Women’s healthcare during menopause and midlife, a once neglected sector, is experiencing unprecedented growth, fueled by increased awareness, consumer demand, innovation in clinical care and a surge in investment activity. As awareness grows regarding the unique health needs of women during midlife, new clinical models, digital health solutions, and therapeutic options are emerging, offering a great deal of opportunity. Investors must navigate regulatory compliance when evaluating opportunities in this sector.
Emerging Research
Advancements in clinical research increasingly illuminate the complex connections between menopause and underlying health conditions. Researchers found that the hormonal changes associated with menopause, particularly the decline in estrogen, can influence the risk and progression of conditions such as cardiovascular disease, osteoporosis, diabetes and cognitive decline. Studies show that postmenopausal women are at a higher risk for heart disease and bone fractures due to changes in lipid profiles and bone density. Additionally, menopause is linked to metabolic syndrome, sleep disorders and mood disturbances, highlighting the need for a holistic approach to women’s health during this life stage. Ongoing research also explores the genetic, immunological and environmental factors that may mediate these associations, aiming to identify biomarkers and mechanisms that could lead to earlier detection and more personalized interventions.
In response to these findings, there has been a significant increase in investment in menopause-related research, and the development of new therapies has increased. While public sector funding remains in flux, the private sector recognizes the unmet medical needs of menopausal women, leading to expanded venture capital investment in biotech startups focused on women’s health. For example, “femtech”-focused funds such as Portfolia’s FemTech Fund and Springboard Enterprises invest in startups developing menopause diagnostics, therapeutics and digital solutions.
Digital Health and Telemedicine
The rise of perimenopause and menopause-focused telehealth platforms presents significant growth potential. The digital health and telemedicine space has seen the emergence of companies such as Evernow and Midi Health, both offering telehealth services for menopause care, including hormone therapy, weight management, and emotional counseling and support. These companies attracted significant investment from venture capital firms.
In the age of consumers demanding flexibility, telehealth is often a preferred form of care; however, investors should be aware of several compliance considerations in this area. Telehealth providers must comply with each state’s licensure requirements, which can vary. Failure to ensure proper licensure for clinicians, including nurse practitioners and physician assistants, can result in enforcement actions, fines and reputational harm. Some states restrict telehealth prescribing of controlled substances, including hormone therapies, and noncompliance with such laws may lead to DEA investigations or state board sanctions. In addition, the corporate practice of medicine restricts nonphysician ownership or control of medical practices in certain states, requiring careful structuring of arrangements involving clinicians.
Apps and telehealth platforms offering menopause management must comply with Food and Drug Administration (FDA) regulations as medical devices (specifically Software as a Medical Devices or “SaMD” regulations and guidance) if they provide diagnostic or therapeutic functions. The FDA’s Digital Health Policy Navigator and recent guidance on clinical decision support tools, AI-enabled device software functions and the FDA’s cybersecurity guidance are relevant. Menopause-focused digital health platforms may be required to comply with HIPAA or the FTC Health Breach Notification Rule and possibly state privacy. In some states, sensitive health data, which may include reproductive and sexual health information, is subject to heightened scrutiny.
Pharmaceutical and Therapeutic Innovation
Novel therapeutics, including hormonal and nonhormonal treatments, as well as personalized medicine approaches, attract venture capital and strategic investment. Monitoring the FDA initiatives and intellectual property landscape is critical.
Legal risks in this space include the need for rigorous FDA review of hormone replacement therapies and novel therapeutics. Investors should scrutinize clinical trial data, regulatory submissions, communications with the FDA and ongoing safety monitoring obligations. The FDA also issued warnings to companies making safety and efficacy claims about compounded bioidentical hormones, and companies marketing these products risk enforcement actions, product seizures and penalties. Providers and investors should monitor evolving guidance and enforcement trends. Intellectual property risks, such as patent disputes and freedom-to-operate issues, are common, making diligence on intellectual property portfolios and pending litigation essential.
Consumer Health and Wellness
The femtech sector is expanding to include wearables, supplements and wellness products for women in perimenopause and menopause. For example, Kindra provides menopause-focused supplements, Elvie makes wearables for pelvic health and menopause symptom tracking, and Womaness is a consumer brand for menopause skincare and supplements. These companies received backing from Female Founders Fund (Kindra), Octopus Ventures (Elvie) and Unilever Ventures (Womaness). Risks in this area include close scrutiny by the Federal Trade Commission (FTC) and the FDA of health-related marketing claims. Unsubstantiated or false and misleading statements about efficacy or safety can result in warning letters, fines and product recalls. Some wearables may be regulated as medical devices or drugs, triggering additional compliance obligations. For example, the FDA recently sent a warning letter to a wearable company, claiming its blood-pressure monitoring product was an “adulterated and misbranded medical device” marketed without required FDA clearance or approval. Furthermore, consumer platforms require investors to consider securing and protecting sensitive health data and complying with HIPAA (if acting as a covered entity), FDA cybersecurity guidance (if a medical device) and other state privacy laws. Moreover, data breaches or improper use of reproductive health data can lead to liability.
The FTC and FDA closely monitor marketing claims related to menopause products and services. Companies must ensure that all claims are substantiated and avoid misleading or unsubstantiated statements regarding efficacy or safety.
Employer and Payer Engagement
Employers and health plans increasingly offer menopause-focused benefits as part of women’s health initiatives. Startups providing B2B solutions may benefit from this trend. Companies such as Carrot Fertility are expanding into menopause benefits for employers. Progyny, another company offering benefits though employers, provide comprehensive women’s health solutions including menopause support. Legal considerations include compliance with ERISA and related federal regulations for employer-sponsored health benefits. Misclassification of benefits or improper plan administration can trigger Department of Labor investigations. Additionally, sharing employee health data with third-party vendors requires robust privacy safeguards and clear consent mechanisms.
The menopause and midlife health sectors are poised for growth, but legal and regulatory compliance is essential for sustainable success. Investors should conduct robust diligence on regulatory pathways, data privacy and clinical claims, while remaining mindful of corporate structure and investment risks. Companies should proactively engage with legal counsel to navigate evolving federal and state requirements.
For more information or to discuss specific legal or investment considerations in the menopause and midlife health sector, contact one of the authors.
For additional insights on women’s healthcare topics, refer to the following alerts:
Unlocking Opportunities at the Intersection of Women’s Health, Wellness and Medical Aesthetics (Sept. 24, 2025)
The Fertility Economy: Where Science Meets Market Demand (Sept. 4, 2025)
From Delivery to Recovery: Unlocking Value in Postpartum Health (Aug. 27, 2025)
Frontiers in Women’s Health: Where Investor Opportunities Meet Unmet Need (Aug. 19, 2025)