Fertility
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.
Onto Health has acquired Levy Health, a fertility software company providing precision diagnostics and patient intake for reproductive medicine.
The acquisition, fuelled by Onto Health’s US$20m Series A fundraise in April, supports its plan to build scalable, tech-enabled infrastructure for reproductive medicine.
Onto founder Roohi Jeelani, MD, called it the first of several moves in the company’s expansion strategy in a LinkedIn post, adding that there was “more coming soon”.
She said: “This isn’t just an acquisition, it’s proof of how we’re building Onto: physician-led, tech-enabled, and built to scale without losing the personal touch fertility patients deserve.”
Headquartered in Chicago, Onto Health combines evidence-based fertility care with artificial intelligence-driven diagnostics, clinical automation and longevity science.
AI-driven diagnostics use software to analyse patient information and support clinical decision-making, rather than replace clinicians.
Levy Health, founded in Berlin with US offices in San Francisco, helps medical providers identify endocrine disorders more quickly and helps clinics streamline fertility workups.
Endocrine disorders affect the body’s hormone system, which can influence ovulation, menstrual cycles and fertility.
Co-founder Caroline Mitterdorfer said joining Onto would expand Levy Health’s fertility care tools to more clinics and patients, helping physicians focus on patient care.
Onto opened its first clinic in Chicago in February, with plans for three more in the greater Chicago area.
The company said in April that it would use its new funding, led by Artis and Humania, to support additional operations in the US and expand into the Gulf Cooperation Council.
The Gulf Cooperation Council includes six Arab states bordering the Persian Gulf.
Softening ageing ovaries could help women remain fertile for longer, early animal research suggests.
Fertility declines with age for several reasons, including poorer egg quality, fewer ovarian follicles and the gradual stiffening of ovarian tissue.
Existing fertility treatments, including hormone therapy and in vitro fertilisation, mainly address hormonal imbalances or help eggs mature or become fertilised.
Scientists are now examining whether changing the physical structure of the ovaries could provide another route for future fertility treatments.
Stuart A. Cook, of the Cardiovascular and Metabolic Disorders Programme at Duke-National University of Singapore Medical School, published an accompanying commentary on the research.
Researchers led by Shixuan Wang at Huazhong University of Science and Technology in Wuhan, China, collected healthy ovarian tissue from younger, middle-aged and older women.
They also examined samples from patients with polycystic ovary syndrome, known as PCOS, premature ovarian insufficiency, or POI, and endometriosis.
PCOS is a hormonal condition that can disrupt ovulation. POI occurs when the ovaries stop working normally before the age of 40, while endometriosis causes tissue similar to the womb lining to grow elsewhere in the body.
Tests of protein levels and gene activity found higher levels of the inflammatory protein interleukin-11, or IL-11, in ageing and diseased ovaries.
In laboratory experiments, the researchers exposed ovarian fibroblasts to IL-11. Fibroblasts are cells that produce connective tissue.
The protein caused the cells to produce excess collagen, a structural material that can build up during scarring and make tissue stiffer.
The researchers then genetically modified mice so they could not respond to IL-11. The animals developed less ovarian stiffening and maintained better ovarian function as they aged.
Similar results were seen in mouse models of PCOS and POI caused by chemotherapy.
In the final part of the experiment, older mice and rats were injected with a nanoparticle treatment containing small interfering RNA, or siRNA, designed to switch off IL-11.
The treatment made the animals’ ovaries less stiff and improved fertility.
Pregnancy rates among older mice rose from 25 per cent to 50 per cent, while average litter sizes also increased.
More rats treated with the therapy became pregnant and produced larger litters.
The approach remains highly speculative and will require considerably more research before its safety or effectiveness in women can be established.
However, the researchers said blocking the inflammatory pathway could eventually form the basis of new fertility treatments.
They said: “We propose that anti-IL-11 therapy represents a promising translational strategy for delaying ovarian ageing.”
W Group has opened applications for W Accelerate with Merck KGaA and M Ventures, inviting reproductive and maternal health startups, scaleups and spinouts to pitch for direct access to global pharma partnership and strategic investment.
Selected companies will pitch on 5th October, competing for the chance to accelerate their growth through commercial partnerships, investment, or both.
This is the third time Merck KGaA, a global leader in reproductive health, has partnered with W Group on the programme, which exists to close the innovation and investment gap in women’s health by connecting the sector’s most promising startups directly with the corporates and investors positioned to scale them.
What Merck KGaA and M Ventures are looking for
This year’s call is focused on breakthrough solutions in female infertility, fertility preservation, adenomyosis, endometriosis, polyendocrine metabolic ovarian syndrome (PMOS), ovarian insufficiency, preeclampsia and pregnancy comorbidities.
New for this round, applicants choose between three pathways depending on what they need from the programme:
- The Partnership Lane, for companies seeking commercial collaborations and strategic relationships
- The Investment Lane, for founders looking to connect with investors and secure funding to scale
- The Dual Lane, for innovators pursuing both partnership and investment opportunities
How the Accelerate event works
Selected companies get a 1:1 pitch practice session ahead of time, then a private 30-minute session with Merck KGaA and M Ventures leadership on the day itself, small-group sessions with regulatory and investment strategy experts, an “Ask Merck Anything” roundtable, and a VIP networking reception.
Key dates
- Open call launches: 8th July
- Open call closes: 2nd September
- Notification of successful companies: 11th September
- Pitch day: 5th October
Applications are open now at wplatform.typeform.com/to/KGzviBQM.
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