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Start-up secures FDA clearance for stress urinary incontinence device

The device can be used during a specific activity or up to 12 hours for general control over symptoms



Allison L. Watkins, founder and CEO of Watkins-Conti / Source:

The US women’s health start-up Watkins-Conti has obtained 510(k) clearance from the US FDA for its stress urinary incontinence device. 

Yōni.Fit is a device intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women 18 years and older.

The silicone device is a soft vaginal insert that aims to reduce urine leaks without interfering with voluntary urination. It is self-administered and can be used during a specific activity or up to 12 hours for general control over symptoms.

The FDA clearance represents a “substantial milestone” in non-surgical options for the temporary management of urinary incontinence, a condition estimated to affect about one in three women in the US at some point in their lives.

Allison L. Watkins, founder and CEO of Watkins-Conti, said: “My lived experience as a new mother with SUI gave me the inspiration for Yōni.Fit.

“The options available to me at the time did not complement my lifestyle as a working mom with two small children.

“Listening to patients on their journey and innovating accordingly is paramount. I am committed to developing even more solutions for women’s pelvic health, using the Yōni.Fit device as a self-care platform that could potentially include diagnostics and drug delivery.”

Fifty-eight participants were enrolled in a randomised, controlled study of Yōni.Fit in women with SUI. The study was conducted by urogynaecologists at Stanford, NYU Langone, and Jefferson Health.

Of the participants completing the evaluation phase, a significantly higher percentage experienced clinically meaningful reduction in 12-hour pad weights with the Yōni.Fit device compared to the control device.

Karolynn T. Echols, director and associate professor of female pelvic medicine and reconstructive surgery at Thomas Jefferson University and an investigator in the Yōni.Fit clinical study, said: “My patients with stress urinary incontinence want a solution that is effective and convenient – one that accommodates the reality of their busy lives and does not interfere with voluntary urination.

“The cost and downtime associated with surgery can be prohibitive for some women.”

Dr Kate C. Arnold, chief medical officer of Watkins-Conti, added: “I believe Yōni.Fit will be an appealing and effective self-care solution for patients who value convenience and want to be in control of their pelvic health.

“We are committed to helping all women, including those in rural areas and in medically underserved communities, where access to surgery would be challenging.”

Ross Watkins, president of Watkins-Conti, shared: “With this FDA clearance, Watkins-Conti is now positioned to help this important and underserved market.”


‘Groundbreaking’ endometriosis study identifies patient priorities



A “groundbreaking” study into endometriosis has identified three areas for future research that can help improve the outcomes for women with the condition.

The study, commissioned by Endometriosis New Zealand, attracted 1,262 participants, including 1,024 people with confirmed endometriosis, making it the largest ever study involving endometriosis patients and supporters in New Zealand.

Study participants identified the management and treatment of endometriosis, the need for a better understanding of its cause and improvements to diagnostic capability as the three main priorities for further research.

While these findings provide a clear pathway for future work, Endometriosis New Zealand chief executive, Tanya Cooke, said endometriosis research had historically been underfunded.

“With an estimated 120,000 New Zealanders living with endometriosis, much more needs to be invested into finding solutions,” Cooke explained.

“The reality is the outcomes for many endometriosis patients are pretty poor, with diagnosis often taking many years and treatment patchy across the country.”

Estimates based on Australian data suggest that endometriosis is likely to be costing New Zealand somewhere in the range of $1.3-1.5bn annually through increased healthcare costs and lost workforce productivity.

Cooke said: “The good news is that our findings align closely with those in Australia and provide three clear priorities for future research – improved treatment options, causation and better diagnostic capability.

“What New Zealand now requires is proper funding for a future research programme that can investigate these priorities more closely and improve the outcomes for individuals living with endometriosis.”

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Virtual care platform secures US$46m to address US maternal health crisis

Pomelo Care will use the funding to scale its care model and improve maternal and infant outcomes



Marta Bralic Kerns, founder and CEO of Pomelo Care

The US virtual maternity care platform Pomelo Care has secured US$46m in funding to address the US maternal health crisis.

One in 10 babies born in the US today start their life in a neonatal intensive care unit.

Healthcare access continues to worsen, with one in eight births occurring in US counties with limited-to-no access to maternal care. Due to significant gaps in postpartum care, about half of pregnancy-related deaths in the US occur after hospital discharge.

The evidence exists for how to identify people at highest risk for complications and which interventions are most effective, but existing data gaps and provider capacity challenges make it difficult to apply these interventions at scale.

Pomelo has developed a care model that aims to address these challenges by analysing claims and health record data to identify individual risk factors and providing virtual pregnancy, postpartum, and infant care to patients to reduce those risks.

“We’ve long known what works to reduce maternal and infant complications,” said Marta Bralic Kerns, founder and CEO of Pomelo Care.

“The questions have always been: can you identify the patients who are at highest risk, can you deeply engage them in care to drive uptake of the prevention strategies we know work, and can you do it in the highest risk populations with the most limited access to care?”

“This data demonstrates that we absolutely can. And with this additional funding, we’ll have the opportunity to scale our care model to more pregnant people across the country.”

The funding, led by existing investors First Round Capital and Andreessen Horowitz (a16z) Bio + Health, is hoped to help Pomelo accelerate its partnerships with payors across the US and increase access to “evidence-based” care.

Josh Kopelman, partner at First Round Capital and Pomelo board member, said: “It’s rare to come across an opportunity where the incentives between patient, provider and payor are all aligned.

“Marta and the Pomelo team have found an incredible opportunity to dramatically improve outcomes for the highest risk populations, while helping payors reduce their avoidable costs.”

Vineeta Agarwala, general partner at a16z Bio + Health and Pomelo board member, added: “Pomelo is one among a small set of health tech companies that have earned true scale.

“This scale is evident in our partnerships with major Medicaid and commercial plans covering over three million lives, which create the opportunity to collaborate with OB providers, labour and delivery wards, and NICUs nationwide, while serving hundreds of thousands of expecting mothers and newborns with high quality, technology-enabled care.”

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One in three UK fertility patients seek treatment abroad due to high costs

Expensive fertility treatments prompt UK patients to seek help abroad



One in three fertility patients in the UK seek treatment abroad due to high costs, a new survey has shown.

Fertility Family has gathered insights from 429 UK participants who have experienced difficulties with infertility.

The Infertility Awareness Report found that the high cost of fertility treatment in the UK has driven over one in four people to spend over £10,000 on both treatments and investigative procedures.

The research showed around 35 per cent of people struggling with infertility have considered seeking fertility treatment abroad due to the prospect of lower costs.

Of those seeking fertility treatment in a foreign country, however, only 14 per cent believed that clinics abroad have a higher success rate.

Of those actively trying to conceive almost one in five have used their life savings in the pursuit of having a child, whilst 25 per cent have paid for their fertility treatments using a credit card.

Dr Gill Lockwood, consultant at Fertility Family, said: “While we tend to cast our gaze on women when it comes to infertility, case studies have shown that infertility can impact both women and men in similar ways. However, women have been observed to seek help more than men.

“Although the psychological struggles of infertility can be overwhelming, many patients ultimately reach some type of resolution. Some of the alternatives include becoming parents to a relative’s children, adopting children, or deciding to adopt a child-free lifestyle.

“Needless to say, this resolution is usually psychologically demanding, and patients may feel forever impacted by the experience of infertility.”

A combination of fertility struggles and accessible healthcare have impacted people across the UK significantly, with one in two admitting to feeling “ashamed” due to their difficulties trying to conceive.

A further 31 per cent reported feeling that other people think “less” of them due to their fertility struggles, showcasing the need for better mental health support.

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