本期 HerNews 精选女性健康领域的投融资、企业动态、产品创新与政策资讯,供快速浏览。
共 16 条精选 · 点击标题阅读原文
Healthcare Investment
2 条May Health Raises $11.7M to Advance its Novel Technology to Treat PCOS-related Infertility
May Health, a medtech firm focused on PCOS-related infertility, has raised €10 million ($11.7M). Existing investors Sofinnova Partners, Bpifrance, and Trill Impact participated, with new investor Nexpring Health joining. The funding will support the REBALANCE pivotal IDE trial in the U.S. and European launch planning for its CE-marked Anavi™ System. The one-time office-based procedure aims to restore ovulation for women unresponsive to first-line therapies, addressing a major unmet need in global women’s health.
Flourish Care Raises $5.7M Oversubscribed Seed Round to Scale Nationwide Insurance-Covered Doula Network
Flourish Care, a leading maternal health platform offering hybrid virtual/in-person doula support, has raised $5.7M in oversubscribed seed funding led by Zeal Capital Partners. Backed by insurance coverage across 46 states, it serves over 20 million covered lives via commercial health plans and Medicaid. Its tech-driven network integrates certified doulas into clinical workflows, improving outcomes and cutting costs. Studies show doula care lowers C-sections, preterm births and NICU admissions. The funding will accelerate national expansion and AI risk-prediction tool development.
Corporate Highlights
6 条Daré Bioscience Receives FDA IND Clearance for Phase II Study of DARE-HPV for Persistent High-Risk HPV
Daré Bioscience received FDA clearance of its IND for a Phase II study of DARE-HPV, a potential treatment for persistent high-risk HPV infection, one of the main drivers of cervical cancer. The program is notable because it targets a clinically important intervention point before progression to more serious cervical disease. Positive data could help expand therapeutic options in women’s reproductive tract health and reinforce Daré’s profile as a focused innovator in underserved women’s conditions. In a sector often criticized for thin pipelines, that kind of asset-level progress matters.
Study Confirms Safety and Effectiveness of IceCure's Cryoablation for Breast Fibroadenomas
An independent PLOS ONE study found that IceCure Medical’s ProSense® cryoablation system safely and effectively treats breast fibroadenomas. Tumor volume decreased by about 80.6% at six months and 92.9% after one year, and the technique was effective even for larger lesions when the probe was repositioned during treatment.
WHOOP Launches Women's Health Biomarker Testing and Cycle Insights
WHOOP announced new female-focused biomarker testing as part of its Advanced Labs program, adding 11 blood biomarkers related to women’s health.
Evofem Reports Fifth Straight Year of Net Sales Growth Achieves Record $20.2M Net Sales in 2025
Evofem Biosciences reported its fifth consecutive year of net sales growth, with record net sales of $20.2 million in 2025, driven by its hormone-free contraceptive gel PHEXX. Operating income reached $3.4 million, swinging from a $7.7 million loss in 2024. The company cut operating expenses by 38% to $16.8 million. Progress includes manufacturing cost-reduction plans, advancing regulatory approvals in the UAE, and ongoing NIH-funded Phase 4 trial for SOLOSEC.
Hope Medicine Initiates Phase III Trial of HMI-115 for Endometriosis
Hope Medicine announced that the first patient has been dosed in a Phase III clinical trial of HMI-115, a first-in-class monoclonal antibody for treating moderate-to-severe pain associated with endometriosis. The study is a multicenter, randomized, double-blind, placebo-controlled trial with a 24-week treatment period, led by Peking Union Medical College Hospital.HMI-115 is currently the first non-hormonal therapy for endometriosis to enter Phase III clinical development. Earlier Phase II results showed significant pain reduction without affecting female hormone levels or causing menopausallike side effects. The drug has also received FDA Fast Track designation and Breakthrough Therapy designation from China’s NMPA, highlighting its clinical potential
Dare Bioscience Reports 2025 Financial Results & Launches DARE to PLAY™ Unveils Multi-Product Women's Health Pipeline
Daré Bioscience outlined a broad commercial and pipeline update, led by national pre-fulfillment availability of DARE to PLAY, its topical sildenafil cream for women, with revenue expected to begin in the second quarter of 2026. The company also expects to launch Flora Sync LF5, a vaginal microbiome-focused product, while continuing to advance Ovaprene in phase 3, DARE-HPV toward phase 2, and menopause-focused hormone therapy programs. The significance lies in Daré’s increasingly diversified women’s health model, spanning sexual health, vaginal health, contraception, infectious disease, and menopause. It also reflects a more hybrid commercialization approach combining regulated development with near-term market entry.
Product Innovations
3 条Femasys Advances FemBloc Toward U.S. Approval with Initiation of Pivotal Trial Enrollment
Femasys announced on March 10 that patient enrollment had started in the pivotal FINALE trial for FemBloc, its nonsurgical permanent birth control candidate. The milestone is strategically important because permanent contraception has long been dominated by surgical options, leaving room for a safer, office-based alternative if supported by solid clinical evidence. For women’s health stakeholders, the trial represents more than a product update: it points to continued innovation in reproductive interventions designed to improve accessibility, reduce procedural burden and expand patient choice in gynecologic care.
Beijing Wuhe Boao Pharmaceutical has initiated a Phase 2 clinical trial for WH007 in patients with polycystic ovary syndrome (PCOS)
Led by Principal Investigator Prof. Sun Aijun from Peking Union Medical College Hospital, the trial involves 12 leading clinical centers across China. WH007 is a natural drug candidate derived from the API of the company’s marketed product, designed to regulate the hypothalamic-pituitary-ovarian (HPO) axis. The study will evaluate efficacy and safety across multiple doses in improving hyperandrogenism, menstrual irregularity, ovulatory dysfunction, and metabolic abnormalities in PCOS patients.
Bayer has launched a Phase III study of Mirena for the treatment of nonatypical endometrial hyperplasia, targeting a women’s health condition with no approved therapies
The move expands Mirena’s strategic role beyond contraception into gynecologic disease management, particularly in uterine health. If the study succeeds, Bayer could strengthen its position in a clinically meaningful and commercially attractive niche where physicians need effective, lower-burden treatment options. The development also underscores continued industry interest in maximizing lifecycle value from established women’s health brands through new indications.
Policy and Advocacy News
1 条Brief
4 条Bayer Highlights Lynkuet (elinzanetant) Market Rollout in 2026 Financial Update, Bolstering Its Menopause Care Commitment
Bayer highlighted the market rollout of elinzanetant, branded as Lynkuet, during its March 2026 financial update, reinforcing the company’s commitment to menopause care despite broader portfolio reshaping.The launch matters because non-hormonal treatment options for vasomotor symptoms remain relatively limited, while demand is rising across aging female populations and among patients who are unwilling or unable to use hormone therapy. Bayer’s positioning of the asset as a potential blockbuster suggests menopause is still one of the most commercially relevant and medically underserved categories in global women’s health.
Merck announced the first prescriptions of Pergoveris® (recombinant human FSHα + LHα) in Guangdong, Hainan, Guizhou and Henan
As the world’s first recombinant fixed-dose combination for ovarian stimulation, Pergoveris improves pregnancy outcomes in women aged >35 and poor ovarian responders. In China, it is indicated for follicular development in females with severe LH/FSH deficiency. Infertility affects 18% of Chinese couples, with 32.9% of IVF patients ≥35. Backed by 100+ years of fertility expertise, Merck continues to advance assisted reproductive solutions in China.
Organon accelerates Women's Health progress across Asia Pacific with 2026 Her Health Grants
Organon announced the 2026 Her Health Grant recipients for Asia Pacific on March 30, backing organizations that improve access, equity, and informed choice for women and girls. The initiative focuses on real-world gaps in contraception and reproductive health across the region. For Organon, the grants are more than philanthropy: they reinforce the company’s strategic positioning in women’s health by building local partnerships, strengthening community pathways, and deepening relevance beyond product sales. That matters in Asia Pacific, where unmet need remains substantial and ecosystem influence often drives long-term market presence.
