In this series, we explain why we invested in our current portfolio companies. In the process, we hope to highlight the white spaces in women’s health and the life sciences — as well as the people, products, and companies working to fill those gaps. The name “Under the Microscope” refers both to our extensive due diligence process and our investment focus on healthcare and the life sciences.
1.3 million women become menopausal every year — and that number is only going to grow. A 2015 study estimates that 1.2 billion women across the world will be menopausal or post-menopausal by the year 2030. (Note: the data throughout this article uses “women” to refer to those who are capable of biologically female to be consistent with the research done on menopause.)
Menopause brings its own side effects and symptoms, and a 2020 study broke down just how common some of those symptoms are. It reported that 75% of women experience vasomotor symptoms (such as hot flashes, night sweats, palpitations, and migraines), 60% of women experience urogenital symptoms (such as vaginal atrophy/dryness, urethral atrophy, stress incontinence, and sexual dysfunction), and 45% of women experience psychogenic symptoms (such as anxiety, depression, and loss of concentration). Other side effects can include insomnia, mood disorders, and weight gain.
Madorra is developing a hormone-free, non-invasive option to treat one of the common symptoms of menopause: vaginal dryness.
Vaginal dryness falls under vaginal atrophy (also known as atrophic vaginitis), which refers to the deterioration of vaginal tissue due to a lack of estrogen. Around 50% of menopausal women experience vaginal atrophy and, unlike hot flashes or other common symptoms of menopause, vaginal atrophy is permanent and can worsen without treatment.
One common treatment option for vaginal atrophy is hormone therapy (HT, also known as menopause hormone therapy or MHT). During hormone therapy, menopausal women take estrogen and (usually but not always) progesterone: the two female hormones. Despite the popularity of HT, an article published by the American Cancer Society summarizes, “…Well-conducted studies have led many doctors to conclude that the risks of [HT] often outweigh the benefits.” Based on data from the Women’s Health Initiative’s 15-year-long research project on menopause, patients taking hormone therapy had increased risks for strokes, heart attacks, blood clots. (The WHI studies were concluded earlier than scheduled because of the increased risks to the women taking hormone therapy in addition to the study’s inability to achieve its goal: to prevent heart disease in menopausal women.) A 2020 article echoed these sentiments about HT and advises that “hormone therapy should only be used for the shortest duration of time and at its lowest effective dose, as it increases the relative risk of breast cancer, ovarian cancer, thromboembolism, stroke, and coronary heart disease” (though all cases should be assessed on an individual basis).
While menopausal women may be hesitant to take HT because of these side effects, breast cancer survivors — about 70% of whom experience vaginal dryness — don’t even have the option of taking HT in the first place because estrogen stimulates cancer regrowth. A 2015 study even titled its report “Atrophic Vaginitis in Breast Cancer Survivors: A Difficult Survivorship Issue” to highlight the difficulty of treating vaginal dryness for this group of women. As the study states, “Atrophic vaginitis can be difficult to manage in symptomatic women, and even harder to manage in symptomatic breast cancer survivors due to restrictions in the use of hormones.”
Current treatment options for breast cancer survivors include lifestyle modifications (such as quitting smoking), moisturizers and lubricants, and vaginal estrogen. However, according to one vaginal atrophy-focused study, moisturizers and lubricants have only a 32% satisfaction rate because they can be messy, inconvenient, and unable to provide “adequate relief.” Vaginal estrogen is a topical treatment, which can offer relief while reducing the amount of estrogen absorbed in the bloodstream — thus decreasing the adverse risks of HT. While long-term safety still remains a concern for 41% of the women who used vaginal estrogen therapy, 40% felt they had no other treatment option.
Madorra offers an alternate treatment option. Madorra uses ultrasound technology to increase blood flow and lubrication naturally to deliver relief from vaginal dryness without requiring any invasive vaginal insertion, messiness, or pharmaceuticals. Madorra’s device not only will be the first non-invasive device to treat vaginal dryness but is non-hormonal as well, thereby allowing breast cancer survivors to access this treatment option.
In fact, Madorra is initially targeting breast cancer survivors with vaginal dryness. With over 3.5 million breast cancer survivors currently living in the United States, more than 276,000 expected to be diagnosed in 2020 alone, and about 70% of breast cancer survivors experiencing vaginal atrophy, Madorra is addressing a large market that needs a non-hormonal option. Subsequent market expansion will encompass menopausal women experiencing vaginal dryness. The company has already demonstrated initial safety and efficacy with three studies and has further studies for FDA clearance in its pipeline.
We shouldn’t ignore menopausal women
As a 2020 article about the taboo of menopause states, “We have to stop ignoring…[menopausal] women.” Madorra doesn’t ignore these women — nor does it ignore breast cancer survivors. Instead, the company caters to these groups’ specific health issues, wants, and needs by offering a non-invasive, non-hormonal device that can increase vaginal blood flow, improve sexual health, and, in the process, bring back a much-desired quality of life.
At Avestria Ventures, we look for early-stage women’s health and female-led life science companies with products or technologies that improve healthcare quality and/or access, lower costs, induce clinical or behavioral change, are evidence based, have scalable commercialization plans, and have a sustainable competitive advantage. Know one? Contact us via our website, LinkedIn, or Twitter.