Three leaders in menopause innovation have been shortlisted for a Femtech World Award.

The Menopause Innovation of the Year award, sponsored by Cross-Border Impact Ventures (CBIV), recognises those showing exceptional innovation in addressing the health, wellbeing and quality-of-life needs of people navigating perimenopause, menopause, and beyond.

CBIV is 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)

The Menopause Innovation of the Year award is one of 10 being celebrated at Femtech World’s third annual awards event.

The winner of this and all other awards will be revealed at a virtual event on June 19.

Congratulations to the shortlist and thank you to everyone who entered.

Menopause Innovation of the Year Shortlist

Noctera by Bonafide is a hormone-free, prescription-free, melatonin-free dietary supplement designed to combat sleep disruptions caused by hormonal changes – it’s been shown to improve quality of sleep, reduce sleep disturbances and increase daytime energy.

While other dietary supplements for sleep exist, products targeted at menopausal women focus more on managing night sweats because of their relationship to disrupted sleep. Noctera is a true menopausal sleep product targeting sleep disruptions caused by hormonal changes.

A randomized, double-blind, placebo-controlled trial demonstrated that Noctera significantly enhances sleep quality in perimenopausal and postmenopausal women who are experiencing moderate-to-severe sleep disturbances. 

Owning Your Menopause (OYM) was founded by Kate Rowe-Ham — personal trainer, bestselling author, and perimenopause survivor — with a single mission: to give midlife women expert-led fitness, nutrition, and wellbeing support that is designed specifically for them.

The result is a platform that members describe as feeling made for them. That is not an accident. It is the outcome of deep empathy, expert knowledge, and relentless commitment to a community that has historically been underserved by both the fitness industry and healthcare system.

OYM is not just an app. It is evidence that the right technology, in the right hands, can transform health outcomes for women who need it most.

The Womeno digital platform, Womeno App and Womeno-Friendly Workplaces programs combine holistic,science-driven, and deeply user-centered approach in addressing one of the most overlooked yet critical areas in women’s health.

One of the strongest reasons for this nomination is Womeno’s team commitment to practical, evidence-based solutions.

Rather than relying on trends or anecdotal wellness claims, Womeno integrates medical expertise, research-backed insights, and easy-to-use digital tools that empower every woman to make informed decisions about her health.

The FDA has delayed approval of camizestrant while it reviews new analyses submitted by AstraZeneca after advisers voted against the breast cancer drug.

The US regulator had been considering whether to approve the oral treatment after a phase 3 switching study in a specific group of breast cancer patients.

Camizestrant is an oral SERD, or selective oestrogen receptor degrader. These drugs are designed to block and break down oestrogen receptors that can help some breast cancers grow.

AstraZeneca filed for approval based on the phase 3 Serena-6 trial, which tested a treatment-switching approach.

Patients in the study received an aromatase inhibitor and a CDK4/6 inhibitor. Aromatase inhibitors lower oestrogen levels, while CDK4/6 inhibitors are targeted cancer drugs that help slow cancer cell growth.

After detecting an ESR1 mutation, investigators switched the aromatase inhibitor to camizestrant.

An ESR1 mutation is a change in a gene linked to the oestrogen receptor. It can make some breast cancers less responsive to standard hormone treatments.

AstraZeneca said switching to camizestrant was linked to a 56 per cent increase in progression-free survival.

Progression-free survival measures how long a patient lives without their disease getting worse.

However, the FDA raised questions about the study design.

An FDA advisory committee later voted six to three that AstraZeneca had failed to show camizestrant provides a clinically meaningful benefit.

The vote was a setback for the company’s hopes of approval, although the FDA can go against advisory committee recommendations.

After the setback, AstraZeneca submitted additional analyses requested by the FDA.

The company said the analyses include data on circulating tumour DNA clearance linked to longer-term efficacy outcomes.

Circulating tumour DNA refers to fragments of genetic material from cancer cells that can be found in the blood.

AstraZeneca is expected to share the data next week at the American Society of Clinical Oncology annual meeting.

The FDA has now delayed its ruling while it reviews the additional information. AstraZeneca did not provide a new decision date.

Three-month delays are typical and, during the second Trump administration, have been common.

After budget cuts reduced its workforce, the FDA delayed rulings on assets including Bayer’s Lynkuet, Biohaven’s troriluzole and Sanofi’s tolebrutinib. The FDA reportedly blamed a “heavy workload and limited resources” for one delay.

The agency has continued to delay rulings this year, with Biogen, Savara and Travere Therapeutics among the companies to say the FDA has extended reviews of their drugs.

Like AstraZeneca, those three companies faced delays after submitting additional information that the agency needed time to review.

If the additional analyses address the regulator’s concerns, AstraZeneca could still secure approval for a drug it has estimated could generate peak sales of more than US$5bn.

Guggenheim Securities analysts recently described the Serena-6 study as “a limited commercial opportunity in our and [AstraZeneca’s] view”.

AstraZeneca is also running two adjuvant studies and a trial in a first-line setting as it seeks to position camizestrant across different stages of breast cancer care.

Adjuvant treatment is given after primary treatment, such as surgery, to reduce the risk of cancer returning. First-line treatment is the first therapy given for a disease.

Roche reported the failure of its rival oral SERD in first-line breast cancer in March, but AstraZeneca executives have argued that their trial designs and drug candidate are different.

Last week, Europe’s Committee for Medicinal Products for Human Use issued a positive opinion on camizestrant.

The drug is expected to be marketed as Etcamah in Europe.

Wearable technology could revolutionise how women understand and manage their menstrual and hormonal health, according to a major new review that assessed dozens of studies involving data from millions of participants.

The review, which examined 40 studies with cohorts ranging from small pilot groups to nearly 19 million participants, found that devices such as the Oura Ring, Apple Watch, Fitbit, WHOOP band and Garmin watches are capable of detecting meaningful physiological changes across the menstrual cycle – and could one day help identify conditions far sooner than current methods allow.

The findings come as growing attention is being paid to the economic and personal toll of menstrual health problems.

Up to 90 per cent of women report cycle-related symptoms including pain, bloating and mood swings, while up to 40 per cent suffer from premenstrual syndrome.

A more severe condition, premenstrual dysphoric disorder, affects up to 8 per cent of women. In economic terms alone, menstrual and perimenopausal symptoms are estimated to cost the United States more than US$26 billion a year.

Researchers found that wearables were able to reproduce well-established hormonal patterns in real-world settings.

Skin temperature was found to be lower in the first half of the cycle before ovulation, and higher afterwards, consistent with known effects of progesterone.

Resting heart rate rose by around two to four beats per minute from the pre-ovulation phase to the days following it.

Heart rate variability, a marker of nervous system activity, was highest in the early cycle and lowest in the premenstrual phase, with lower readings linked to symptoms of PMS and PMDD.

The review also challenged some long-held assumptions.

Digital data suggested that ovulation tends to occur later and more variably than previously thought, with the pre-ovulation phase averaging 15 to 17 days rather than the 13 to 14 days typically cited.

Skin temperature was also found to dip most sharply more than five days before ovulation – not immediately before it – a finding the authors said could have practical implications for women using cycle tracking for contraception or conception.

Large datasets revealed that cycle patterns vary considerably between individuals and across a lifetime.

Nearly 20 per cent of women showed significant cycle-to-cycle variability, and both low and high body weight were linked to longer and less predictable cycles.

The data also pointed to racial differences in menstrual characteristics that had previously gone largely undetected in smaller laboratory studies.

On contraception, the review found that combined hormonal contraceptive users showed flatter, inverted heart rate variability patterns across the cycle, while progestin-only methods produced trends closer to natural cycles.

The authors cautioned that most research has been conducted in the United States and Europe, with predominantly white participants, and called for broader, more diverse studies.

They also flagged significant gaps in research on perimenopause, partly because many studies excluded women with irregular cycles.

Despite these limitations, researchers concluded that wearable devices hold genuine promise for helping women monitor their health and enabling earlier identification of conditions that might warrant medical attention – provided privacy safeguards and standardised research methods are put in place.