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Menopause

Clinical study to investigate menopause app

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A new 12-week clinical study is to investigate the MENO! App, which has been designed to support symptoms relief for women experiencing menopause. 

One in four women suffer from severe menopause symptoms such as hot flashes, sleep disturbances, and mood changes that significantly impact their quality of life and work, yet treatment options remain limited and often inaccessible.

The decentralised, randomised-controlled clinical study will take place in Germany and study will evaluate the effectiveness of MENO! App, enrolling women aged 40 to 65 experiencing bothersome menopausal symptoms.

Participants will be randomised into two groups, one using the MENO! App and the other receiving standard care. After completion, the control group will also gain access to the app, ensuring all participants benefit from this innovation.

“We invest in innovative digital health solutions that address the individual needs of women at various stages of life,” said Professor Pia Wülfing, chief clinical officer for Sidekick Health Group, which has developed the app, and a licensed OB/GYN.

“Our focus lies in combining technology with medical expertise to improve healthcare outcomes.”

MENO! App is a CE-marked digital therapeutic for menopause, offering evidence-based cognitive behavioural therapy (CBT) specifically designed to reduce symptom burden.

The app provides a non-hormonal, accessible alternative to help women manage their symptoms holistically. The app integrates behavioural interventions with lifestyle support.

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Awards to spotlight leaders in menopause innovation

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Femtech World is to celebrate game-changing menopause innovations at its global awards event.

The Femtech World Awards, now in their third year, celebrates the brightest lights in women’s health innovation.

The event celebrates some of the best examples of leadership, innovation and impact in key areas that affect women’s health and wellbeing. 

The winner of the Menopause Innovation of the Year award will have shown exceptional innovation in addressing the health, wellbeing and quality-of-life needs of people navigating perimenopause, menopause and beyond.

Consideration will be given to impact, inclusivity accessibility and the ability to break stigma while delivering meaningful solutions.

This award celebrates those leading the way in redefining how menopause is understood and supported across healthcare and society.

The award is sponsored by Cross-Border Impact Ventures (CBIV) –  an impact venture capital firm on a mission to revolutionise venture investing in health technology.

CBIV invests in early-growth stage health technology companies commercialising medical devices, diagnostics, therapeutics, and digital health innovations and leveraging cutting-edge technologies like Artificial Intelligence (AI) and Machine Learning (ML).

All innovations CBIV finances are relevant to women’s, children’s, and adolescents’ health and located in North America and Europe, with the ability to scale technologies to emerging markets.

CBIV is driven by the belief that good health should not be restricted by gender, age, race, wealth, or borders and seeks to expand access to their portfolio’s world class technologies inclusively and globally. 

Annie Thériault, managing partner, Cross-Border Impact Ventures , said: “Being part of the FemTech World Awards gives us a front-row seat to the most exciting breakthroughs in women’s health.

“It’s a powerful way to stay connected to the pulse of innovation and the future of care.”

Find out more about the awards and enter for free here.

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Women’s health could unlock US$100bn by 2030

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Addressing women’s health could unlock US$100bn by 2030 in the US alone, a new report has found.

The World Economic Forum has published its Women’s Health Investment Outlook to highlight undercapitalised opportunities in women’s health.

A Boston Consulting Group analysis cited in the report estimates that treating four major conditions that disproportionately affect women could unlock this value by 2030.

The four areas are cardiovascular disease (heart and blood vessel disease), osteoporosis (bone thinning), menopause and Alzheimer’s disease.

These common, high-burden conditions remain underserved.

The report notes that, despite women making up half the global population, women’s healthcare attracts only six per cent of private healthcare investment, and companies focused exclusively on women’s health receive less than one per cent.

Around 90 per cent of current investment is concentrated in reproductive health, maternal care and women-specific cancers.

The authors say the true burden and potential of women’s healthcare have been obscured by fragmented data, historical bias, a lack of women in relevant leadership roles and misaligned incentives.

Half of private investments in women’s health-specific companies are at pre-seed or seed stage, and the sector is gaining momentum.

The report points to acquisitions in pelvic health, diagnostics and rising institutional interest in scalable platforms.

Six areas show strong potential for investment: women’s cancer therapeutics; virtual women’s healthcare and benefits management; remote maternal health monitoring; women-focused mental health platforms; women-first longevity and wellness concierge services; and wearables and platforms for women’s metabolic health.

Given the spa and wellness sector’s majority-female clientele, operators could host selected treatments if they extend their facilities.

Suppliers and innovators can also play a key role in creating and adopting women’s healthcare technologies, with devices to support pelvic health already supplied to high-end health clubs and spas to address continence and pelvic pain.

The report was published in collaboration with Boston Consulting Group, with contributions from the investment community, healthcare professionals and others.

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Round up: First wearable detects symptoms of perimenopause, and more

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

First wearable detects and decodes the symptoms of perimenopause

AI-driven women’s health company, IdentifyHer, has launched Peri, the world’s first wearable designed to detect and decode symptoms of perimenopause.

“75 per cent of perimenopausal women experience life-disrupting symptoms, yet perimenopause is treated like a mystery or an inevitability that women simply have to power through,” said Heidi Davis, co-founder of IdentifyHer.

“We reject this. Women deserve real data, validation, and support during this profoundly overlooked stage of life

“With Peri, we are pioneering a new era of women’s healthcare; one where women are in control of their health and equipped to manage the symptoms that shape how we feel – physically, mentally and emotionally.”

For most women perimenopause begins in the early to mid-40’s and brings wide-ranging symptoms that are often dismissed by healthcare providers.

Using biosensing technology and AI-driven analytics, Peri is a wearable device that passively tracks physiological signals to identify perimenopause symptoms and delivers personalised insights.

It helps women address perimenopausal challenges like anxiety, hot flashes, sleep disruption, nights sweats and more – issues that could have long-term health implications.

The device profiles these symptoms across the menstrual cycle, examining their interrelationships, and tracking changes over time.

“Heidi and I first launched IdentifyHer with the mission to support women’s long-term health, and immediately recognised that to do this, we need to address the gap in perimenopause symptom data,” said Donal O’Gorman, COO and co-founder of IdentifyHer.

“Our goal with Peri is to demystify perimenopause, but more importantly, to empower and reassure women they are not alone in what they’re feeling and it is possible to take proactive action towards their health.”

Emm raises £6.8m to launch world’s first smart menstrual solution

UK-based biowearable tech company, Emm, has raised £6.8m in an oversubscribed seed funding round, to bring the world’s first smart menstrual cup and connected app to market.

Creating a new category of “smart menstrual care”, Emm will equip users to understand their individual menstrual baseline and track key metrics for personalised insights into their menstrual health.

The funding will support Emm in bringing the product to market and accelerating the pathway to further clinical product development, as the business moves to transform the research, diagnosis and treatment of reproductive and menstrual health conditions.

Results published on potential endometriosis treatment

Biotech company Hope Medicine has announced that the results of a proof-of-concept Phase II clinical trial evaluating HMI-115 (a human monoclonal antibody targeting the prolactin receptor) for the treatment of endometriosis-related pain have been published in The Lancet Obstetrics,  Gynaecology, & Women’s Health.

The research, carried out in collaboration with Peking University, Peking Union Medical College Hospital, Shandong University, and other institutions, aimed to evaluate the safety, tolerability, and preliminary efficacy of HMI-115 in premenopausal women with moderate to severe endometriosis-related pain.

Results showed that at the end of the 12-week treatment period, dysmenorrhea NRS scores decreased by 41 per cent, 34 per cent, and 27 per cent in the 240 mg, 120 mg, and 60 mg HMI-115 groups, respectively, compared to the 18 per cent reduction in the placebo group.

Non-menstrual pelvic pain NRS scores also decreased across all HMI-115 dosage groups, with sustained efficacy observed at Week 25.

The company says that percentage reductions of dysmenorrhea and non-menstrual pelvic pain in the 240 mg group was statistically significant compared to placebo.

Additionally, HMI-115 groups showed improvements in the Endometriosis Daily Impact Pain (EDIP) scores and reduced use of NSAID rescue medications.

In terms of safety, the incidence of treatment-emergent adverse events (TEAEs) was 56 per cent, 59 per cent, 75 per cent, and 37 per cent in the 60 mg, 120 mg, 240 mg HMI-115 groups, and placebo group, respectively.

The most common adverse events included injection site itching and rash, dizziness, nausea, nasopharyngitis, and headaches.

No treatment-related deaths or serious adverse events were reported. Unlike existing hormonal therapies, HMI-115 did not cause hypoestrogenic side effects such as hot flashes or depression, and bone mineral density and key sex hormone levels remained stable during treatment.

This study is the first to clinically validate the potential of blocking prolactin receptor signaling to alleviate endometriosis-related pain.

Its non-hormonal mechanism of action avoids interference with ovulation and menstrual cycles, offering a promising new option for patients with fertility intentions.

The research team stated that these findings provide a strong foundation for initiating longer-duration Phase III trials to further evaluate the clinical benefits and risks of HMI-115.

A month of milestones in breast imaging innovation

Koning Health has said that October marked a substantial month for Koning in its mission to expand access to non-compression breast imaging.

The last several weeks saw the continued expansion of Koning’s technology to new and diverse settings across the country, including the official launch of Gnosis Dx, which introduced a mobile breast imaging and diagnostics platform powered by the Koning Vera Breast CT (KBCT) on the West Coast.

Designed to travel directly into communities, the Gnosis trailer is meant to reduce barriers to early detection and address disparities in access in the state of California.

On Manhattan’s Upper East Side, Pink Medical celebrated its grand opening this month with a ribbon-cutting event led by fashion icon Nicole Miller. This New York City location aims to redefine the breast imaging scene in the Big Apple.

Koning’s installation at Mount Sinai Medical Center in Miami brought the Vera system to one of Florida’s most respected medical institutions.

The device will be used both clinically and for research, advancing the understanding of breast CT’s role in precision detection and patient-centered imaging.

Koning continues to expand its international reach as the only breast CT manufacturing company that has received global critical regulatory and quality achievements including Koning’s 3D breast imaging system remains the only FDA-approved breast CT device commercially available for diagnostic use in the US.

The company is also seeing progress advancing in Australia (TGA) and through Europe’s GMED for CE Mark.

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