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Round up: FemHealth Ventures closes oversubscribed US$65m Fund II, and more

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Femtech World explores the latest business developments in the world of women’s health.

FemHealth Ventures closes oversubscribed US$65m Fund II

FemHealth Ventures, a women’s health-focused venture capital firm, has closed on FemHealth Ventures Fund II at US$65m.

The oversubscribed raise brings the firm’s assets under management to US$100m across two funds and further solidifies FemHealth Ventures’ position as a category-defining investor in women’s health innovation.

The fund received significant support from existing limited partners alongside new investors aligned with the firm’s mission to transform women’s health.

“We are thrilled to announce the successful close of Fund II, more than doubling the size of our inaugural fund,” said Maneesha Ghiya, managing partner of FemHealth Ventures.

“This raise reflects growing recognition that women’s health innovation offers both substantial societal impact and compelling investment potential.

“We are grateful for the trust our limited partners continue to place in us.”

“The next generation of transformative women’s health companies will be led by visionary founders, and we are honored to support them,” added Sara Crown Star, Venture Partner at FemHealth Ventures.

Fund II will continue investing across drugs, devices, diagnostics, and digital / AI-enabled technologies that address unmet needs in women’s health.

FDA clearance for wearable supporting urinary incontinence

BlueWind Medical has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its enhanced Revi wearable designed to deliver therapy more effectively and seamlessly support long-term symptom relief for patients with urgency urinary incontinence (UUI).

The updated Revi wearable features a streamlined, easy-to-use design with a smarter, user-friendly interface, while retaining the same simple, three-button control.

Together, these enhancements are intended to make it easier for patients, giving them greater confidence, control, and convenience in managing their UUI.

The Revi System offers personalised therapy that adapts to each person’s unique and changing UUI symptoms with adjustable, wearable control; symptom relief, with 79 per cent of patients achieving a 50 per cent reduction in UUI; and a strong safety profile, with no device- or procedure-related serious adverse events, no device migrations, and no device revision procedures.

“We are proud to lead the next generation of technology for the treatment of urgency urinary incontinence,” said Kerry Nelson, CEO of BlueWind Medical.

“BlueWind has been at the forefront of the field, pioneering implantable tibial neuromodulation for UUI. Our strong clinical evidence and our focus on patient comfort and satisfaction show that when patients can personalize their therapy, outcomes improve.

“The enhanced wearable continues that philosophy by making therapy easy to use, adaptable to each patient’s lifestyle, and supportive of long-term use.

“All of this helps patients achieve durable symptom relief and overall satisfaction.”

CE Mark for treatment for women with PCOS-related Infertility

Medical device company May Health has announced that its novel technology to treat PCOS-related infertility, the Anavi System, has received CE Mark certification.

The CE Mark, granted under the European Union’s Medical Device Regulation (EU MDR) 2017/745, is a significant regulatory milestone that enables commercialization in the European Union.

The Anavi System is treatment offered as a one-time, office-based procedure intended to restore natural ovulation in women with PCOS-related infertility who do not respond to, are contraindicated for, or decline first-line medications.

Building on the established success of laparoscopic ovarian surgery to restore ovulation, this approach translates a laparoscopic procedure into a more accessible, ultrasound-guided in-office option.

The Anavi System delivers targeted radiofrequency (RF) energy to ablate a small fraction of ovarian tissue with the aim of re-initiating ovulatory cycles, offering an alternative for women who are not ready, willing, or able to advance to IVF.

“Approximately 80 per cent of women with PCOS have oligo-anovulatory infertility, a condition characterised by lack of ovulation,” said Dr Saad Amer, lead investigator of the ULTRA EU study, expert in PCOS, endometriosis, and infertility, and professor at the University of Nottingham.

“Moreover, 20–30 per cent of those women do not respond to first-line ovulation induction therapies.

“The Anavi System provides a compelling treatment option that restores ovulation in women with PCOS without the use of any hormonal therapy, and as a single, in-office procedure that can be efficiently incorporated into the care pathway for appropriate PCOS women.”

CE Mark certification for the Anavi System was supported by safety and feasibility data from the ULTRA clinical studies conducted in Europe and the United States.

Participants were women with PCOS who were anovulatory or oligo-ovulatory and had failed to respond to first-line pharmacologic treatments, or who were contraindicated for or declined such treatment.

A preliminary analysis from the ULTRA studies presented at the European Society of Human Reproduction and Embryology (ESHRE) Annual Meeting in 2025 demonstrated that, in 26 of 32 women evaluable at 12 months, 77 per cent reported ovulation, with 13 women experiencing spontaneous ovulation and seven women ovulating after first-line medications were resumed.

At 12 months, a 46 per cent cumulative pregnancy rate was observed, including 10 spontaneous pregnancies (seven with and three without the restart of first-line medication) and two pregnancies with assisted reproductive technology (one intrauterine insemination (IUI), one IVF), resulting in six live births at the time of reporting.

The most common procedure-related adverse events were reported as mild and included vaginal bleeding, pain, and headache.

The CE Mark permits commercialization of the Anavi System in the European Union, with rollout planned on a country-by-country basis.

Partnership to to expand access to rapid STI testing

Testmate Health and Intermountain Health have announced a strategic partnership and investment to accelerate access to rapid, low-cost molecular tests for sexually transmitted infections (STIs) in the US.

The collaboration enables Intermountain Health and Testmate Health to bring lab-quality STI diagnostics to at-risk communities.

STIs remain a largely silent epidemic, with 80 per cent of chlamydia and gonorrhea infections going undiagnosed each year.

Populations most affected include college students, LGBTQ+ communities, and rural or low-resource clinics face significant barriers to timely testing and treatment.

This partnership and investment directly address that gap by bringing high-accuracy, low-cost diagnostics to the people and places that need them most.

“Our partnership and investment in Testmate reflects our commitment to solutions that make care faster, more accessible, and equitable,” said Karen Brownwell, vice president of Lab Services at Intermountain Health.

“When these STI tests become FDA-approved in the US, Testmate’s innovative approach to molecular diagnostics will allow us to deliver lab-quality results outside traditional lab settings, directly impacting communities that have historically lacked access to timely testing.”

Testmate’s single-use, reader-free molecular test for Chlamydia trachomatis and Neisseria gonorrhoeae, are able to deliver lab-quality results in under 30 minutes without central lab infrastructure.

The molecular tests are easy to use and compatible with both urine and swab samples, enabling rapid, private and stigma-free testing.

“This partnership and investment empowers people to take control of their sexual and reproductive health without barriers, stigma, or waiting,” said Dr Siew-Veena Sahi, CEO and founder of Testmate Health.

“By partnering with Intermountain Health, we could scale access to diagnostics in a way that changes outcomes for patients and communities alike.”

Through combining Testmate’s physician-built diagnostics with Intermountain’s infrastructure and clinical expertise, the programme aims to dramatically increase early detection, improve treatment, reduce loss to follow-up and lower healthcare costs.

Insight

UK reviews surrogacy firm over rejected insurance claims

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The UK government is reviewing a surrogacy firm after complaints that medical insurance claims involving surrogates in Mexico were rejected.

The Department of Health and Social Care (DHSC) is considering whether UK-based provider My Surrogacy Journey should remain listed on gov.uk as one of four domestic surrogacy agencies available to intended parents.

The review follows allegations concerning its Mexican sister company, where surrogates are based.

Health minister Diana Johnson said: “The department is looking into the allegations about My Surrogacy Journey.

“As part of that assessment, the department will consider whether it is appropriate for that company to remain on the gov.uk list of agencies.”

Emails sent by My Surrogacy Journey chief executive Michael Johnson-Ellis and seen by the Guardian suggest multiple surrogate women in Mexico had their insurance claims rejected.

The emails also suggest 300 couples using the company were moved to a new insurance provider because of the increased risk of claims being rejected.

Commercial surrogacy is banned in the UK, where only altruistic arrangements are permitted.

My Surrogacy Journey operates a not-for-profit UK branch alongside for-profit sister companies in Mexico and the US. All three companies have the same owners and chief executives.

The reported insurance issues relate to surrogacy arrangements in Mexico.

One couple told the Guardian they paid tens of thousands of pounds to cover medical costs after their surrogate had a hysterectomy during childbirth and an insurance claim was refused.

The Guardian said it understood that at least five sets of parents said they had to cover medical costs after insurance claims were rejected.

In an email to the couple whose surrogate underwent a hysterectomy, Johnson-Ellis wrote: “We have already told you that the insurance companies have been declining some of the claims and we are actively working with the broker to get this issue resolved but you should also consider that they may not be paid out and there is nothing we are able to do to change this …

“We appreciate this is not an insignificant sum but this genuinely is out of our control.”

Johnson-Ellis also said the company had switched insurance providers, writing: “We’re also managing this for 300 other journeys, which is a complex position to be in.”

Lawyers acting for My Surrogacy Journey said the company did not comment on individual cases, but that existing insurance policies were in place and claims continued to be accepted and processed.

They said the company understood that a small number of claims had been rejected and was supporting people seeking to resolve those claims with an insurer.

Under the surrogacy arrangements, intended parents are understood to be contractually required to cover medical costs not paid by an insurer.

The couple said they had been recommended the company’s Mexico option. Its website advertises that intended parents using the route can have a baby in “under 18 months”.

They said they were told the UK route could take up to five years and that the US option was much more expensive.

Lawyers for My Surrogacy Journey said prospective parents are given information about typical timelines, costs, legal frameworks and practical considerations, and that the 18-month timeframe is indicative only.

The couple said their surrogate developed placenta accreta, a serious condition in which the placenta attaches to the wall of the uterus.

Emails from Johnson-Ellis acknowledged that the insurance provider investigated the birth after the surrogate experienced health complications.

The parents are considering legal action, while the Guardian said it understood at least four other couples were reviewing their options.

Phil Brickell, MP for Bolton West, raised concerns in parliament about a separate couple who had used My Surrogacy Journey.

He said: “Two of my constituents recently travelled to Mexico, where their children were born by surrogacy.

“Those births were facilitated by a company called My Surrogacy Journey, which is listed on gov.uk.

“While in Mexico, they had repeated traumatic experiences with the company relating to issues including insurance for their children, accusations of bullying towards staff and repeated efforts to silence any constructive criticism.

“I understand that other members of this house have received similar complaints.”

Brickell called for My Surrogacy Journey to be removed from gov.uk pending a review by the Human Fertilisation and Embryology Authority.

Lawyers acting for My Surrogacy Journey said the company was communicating with DHSC and was confident any issues could be resolved.

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Fertility

Spain football federation partnership to offer players egg-freezing and fertility treatment

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Spain’s football federation will offer national team players egg-freezing and fertility treatment through a clinic partnership running until 2029.

The agreement with the Tambre clinic in Madrid will give Spain’s World Cup winners more options to pursue motherhood when they feel the time is right.

The Royal Spanish Football Federation (RFEF) said the agreement covers all national team players, including the futsal team, as well as Primera Division referees and assistants and all other federation employees.

It is the latest policy introduced by the RFEF as it seeks to lead the way in work-life balance and maternity protection.

The federation has also introduced measures allowing players to travel with their children during major tournaments. The scheme was extended to the men’s team during their successful World Cup campaign in North America this past summer.

RFEF president Rafael Louzán said: “If Spain and its national teams are the best in the world on the pitch, they must also be the best in matters such as work-life balance.

“This is a new, comprehensive and pioneering benefit that extends to all federation employees. Today is a great day for the entire Spanish football family.”

The agreement followed a direct request from players after discussions with national team captains, including London City Lionesses midfielder Alexia Putellas.

Putellas told Spanish outlet El País: “As a group of captains, we had a concern — because experiencing a World Cup is vital for a player — regarding the difficulty of reconciling that with the desire to become a mother.”

“It’s a desire I didn’t originally have but developed some time ago.

“Thanks to the incredible work done by the federation, an agreement has been reached with a clinic allowing us to freeze our eggs while we are still active players, for as long as we wish.

“For me, this is a huge step forward; the federation understands that you are serving your country in a way that runs counter to your biological clock — that you can’t simply pause your career to become a mother because you need your body to do your job.”

The announcement follows Chelsea becoming the first Women’s Super League club to offer similar fertility treatment options to its players.

The move has also drawn criticism.

Spanish triple jumper Ana Peleteiro-Compaoré Brión said on Instagram: “The problem obviously isn’t freezing eggs.

“The problem is: why does the institution these women work for have an interest in financing them to delay their motherhood?

“And here there’s a problem that for me changes absolutely everything.

“Is this measure intended to make it easier for women to be mothers or is it intended to make it easier for them not to be while they’re playing?”

Spain are the current world champions in both the women’s and men’s games.

The women will attempt to defend their title at the 2027 World Cup in Brazil next summer.

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Pregnancy

Paracetamol use may impact future fertility, studies suggest

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Paracetamol use in pregnancy was not linked to autism or ADHD, while separate research found reproductive differences in girls exposed before birth.

One study analysed health records from more than 120,000 children and found no increased risk of autism following prenatal paracetamol exposure.

A separate analysis of nearly 100,000 children also found no increased risk of ADHD among those born to mothers who used the painkiller during pregnancy.

Researchers from the Hong Kong Hospital Authority examined electronic health records covering pregnancies between January 2001 and December 2023.

The autism analysis included 124,333 children, who were nine years old on average and split almost evenly between males and females. There were 3,445 autism diagnoses, representing 2.8 per cent of the group.

The ADHD analysis involved 97,285 children, who were seven years old on average and also split evenly between males and females. There were 5,168 ADHD diagnoses, representing 5.3 per cent.

Women prescribed paracetamol during pregnancy were more likely to be older and have pre-existing conditions including psychiatric disorders, as well as reasons for taking the drug such as infection, fever or chronic pain.

No association was found between prenatal paracetamol exposure and either autism or ADHD.

The findings did not differ according to the trimester in which paracetamol was taken or whether use was intermittent or daily. Advanced maternal age, defined as pregnancy in women over 35, did not alter the findings.

The researchers wrote: “Paracetamol remains a safe and essential analgesic [pain reliever] and antipyretic [fever reducer] during pregnancy, whereas alternatives, such as NSAIDs and opioids carry well-documented risks.

“Unwarranted reluctance to use paracetamol could lead to undertreatment of pain and fever, or the use of more harmful alternatives, both posing risks to the pregnancy and developing fetus.”

The authors said women should assess paracetamol use with guidance from their doctor.

A separate study involving 685 pregnant women without pre-existing conditions and 302 infant daughters found associations between prenatal paracetamol exposure and differences in reproductive organs and hormone levels.

Researchers from Copenhagen University Hospital enrolled the women during their first trimester and assessed them during the first trimester, third trimester and again when their babies were three months old.

At around three months, infants experience a temporary rise in reproductive hormones sometimes called mini-puberty.

Pregnant participants completed questionnaires every two weeks about their use of pain medicines including paracetamol. Infant girls underwent ultrasound scans of their reproductive organs and blood tests to measure hormone levels.

Researchers also examined a separate group of 1,210 girls followed from infancy to adolescence whose mothers reported paracetamol use during the third trimester.

Three-month-old girls exposed to paracetamol before birth had an average 40 per cent smaller ovarian volume, 13 per cent smaller uterine volume and 23 per cent fewer ovarian follicles.

Girls exposed during the first trimester also had lower levels of Anti-Müllerian hormone, a marker of ovarian function.

Among the older girls, those exposed before birth were more likely to have smaller uteruses at puberty and smaller ovaries during their teenage years.

Dr Margit Bistrup Fischer, lead study author and postdoctoral researcher in the Department of Growth and Reproduction at Rigshospitalet hospital in Denmark, said: “Animal studies have demonstrated that impaired formation of ovarian follicles can lead to reduced fertility and earlier reproductive aging.

“Whether the differences observed in our study have implications for fertility and age at menopause in humans remains unknown and will require long-term follow-up of the girls in our cohort.”

She cautioned that women who had used paracetamol during pregnancy “should not be alarmed by our findings”, as the study found associations rather than direct causation and outcomes for individual women and children are unclear.

“Importantly, our study does not evaluate whether [acetaminophen] causes reproductive problems, nor does it provide evidence that prenatal exposure affects future fertility or age at menopause,” she said.

“Although we observed similar associations in an independent cohort, long-term follow-up is needed to determine whether these early-life differences have any clinical significance later in life.”

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