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US company launches large-scale study to investigate the “burdens” of incontinence

The results are hoped to inform the development of new treatment options for women

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The US medical device company Axena Health has announced a large-scale study to investigate the “burdens” of incontinence on women in low- and middle-income countries and improve access to treatment.

The study will examine how women could access treatment within local healthcare delivery systems and in a manner that accommodates cultural norms.

The results, the company says, will be available in late 2023 and will inform the development of new treatment options based on the Leva Pelvic Health System, a digital health treatment for urinary incontinence (UI).

“When it comes to incontinence, there is a need to generate community awareness that it is treatable and sensitisation and training of health workers to increase screening, deliver conservative and surgical treatment, and provide adequate follow-up,” says Mohan Chandra Regmi, Professor of Obstetrics and Gynaecology and chief policy advisor for the Government of Nepal.

“The scope is simply huge.”

Approximately one-third of women in low- and middle-income countries experience at least one pelvic floor disorder, such as urinary or faecal incontinence.

Pelvic floor muscle training (PFMT) is globally accepted as first-line treatment for bladder and bowel leakage.

Beginning in Nigeria and Kenya, the study will gather feedback from women living with incontinence, their family members, and clinicians to gain perspective on the impact of incontinence on women’s daily lives, symptom management strategies and how they access treatment through local healthcare systems.

Axena Health says it will use these data to develop a treatment with Leva technology to support access to effective treatment for incontinence that is “culturally acceptable” and available within existing healthcare pathways.

A second phase of the work will include formative and implementation research and is expected to include additional countries in Africa and South Asia.

“Urinary incontinence is a global health problem,” says Jessica McKinney, Axena Health’s VP of clinical affairs and global health.

“The physical, psychosocial, and economic burdens for women are significant and have been well documented primarily in high income countries. There is evidence in all settings that women’s livelihoods may be negatively impacted, and they may experience limited participation in family and community life.

“It is also true that UI is universally undertreated, and many women live with the health condition for the rest of their lives.

“Our intention with this study is to better understand and share women’s lived experiences with incontinence and direct actionable changes in awareness and treatment.”

The World Health Organization identifies urinary incontinence as a maternal morbidity and as a health priority for aging women, which includes a “strong recommendation” for PFMT.

Data from the US indicates that as few as 25 per cent of women with a pelvic floor disorder perform PFMT despite a clinician’s direction. Of those who perform PFMT, fewer than 25 per cent perform exercises adequately.

Eileen Maus, CEO of Axena Health, says female incontinence is a significant unmet health need for millions of women worldwide.

“We believe we’re uniquely able to help,” she adds.

“We’re grateful to our funding partner, AXA IM Alts, which is committed to providing innovative solutions to global health challenges and supports our goals.

“Our hope is that this work will help strengthen health systems and build greater capacity for women’s healthcare with key partners in lower-resourced settings in and outside of the US.”

Fertility

Vipoglanstat trial reaches recruitment halfway point

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Vipoglanstat has reached the halfway point for patient recruitment in a phase 2 endometriosis trial.

Gesynta Pharma said 50 per cent of the target of 190 patients have been randomised in the NOVA trial.

The study is evaluating vipoglanstat, described by the company as a novel, non-hormonal, non-opioid drug candidate for the treatment of endometriosis.

Endometriosis is a chronic inflammatory condition where tissue similar to the lining of the womb grows outside the uterus, often causing severe pain and, in some cases, infertility.

The condition affects more than 10 per cent of women of reproductive age.

Top-line results from the study are expected in 2027.

The NOVA trial is a randomised, double-blind, placebo-controlled phase 2 proof-of-concept study evaluating vipoglanstat in women with endometriosis across Europe.

This means patients are assigned to treatment groups by chance, neither participants nor researchers know who receives the drug or placebo during the study, and the results are intended to show whether the treatment has enough evidence to move into later testing.

The trial is assessing the efficacy and safety of two dose levels of vipoglanstat and will provide information for the design of a subsequent phase 3 programme.

Eva Johnsson, chief medical officer and vice president of clinical development at Gesynta Pharma, said:

“Reaching the halfway point in patient recruitment marks a major milestone for our Phase 2 clinical trial in endometriosis. Achieved well ahead of schedule, the rapid progress reflects strong participation from clinical sites and great interest among eligible participants. This momentum highlights the urgent need for better treatments.

“We are now eager to complete enrolment and proceed to the next phase of evaluation.”

Patric Stenberg, chief executive of Gesynta Pharma, said:

“The NOVA trial is a significant advancement in a field with few ongoing clinical trials, and a key step toward establishing a strong foundation for a future Phase 3 programme for vipoglanstat.

“Given the immense medical need, our focus remains on delivering a treatment that is highly effective, safe, and well-tolerated.”

Vipoglanstat is an orally active drug candidate designed to reduce pain and inflammation by targeting mPGES-1, an enzyme that produces prostaglandin E2, a substance linked to inflammation in endometriotic lesions.

A preclinical proof-of-concept study in an advanced endometriosis model found that vipoglanstat significantly reduced pain-related behaviours and endometriotic lesion burden.

Gesynta said previous clinical studies have supported the drug candidate’s safety, tolerability and pharmacodynamic effects in humans. Pharmacodynamic effects refer to how a drug acts in the body.

NOVA stands for the Non-hormonal Option, a Vipoglanstat Assessment trial.

Endometriosis commonly presents with severe period pain, known as dysmenorrhoea, pain between periods, pain during sexual intercourse, gastrointestinal symptoms and infertility.

Current management is typically limited to painkillers, hormonal therapies and surgery.

Despite its prevalence, Gesynta said endometriosis remains a critically underserved area of women’s health.

The company said the disease is significantly underdiagnosed and undertreated, with few new treatment options available to patients.

Approximately 190 patients aged 18 to 45 will receive vipoglanstat or placebo over four menstrual cycles.

The primary objective is to evaluate the effect of vipoglanstat on endometriosis-related pain during non-menstrual days.

Secondary objectives include assessing the effect on menstrual pain, known as dysmenorrhoea, pain during sexual intercourse, known as dyspareunia, use of opioid rescue medication and quality-of-life measures.

Changes in endometriotic lesions, areas of tissue linked to the condition, will also be explored using MRI scans.

Gesynta Pharma said its research on targeting mPGES-1 began at Karolinska Institutet in Sweden.

The company said a second drug candidate, GS-073, is ready to enter clinical phase 1 for the treatment of chronic inflammatory pain.

Gesynta Pharma’s shareholders include Hadean Ventures, Industrifonden, Innovestor Life Science, Linc, HealthCap, XGen Venture and other specialist investors.

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Femtech World Awards 2026: Celebrating initiatives that move women’s health forward

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By Wolfgang Hackl, CEO, OncoGenomX Inc., Allschwil, Switzerland

As the FemTech World Awards 2026 winners are revealed, it is a privilege to reflect on the Research Award 2026 sponsored by OncoGenomX Inc., and on the exceptional standard set by this year’s finalists.

On behalf of OncoGenomX Inc., sincere thanks to every applicant and congratulations go to the nominees whose work continues to push women’s health innovation forward.

Research Awards matter because they do more than recognize excellence in a single moment; they help elevate the science, courage, and systems thinking needed to transform women’s health at scale.

This year’s three finalists represented three different but equally important forms of progress. Natural Cycles brought forward one of the largest studies ever conducted on menstrual and ovulatory patterns in perimenopause, analysing nearly one million cycles from more than 197,000 women across over 140 countries.

That project stood out for both its dataset scale and its ability to translate new evidence into a regulated product designed to support women navigating a historically under-researched life stage.

IVI RMA stood out for scientific rigor and clinical precision. Its multicenter, double-blinded, non-selection study on non-mosaic segmental aneuploid embryos offered high-quality evidence on implantation and live birth outcomes, helping move fertility care away from assumption and toward a more evidence-based approach to embryo management and patient counseling.

UN ESCAP’s ‘Femtech in South-East Asia: Unlocking innovation for women’s health’ stood out for a different reason.

Rather than focusing on one product area or one clinical question, it mapped an entire emerging ecosystem.

The report examined the state of femtech across key South-East Asian markets, documented barriers such as financing gaps, stigma, weak ecosystem support, and data challenges, and then translated that research into practical recommendations for governments, investors, founders, and ecosystem builders.

In many ways, all three finalists are winners.

Each project excelled on core evaluation criteria including originality, relevance, coherence, effectiveness, efficiency, impact, and sustainability.

Each also offered something genuinely valuable to the future of women’s health: stronger evidence, clearer decision-making, more informed product development, and greater visibility for unmet needs that have gone too long without sufficient attention.

The final decision was therefore a genuine head-to-head race.

The jury supported its discussion with a numerical scoring approach, but it also looked carefully at systems impact: the extent to which a project not only advances one intervention, but improves the wider conditions under which innovation can emerge, scale, and endure.

That perspective mattered in this category, because the strongest research is not always only the most technically impressive; sometimes it is the research that opens doors for many future innovations to follow.

On that basis, the OncoGenomX Jury selected UN ESCAP as the winner of the Research Award.

The decisive factor was not simply that the report was comprehensive, though it was.

It was that the project helps change the environment around innovation itself.

It provides a practical roadmap for strengthening research, improving data governance, expanding founder support, addressing gender bias in investment, scaling innovative finance, and integrating women’s health more fully into policy and development agendas.

That broader enabling effect is what distinguished the UN ESCAP project. Natural Cycles demonstrated outstanding research translation, and IVI RMA demonstrated exceptional clinical rigor.

UN ESCAP, however, showed how research can influence the structures that determine whether many other femtech solutions will ever be funded, adopted, trusted, and scaled. In that sense, its impact reaches beyond one company, one product, or one clinical pathway, and toward a healthier innovation landscape overall.

Warm congratulations again to all finalists and nominees.

And special congratulations to UN ESCAP on receiving the OncoGenomX Research Award at the Femtech World Awards 2026.

The jury’s decision reflects deep respect for all three projects and a shared belief that women’s health advances fastest when excellent science is paired with the power to reshape the systems around it.

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Wellness

WEC Chair calls out Health Minister’s delay on banning BBLs and other harmful cosmetic procedures

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WEC chair Sarah Owen has criticised delays over a ban on high harm cosmetic procedures, including liquid BBLs.

The Women and Equalities Committee has published a letter from health minister Karin Smyth after the government missed the 18 April deadline to respond to the committee’s report on cosmetic procedures.

The report, published on 18 February, recommended that high harm procedures such as liquid Brazilian butt lifts, known as BBLs, should be banned immediately without further consultation.

MPs said the government is “not moving quickly enough” in introducing a licensing system for non-surgical cosmetic procedures and “should accelerate regulatory action”.

They also warned that “this lack of timely action is fostering complacency in self-regulation” within the industry.

In her letter, Smyth said the Department of Health and Social Care had “taken the decision to first of all focus on introducing legal safeguards for the cosmetic procedures posing the highest risks and I can confirm that we plan to consult on draft regulations in June”.

The letter added:

“Our intention is to issue a formal government response to the WEC report, once our consultation setting out our proposed approach and underpinning legislation is published.

“I acknowledge the concerns around the government’s pace of delivery in this area but, as you will appreciate, this is a complex area of policy and striking the balance between increased patient safety, placing new requirements on businesses and introducing proportionate and enforceable regulation is challenging.

“I recognise that regulation has not kept pace with the expansion of the aesthetics industry and, on that basis, I can assure you that we are committed to implementing licensing in the current parliament.”

Owen, chair of the Women and Equalities Committee and Labour MP, said:

“Further consultation and delay on clamping down on high harm procedures such as liquid BBLs is unacceptable. It allows unscrupulous people to continue to put women at risk and lets down those who have lost loved ones following these practices or who have come to serious harm themselves.

“As WEC’s report warned back in February, procedures that are deemed high risk such as liquid BBLs and liquid breast augmentations, which have already been shown to pose a serious threat to patient safety, should be banned immediately.

“While it is positive to hear a licensing system for non-surgical cosmetic procedures will be introduced within this Parliament, this issue requires faster regulatory progress, particularly in high harm areas, and the Government is not moving quickly enough.

“The Committee previously heard a powerful and shocking testimony from a woman who developed sepsis after having a liquid BBL. Her experience and those of many others provides clear evidence of the need to tackle this evolving wild west.”

A liquid BBL is a non-surgical procedure intended to alter the shape of the buttocks.

Sepsis is a potentially life-threatening response to infection that can lead to organ damage if not treated quickly.

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