Diagnosis
Round up: Restoring immunity in menopausal women with HRT and more
Femtech World explores the latest research developments in the world of women’s health.
Phase 2 trial of non-hormonal endometriosis treatment completed
Hope Medicine has completed a global Phase 2 study evaluating the safety and efficacy of non-hormonal endometriosis treatment – HMI-115.
HMI-115 is a monoclonal antibody that blocks the prolactin receptor, and is a potential first-in-class treatment for endometriosis.
This study included 108 female patients with surgically diagnosed endometriosis in the US, Poland and China.
According to the company, the treatment demonstrated statistically significant improvement of endometriosis associated pain.
HMI-115 was well-tolerated with no treatment-related serious adverse events.
Specifically, at the end of the study treatment, the least-square-mean dysmenorrhea pain score was reduced by 42 per cent in the 240 mg q2w group, compared to that of the baseline.
The least-square-mean non-menstrual pelvic pain score was reduced by 52 per cent.
These reductions are statistically significant. No typical peri-menopausal symptoms were reported.
There were no significant changes in menstrual patterns, bone mineral density and sex hormone levels including estradiol, LH, FSH and progesterone.
Lan Zhu, director of gynecology at Peking Union Medical College Hospital and leading investigator of the study, said: “HMI-115 relieved endometriosis pain in women without disturbing their sex hormones.
“It can potentially shift the treatment paradigm.
“We will be able to treat women without menopausal side effects or even infertility.”
Nathan Chen, CEO of Hope Medicine says that the company is now communicating with key regulatory agencies, including FDA and NMPA, to finalise the Phase 3 protocol and to initiate global Phase 3 studies.
Hormone replacement therapy may help restore immunity in menopausal women
Hormone replacement therapy (HRT) may help reverse changes in the immune system caused by menopause, potentially booting immune health, a new study has found.
The research reveals new evidence that menopause significantly alters women’s immune system, increasing their vulnerability to infections.
The study is the first detailed analysis of how ageing and sex differences influence monocytes, a key group of immune cells that act as the body’s first responders to infection.
Analysing blood samples, the team found that after menopause, women develop more inflammatory types of white blood cells called monocytes, which are less effective at clearing bacteria.
These changes were linked to lower levels of complement C3, an immune protein that helps monocytes engulf and destroy harmful microbes.
In contrast, men of the same age did not show these changes, suggesting menopause has a uniquely disruptive effect on female immunity.
To test whether hormone therapy could influence this decline, the researchers studied peri-and post-menopausal women taking HRT.
They found that these women had healthier immune profiles, with fewer inflammatory monocytes and stronger infection-fighting ability as compared to age-matched controls.
Levels of complement C3 in their blood were also higher in those taking HRT, bringing them close to the immune status of younger women.
HRT is already prescribed to manage symptoms, but this study suggests it may also help maintain immune health and reduce infection risk in later life.
The researchers caution, however, that more work is needed to confirm whether HRT reduces real-world infection rates, and to understand how different formulations or delivery methods affect the immune system.
The authors caution that while the findings are promising, the study does not mean HRT should automatically be prescribed for immune health.
More research is needed to confirm whether women taking HRT have lower infection rates in real-world settings, and to investigate how different types and route of HRT administration may affect the immune system.
New imaging technique helps us understand how eggs mature and ovaries age
The ticking of the biological clock is especially loud in the ovaries — the organs that store and release a woman’s eggs.
From age 25 to 40, a woman’s chance of conceiving each month decreases drastically.
For decades, scientists have pointed to declining egg quality as the main culprit.
But new research from UC San Francisco and Chan Zuckerberg Biohub San Francisco shows that the story is bigger than the eggs: The surrounding cells and tissues of the ovary play a crucial role in how eggs mature and how quickly fertility wanes.
Understanding these changes may hold the key not only to extending fertility, but also to improving health.
The risks of many age-related diseases rise after menopause or ovary removal, and slowing ovarian aging could help reduce these risks.
The team set out to profile what normal ageing looks like in the ovaries of mice and humans.
First, they developed a new three-dimensional imaging technique that allowed them to visualise eggs in the ovaries without having to slice the organs into thin layers, as had been done before.
In mice that were the equivalent of 30 to 40 human years, they observed a dramatic drop in both immature resting eggs that are waiting in reserve and in growing eggs that are beginning to mature for ovulation.
And just like women in their 30s, the mice did not conceive easily with in vitro fertilisation (IVF).
When the scientists extended their 3-D imaging to human ovaries, they uncovered an unexpected finding: Eggs are not evenly scattered throughout the ovary.
Instead, they cluster in “pockets” surrounded by egg-free zones. With age, the density of eggs within these pockets declines.
“This was a surprise, we assumed eggs would be distributed more evenly based on what we see in the developing ovary,” said Laird, who is a Biohub investigator and a member of the Eli and Edythe Broad Center for Regeneration Medicine at UCSF.
“These pockets suggest that even within one ovary, the environment around an egg may influence how long it lasts and how well it matures.”
Next, the researchers teamed up with Neff’s group at the Biohub to study what genes were active in ovary cells as they aged.
Ovarian tissue from humans is hard to come by, and eggs are large and incredibly fragile.
So, instead of using standard miniature devices that separate and tag cells to sequence their active genes, the group painstakingly isolated individual eggs by hand to separate them from other cells.
After studying nearly 100,000 mouse and human cells, they identified 11 major cell types found in the ovaries, including one surprise: Glia, a type of support cell typically associated with nerves and most extensively studied in the brain, were in the ovaries.
At the same time, the study revealed that sympathetic nerves, the same nerves involved in the “fight or flight” response, form dense networks in ovaries that become even more dense with age.
When the researchers ablated these nerves in mice, the animals had more eggs in reserve but fewer that matured, suggesting the nerves help decide when eggs start growing. Together, the observations on glia and sympathetic nerves suggest a new role for the nervous system in ovarian health.
Other support cells called fibroblasts also changed with age, triggering inflammation and scarring in the ovaries of women in their 50s, years earlier than such scarring appears in organs like the lungs or liver.
“This all points to a brand-new line of inquiry about how nerves, blood vessels, and other cell types communicate with eggs,” Laird said.
“It tells us that ovarian ageing is not just about the egg cells but about their whole ecosystem.”
The new roadmap of healthy ovaries over time offers a starting place to ask how ovarian aging changes in different situations.
The team is already launching studies probing whether some drugs could change the timing or speed of ovarian aging, she said.
Ultimately, they hope to uncover ways to slow or delay ovarian aging, to impact both fertility and other diseases, like cardiovascular disease, which are common in women after menopause.
“The fountain of youth may actually be the ovary,” said Eliza Gaylord PhD, a postdoctoral fellow at UCSF who is co-first author of the study.
“Delaying ovarian ageing could promote healthier aging overall.”
Hormonal birth control can influence emotions and memory
A new study shows that hormonal contraceptives appear to shape how women experience emotions in the moment and how they remember emotional events later.
Researchers compared women using hormonal contraceptives with women who were naturally cycling.
Participants viewed positive, negative and neutral images while applying different emotion regulation strategies, such as distancing, reinterpretation or immersion, and later completed a memory test.
Women on hormonal contraceptives showed stronger emotional reactions compared to naturally cycling women.
When they used strategies like distancing or reinterpretation, they remembered fewer details of negative events, though their general memory remained intact.
In other words, they could recall the overall event but not all of the specifics. That gap may actually be helpful, allowing women to move on instead of replaying unpleasant details.
Strategies like immersion boosted memory for positive images in both groups, making happy moments stick more clearly.
The findings add weight to a question many women have had but few studies have answered: How does birth control affect not just the body but the mind?
Emotion regulation and memory are tied to mental health outcomes such as depression, and this research suggests hormonal contraceptives may influence those processes in subtle but meaningful ways.
The researchers plan to expand the work by studying naturally cycling women across different menstrual phases and by comparing types of hormonal contraceptives, such as pills versus IUDs.
A new reporting tool built specifically for obstetrics and maternal-fetal medicine has launched, aimed at teams managing increasingly complex pregnancies with limited time and resources.
Trice Imaging has released Trice Workspace Reporting, which connects imaging, reporting and longitudinal patient data in a single workflow to support faster clinical decision making.
Birth rates are falling worldwide, but pregnancies are getting more complicated. Advanced maternal age, IVF-assisted pregnancies, rising obesity rates and a higher prevalence of hypertension and diabetes mean more cases now require specialist monitoring, advanced imaging and multidisciplinary care.
At the same time, clinical teams are stretched and facing growing administrative demands.
Trice Workspace Reporting brings together customisable reporting, dynamic pregnancy dating and longitudinal patient history with an AI-ready, EHR-interoperable infrastructure, all inside the company’s Tricefy image management platform.
The company says it aims to accelerate standardised and synchronised report turnaround, support timely clinical decisions and improve operational efficiency for fetal medicine services.
“Maternal fetal medicine teams are managing increasingly complex pregnancies while being asked to do more with limited time and resources,” said Mark A. Samii, chief revenue officer at Trice Imaging.
“Trice Workspace Reporting is designed to remove unnecessary friction from reporting by creating a structured digital foundation that supports today’s need for connected clinical workflows.
“It also provides a digital foundation as practices prepare for tomorrow and the evolution of AI-enabled fetal assessment, anomaly detection and outcome prediction technologies.”
Trice Imaging describes its mission as transforming the women’s health journey by connecting physicians, patients and healthcare systems. From independent practices to large hospital ecosystems, it aims to reach the entire women’s health continuum, spanning IVF and reproductive health, maternal-fetal medicine and OB/GYN, and onwards to lifelong women’s health.
For more than 17 years the firm has worked on cloud-based storage, retrieval, display, organisation and exchange of ultrasound medical images and associated information across health environments.
Its wider platform now extends to dynamic clinical reporting, AI-driven workflow optimisation, data analytics and secure patient engagement.
Trice Imaging holds regulatory and data protection clearances in 40 countries. It has offices in Miami and Stockholm, alongside a growing network of global distributors.
Two endometriosis tests could cut years from diagnosis after NICE backed their temporary NHS use in England and Wales.
EndoSure and Endotest have been recommended in draft guidance, with one able to provide results in 45 minutes.
Endometriosis affects around one in 10 women of reproductive age. It occurs when tissue similar to the womb lining grows elsewhere, including around the ovaries and fallopian tubes.
Symptoms can include painful periods, painful bowel movements, pain when urinating and pain during or after sex.
Diagnosis can involve ultrasound scans, magnetic resonance imaging (MRI) or laparoscopy. A laparoscopy is keyhole surgery in which a camera is inserted through a small cut in the abdomen.
Despite the effect the condition can have on physical and mental health, women can wait years for a diagnosis.
The average wait in the UK is nine years and four months, rising to 11 years for women from ethnically diverse communities, according to the National Institute for Health and Care Excellence (NICE).
Long waits can increase suffering, prolong poor health and allow the condition to progress, making it more difficult to treat.
Dr Anastasia Chalkidou, NICE’s healthtech programme director, said: “A diagnosis of endometriosis can for some women take the best part of a decade, with the UK average standing at nine years and four months, and rising to 11 years for those from ethnically diverse communities.”
She said delays could lead to chronic pain affecting daily life, relationships and work.
She added: “These technologies have the potential to change that by giving primary care professionals better non-invasive tools to identify endometriosis earlier, allowing earlier and better treatment.
“Our draft guidance reflects our commitment to getting promising innovations to patients quickly, while making sure the evidence to support their wider use is built in a rigorous way.”
Endotest examines a saliva sample for microRNAs, tiny biological markers that can indicate the presence of endometriosis.
The sample is sent to a laboratory and the result returned to a GP or another healthcare professional to inform the next steps in diagnosis and care.
EndoSure uses sensor pads placed on the abdomen to measure electrical signals in the gut.
Women must fast for between six and eight hours before the 45-minute test. During the procedure, they drink water until they feel full, helping the device record gut activity accurately.
Results are available as soon as the test is complete.
The draft recommendation, published on Tuesday, approves both technologies for three years while further evidence is collected on how well they work.
NICE will then decide whether to approve them permanently for NHS use.
NICE said a third test, DotEndo, needs more research before it can be recommended.
EndoSure and Endotest are not designed to diagnose the condition on their own.
They are intended for women whose symptoms still suggest endometriosis after a normal clinical examination and negative or inconclusive imaging results, or when imaging has not been carried out.
Dr Gail Busby, a consultant gynaecologist at Manchester University NHS Foundation Trust, said: “These tests are a gamechanger because they give us answers much earlier, without the need for invasive surgery, and that means we can start the right treatment sooner.
“An earlier diagnosis doesn’t just change one person’s life, it frees up appointments and surgical slots for everyone waiting for care.”
Emma Cox, of Endometriosis UK, welcomed the tests.
She said their introduction should be supported by education for GPs and nurses to ensure prompt access and prevent symptoms from going unrecognised.
Xella Health has launched what it calls the first AI precision health platform built for the XX chromosome.
The company says it aims to address a lack of diagnostic precision and clinical research focused on female biology.
Women make up half of the population and account for 80 per cent of consumer healthcare decisions, but research into women’s health has historically received less funding than male-focused studies.
Kelly Lacob, Xella Health co-founder and chief executive, said: “Women have been trapped in a diagnostic dark age experiencing debilitating symptoms like severe period pain, bloating and GI issues, exhaustion, and brain fog, routinely dismissed by the healthcare system.
“This dismissal results in women being diagnosed four years later than men, on average, for the same conditions, and a seven-to-10-year delay for women to receive an accurate diagnosis for conditions like endometriosis.
Stalling necessary care and treatment results in prolonged suffering with chronic pain, heightened infertility risks, and declining mental health.
Xella is here to replace the systemic medical gaslighting women have endured for generations.
We are handing women the evidence and information they need to advocate for themselves and secure faster, accurate diagnoses before early-stage conditions spiral.”
Xella says its AI examines billions of data points from clinical information and multi-omic biomarkers to assess the probability of more than 130 conditions specific to female biology.
Multi-omic data combines information from several biological areas, including genes, proteins and hormones.
The conditions assessed include polyendocrine metabolic ovarian syndrome, or PMOS, formerly known as polycystic ovary syndrome, as well as perimenopause and endometriosis.
Xella was founded by Lacob, Adriana Dantas and Dr Jesus Ching, who developed the concept while working together on molecular diagnostics at Mammoth Biosciences.
The founders say the platform is designed to provide information about possible underlying causes through advanced testing and long-term care of a kind often available only through expensive concierge services.
They drew on personal experiences to build a service intended to identify small changes in a woman’s biological baseline.
Members complete an initial health questionnaire before having blood taken at a local partner laboratory such as Quest or Labcorp.
A phlebotomist can also visit a member’s home for an additional charge.
The company’s AI analyses biomarker data from genomics, proteins and hormones alongside symptoms, lifestyle risks and medical history.
Xella says this information is used to screen for more than 130 female-specific conditions, including PMOS, Hashimoto’s disease, premenstrual dysphoric disorder, endometriosis and perimenopause timelines.
Hashimoto’s disease is an autoimmune condition in which the immune system attacks the thyroid gland.
Premenstrual dysphoric disorder, or PMDD, is a severe form of premenstrual syndrome that can cause significant emotional and physical symptoms.
The results are processed through Xella’s own dry laboratory, which the company says is certified under the US Clinical Laboratory Improvement Amendments and accredited by the College of American Pathologists.
A dry laboratory analyses data using computing and other non-experimental methods rather than carrying out traditional laboratory procedures.
The findings are turned into a personalised healthcare plan and reviewed with a certified telehealth doctor.
The doctor may recommend immediate clinical action, including personalised hormone therapy or referrals to genetic counsellors, pelvic floor physiotherapists and reproductive endocrinologists.
Reproductive endocrinologists are doctors who specialise in hormones, fertility and reproductive health conditions.
Dantas, co-founder and chief operating officer, said: “Women’s health data has historically been treated in isolated silos – a hormone test here, an ultrasound there – but no one was connecting the dots across the entire biology.
“By tracking unique biological patterns longitudinally across cycles and life stages, we aren’t just providing data, but a clear path forward.”
Xella’s clinical advisers include Dr Allison Kurian, director of Stanford Women’s Clinical Cancer Genetics Program and professor of medicine, epidemiology and population health at Stanford.
They also include Dr Lynn Westphal, a reproductive endocrinology and infertility specialist and chief medical officer of Kindbody.
Xella has received US$4.7m in angel and pre-seed funding from Precursor Ventures, Capital F, Ulu Ventures and Swizzle Ventures.
Other funds and angel investors from healthcare, diagnostics and consumer technology also participated.
Margaret Coblentz, co-founder and general partner of Capital F, said: “Women’s health is one of the highest-momentum categories in the market today, driven by a US$15tn female economy.
“Xella represents exactly how Capital F sees women’s health evolving: deep clinical expertise paired with a consumer-first mindset, and a genuine opportunity to unlock the next generation of healthcare.”
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