NovvaCup

Approximately 87-107 million Americans experience menstrual cycles and many rely on traditional period care products such as single-use pads, liners, and tampons to manage their symptoms. For environmental, economic, and comfort reasons, a growing number of modern consumers are turning to more sustainable period care products such as the menstrual cup. Menstrual cups provide customers with longer wear-time, improved biocompatibility, and a lower carbon footprint at a lower cost than disposable period products. However, we found that most menstruators find the cup-like design of currently available models to be “intimidating,” “confusing,” and “uninviting” in customer interviews, with only 1 in 4 customers opting to try a menstrual cup. Currently available menstrual cups have a 11% overall discontinuation rate with 20% of users reporting challenges with manual insertion and 8% experiencing difficult and unhygienic removal, demonstrating a need to innovate in sustainable period products. (Rendering of conventional menstrual cup usage.)

Cultural beliefs and taboos similarly prevent women from accessing period care and women's health, and for those with access, the average clinical wait time for OB-GYN in the United States is 31.4 days. Women’s health diagnostic techniques are seriously antiquated and in desperate need of technological innovation. As such, expansion of our medical-grade silicone cup for novel period wellness and health services is a long-term value proposition strategy for NovvaCup. The use of menstrual cup technology for menstrual blood-based diagnostics would not only be a technical breakthrough for women’s healthcare but also offer an opportunity to negate many barriers to care, such as long clinic wait times and cultural stigmas surrounding menstruation, and make women’s reproductive healthcare more efficient and accessible.

By addressing major pain points in current models, we designed a device that improves user experience and comfort at each stage of the menstrual cup usage lifecycle. Our flagship product is a multi-phasic self-collapsible menstrual cup for easy and comfortable use without the stress and mess associated with cups currently on the market. Upon market entry, NovvaCup is positioned to grow into a leader in sustainable period care products that also provide a bridge to gynecology and women’s health as a pioneering healthcare platform. User demographics span a spectrum of socioeconomic conditions from low-resource rural environments to busy urban settings to offer diverse opportunities to increase need-based access to menstrual care for marginalized communities and to serve growing customer demand for innovative and sustainable women’s healthcare technology.

Our flagship product is a multi-phasic menstrual cup for easy and comfortable use without the stress and mess. By addressing major pain points in current models, our device improves user experience for each stage of menstrual cup use. The NovvaCup includes built-in features intentionally designed to provide a comfortable and ergonomic user experience during insertion, wear, collapsement, containment, sanitization, and storage for reuse. Specifically, our patent-pending design offers two unique performance benefits over other menstrual cups: (1) NovvaCup can collapse and expand to allow the cup to effortlessly narrow during insertion and then expand once inside; and (2) conformational changes of NovvaCup during removal enclose the cup’s contents for a hygienic experience. This is intended to mimic the user experience of tampons, which are the most popular insertable period care product. NovvaCup customers will be able to discretely receive our products from our online store in the mail or at selected local retail partners to make sustainable period products widely available to the general population. (Rendering of NovvaCup.)

Next, we plan to leverage NovvaCup’s competitive advantage as a superior sample collection device to revolutionize women’s health diagnostics. NovvaCup will serve as a novel platform for period care products that serve health and wellness needs in the clinic. We are well-positioned and well-timed to address the many unmet needs in women’s health services and diagnostics ranging from STIs to menopause. Preliminary evaluations of biomarkers, chemical composition, and physical characteristics of menstrual blood for the monitoring of menstrual irregularities and other common gynecological indications such as endometriosis have shown promising diagnostic correlations in recent studies. Unlike our early competitors in the emerging femtech market, NovvaCup’s period care product features and consumer access makes our care services more widely accessible for potential patients to better understand their health. Research and development of a lab-based mail-back model for menstrual blood sampling and diagnostics are currently underway. Successful utilization of NovvaCups for menstrual blood diagnostics would be a breakthrough for women’s health at home, aid women in overcoming barriers of current stigma and access to healthcare, and assist patients in better understanding of their reproductive health.

NovvaCup would be helpful for any menstruating individual interested in a more biocompatible, economic, and environmentally-friendly solution to sustainable period care. The average menstrual cup user is an educated 16-36 year-old woman with a regular period who is motivated to buy non-traditional period products for a variety of reasons relating to personal health, comfort, financial stability, and/or environmental sustainability. Early adopters of the NovvaCup are likely women who live and work in rural and outdoor settings and those with busy lifestyles that require long weartimes. By improving menstrual cup usability, NovvaCup has the potential to serve the 7 million Americans who have abandoned unsatisfactory menstrual cups as well as the estimated 63 million Americans who have considered buying reusable period products but were hesitant to try currently available cups. 

A large spectrum of women from a variety of socioeconomic conditions, resource settings, and environments will benefit from NovvaCup’s period care products and period health services, particularly women in low-resource areas, rural settings, and regions with high levels of stigma against women’s reproductive health. Period poverty, the lack of access to menstrual hygiene products, adequate sanitation facilities, and education about menstruation, affects individuals who are unable to afford or access products as well as those who may not have access to clean water or facilities for managing their menstruation. This lack of access can have significant impacts on physical health, mental well-being, and overall quality of life, and hinder one’s ability to fully participate in school, work, and other activities. NovvaCup would aid in the alleviation of these socioeconomic burdens by increasing need-based access to menstrual care while providing improved reproductive healthcare. 

Period poverty and access barriers to women’s healthcare are overlapping global issues that disproportionately affect marginalized communities, including women and girls in low-income countries, homeless populations, and those living in regions with limited resources or infrastructure. As an innovative women’s healthcare technology, NovvaCup diagnostics has the potential to accelerate health outcomes for many of these groups by improving the tracking, detection, and treatment of various STIs and gynecological indications such as menstrual irregularities, polycystic ovarian syndrome, cervical cancer, endometritis, and endometriosis.

Leadership:

• Danielle Nicklas, Chief Executive Officer, PhD in Pathobiology
• Clarissa Ren, Chief Medical Officer, MD
• Mostafa Borahay, MD, PhD, MBA, MSc (Director of General Gynecology & Obstetrics, Johns Hopkins Bayview Medical Center)

Advisory Board:

• Rachel Shapiro, PhD in Chemical and Biomolecular Engineering (Vaginal Nanomedicine)
• Marnie Peterson, PharmD, PhD (Infectious Diseases & Experimental Therapeutics), part-time

Dr. Nicklas and Dr. Ren have taken NovvaCup through intensive ideation, validation, and customer discovery to develop our final prototype model of combined period care and menstrual health tracking. Supported by Dr. Borahay, a world-renowned Physician Scientist in the field of menstrual disorders and other gynecologic conditions, and an advisory board of experts in vaginal nanomedicine and infectious diseases, our pilot model (anticipated for early 2025) aims to characterize feedback of our user-friendly cup design and preliminary diagnostic panel for STIs and other gynecologic indications in order to provide women’s healthcare that requires little to no clinical attendance or wait time. Dr. Borahay has the infrastructure for clinical studies including study design, regulatory approvals such as FDA and Institutional Review Board, recruitment of participants, and the collection and analysis of data at the Johns Hopkins University in Baltimore, MD. Our team has robust expertise in the scientific, technical, and clinical fields of women’s health with many members of our growing team successfully completing several preclinical validation studies as well as large scale clinical trials. 

We have a MVP for bench-model testing and preliminary customer feedback. This is an early-stage prototype of our patent-pending low-risk Class 2 medical device. The NovvaCup team has already met with the FDA to review our regulatory pathway in anticipation of beta-testing our product design and business model features in early 2025.

In our customer discovery and market research, NovvaCup has learned to navigate through the many complex spaces relating period health and women healthcare. The MIT Solve challenges takes aim at many of the same problem areas that NovvaCup is working to solve. Specifically, the NovvaCup model relies on bridging gaps in period poverty, closing barriers to period health, and increasing education and outreach to marginalized communities. These same socioeconomic and structural barriers are part of the solution to MIT's Global Health Equity challenge aims, and NovvaCup is eager to partner and find solutions together.

In the modern menstrual healthcare market, there is growing consumer demand for products that are more cost-effective and eco-friendly. Traditional single-use pads, liners, and tampons generate an estimated 200,000 metric tons of waste every year and cost the average American menstruator at least $18,000 in lifetime spendings to manage menstruation. The menstrual cup is an ideal alternative to disposable products and is the most popular reusable period product on the market. However, modern menstrual cups are very difficult to use due to their rigid and unintuitive designs. Despite cups entering the public consciousness, less than 30% of potential users we spoke with had actually tried a menstrual cup. Our data showed that the leading factors for being hesitant about menstrual cup use were usability (27.8% for either difficult to insert or difficult to remove), mental intimidation (16.7%), concern for discomfort/irritation (16.7%), and lack of knowledge about menstrual cups (14.6%).

Furthermore, for those who do try a menstrual cup, 11% of users discontinued use with 20% of users reporting difficulty with manual insertion and 8% experiencing difficult and unhygienic removal (The Lancet). For participants in our customer interviews who had used menstrual cups before, the top dislike about menstrual cups was usability (31.3%; both insertion and removal). To better improve menstrual cup adoption and retention through superior user experience, we have created the NovvaCup. NovvaCup has a dynamic, multi-phasic design that makes cup insertion and removal quick, easy, and mess-free. Increasing the adoption of menstrual cups can ultimately reduce costs of period care to menstruating individuals to help alleviate period poverty and reduce our environmental footprint on the Earth.

Beyond transforming menstrual cups, our customer interviews and literary reviews have demonstrated the remaining cultural stigma and taboo surrounding menstruation, menstrual products, and women’s health. NovvaCup is positioned to grow into a “one stop shop” for menstrual care and provide a bridge to gynecology and women’s health as an pioneering menstrual diagnostic and healthcare platform. There is a serious need for technologies addressing the barriers to diagnostics of common gynecological indications such as endometriosis and STIs. In one study, only one-fifth of sexually active high school students reported regular testing for an STI (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9126309/). Some of the barriers to testing for STDs included lack of knowledge of STDs and available services, cost, shame with seeking services, and long clinic wait times (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC436061/). NovvaCup plans to address these challenges in the long-term through delving into the diagnostic space using menstrual blood collected from menstrual cups.