Diagnosis
Why investing in women’s health innovation is a smart bet

By David Buller, Managing Partner at KELES
The macro opportunity: women are half of the population
In 2024 alone, women’s health start-ups raised a record $2.6 billion, up 55 per cent from the previous year.
In addition to increasingly recognised health needs in menopause, fertility and female-specific cancers, there are conditions such as cardiovascular disease, diabetes and Alzheimer’s, to name a few, that affect women disproportionately as compared to men, which then leads to the creation of large care gaps.
Whilst conventional care pathways, medications, dosages and treatments are often geared to accommodate males, this has created gaps in clinical pathway guidelines for women and their health.
The opportunity for transforming and investing in women’s health is growing. Where should investors focus capital, and what will substantially improve women’s health for the future?
Venture Capital will back scalable, system-level solutions
Despite the growing attention on women’s health and FemTech, successful venture-backed companies need to attract the female healthcare population.
The technologies that do this will be those that are payor-reimbursed (government, insurance or employer), can embed into patient care pathways, address wide-scale unmet needs, and have a clear exit strategy. Women’s health companies, just like any other digital health venture, need to consider how they integrate with the health system as a whole and forge a clear route to market.
The best companies will drive the new standard of care and address critical needs, for example, those improving essential surgeries, or developing new therapies, and those that substantially increase quality of life for a significant number of women.
With these considerations about scaling and prevalence in mind, the opportunities for founders and investors are great. What kind of technologies should we consider?
- Those combating major gaps in existing care pathways. For example, endometriosis affects an estimated 10 per cent of women, yet diagnostic delay still averages eight years. Technologies that shorten diagnosis transform millions of lives and are rapidly adopted by payers.
- AI and platform technologies. Utilising the latest AI capabilities can improve accuracy and speed in health, especially in diagnostics and drug development, and support the vision of care for women. We must ensure that data is representative of women and female patient groups. Greater assimilation and integration of truly representative datasets can allow more informed care decisions, and can enhance female patient selection for clinical trials.
- High-prevalence conditions and health issues. Some conditions affect a startling number of women and can contribute to significant strains on global health systems. Fertility and pregnancy, post-partum depression, endometriosis, menopause and osteoporosis, breast cancer and diabetes are just some examples of highly prevalent and widespread health needs. AI and tech enable a huge step change in addressing issues that were completely undertreated.
Building a women’s health ecosystem that thrives: future innovation will originate from women
Achieving a healthy ecosystem of market-ready innovations in women’s health requires more than collaboration between start-ups, healthcare providers and investors. It needs a momentum of female-led founders to break the barriers, and get the right tech, innovation and products to the women who need them.
Breakthrough ideas often come from those who have experienced the pain points firsthand. Yet, if we look at women’s health, fewer than one in five digital-health start-ups is founded by a woman, and the percentage drops further in med-tech and biotech.
Encouragingly, the raw talent already exists. Across Europe, women already dominate many healthcare practitioner positions and master’s level qualifications in health and life sciences, and in many EU countries, they hold a slight majority of PhDs in these fields. Cities such as Lisbon, Copenhagen and Barcelona are making progress on gender balance among principal research investigators.
The challenge is in the translation: channeling the expertise into biotech and health companies that will scale well and make a significant impact on women’s health. So we should continue:
- Encouraging women in the scientific and healthcare ecosystem to experiment and innovate, and bring new technologies to market.
- Building an inclusive environment for female founders.
- Investing in female-led companies producing scalable solutions for women’s health.
Measuring returns by better health: an investor’s framework
Adhering to strong ethical principles is a core foundation of any good investment in healthcare. By embedding these principles into an investment framework, we are more likely to see capital deliver sustainable, long-term value.
At KELES, we evaluate our portfolio companies against core criteria. Applying these criteria to solutions for women’s health, companies can drive significant innovation and progress to support equitable healthcare. Many women’s health companies have the opportunity to meet and exceed these principles, and drive significant innovation and progress to support equitable healthcare.
- Accessibility – does the solution broaden access and availability of healthcare for women?
- Ethical use of data – is sensitive health data handled with the highest standards of privacy and fairness, and includes truly representative data?
- Improved outcomes – does the technology enhance healthcare outcomes for women?
By tying capital to these measurable goals in women’s health, and prioritising investments in women-led ventures that show clear market value, we can accelerate innovation that truly meets women’s healthcare needs – and has real impact worldwide.
Hormonal health
Tampons could track MS nerve damage, study suggests

Menstrual fluid collected from tampons could one day provide a simple, non-invasive way to measure a biomarker of nerve damage and potentially track disease activity in neurological conditions such as multiple sclerosis (MS), new research suggests.
Because neurofilament light chain, or NfL, has emerged as a promising biomarker of MS, detecting it in menstrual fluid raises the possibility of monitoring disease activity through the natural monthly cycle of menstruation.
Researchers at Nextgen Jane, in collaboration with Siemens Healthineers, found that NfL, a protein released when nerve cells are damaged, can be reliably detected in tampon-collected menstrual samples.
“Finding that NfL tracks with estrogen levels in menstrual fluid, independent of how much blood is in the sample, tells us there is real biology here, not just contamination,” said Ridhi Tariyal, chief executive and co-founder of Nextgen Jane.
“That changes what this specimen means for neurology.”
In MS, the immune system mistakenly attacks healthy parts of the brain and spinal cord, causing inflammation and damage that can lead to symptoms such as fatigue, numbness, muscle weakness, and problems with balance or vision.
Confirming a diagnosis of MS usually requires a combination of physical and neurological examinations, MRI scans to check for brain and spinal cord damage, and lab tests.
These can include detecting certain proteins in cerebrospinal fluid, the fluid that surrounds the brain and spinal cord, which may indicate inflammation in the brain or spinal cord.
After diagnosis, patients are usually monitored through clinical assessments and routine MRI scans, which help doctors detect changes in disease activity and determine whether treatments are working.
However, MRI assessments can be costly and are usually done once or twice a year, which can prevent doctors from spotting early changes and making timely treatment adjustments.
Because of these challenges, researchers have long sought cost-effective, more accessible biomarkers that could help detect MS earlier, monitor disease activity over time, and evaluate treatment response.
One of the most promising candidates is NfL, a protein found in nerve cell fibres that is released into the bloodstream and cerebrospinal fluid when nerve cells are injured.
To explore whether menstrual fluid could serve as a source for detecting this biomarker and, more broadly, as a non-invasive specimen for monitoring neurological, hormonal and inflammatory signals, researchers analysed 99 tampon-collected menstrual fluid samples from 91 participants.
They used Siemens Healthineers’ highly sensitive NfL assay on its automated testing platform. The team also measured hormonal and inflammatory molecules.
NfL was detected in 98 of the 99 menstrual fluid samples analysed, suggesting the biomarker can be reliably measured in tampon-collected samples.
The researchers also found that NfL levels were associated with estradiol levels, a form of the hormone oestrogen, and that this relationship remained significant even after adjusting for differences in blood content between samples.
By comparison, levels of inflammatory markers were more strongly linked to blood content itself.
According to the researchers, this suggests NfL detection was not merely the result of blood contamination, but may reflect biologically meaningful changes that could potentially be tracked over time through routine menstrual sampling.
Building on these findings, Nextgen Jane is now planning prospective studies to investigate whether menstrual NfL and other neurological proteins can be used to track disease activity over time in conditions such as MS.
“The menstrual cycle provides a built-in longitudinal framework: the same individual, the same biological process, month after month,” said Stephen Gire, chief scientific officer at Nextgen Jane.
“Coupling the NextGen Jane platform with Siemens Healthineers’ highly sensitive NfL assay gives us a path to study neurological biomarker trajectories in a way that has not been possibe before.”
Diagnosis
Artera receives FDA Clearance for breast cancer platform

Artera has won FDA clearance for ArteraAI Breast, its breast cancer platform for patients with early-stage HR-positive, HER2-negative invasive breast cancer.
ArteraAI Breast is the first and only FDA-cleared digital pathology-based risk stratification tool for breast cancer.
These FDA milestones come alongside recent CE marking for both the ArteraAI Prostate Biopsy Assay and the ArteraAI Breast Cancer Assay in the US and Europe.
“FDA clearance for ArteraAI Breast represents a significant expansion of our FDA-cleared AI platform in oncology,” said Andre Esteva, chief executive and co-founder of Artera.
“This milestone reflects the growing role of our technology across multiple cancer types. Breast cancer care is highly nuanced, with treatment decisions that depend on individualised risk.
“Our goal remains consistent across prostate and breast cancer, and beyond: to help clinicians translate complex data into more precise, personalised treatment decisions across the cancer journey.”
ArteraAI Breast generates an AI-derived risk score showing the likelihood of distant metastasis, meaning cancer spreading to another part of the body, in patients with early-stage HR-positive, HER2-negative breast cancer.
Using digitised histopathology images, which are scanned tissue sample images, alongside patient clinical variables, the model sorts patients into low-risk and high-risk groups based on a predefined risk score cut-off.
In early-stage HR-positive, HER2-negative breast cancer, deciding the right intensity of treatment can be complex because clinical and pathological factors vary. Artera said the tool is designed to support clinicians within established decision-making frameworks.
Data presented at the 2025 San Antonio Breast Cancer Symposium evaluated the model in early-stage breast cancer and demonstrated the potential to inform chemotherapy benefit in certain patient populations.
“This clearance represents an important advance on the road to personalising treatments for patients with early-stage breast cancer,” said Eric Winer, medical oncologist and director of the Yale Cancer Center.
“Using AI and digital pathology has the potential to streamline operational workflows, while creating a strong interdisciplinary linkage between oncology and pathology. This approach may further improve the clinicians’ ability to help patients make the best treatment decisions.”
ArteraAI Breast is designed to integrate directly into standard pathology workflows using routine surgical resection samples, without requiring additional tissue or separate specimen collection.
This approach allows the software to provide same-day results, enabling pathology laboratories to give clinicians patient-specific prognostic risk information alongside standard histopathology reports.
Diagnosis
Nurse celebrates role in trial that enhanced breast cancer surgery outcomes

A nurse who works with breast cancer patients has spoken of her pride after joining a trial that improved breast cancer surgery after her own diagnosis.
Heidi Jones, a 53-year-old staff nurse on the surgical day unit at Basildon Hospital, is a mother of two from Corringham in Essex and works with breast cancer patients daily.
She was diagnosed with breast cancer in 2025, the day after her birthday. She told ITV News Anglia that she had jumped at the opportunity to take part in the trial.
“I said yes because we need to get out there about the advancements in treatment and in surgery and medicines,” she said.
“Cancer is a big thing, so whatever you can do to improve the treatment of the cancer, I was all for it.”
Mid and South Essex NHS Foundation Trust was one of two UK centres taking part in the trial, alongside 21 others across the US, Canada and Austria.
The trial involved using a breast cancer locator, or BCL, a customised 3D mould matched to the unique dimensions of the patient’s tumour and breast.
The BCL is then placed over the patient during surgery, giving teams more detailed guidance on the tumour’s shape, size and location.
Results found a 34 per cent reduction in the number of second surgeries needed, and a 32 per cent reduction in cases where cancer remained after surgery.
Surgeon Wayne Chicken said the new technique could have a big impact on some patients.
“I’ve been working in breast surgery for 25 years, and breast surgery has changed radically in those 25 years,” he said.
“Now we’re trying to do less and less, the minimum necessary to control the disease, rather than big procedures and potentially over-treat cancers. This is doing the minimum necessary to treat the cancer.”
This actually uses the information from the MRI scans to plan, so the impact is less surgery and more likely to get it right in a single operation.
Using the BCL system, Jones’s breast cancer surgery was a success, with the tumour removed completely.
“I do talk about things quite openly, and I use it now when the ladies are coming in. I’ll tell them I’ve gone through it,” she said.
“It just gives them that little bit more to let them know someone else has come through [treatment] and has come through the other side.
“I feel proud that I actually took part in it. I feel privileged to have taken part in it and been asked to do it.
“I’m extremely glad it’s been really successful as well. I was lucky, I class myself lucky.”
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