NHS approves Elahere. Contraline closes $92.5M. Flo Health faces a second privacy complaint in Europe.
The NHS in England approved mirvetuximab soravtansine (Elahere) for chemotherapy-resistant ovarian cancer this week, ending a 20-year gap in treatment options for the disease. Up to 400 women annually qualify under the NICE approval, which is limited to patients whose tumors express the FRα protein and who have already failed platinum-based chemotherapy. In the pivotal trial, 37% of patients on Elahere saw tumor reduction of at least 30%, more than double the 16% response rate on standard chemotherapy.
Ovarian cancer kills approximately 185,000 women globally each year. Most are diagnosed at a late stage. This approval does not change either of those facts, but it adds a viable second-line option where none existed.
Five stories inside, plus quick hits.
VIA FutureFemHealth
Contraline raised $92.5 million in a Series B round after its NES/T Gel completed a Phase 2b trial involving 462 couples. The company will enter Phase 3 development in 2027 with what would be the first pharmacological male contraceptive to reach that stage. Elation Health acquired women’s health startup Aster, which previously raised $2.8 million. Flo Health settled a privacy lawsuit for $8 million last year and now faces a new complaint in the Netherlands regarding its handling of sensitive reproductive health data. The European Commission approved AbbVie’s AQUIPTA (atogepant) for acute migraine treatment. Alife Health received FDA clearance for Embryo Predict, an AI-powered embryo assessment tool, supported by a multi-centre clinical trial involving 440 patients. The French Femtech sector has grown to 200 startups, with 23% already profitable and seven benefiting from reimbursement. Clue partnered with German private health insurer SDK, making it the first period and menstrual cycle tracking app covered by health insurance. Walmart is rolling out Nella's pelvic exam comfort kit nationwide. ŌURA Ring 5 is 40% smaller than its predecessor and includes new features like GLP-1 Insights, blood pressure trend monitoring, and AI-powered health guidance. Adora Health partnered with Medicash to provide menopause support through employer-funded health benefits. Cosm Medical partnered with Duke Health and Mayo Clinic to develop patient-specific recovery devices for pelvic floor surgery.
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— The Luteal Editorial Team
VIA FemTech World
Up to 400 women a year in England could benefit from mirvetuximab soravtansine (Elahere), the first new drug for chemotherapy-resistant ovarian cancer approved by the NHS in over 20 years. NICE approved mirvetuximab soravtansine for patients with epithelial ovarian, peritoneal, or fallopian tube cancer that has resisted platinum-based chemotherapy and whose tumors contain the FRα protein. In a global clinical trial, 37% of patients on the drug saw tumors shrink by at least 30%, compared to 16% of those on chemotherapy. This approval offers a new treatment option for ovarian cancer patients.
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— The Luteal Editorial Team
VIA FemTech World
British women were 47% more likely to report feeling angry than a year earlier, according to the Hologic Global Women’s Health Index, which surveyed over 76,000 women and girls globally. More than 20% of women in Britain reported experiencing feelings of rage for much of the previous day, placing the UK sixth among 37 European countries for anger. Over three in ten UK women also reported chronic health problems, an increase of 7% from the previous year. This indicates a deteriorating mental and physical health landscape for women in the UK, creating opportunities for femtech solutions addressing chronic conditions and mental wellbeing.
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— The Luteal Editorial Team
VIA PR Newswire Health
HydroMARK™ Plus markers, designed for breast care with proprietary hydrogel technology, received a CE mark. This CE mark expands the product's access across Europe. Manufacturers of breast care devices gain market access in European Union countries by meeting CE mark requirements.
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— The Luteal Editorial Team
VIA FemTech World
A Tulane University study analyzing approximately 950,000 atrial fibrillation patients found that being female may not universally raise stroke risk. Instead, increased stroke risk in women primarily appears among those aged 75 and older, who had one additional stroke per 629 patients compared to men in the same age bracket with no additional risk factors. This challenges the long-standing assumption that female sex inherently increases stroke risk in AF patients, potentially impacting how clinicians prescribe anticoagulants.
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— The Luteal Editorial Team