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Recession is looming, but it’s not all bad for femtech start-ups

Although opportunities in women’s health accelerate, investors remain cautious

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As the International Monetary Fund (IMF) is signalling the unofficial start of recession, digital health funding slows amid investment uncertainty.

The past six months have brought new challenges for both investors and entrepreneurs. With higher-than-expected inflation, global financial conditions are becoming tighter and the world economy is on the brink of facing one of its weakest years since 1970.

The outlook for the global economy has “darkened significantly” in recent months, said IMF chief, Kristalina Georgieva, predicting a tough 2022, and an “even tougher 2023”.

IMF officials announced that inflation was higher than forecast with prices in the US raising at a 40-year high of 9.1 per cent in June. In Britain inflation has jumped from almost zero during the pandemic to 9.1 per cent and is expected to top 11 per cent by October.

Although modest inflation can be attractive to consumer goods companies, very high inflation rates could make planning and investment decisions harder, analysts say.

Femtech has been a growing area of interest with funding reaching US$2.5bn in December 2021. However, experts believe that investment in the buzzy sector will slow down.

“Femtech is still a very immature market in many ways,” says Becky Warnes, business consultant and NHS advisor. “Getting tech into health systems is going to be very difficult for all start-ups, but particularly for those in femtech.”

According to data from the venture fund, Rock Health, digital health start-ups banked over US$29.1bn in 2021, but femtech companies enjoyed three per cent of the funding.

“Women’s health is a very specific investment vertical,” says Priya Oberoi, angel investor and founding general partner at Goddess Gaia Ventures. “However, women are starting to realise the need for differentiated health care and the demand is going up.

“We are in an era where entrepreneurship has been slightly glamorised and for that reason alone, more start-ups and entrepreneurs will emerge. The process will remain the same. What is going to change is the speed of the investment.”

Indeed digital health funding fell in the first half of 2022, according Rock Health, suggesting that a drop in funding could be caused by start-ups looking to trim costs and reduce positions.

The report has shown that investment fell significantly in the first quarter of 2022, with digital health start-ups raising US$6bn compared with US$7.3bn in the fourth quarter of 2021.

The funding slowdown means the environment is shifting and start-ups need to learn how to navigate the new economic landscape and adapt to competition.

“Investors will be willing to invest where there’s historical return on their investment and where there is going to be a real profit,” says Warnes.

“Femtech has certainly many values-driven driven businesses, but I think when it comes to putting money on the table, investors will look for start-ups with valid solutions to valid problems.”

For Tess Cosad, former research analyst and founder of the London-based femtech start-up, Bea Fertility, the economic consequences of the pandemic are complex.

“At the seed stage, we are all having to figure out how to contend with smaller rounds, lower valuations and longer runway.

“Any business that was going to take longer to get to profitability is now going to struggle to raise more capital. There is definitely potential for some incredible companies to come out of this and I’d love to see more investors ‘taking a risk’ and backing more women’s health companies.”

Oberoi advises entrepreneurs to start talking to investors earlier on.

“Make sure your pitch deck is very clear and that your lexicon illustrates what you are trying to solve with much more clarity. Find out what’s the economics of solving those problems and use those statistics to build a global picture.

“Start-ups are doing a brilliant job. Now they need to adapt and think more carefully about their numbers, their unit economics and ultimately, about what they are trying to achieve.”

 

 

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Most IVF add-ons not backed by reliable evidence, research finds

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Most IVF add-ons lack reliable evidence, with benefits either absent or inconclusive, the largest review of its kind has found.

More than 70 per cent of IVF patients in the UK, Australia and New Zealand reportedly pay for one or more additional treatments.

However, researchers found that most of the procedures, medicines and techniques had no effect on fertility or were backed by limited or low-quality evidence.

Unproven add-ons can also lead to false hope, greater financial strain and unnecessary medical procedures at an already difficult time for patients.

Dr Sarah Lensen, of the University of Melbourne, said: “In many countries, infertility care is largely provided by private clinics where IVF is highly commercialised, and some add-ons are extremely expensive.

“Our review finds a lack of evidence that most of the IVF add-ons we assessed provide any benefit to patients. Unproven add-ons can lead to false hope, greater financial strain and unnecessary medical procedures at what already can be a very difficult time for patients.”

Researchers said concerns have grown in recent years about potentially untrustworthy randomised controlled trials in reproductive medicine, including studies of IVF add-ons.

The team set out to review the effectiveness and safety of 10 commonly offered add-ons using trustworthy studies.

Researchers initially identified 157 potentially eligible randomised controlled trials but excluded 72 because of concerns about their reliability.

Randomised controlled trials compare treatments by assigning participants to different groups, helping researchers assess whether an intervention causes a particular outcome.

The team combined data from the remaining 85 trials in a meta-analysis, which brings together findings from several studies.

The review found no effect on fertility or inconclusive evidence for seven of the 10 add-ons examined.

These included acupuncture, which involves inserting thin needles into points on the body, and corticosteroids, medicines that reduce inflammation and suppress immune activity.

Endometrial receptivity testing was also not backed by reliable evidence. The procedure involves taking a sample from the lining of the womb to examine patterns of gene activity.

Another add-on was intralipid infusion, which delivers a fat-containing liquid into the bloodstream.

Researchers separately examined injections of platelet-rich plasma into the ovaries and infusions of platelet-rich plasma into the womb.

Platelet-rich plasma is made from a patient’s blood and contains a high concentration of platelets, which play a role in healing.

The seventh treatment was pre-implantation genetic testing for aneuploidy, which examines embryos to check whether they have the expected number of chromosomes.

The review found only weak evidence of a possible benefit from three other add-ons.

EmbryoGlue, an embryo transfer medium containing hyaluronic acid, may increase the probability of pregnancy and live birth. However, the evidence on live birth rates was not considered robust.

Endometrial scratching, a minor procedure that deliberately disturbs the lining of the womb, may also increase the probability of pregnancy and live birth.

Physiological intracytoplasmic sperm injection, known as PICSI, selects sperm based on their ability to bind to hyaluronic acid. Weak evidence suggested it may reduce the risk of miscarriage.

Lensen said: “There is widespread misinformation about IVF add-ons with private clinic websites and patient forums on social media – major information sources for patients – often overstating the benefits and omitting the costs and risks of add-ons.

“IVF clinics and clinicians should carefully consider whether it is appropriate to offer unproven add-ons, as their availability is often perceived by patients as implicit endorsement of benefit.”

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Changes in AI mammogram risk scores help predict future breast cancer

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Changes in AI mammogram scores may help predict breast cancer years before diagnosis, research involving more than 54,000 women suggests.

Scores rose steadily among women who later developed the disease but remained broadly stable among those who did not.

The increase could be detected up to six years before diagnosis and became much steeper during the final two years.

Researchers led by Professor Constance Lehman, of Harvard Medical School and healthcare technology company Clairity, analysed screening mammograms taken between 2009 and 2019.

They used a validated, open-source deep learning model to calculate five-year breast cancer risk scores from the images alone.

Deep learning is a form of artificial intelligence trained to recognise complex patterns in large amounts of data.

The model examined the whole mammogram rather than relying on a limited, predetermined feature such as breast density.

Models of this kind have performed better than traditional risk models and breast density alone when estimating a woman’s five-year breast cancer risk.

The study initially included 239,703 consecutive two-dimensional screening mammograms from 89,882 patients across six imaging sites spanning urban tertiary, community-based and rural settings.

All were standard bilateral full-field digital mammography examinations, taken with or without digital breast tomosynthesis.

Digital breast tomosynthesis uses multiple low-dose X-ray images to create a three-dimensional view of the breast.

After exclusions, the final analysis involved 54,014 women with a median age of 61 and a total of 158,807 mammograms.

Each woman contributed one index examination and up to six previous annual mammograms. Women had a median of three scans each.

For women who developed cancer, the index examination was their final screening mammogram within the year before diagnosis. For the cancer-free group, it was their final mammogram during the five-year study period.

The model did not use demographic information, clinical records or historical imaging data when calculating each score.

Of the women included, 817, or one per cent, were diagnosed with breast cancer within 365 days of their index examination.

This included 451 women, or 55 per cent, with invasive breast cancer and 118, or 14 per cent, with ductal carcinoma in situ, known as DCIS.

DCIS occurs when abnormal cells are found inside a milk duct but have not spread into the surrounding breast tissue.

The cancer type was unknown for the remaining 248 patients, representing 30 per cent of the cancer group.

A total of 682 cancers, or 83 per cent, were detected through screening, while 135, or 17 per cent, were interval cancers diagnosed between routine mammograms.

The other 53,197 women were not diagnosed with breast cancer during follow-up and formed the cancer-free comparison group.

Professor Lehman said: “We observed clinically relevant differences in risk trajectories between women who did and did not develop cancer. The increase in scores among cancer patients was detectable as early as six years prior to diagnosis and became more pronounced over time.”

Among women later diagnosed with the disease, the median score rose from 2.1 five to six years before diagnosis to 6.6 at the index examination.

Scores among cancer-free women remained stable, with median values ranging from 1.8 to 2.2 throughout the study.

The rise among women who developed cancer was steepest during the two years before their index examination.

Professor Lehman said: “These findings demonstrate signals, invisible to the human eye, in the image alone can predict future risk. This is exciting, because 85 per cent of women diagnosed with breast cancer do not have a significant family history of breast cancer or known genetic mutations.”

Most breast cancers are considered sporadic, meaning they are not driven by inherited genetic changes or a family history of the disease.

Traditional risk models have a limited ability to distinguish between women who will and will not develop breast cancer when used across large screening populations.

Researchers said tracking how scores change over time could provide more information than calculating risk at a single appointment.

Professor Lehman said: “AI-derived risk scores can identify patients who are otherwise predisposed to the disease, and our findings demonstrate that image-based AI risk scores evolve over time and that changes in those scores may provide additional information about future breast cancer risk.”

The patterns remained consistent when women were grouped by age and breast density.

Breast density describes the amount of fibrous and glandular tissue visible on a mammogram. Dense tissue can make cancers harder to detect and is also associated with an increased risk of the disease.

Researchers said image-based scores could support personalised screening and risk-reduction strategies without relying on self-reported or inconsistent clinical information.

Professor Lehman said: “These trends remained robust across subgroups defined by age and breast density, further supporting the generalisability of our findings. This is particularly relevant given persistent disparities in screening performance across patient populations. A dynamic biomarker approach grounded in the imaging data could mitigate some of these disparities by enabling risk-based personalisation that does not rely on self-reported or inconsistent clinical data.”

A biomarker is a measurable sign that can indicate a person’s health, disease risk or response to treatment.

Changing scores could eventually help clinicians identify women who may benefit from additional imaging or measures intended to reduce their risk.

Professor Lehman said: “With the power of AI, computer vision, and the ability to extract predictive data, we are able to apply the power of imaging to risk assessment and preventing disease from developing. Having a dynamic risk score opens up a whole new domain of more effective preventive therapies for breast cancer, similar to how we screen for and treat patients with high cholesterol and hypertension.”

AI image-based risk scores are included in the 2026 National Comprehensive Cancer Network guidelines.

The guidelines recommend that, from the age of 35, women with an elevated five-year risk score of more than 1.7 per cent consider breast MRI alongside annual mammography.

An AI image-based model approved by the US Food and Drug Administration is already being used to calculate five-year breast cancer risk at selected US healthcare institutions.

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UK LGBTQ+ population faces barriers to fertility treatment, research finds

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LGBTQ+ people across the UK face discrimination, funding inequalities and gaps in fertility care, research has found.

Eligibility for NHS-funded treatment varies across the country, while many services are still structured around heterosexual couples.

People with diverse sexual orientations and gender identities can be left navigating complex systems, paying more for treatment and explaining their needs to healthcare professionals.

Co-author Dr Chloe He, of the UCL Institute of Epidemiology and Health Care, said: “Legal access is not the same as equitable access. LGBTQ+ patients are forced to navigate a Kafkaesque fertility care system alone – researching, self-advocating, and often educating the doctors and nurses treating them.

“In our study, we saw clinicians with no formal LGBTQ+ training, gay men pressured into being relentlessly cheerful to prove parent-worthiness to surrogacy services, and patients travelling hundreds of miles for care after experiencing transphobia at local clinics.”

The University of Stirling-led research involved 54 participants and 36 in-depth interviews with people who had used fertility services and professionals working in or alongside fertility care across the UK.

Researchers from Stirling, SKEMA Business School and University College London examined the extra work undertaken by LGBTIQA+ people seeking to have children.

They called this “reproductive labour”, which includes researching treatment, advocating for themselves, covering additional costs and educating clinicians.

The researchers said this work was used to manage “reproductive bioprecarity”, a term describing the uncertainty and vulnerability people can face while seeking reproductive healthcare.

The study, funded by a Santander Universities Research Grant, primarily reflected the experiences of cisgender lesbian participants.

One participant, Amanda, said she and her partner, Amy, spent a long time trying to find a GP willing to discuss fertility with them.

The couple eventually underwent fertility tests through the NHS, but their private clinic rejected the results because they had not been referred by a GP.

They had to repeat the tests and pay for them privately.

The researchers said lesbian couples are often required to self-fund multiple rounds of intrauterine insemination before becoming eligible for NHS support.

Intrauterine insemination, or IUI, involves placing sperm directly into the womb.

Gay men usually have to pursue surrogacy, which is not funded or supported by the NHS, while transgender people can face long waits to save eggs and sperm to allow them to have children.

Lead author Dr Carolyn Wilson-Nash, senior lecturer at the University of Stirling Business School, began investigating the issue after she and her wife made multiple attempts to conceive and faced challenges throughout the process.

The couple funded almost the entire process themselves and consulted a GP who had no experience of supporting same-sex couples seeking fertility care.

The researchers called for clearer treatment pathways, more inclusive services and better training for healthcare staff.

Dr Wilson-Nash, who is now the mother of a three-year-old boy, said: “The way the current system for fertility services is set up in the UK can lead to unequal pathways for the LGBTIQA+ population.

“For example, heterosexual couples can access NHS-funded in vitro fertilisation (IVF), whereas lesbian couples are often required to self-fund multiple rounds of intrauterine insemination (IUI) before becoming eligible for NHS support.

“Gay men usually have to pursue surrogacy, which is not funded by or supported by the NHS.

“And transgender individuals often face long waiting times to save eggs and sperm to allow them to have children. So legal access does not necessarily translate into equitable or inclusive care.

“Building a family should be neither exclusive nor this difficult. Fertility services should be available to all, regardless of their sexual orientation or gender identity.”

Laura-Rose Thorogood, founder of LGBT Mummies and part of the UK’s Fertility Justice Campaign, said: “Right now, intended LGBTQIA+ parents are being discriminated against because of who they are, and who they love.

“This is ultimately forcing them down alternative pathways which in turn put them at long-term risk physically, psychologically and socially.

“By providing access to treatment, our community can thrive and create the families they dream of by their chosen route.”

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