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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.

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UK femtech investment surges 194% in a decade, research finds

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UK femtech investment has risen by more than 194 per cent over the past decade, with deal activity and funding both increasing, new research has found.

The number of deals increased from 18 in 2015 to 53 in 2025, while total funding rose from £9.4m to more than £100m over the same period.

Despite the growth, deal volume and value remain relatively low compared with other parts of the health and care market. Healthcare recorded 69 deals in 2015 and 171 in 2025.

More companies have raised funding over the past decade, while investment values have also increased. Average deal size more than doubled from £527,000 in 2015 to £1.9m in 2025.

Some of the largest funding rounds last year included SheMed at more than £37m, Gaia at £12m, emm at £6.8m and Hertility at £5.9m, with the majority of investors based in the UK.

The research found femtech remains largely early-stage, with seed investments accounting for most deals.

However, venture capital involvement has increased over the past decade, which the research said showed the market was becoming more mature. The number of VC deals rose by 600 per cent.

Vicky Protano, corporate partner at Mills & Reeve, which conducted the research, said: “Over the last decade, the UK femtech ecosystem has expanded, both in terms of deal activity and funding levels. This positive upward trend demonstrates growing investor confidence in femtech and increasing institutional interest in the sector.

“Whilst companies in femtech have relied heavily on angel investors and angel networks to fund their growth ambitions, dynamics are shifting, with more venture capital and PE investors appearing in funding rounds. However, this is just the beginning and there is still more to do. While the sector has experienced strong growth, more work needs to be done to create the right funding environment that is balanced and evenly spread across the UK.”

The research found most deals had taken place in London. While the capital has strengthened its position as the UK’s main hub for femtech start-ups, regional clusters are gradually emerging elsewhere.

Protano said: “Whilst London clearly remains a dominant location for women’s health businesses and investment – both in terms of deal activity and total funding – there is a gradual move to regional expansion outside of the capital, with the South West, South East and the East of England showing increased investment activity in the femtech sector. What the data also highlights is a growing North/South divide, with areas such as the North East, North West, and Yorkshire & Humber significantly underrepresented in the national figures.

“As a national firm, we are also witnessing that similar divide. More investments are being made into women’s health businesses based in the South – and more businesses are, often as a result, locating themselves there, rather than in the North. This is representative of the investment landscape as a whole. However, growth in the femtech sector is being supported by growing regional innovation hubs, the increasing influence of university spin-outs, as well as improved support for start-ups at a regional level.”

She added: “Looking at the positives, we have advised and are continuing to advise on some significant investments in the sector. This further evidences the growing nature of femtech, with sector specific investors also coming to the market.”

Examples include Northern Gritstone’s investment in IVF technology business IVF Micro and Phoenix Private Equity’s investment in London Gynaecology, a provider of private gynaecology clinics.

Other deals include an EKA Ventures-led investment in tech-enabled postnatal care company Hesta Health and Amulet Capital’s acquisition of TFP Fertility.

September marks 10 years since the term “femtech” was coined by Ida Tin, co-founder and chief executive of Clue, one of the first period-tracking apps for women, and founder of think tank Femtech Assembly.

The global market grew to US$9.12bn in 2025 and is projected to reach US$41.4bn by 2034.

Despite that growth, women’s health is still not treated as a priority and significant gender inequalities remain globally in research, trials, diagnosis and treatment, continuing to disadvantage women.

Tin said: “I want men with money and power to get femtech on their radar. The business opportunity is there. The societal economic argument is there.”

Charlotte Lewis, commercial health lawyer at Mills & Reeve who specialises in healthtech and women’s health, said: “For far too long, ongoing disparities in women’s healthcare across the UK have adversely impacted women’s health outcomes, often resulting in prolonged diagnosis and treatment – some of which are well publicised, including the time it takes to diagnose women’s health issues such as endometriosis and rising maternal mortality rates.

“However, we are seeing the landscape beginning to shift in a more positive direction. Our experience is that this is helped by more open discussion and conversations which highlight the issues.

“The data around the sector is valuable and growing and demonstrates the progress that is being made from an investment point of view, creating a better environment where digital innovation can thrive, with a renewed focus on prevention through market-leading consumer-driven products.

“The UK has a real opportunity to transform women’s healthcare into a model of fairness, accessibility, and excellence, and femtech businesses have a crucial part to play in achieving this transformation. As a firm, Mills & Reeve is passionate and dedicated to continuing to influence and support this transformation.”

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Cross-Border Impact Ventures raises US$58m for women and children’s health

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A women’s and children’s health technology fund has raised US$58m at its first close towards a target size of US$125m.

Managed by Cross-Border Impact Ventures (CBIV), the Children’s Health Technology Fund II will invest in companies developing technologies for conditions that affect women and children specifically, differently or disproportionately.

It will mainly target Series A and Series B companies developing medical devices, diagnostics, therapeutics and AI-enabled digital health technologies, while retaining the option to invest earlier in selected high-potential businesses.

Annie Thériault, managing partner at Cross-Border Impact Ventures, said: “Women’s and children’s health is one of the largest and most attractive opportunities in healthcare today.

“We’re seeing a convergence of scientific innovation, policy support and institutional capital that is accelerating the development of technologies with the potential to improve millions of lives.

“This is a true blue sky opportunity, one where competition remains limited, and the potential to generate outsized returns is significant.

“Fund I validated our investment strategy, and Fund II allows us to build on that momentum at a time when the market is ripe for investment.”

The first close attracted commitments from returning and new institutional investors, and the fund is expected to reach its final close in 2027.

Its predecessor raised US$90.3m and invested in 11 technology companies across maternal and fetal health, neonatal care, cardiovascular disease, oncology, respiratory health, reproductive health and gut health.

The first fund also achieved a strategic exit and helped its portfolio companies reach more than 356,000 women and children across 32 countries.

The second fund will continue to focus on early-growth-stage deep technology companies commercialising healthcare technologies that could generate financial returns alongside measurable health outcomes.

A climate element has also been added to the investment process, while the approach to measuring impact has been strengthened.

The healthcare sectors covered by the investment strategy are estimated to be worth US$625bn today and are projected to grow to US$1.1tn by 2035.

The forecast is linked to advances in AI, diagnostics, medical devices and precision medicine, alongside increased attention on longstanding gaps in healthcare for women and children.

CBIV said its second Women’s and Children’s Health Technology Fund builds on the strategy used for its first vehicle.

Since launching in 2021, CBIV has built an investment platform focused on women’s and children’s health technologies.

The firm has reviewed more than 2,000 investment opportunities since launching its first fund, selecting 11 companies with technologies intended to deliver commercial returns and measurable health impact.

Alongside providing capital, CBIV works with portfolio companies on commercialisation, regulatory and market expansion strategies, access to non-dilutive funding and governance through board participation.

It also works to expand healthcare access in underserved markets through its impact platform.

CBIV said this approach has helped portfolio companies secure FDA clearances, complete strategic exits, expand into more than 30 countries, attract further investment and grow across high-income and low- and middle-income markets.

Portfolio companies include Sonio, which develops AI-powered fetal ultrasound software and was acquired by Samsung Medison in 2024.

The integration of Sonio’s technology into Samsung ultrasound systems is under way, with the aim of expanding access globally.

Cardiosense received US FDA De Novo approval for its PCWP Analysis Software, which enables non-invasive assessment of a key indicator used in heart failure. The company says this includes forms of the disease affecting 1.5m women in North America.

mOm Incubators received US FDA clearance for its neonatal incubator and has deployed devices in hospitals and humanitarian settings across several regions. The company estimates the technology has reached 18,000 patients.

Daye has launched a patented diagnostic tampon for HPV and vaginal health screening. The technology has been piloted in the NHS and is expanding into North America and sub-Saharan Africa.

More than 13,000 patients have used the technology, with peer-reviewed clinical validation carried out across the UK, Tanzania and Nigeria.

Investors committing to the second fund include KfW on behalf of the German Federal Ministry for Economic Cooperation and Development, the Skoll Foundation with Capricorn Investment Group, Ceniarth, Equality Fund with RockCreek Group and Wire Group.

Several family offices and high-net-worth individuals have also invested, with some returning investors increasing their commitments.

CBIV said its investment and impact approach received BlueMark Platinum status in 2024, complies with SFDR Article 9 and has received multiple ImpactAssets Emerging Impact Manager designations.

Donna Parr, managing partner at Cross-Border Impact Ventures, said: “Fund I reinforced what we’ve believed from the beginning: some of the most compelling investment opportunities in healthcare exist in areas that have historically received too little attention.

“Advances in AI, diagnostics, medical devices and precision medicine are creating entirely new opportunities to improve care for women and children while building highly valuable companies. We’re seeing growing recognition from investors that financial returns and measurable health impact are mutually reinforcing.”

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TidalSense raises £14m to expand five-minute COPD test across NHS

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Cambridge health tech company TidalSense has secured £14.2m in funding led by Cross-Border Impact Ventures to expand its AI-powered lung disease test across the NHS and into Europe and the US.

The investment, which also includes returning backers BGF, Airstream Capital and Foresight Group, will fund the rollout of a handheld diagnostic device that can detect chronic obstructive pulmonary disease (COPD) in as little as five minutes.

It will also support the development of software to diagnose asthma using the same platform.

Donna Parr is managing partner at Cross-Border Impact Ventures.

She said: We look for technology that doesn’t just have a compelling story, but a body of clinical evidence behind it.

“TidalSense has both, with a CEO who has lived the problem she’s solving, and a product that’s already live within the NHS healthcare environment, saving time for patients who have waited years for an answer.

“It is also technology that can improve access to appropriate treatment for COPD sufferers on a global basis and especially for women who are often misdiagnosed.

“This is exactly the kind of impact we want to make with our investments.”

COPD, a progressive condition that restricts airflow and makes breathing increasingly difficult, is the third leading cause of death in England, according to the NHS.

It is responsible for about 30,000 deaths each year and costs the health service an estimated £1.9bn annually.

The company believes its technology could transform how respiratory disease is diagnosed by replacing the need for conventional spirometry in many settings.

Patients simply breathe normally into the handheld device for 75 seconds while artificial intelligence analyses the breath in real time.

A diagnosis is then displayed on screen, allowing clinicians to complete the entire process in around five minutes.

TidalSense says the technology allows clinicians to assess as many as six patients an hour, compared with roughly one an hour using spirometry, which has remained the standard diagnostic test for COPD despite changing little since it was first developed in the 19th century.

Spirometry requires patients to perform forceful breathing manoeuvres and typically needs specialist staff to administer.

TidalSense chief executive Ameera Patel said: “Our ambition is really bold and broad, and it is to have a really significant impact at a population level on chronic respiratory diseases like COPD and asthma.

“We want the test to be available to anyone the first time they present with symptoms, so there’s no bias in accessibility based on where you live, your socio-economic status or your ethnicity.”

Founded in 2013 by chief engineering officer Julian Carter, who holds a PhD in microelectronics and has more than 35 years’ experience developing medical devices, TidalSense has spent more than a decade building the technology.

Its AI models have been trained on more than 2.5 million recorded breaths to identify the distinctive patterns associated with COPD.

The device was introduced into the NHS last year and is now being used by public health providers in Suffolk, north-east Essex, Wales, Glasgow and community lung screening clinics across the south of England.

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