News
FDA approves application for investigational hormone-free contraceptive
Ovaprene could become the first FDA-approved monthly, self-administered, hormone-free contraceptive product

The Food & Drug Administration has approved an Investigational Device Exemption (IDE) application to allow the US company Daré to conduct an efficacy study of its hormone-free contraceptive.
Daré Bioscience, a clinical-stage biopharmaceutical company aiming to advance innovative products for women’s health, has designed Ovaprene to prevent pregnancy by releasing a locally acting, non-hormonal agent which impedes sperm motility, and physically blocking sperm from entering the cervical canal with a knitted polymer barrier.
The IDE approval reflects that the FDA determined the company provided sufficient data to support the initiation and conduct of the study.
The IDE submission included the results of the postcoital test (PCT) clinical study of Ovaprene, in which Ovaprene prevented all sperm from entering the cervical canal across all women and all cycles evaluated. PCT clinical trials have been used as a surrogate marker for contraceptive effectiveness.
“We are driven to bring forward innovative options that support women’s health and wellness, and we are motivated to accelerate the development and introduction of differentiated product candidates, like Ovaprene, which is both hormone-free and designed to be conveniently kept in place vaginally continuously over the weeks between menstruation,” said Sabrina Martucci Johnson, president & CEO of Daré Bioscience.
“When it comes to contraception, many of the top-selling brands in the category are delivering both convenience and efficacy, suggesting that women and healthcare providers have a preference for contraceptive methods that are effective, that don’t need to be administered every day, and that don’t require action at the time of intercourse.”
In order for the planned study to serve as the primary clinical support for a future marketing approval or clearance, the FDA provided additional study design considerations with the IDE approval letter.
“The FDA communication confirms our alignment on a number of key aspects of the clinical study, including the adequacy of a 12-month (13 menstrual cycles) duration,” explained Johnson.
“The additional study design considerations provided by the FDA are considered by the administration to be recommendations that do not need to be addressed in order for us to initiate and conduct this study. However, implementing the guidance that we received will further position this pivotal study to collect safety and effectiveness data that will support the submission of a Premarket Approval (PMA) application.
“We look forward to working with our collaborators at the NIH and at Bayer to review and implement the recommendations and we are targeting mid-year 2023 study recruitment initiation.”
The single arm, non-comparative, pivotal Phase 3 contraceptive study of Ovaprene will evaluate its effectiveness as a contraceptive device along with its safety and usability. If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the US and other countries.
In January 2020, Daré and Bayer announced an exclusive licensing agreement for US commercial rights to Ovaprene. Under the agreement, Daré received an upfront payment and access to Bayer’s extensive clinical and market capabilities while retaining control over Ovaprene’s development and regulatory approval process.
Bayer received the right to obtain exclusive rights to commercialise the product in the US following completion of the clinical trial being undertaken by Daré.
If Ovaprene is approved by the FDA, it could be the first monthly non-hormonal contraceptive product for women and a first-in-category option for women seeking a hormone-free, self-administered and monthly birth control method.
News
Menstrual health innovation shortlist revealed

We are thrilled to announce the shortlist for the Menstrual Health Innovation Award at the third annual FemTech World Awards.
This award, sponsored by Premom exists to celebrate the trailblazers redefining what menstrual health means in the modern world.
It recognises breakthrough products, services, and initiatives that are pushing boundaries in technology, product design, education, accessibility, and destigmatisation.
Premom’s innovative ovulation prediction app combines a digital ovulation test reader, intelligent fertility charting, and customised cycle insights to simplify the path to motherhood.
Sister company easy@Home was the first brand in the USA to offer personalised testing solutions and devices, and has become the largest volume seller of ovulation tests in the country.
Premom’s sponsorship of this award reflects a shared commitment to empowering women with better tools, better knowledge and better outcomes across every stage of their reproductive health journey.
This year’s shortlist is a testament to the remarkable breadth of innovation happening across the femtech landscape, from wearable bioelectronics to mission-driven apps reaching underserved communities across the globe.
Congratulations to the finalist and thank you to everyone who nominated.
Menstrual Health Innovation Shortlist
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Founded by healthcare designer Kateřina Rydlová, who wanted to manage her own period pain without relying on medication, Body Moody has developed a discreet, wearable heated bodysuit that delivers targeted warmth to the abdomen and back – quietly, under everyday clothing.
Made from soft viscose, controlled via a companion app, and built for 200+ washes and over five years of use, the bodysuit is as practical as it is pioneering.
Their borrow-then-buy model lowers the barrier to entry and early customer feedback speaks for itself, with users reporting that they have gone from averaging multiple painkillers per cycle to needing none at all.

Eshe is a women’s health ecosystem built for a part of the world that femtech has long overlooked.
Rooted in Sub-Saharan Africa, where 69 per cent of global maternal deaths occur, 65 per cent of women and girls in Kenya cannot afford sanitary pads, and over 60 per cent of women lack access to preventive healthcare, Eshe was created to meet women where they are.
The Eshe app offers daily menstrual cycle and fertility tracking, pregnancy monitoring, mental wellbeing check-ins, in-app consultations with qualified doctors, and health education content, all in one place.
By identifying irregular cycles, missed periods and mental health changes, the platform nudges users toward timely action rather than emergency intervention.

Polycystic ovary syndrome (PCOS) affects almost one in five women, making it the leading cause of infertility and a significant risk factor for conditions spanning obesity, cardiovascular disease, cancer, and cognitive decline.
Despite this staggering burden, there has not been a new treatment option in seven decades – until now.
LoOoP is a bioelectronic device paired with the MyLoOoP companion app, designed to address both the metabolic and menstrual symptoms of PCOS with the ultimate ambition of avoiding, delaying, or reducing its long-term complications.
The MyLoOoP digital platform goes further still, combining evidence-backed content, clinically validated journaling tools, a validated phenotyping algorithm, and an inclusive community – closing the persistent gaps in PCOS diagnosis, information and care.
What happens next
The shortlist will be judge by a Premom representative who will announce the winner at a virtual event on June 19.
The winner will receive a trophy and be interviewed by a Femtech World journalist.
Mental health
Dr-Julian helps deliver breakthrough mental health support for Black and ethnically minoritised mothers

A groundbreaking digital perinatal mental health pilot for Black and ethnically minoritised women has helped women access support faster, complete therapy at higher rates, and recover more successfully than national averages.
The partnership between digital tech company Dr-Julian and The Essential Baby Company Ltd within a new model of mental health care named haPPIE SHE Cares – who offer personalised support for women sharing their healthcare experiences, showed results well above NHS benchmarks for Black and ethnically minoritised women.
The pilot was created to help women who are less likely to use traditional mental health services during pregnancy and in the first year after giving birth.
By combining trusted community referrals, culturally aware support, and fast access to therapy through Dr-Julian’s online and virtual care platform, the programme delivered standout results.
Every woman who joined the pilot started therapy, 90 per cent completed treatment, and 74 per cent recovered; well above the NHS benchmark of around 52 per cent.
Women referred through community organisations accessed support in just one day on average, compared with around 21 days through many standard services.
Even the programme’s regular referral route reduced waits to 13 days.
The findings come as NHS leaders continue to focus on maternity inequalities and unequal access to mental health care.
Black and ethnically minoritised women can face barriers including stigma, language needs, lack of trust in services, childcare pressures, and difficulty navigating complex systems.
The haPPIE SHE Cares model was designed to break down those barriers by working with trusted community groups, offering culturally informed support, and where possible matching women with therapists who understood their background or language.
Gemma Poole for The Essential Baby Company said: “Too many women who need help feel unseen, unheard or unable to get support when they need it most.
“This project shows that when services are built around trust, culture and community, women engage, recover and thrive.
“This early success could provide a blueprint for reducing inequalities in maternal mental health care across the UK. Behind every statistic is a mother who felt supported, a family that benefited and a woman who found her voice.
“Mental healthcare must work for every community. This partnership shows that when high-quality therapy is combined with culturally responsive support, outcomes improve and women get help faster.
We are proud to have provided the therapists, virtual care systems and digital pathways behind this programme. We believe this model could help NHS organisations nationwide cut waiting times and improve recovery rates.”
Women who took part described the programme as life-changing, saying it reduced isolation, gave them confidence speaking with healthcare professionals, and made them more willing to seek help.
With growing pressure on maternity and mental health services, leaders behind the project say the pilot offers a practical solution that improves care while helping cut long waiting lists.
Plans are now being explored to expand the model through training, regional partnerships, and future funding.
Diagnosis
Women unaware of gynaecological cancers

Only one per cent of women can name all five gynaecological cancers, new research suggests, as 21 women in the UK die every day of the diseases.
The report also found that 31 per cent of women have put off or avoided seeking medical advice for gynaecological symptoms.
It also found that 43 per cent of women invited for cervical screening said barriers had put them off attending, while 18 per cent of respondents aged 25 to 34 who had been invited had never attended.
The five main gynaecological cancers are womb, also called uterine, ovarian, cervical, vulval and vaginal cancer.
The Lady Garden Foundation said that, while progress has been made since the UK government’s 2022 Women’s Health Strategy aimed to improve gynaecological cancer care, significant challenges remain.
John Butler, medical director and trustee at the Lady Garden Foundation, said: “The fact that only one per cent of the population can name the diseases that directly affect half of us underscores a significant awareness gap, impacting individuals’ ability to recognise vital signs and symptoms or seek timely medical help.
“Addressing this isn’t just about awareness; it’s a critical public health priority. Our collective efforts are essential to ensure the latest commitments announced by this government translate into tangible change that saves lives.”
The report said key reasons for delaying medical advice included difficulty making appointments, embarrassment and, for cervical screening, fear of pain or previous bad experiences.
Women also reported challenges within healthcare interactions, including feeling “not taken seriously”, “dismissed” or “not believed” when seeking gynaecological advice.
Jenny Halpern Prince, chief executive and charity co-founder, said: “We frequently hear reports of women feeling ‘not taken seriously,’ ‘dismissed,’ or ‘not believed’ when seeking gynaecological advice.
“These experiences highlight crucial areas where we can improve patient support and trust within our healthcare system, ensuring women receive the empathetic and effective care they need.”
The Lady Garden Foundation said it aims to increase awareness of both the charity and the five gynaecological cancers.
It also aims to serve as a primary entry point for reliable, stigma-free information, helping people understand their bodies, recognise symptoms and overcome barriers to accessing care.
Its Silent No More Garden was unveiled at the RHS Chelsea Flower Show 2026. Designed by Darren Hawkes, the garden serves as a national call to action, using five sculptures to spark conversations, break long-standing taboos and encourage open dialogue about symptoms and preventative care.
Butler said: “Continued focus and collaborative action are essential to progress.
“The ongoing commitment from the government, alongside societal efforts to break down taboos surrounding gynaecological health, are crucial.
“The Lady Garden Foundation is dedicated to being a beacon of information and support, empowering women with the knowledge they need. We urge everyone to learn the signs, speak up, and help us save lives.”
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