and great interest among eligible participants. This momentum highlights the urgent need for better treatments.

“We are now eager to complete enrolment and proceed to the next phase of evaluation.”

Patric Stenberg, chief executive of Gesynta Pharma, said:

“The NOVA trial is a significant advancement in a field with few ongoing clinical trials, and a key step toward establishing a strong foundation for a future Phase 3 programme for vipoglanstat.

“Given the immense medical need, our focus remains on delivering a treatment that is highly effective, safe, and well-tolerated.”

Vipoglanstat is an orally active drug candidate designed to reduce pain and inflammation by targeting mPGES-1, an enzyme that produces prostaglandin E2, a substance linked to inflammation in endometriotic lesions.

A preclinical proof-of-concept study in an advanced endometriosis model found that vipoglanstat significantly reduced pain-related behaviours and endometriotic lesion burden.

Gesynta said previous clinical studies have supported the drug candidate’s safety, tolerability and pharmacodynamic effects in humans. Pharmacodynamic effects refer to how a drug acts in the body.

NOVA stands for the Non-hormonal Option, a Vipoglanstat Assessment trial.

Endometriosis commonly presents with severe period pain, known as dysmenorrhoea, pain between periods, pain during sexual intercourse, gastrointestinal symptoms and infertility.

Current management is typically limited to painkillers, hormonal therapies and surgery.

Despite its prevalence, Gesynta said endometriosis remains a critically underserved area of women’s health.

The company said the disease is significantly underdiagnosed and undertreated, with few new treatment options available to patients.

Approximately 190 patients aged 18 to 45 will receive vipoglanstat or placebo over four menstrual cycles.

The primary objective is to evaluate the effect of vipoglanstat on endometriosis-related pain during non-menstrual days.

Secondary objectives include assessing the effect on menstrual pain, known as dysmenorrhoea, pain during sexual intercourse, known as dyspareunia, use of opioid rescue medication and quality-of-life measures.

Changes in endometriotic lesions, areas of tissue linked to the condition, will also be explored using MRI scans.

Gesynta Pharma said its research on targeting mPGES-1 began at Karolinska Institutet in Sweden.

The company said a second drug candidate, GS-073, is ready to enter clinical phase 1 for the treatment of chronic inflammatory pain.

Gesynta Pharma’s shareholders include Hadean Ventures, Industrifonden, Innovestor Life Science, Linc, HealthCap, XGen Venture and other specialist investors.

A weight loss jab may improve fertility outcomes in women with PMOS, early findings from an ongoing clinical trial suggest.

The proof-of-concept analysis found that injectable semaglutide may offer reproductive benefits while also addressing obesity and metabolic dysfunction.

It is the first report to examine how injectable semaglutide may improve reproductive outcomes in women with PMOS while also addressing obesity and metabolic dysfunction.

The work forms part of the ongoing RESTORE clinical trial.

Melanie Cree, professor at CU Anschutz and first author of the report, said: “Women with PMOS frequently face a frustrating choice between treatments that target reproductive symptoms and those that address metabolic health.

“Our early findings suggest injectable semaglutide may have the potential to improve both, offering a more comprehensive approach to care.

“This medication is incredibly promising when someone responds with 10 per cent weight loss.”

The trial is examining whether semaglutide can restore ovulation and improve reproductive health in adolescents and adults with polyendocrine metabolic ovarian syndrome, known as PMOS.

PMOS, formerly known as polycystic ovary syndrome or PCOS, is a hormone and metabolic condition linked to irregular periods, raised testosterone levels, infertility risk, obesity and increased cardiometabolic disease.

Cardiometabolic disease refers to conditions linked to the heart and metabolism, such as heart disease, high blood pressure and type 2 diabetes.

Existing treatments, including metformin and hormonal contraceptives, often do not fully address reproductive and metabolic complications at the same time.

The analysis focused on participants aged 12 to 35 who lost at least 10 per cent of their body weight during treatment.

Researchers said reproductive improvements appeared earlier than expected, prompting them to report preliminary findings while the wider study continues.

Cree is also a paediatric endocrinologist at Children’s Hospital Colorado.

Endocrinologists are doctors who specialise in hormones and hormone-related conditions.

Cree said: “What makes this work particularly important is that it focuses specifically on women with PMOS receiving injectable semaglutide.

“Although GLP-1 medications have transformed obesity treatment, there remains a significant need for rigorous data examining how these therapies affect fertility and reproductive function in this population.”

The RESTORE study is evaluating semaglutide treatment in girls and women with PMOS and obesity.

Its broader aim is to determine whether weight loss and metabolic improvements can restore ovulation and improve reproductive outcomes.

Ovulation is the release of an egg from the ovary, a key part of the menstrual cycle and fertility.

The authors said the findings are from an early proof-of-concept analysis and that larger, longer-term studies will be needed to confirm whether the reproductive benefits last.

The findings suggest injectable semaglutide may become a treatment option for women with PMOS seeking improvements in both metabolic and reproductive health, if future studies confirm the results.