Infective vaginitis

Medicines360 and DKT WomanCare are joining forces to increase availability and use of AVIBELA, an affordable, effective, long-acting hormonal IUD developed by Medicines360, across Africa, South and Southeast Asia, Central America, and the Caribbean.SAN FRANCISCO and PARIS, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Medicines360, a global nonprofit pharmaceutical organization specializing in women’s health, and DKT WomanCare, a global marketing and distribution organization focused on increasing the availability and use of high-quality contraceptive and reproductive health products, have entered into a partnership to expand access to AVIBELA, an affordable, quality-assured, long-acting hormonal IUD that is more than 99% effective at preventing pregnancy.1 This important collaboration will help more women learn about, access, and use this highly effective, modern form of contraception. The 52 mg levonorgestrel-releasing intrauterine system (“hormonal IUD”) has been largely inaccessible in lower- and middle-income countries (LMICs) due to factors limiting availability and affordability. An estimated 218 million women in LMICs have an unmet need for modern contraception, resulting in approximately 111 million unintended pregnancies (nearly 1 in 2) each year. 2 With this strategic partnership, more women around the world will have the ability to choose from a broader mix of safe, effective, and affordable contraceptive methods, including AVIBELA. "As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360. “With their proven track record of building markets for new high-quality contraceptives, DKT WomanCare will help us provide more women across the world with the contraceptive options they want and deserve. Together, we will make meaningful improvements in access to build a brighter future for women.” Leveraging their global marketing expertise and reach, DKT WomanCare will increase awareness of AVIBELA, build markets, and ensure broader access across the public and private sectors in Africa, South and Southeast Asia, Central America, and the Caribbean. DKT WomanCare will draw on the experience of its parent company, DKT International, to leverage the organization’s extensive network of national and regional offices alongside DKT WomanCare’s established partnerships with ministries of health, global procurement agencies, social marketing organizations, and commercial distributors. Lauren Archer, DKT WomanCare’s Managing Director, celebrated the partnership. “DKT WomanCare looks forward to leveraging our global partnerships and commercial relationships to ensure every woman, regardless of income, can access affordable, high-quality contraception. We look forward to working with Medicines360 to achieve these goals.” “This partnership is a wonderful opportunity to educate users and practitioners about the benefits of hormonal IUDs, expanding long-term contraceptive options to women everywhere with quality products like AVIBELA,” said Chris Purdy, President of DKT International. As the supplier of AVIBELA, Medicines360 will focus on providing quality assurance and regulatory oversight, as well as ensuring sustainable product supply to DKT WomanCare and global procurement agencies. Together, Medicines360 and DKT WomanCare will meet the growing demand for quality-assured, affordable hormonal IUDs and help build a robust and sustainable global contraceptive market. AVIBELA is a trademark of Medicines360 in countries across Africa, South and Southeast Asia, Central America, and the Caribbean. For more information about AVIBELA, please visit www.avibela.com. AVIBELA™ Important Safety Information Who is not appropriate for AVIBELAContraindications to use of AVIBELA include: pregnancy; use for post-coital contraception (emergency contraception); acute pelvic inflammatory disease (PID) or endometritis or a history of PID unless there has been a subsequent intrauterine pregnancy; infected abortion in the past 3 months; known or suspected uterine or cervical neoplasia; acute liver disease or liver tumor (benign or malignant); conditions associated with increased susceptibility to pelvic infections; congenital or acquired uterine anomaly, including fibroids, that distorts the uterine cavity and would be incompatible with correct intrauterine system (IUS) placement; uterine bleeding of unknown etiology; untreated acute cervicitis or vaginitis, including bacterial vaginosis, known chlamydial or gonococcal cervical infection, or other lower genital tract infections until infection is controlled; known or suspected breast cancer or other hormone-sensitive cancer, now or in the past; a previously inserted IUS that has not been removed; a history of hypersensitivity reaction to any component of AVIBELA (reactions may include rash, urticaria, and angioedema). Clinical considerations for use of AVIBELAUse AVIBELA with caution after careful assessment in patients with coagulopathy or who are taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe or frequent headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removal of the IUS if any of these conditions arise during use. Also consider removing AVIBELA if uterine or cervical malignancy, or jaundice arise during use. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. About 1/3 of women diagnosed with PID developed the infection within a week of AVIBELA insertion, while the remainder were diagnosed more than six months after insertion. PID is often associated with sexually transmitted infection (STI), and AVIBELA does not protect against STIs. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae. Pregnancy related risks with AVIBELAIn the case of pregnancy with AVIBELA in place, advise the woman of the increased risks for pregnancy complications, including miscarriage, premature delivery, infection and sepsis. Ectopic pregnancy should be excluded, and removal of the system should be considered. Removal of AVIBELA or probing of the uterus may result in spontaneous abortion. When a woman becomes pregnant with AVIBELA in place, the relative likelihood of ectopic pregnancy is increased. Ectopic pregnancy may require surgery and may result in loss of fertility. Women with a previous history of ectopic pregnancy, tubal surgery, or pelvic infection have a higher risk of ectopic pregnancy. Be aware of other serious complications and most common adverse reactionsSome serious complications with IUSs like AVIBELA are sepsis, perforation, and expulsion. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of other LNG-releasing IUSs. Aseptic technique during insertion of AVIBELA is essential in order to minimize serious infections such as GAS. Perforation (total or partial, including penetration/embedment of AVIBELA in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy and result in pregnancy. If perforation is suspected, the IUS should be removed as soon as possible. Delayed detection or removal of AVIBELA in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. Partial or complete expulsion of AVIBELA may occur, resulting in the loss of contraceptive protection. Ovarian cysts may occur and are generally asymptomatic but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent ovarian cysts. In a large clinical trial of 1,751 women using AVIBELA for contraception, very common undesirable effects (occurring in more than 10% of users) include procedural bleeding, vaginal bacterial infections, vulvovaginal mycotic infections, nausea or vomiting, and acne. About Medicines360Located in San Francisco, California, Medicines360 is a nonprofit global women’s health pharmaceutical organization with a mission to accelerate the timeline from health innovation to access for all women. Medicines360 is committed to working with healthcare providers, advocacy groups, and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org. About DKT WomanCare Together, non-profits DKT WomanCare and DKT International are among the largest providers of reproductive health products, services, and technology in the world. Operating in more than 100 countries, they leverage principles of social entrepreneurialism and focus on ensuring wide access and availability of products, building up the capacity of health providers, and empowering consumers. For more information, see www.dktinternational.org and www.dktwomancare.org. Contacts:Heidi GlasserDirector of Marketing and Communications, Medicines360hglasser@medicines360.org Lauren ArcherManaging Director, DKT WomanCarelauren@dktwomancare.org References: Avibela (levonorgestrel-releasing intrauterine system) 52 mg [Summary of Product Characteristics and Prescribing Information]. Impact RH360; 2022.Sully EA et al., Adding It Up: Investing in Sexual and Reproductive Health 2019, New York: Guttmacher Institute, 2020, https://www.guttmacher.org/fact-sheet/investing-sexual-and-reproductive-health-low-and-middle-income-countries

San Diego-drugmaker Dare Bioscience describes itself as the rare biotechnology company focused exclusively on womens health, a category it says the broader industry has too often overlooked.But that identity can create hurdles, according to company CEO Sabrina Johnson. At times, she said, investors have been hesitant to fund research presented as womens health, citing their unfamiliarity with the space. How do we frame the conversation so that its clear, at the bottom line, that this is healthcare, said Johnson, who has run Dare since 2017.Drug research and development for conditions only or disproportionately affecting women has long been neglected, resulting in less venture funding for new startups and, for diseases like endometriosis, few treatment options. Reproductive medicine, meanwhile, is in the spotlight in the U.S. following the Supreme Courts reversal of Roe v. Wades protection for abortion and litigation challenging the Food and Drug Administrations approval of the abortion pill mifepristone.Challenges have brought attention, though. Notably, the Biden administration last November launched a womens health initiative that aims to catalyze greater funding and accelerate research. Private investors have already been funneling more money into womens health companies, although the past years downturn in biotech appears to have cooled activity in 2023.There is growing recognition of how under-invested womens health has been historically and therefore the opportunity for innovation and significant returns, said Erika Seth Davies, CEO of Rhia Ventures, a venture firm focusing on maternal and reproductive health equity.Barriers to investmentThe term womens health covers a broad spectrum. Typically it refers to conditions and diseases that are specific to female anatomy or are more prevalent in women than men. Often this is interpreted as meaning reproductive health, involving pregnancy, fertility and menopause.But it can also include gynecological disorders like endometriosis or uterine fibroids, as well as vaginal infections and urinary tract infections. Cancers of the breast, cervix and uterus are generally specific to women, while conditions like migraines and osteoporosis affect women more often than men.On the one hand, there's great opportunity in calling it women's health, said Johnson, referring to how the term can focus attention on who the diseases affect. But on the other hand, fundamentally these are healthcare conditions.While oncology receives significant attention and funding, other conditions under the umbrella of womens health dont, which can impact the kinds of treatments that become available. Lack of funds is often a major reason biotech companies halt research of a drug candidate, or prioritize other programs. And larger companies have chosen to pursue other areas: Bayer, previously a major player in the womens health sector, said last year it would shift focus from womens health to immunology, rare diseases and neurology.Across the ecosystem comprising academic and industry R&D, limited investment in womens health research and development stagnates the required innovation needed to support women with these conditions and others across every stage of a womans life, said Marcel van Duin, chief scientific officer at womens health company Organon.A lack of clinical trial data can also slow progress. Female participants have been underrepresented in early-phase clinical testing, and it wasnt until 2015 before the National Institutes of Health established sex as a biological variable for designing NIH-funded studies. Insufficient information on sex-specific outcomes can make it harder to determine how a potential treatments effect may vary.We have a lack of understanding of female diseases, and then a lack of understanding of diseases that may affect women differently or disproportionately, said Raysa Bousleiman, vice president of healthcare at Silicon Valley Bank, an investment firm now owned by First Citizens Bank. And just because of that lack of data, it becomes more of an uphill battle for these life science companies that are trying to develop solutions.Bousleiman believes terminology plays a role. A lot of [womens health] has some stigma, she said. What I've seen talking to a lot of founders in the women's health space, in biopharma and other sectors is that a lot of men don't even know there's an issue. So you don't want to invest in something you don't know.The numbers certainly bear that out. In 2019 across the U.S. and Europe, $122 billion was invested across 3,225 biopharma deals, according to SVB. Only $1.3 billion, across 60 deals, was invested in womens health biopharma companies.A 2021 analysisof NIH-backed research, meanwhile, found diseases that primarily affect men received more funding than those affecting women.Mifepristones spotlightSince last year, the FDA has been in court over its 2000 approval of the abortion pill mifepristone, which is widely used in the U.S. to terminate pregnancy. The conservative group Alliance for Hippocratic Medicine filed a lawsuit against the FDA and the Department of Health and Human Services last March claiming the agency unlawfully applied its accelerated approval process to the drug. A district court judge in Texas later ruled to suspend the pills approval, drawing appeals from the Biden administration and mifepristones manufacturer.The initial decision sparked concern from the broader biotech sector as some saw the case undermining the FDAs authority and potentially setting a precedent for any group to sue the FDA over controversial drug approvals. Biopharma leaders have spoken against the suit, which presents new risks for investors and companies working in reproductive health.The effect [of the mifepristone case] on biomedical research and development will be far bigger than womens health, said Davies. No corner of the health care industry will be untouched by such a destructive act to politicize a system and processes that are supposed to be grounded in data and evidence.The case has now made its way to the Supreme Court, which is expected to weigh in this spring on whether the pills availability should be limited. (In 2016, the FDA expanded the pills use from seven weeks gestation up to 10 weeks. A few years later in 2021, the agency allowed prescriptions to be delivered by mail.)While the challenge to mifepristone is particularly high profile, its not the first time an FDA decision in reproductive medicine has been challenged. The agencys recommendation to allow over-the-counter use of the Plan B emergency contraception pill was overridden by Barack Obamas Secretary of Health and Human Services in 2011. The FDA later approved OTC access after further litigation.The spotlight of the mifepristone case can cut two ways. While it presents the prospect of new legal risks for reproductive medicine, it also shows the need for safe and effective pharmaceutical solutions, said Bousleiman.More recently, the FDA took a similar step with the birth control pill sold as Opill, which last year the regulator approved as the first oral contraceptive available for OTC use.Success stories like this are important, especially when it comes to moving the needle on womens health investment and encouraging others to pursue a new wave of innovations that will benefit women, Duin said.A growing market?Among the most active areas of investment in womens health is whats termed femtech. These technology-centered companies operate within the healthcare sector, but focus on women-specific needs like fertility and pregnancy. Demand for such services soared after the Supreme Court overturned Roe v. Wade in 2022 and continued to fuel the sector last year.Femtechs growth could have knock-on effects for drug R&D. A lot of these digital health companies are calling out the fact that women's health has been so neglected, Bousleiman said. So it might [also] be bringing investor attention back to the R&D side, because not all women's health issues can be solved with an app or by seeing a provider.R&D investment does seem on the upswing. Across womens health, venture capital funding over the first nine months of 2023 was up by 8%, compared to the same period in 2022. Bousleiman says that, compared to the overall slowdown seen in life sciences last year, the womens health sector experienced something more akin to a speed bump.Investors are also seeing opportunities in womens health companies that arent focused on reproduction. In the third quarter of 2023, these companies saw a single-quarter record of $435 million invested, according to SVBs report. Although the amount pales in comparison to the funding typical of biotech more broadly, the data suggest a positive trend.Success begets success and dollars will follow that, Johnson said.Buy-in from investors can pay back more than some might think. While only about 1% of R&D is invested in female-specific conditions outside of oncology, Johnson says this still led to a large number of drugs that generate more than $500 million in annual revenue.In the U.S., women make many of the healthcare buying and usage decisions, according to the consultancy Oliver Wyman. Additionally, working women in the U.S. spend about $15 billion more than men on out-of-pocket healthcare costs per year, per a report from Deloitte. The additional spending is partly due to pregnancy-related costs, but also because women are more likely to seek out treatments than men and are more likely to be misdiagnosed.A health care system that doesnt work for all people is literally detrimental to U.S. economic growth and prosperity, said Davies. Investors, of course, are concerned with their returns on investment, and also must pay close attention to the health of the larger economic environment.Looking aheadAcross all sectors, venture investment in womens health has more than quadrupled since 2018, per SVB, compared to a 28% increase in healthcare investment broadly. Acquisitions have picked up as well, with 15 companies acquired over the past two years, more than in the four prior years combined.Still, the downturn in the life sciences market has affected the field, with less money invested and fewer exits, such as IPOs or acquisitions, in 2023 than in 2022. Since the life sciences is a capital-intensive field, partnerships with larger companies can help bridge the gap. Organon and Dare partnered in 2022 to bring Dares gel for bacterial vaginosis to market, for example.Womens health companies, like all of biotech, also need to appeal to generalist investors who can provide more funding as companies advance. During a recent webinar, Bousleiman pointed to hopeful signs on that front. We've seen some really impressive activity by these types of firms this year, and believe it'll lead to more investor interest in the space.The Biden administrations new womens health initiative could further help. Launched Nov. 13, the program requires relevant agencies to deliver recommendations on how to advance research in womens health within 45 days. Perhaps relatedly, one week later the FDA announced plans to hold, with the Duke-Margolis Center for Health Policy, a workshop on developing drugs to prevent preterm birth.Organon CEO Kevin Ali has said his company is ready to contribute to the administrations initiative.Well undoubtedly see the impact of this push coupled with further investment in womens health innovation involving academic scientific research, patient organizations, philanthropic leaders, VCs and industry R&D stakeholders on the overall womens health market, added Organons Duin.Executives and investors are optimistic further investment in womens health could be forthcoming. It's about time and I think all the right pieces are in place, said Johnson. '

Priyanka Jain, CEO and co-founder of vaginal health company Evvy, felt more like an educator rather than an entrepreneur when she first set out to raise funds for her startup. The company, which has raised $19 million since inception in 2021, is direct-to-consumer and sells at-home vaginal microbiome tests. Questions she received from investors — mostly men — included: What’s a yeast infection? Is it really that frustrating? Is this really a problem? Indeed, up to 75% of women or people assigned female at birth will have at least one vaginal yeast infection in their life. But with the male-dominated venture capital industry (just 8.6% of venture capitalists are women), many investors simply aren’t aware of these facts. “You have to start with the barrier of what even is this condition, educating them about it, then talking about the prevalence, then talking about the standard of care,” Jain said in an interview. “So it just takes a lot longer for them to jump through the things they have to believe in order to believe in the company.” Jain’s barriers in raising funds are not unique and are faced by many founders of startups that focus on stigmatized women’s health conditions. Despite women representing half of the population, just 3% of digital health funding focused on women’s health between 2011 and 2020, and a majority goes to startups addressing fertility, pregnancy and motherhood, according to Rock Health. But do startups that focus on male stigmatized conditions face the same challenges in raising funds? There is no clear answer. ‘I’ll ask my wife about this’ One experience, in particular, is common to the interaction between women entrepreneurs and men investors: being told they’ll ask their assistant or wife about the condition the company treats. “Obviously, I don’t think anyone wants to talk to their boss about vaginal odor,” Jain remarked with incredulity. “There are plenty of people saying, ‘I’ll ask my wife about this.’ It was kind of frustrating to feel like we were being passed off to people who weren’t investors to evaluate the opportunity, because there were no investors available who had vaginas to help evaluate it.” Jain added that she often feels bad for these women associates who may have to have these uncomfortable, private conversations with their bosses to bring them up to speed on how big of a problem it is for women — and in order for women’s health startups to get funding. Stephanie Estey, co-founder of sexual health company TBD Health in New York City, has had similar challenges with a male VC bringing along his female associate or saying he needs to show the startup’s products to his wife. Despite serving all genders, the company often gets put into a “women’s health box.” The direct-to-consumer company’s services include STI testing and contraceptives. It has raised a little under $5 million. Another women’s health founder, Ellen Rudolph, said she often experienced issues where men investors “wrote me off in the beginning and weren’t paying attention.” Her company, Atherton, California-based WellTheory, serves consumers and employers and offers care for autoimmune conditions, which primarily affect women. The startup has raised $7.2 million. “I had one male investor who said, ‘I believe that there’s a billion-dollar company to be built in this space, but I don’t know if you or I know what that is.’ And I will never forget that,” Rudolph said. “I think the challenge is a little bit that there’s this dissonance because a lot of the time the person you’re pitching to doesn’t have that lived experience or understanding.” All of the above is reason enough for VC firms to hire women partners or promote them to those positions. But it’s not always male investors distancing themselves from women’s health companies. Sometimes it’s women investors who are trying to “diversify away” from the women’s health space, according to Estey. “I think some of the more surprising things have actually been when female investors — who may naturally have empathy for what we’re doing at TBD — actively don’t want to invest in a category that’s often associated with women’s health,” she said. “So they actively try to not invest in women’s health or try to invest in something that is more like FinTech or crypto or something very different.” Rachel Blank, CEO and founder of New York City-based Allara Health, agreed that it’s not always men who question women’s health startups when they’re seeking funding. Allara, which has raised about $16.5 million, is a digital health company that treats gynecological conditions like polycystic ovary syndrome (PCOS) and endometriosis. Blank said she received comments from both men and women who thought there wasn’t a big enough market for her company. But once she explained the data that PCOS affects about one in 10 women of reproductive age — as does endometriosis — investors were receptive. That’s not to say all conversations with investors were met with the kind of passive cluelessness that the women’s health founders shared. Jain said that when talking to women investors, her experience was “split between people who were like ‘Oh my god, this is me’ … and women who were like ‘Huh, I’m now realizing how lucky I’ve been to not be in the cycle of recurrent [vaginal] infections.’” Evvy has also received funding from Virtue, which is led by male investors Sean Doolan and Emre Karatas, who Jain said were receptive to Evvy’s endeavors. “From my first conversation with them, they were like, ‘Wow, there’s so much we don’t know here. We’re gonna go get educated,’” Jain said. “And they came back actually with an unbelievable set of information for me of, ‘Here’s how massive this opportunity is. And we did all this research, and here’s what we learned.’ I was just so amazed by their willingness to learn and desire to really be educated on it.” Do men’s health companies have the same challenges? When direct-to-consumer telemedicine company Hims & Hers started out around 2017, it primarily focused on conditions like erectile dysfunction and hair loss in men. The San Francisco-based company has since expanded into other men’s health conditions, as well as women’s health, and is now public. Before going public, it had raised about $200 million. Melissa Baird, COO of Hims & Hers, said that when seeking funding in the early days, there was some investor discomfort. And since erectile dysfunction isn’t a commonly talked about subject, she said that there were often men and women investors who said that they didn’t know anybody who had this condition, even though statistically speaking they probably did and just didn’t know it. About 30 million men in the U.S. are affected by erectile dysfunction. “I’ve been in meetings where fully grown men would giggle when I mentioned erectile dysfunction, so there definitely was a [taboo] element to it,” Baird said. But once the company started explaining how big of a market there is for its services, “it stopped the giggling pretty fast,” she added. Meanwhile, Maple Grove, Minnesota-based Morari, an early-stage startup focused on premature ejaculation, has had its own struggles in raising funds. The medical device company offers a wearable skin patch that helps delay ejaculation during sex. So far, the company has raised about $3 million from friends, family and angel investors. But when it comes to venture capital funding, the company’s challenges often come from the fact that its product doesn’t have FDA approval yet, according to CEO and Founder Jeff Bennett. He added that there is also an element of discomfort around the topic, “but they don’t come out and say that, they just say it’s not a fit for us.” In this case, he often doesn’t get further information on why the VC chose to pass on the company. “I think anything about sexual health and wellness, given the taboo nature of it, it’s going to be difficult,” Bennett said. What the investors say Several investors agree that women’s health companies focused on stigmatized conditions likely struggle more to get funding than their men’s health counterparts, but said they don’t have the data to prove it. These struggles are most likely due to “who’s in the room,” hinting at the fact that there are more male investors than female, according to Alyssa Jaffee, partner at 7wireVentures. Jaffee has looked at companies for vaginal dryness, PCOS and postpartum leakage. She said she didn’t make an investment in these companies, but not because there wasn’t an opportunity in the space. Rather, it was that the company wasn’t the right fit, she said. “This is health, this is healthcare, this shouldn’t be icky,” Jaffee said. “I think that if you had people in a room who didn’t feel as comfortable with the topic, I can imagine that it would feel that way.” However, 7wireVentures has invested in women’s health companies like Parsley Health, which treats autoimmune conditions, digestive issues, fertility and other areas. It’s also invested in Caraway, which specializes in treating Gen Z women and offers mental, physical and reproductive virtual health. Sean Doolan, founder and managing partner of Virtue, also noted that some of the struggles women’s health companies face may be because there are fewer women VCs. In addition to investing in Evvy, Doolan also invested in Allara before creating Virtue. “I don’t think it’s necessarily controversial to say that a majority of investors are still men. And from both personal and professional experience, I think more men than not might be uncomfortable with having certain conversations about women’s health that they can’t directly relate to.” However, despite this, Doolan noted that he sees far fewer pitches for men’s health than he does for women’s health. Kerry Rupp, general partner of True Wealth Ventures, agreed that women’s health companies face additional challenges, and it partially goes back to the fact that women weren’t included in medical research until relatively recently. In addition, some of these companies struggle with advertising due to the censorship of sexual health information for women. True Wealth Ventures invests in women-led businesses. “I think investors think, ‘Oh, that’s a mess, we don’t want to get into it.’ So not only do they not necessarily understand or want to talk about the women’s health issue, but then they’re also like, ‘Oh, it’s harder for you to actually execute on your customer acquisition strategy,’” Rupp said. Despite these challenges, Rupp has invested in a women’s sexual health company called Rosy, which offers wellness plans for issues like body image, sexual pain, sexual trauma and other areas. She chose to invest in Rosy because it was able to show proof of positive outcomes and that its services are evidence-based. Another investor, while noting that women’s health companies have an uphill battle with the lack of women in the VC world, added that there is another challenge that these startups face that doesn’t have to do with gender. While these types of companies may be successful in a direct-to-consumer business model, it may be harder for them to succeed in a B2B model, according to Ellen Herlacher, partner at LRVHealth. “When you look at a payer, who is probably unlikely to take their eye off the ball from oncology, cardiology, MSK — the things that are very clear cost drivers — and say there are incremental cost savings that you could provide by covering this pelvic floor offering, it’s just never going to rise to the priority because it doesn’t represent a high enough medical cost,” Herlacher said. “On the employer side, there’s just a good amount of fatigue,” she continued. “Employers have done a great job of moving the boulder up the hill when it comes to things like fertility, when it comes to things like access to a variety of services that accompany maternity. But I think it’s going to be hard to convince an employer that they’re going to impact culture or medical costs if they cover at-home STI testing.” Lead with the data What do investors want from the startups pitching to them? Proof and data that their company can make a difference, several investors said. For Doolan, this is what Evvy and Allara provided. “We want to go beyond just the narrative that might catch some emotional strings,” he said. “How does that translate to more of a measurable understanding?” Rupp echoed Doolan’s comments. Showing information like how many people the company could impact and what the financial opportunity is “could be the thing that excites investors,” she said. And when it comes to addressing uncomfortable, stigmatized topics, Herlacher said it’s important to not shy away. “Take it head on,” she said. “Own the fact that it’s uncomfortable. Take on the responsibility of educating the people around the room and then take on the responsibility of explaining why there’s a big business here.”