All posts in “Birth Control”

The Pill Club raises $51M as VCs find new opportunities in women’s health

Through telemedicine and direct-to-consumer sales platforms, startups are streamlining the historically arduous process of accessing contraception.

The latest effort to secure a significant financing round is The Pill Club, an online birth control prescription and delivery service. Consumer-focused investor VMG Partners has led its $51 million Series B, with participation from new investors GV and ACME Capital (formerly known as Sherpa Capital), and existing investors Base10 Partners and Shasta Ventures. The Pill Club declined to disclose its valuation.

Launched in 2016 in San Carlos, California, The Pill Club couples healthcare services with at-home delivery, reaching customers in all 50 states. With a team of doctors, nurses and patient care coordinators, the startup operates its own pharmacy and is licensed to prescribe medication in 35 states. With the new funding, which brings its total raised to $67 million, founder and chief executive officer Nick Chang said he plans to scale the business 50 percent and expand its prescription service across the entire U.S.

“At the end of the day, our company is about empowering women,” Chang told TechCrunch. “What does that mean? It means empowering our patients to make their own healthcare decisions and making reproductive healthcare more common — something to not be shy about or worried about.”

Chang, who has spent his career in medicine and holds an M.D. from Duke University, previously founded Ganogen. The business, which sought to facilitate patient’s access to organ donors, ultimately shut down but was a catalyst to The Pill Club’s formation, as were experiences from Chang’s youth.

“I [grew] up with an older sister who was on birth control since she was 14 for menstrual regulation,” Chang said. “She really felt embarrassed to pick up the medication and to talk to anyone about it and that was really insightful for me. There are so many hurdles in accessing birth control besides clinics being around.”

Some 67 million women between the ages of 13 to 44 live in the U.S.; 19 million of them live in contraceptive deserts, or areas that lack reasonable access to public clinics. The Pill Club wants to eliminate those deserts, as do other companies in the digital health arena.

Digital health has remained one of the hottest destinations for VC investment. In 2018, investors put about $4.5 billion into U.S. companies in the sector, a 17 percent increase year-over-year, according to PitchBook data. Telemedicine startups garnered a record $1.25 billion in funding in that timeframe thanks to large financings for industry leader Oscar, a health insurance startup that raised $540 million in 2018 alone; as well as an $88 million Series A for newcomer Roman, which offers a cloud pharmacy for erectile dysfunction.

Startups focused on women’s health, meanwhile, have continued to garner more attention from VCs. These companies, including The Pill Club and comepetitor Nurx, have not only benefited from the rapid rise of telehealth, but also from a societal shift sparked in part by President Donald Trump and Republican lawmakers’ attempts to limit women’s access to birth control.

“People want to talk about this,” Chang said. “With so much happening from Hollywood to politics … it’s really got some people to say ‘ok, we really need to talk about what we are prioritizing as a society.’”

In addition to accelerating the expansion of its 260-person team, The Pill Club plans to use the investment to explore launching more services within women’s healthcare and to broaden the educational content it offers its customers.

“This is just the beginning of a much broader and bigger movement,” Chang said.

Birth control delivery startup Nurx now offers an at-home HPV testing kit

Telemedicine startup Nurx — once dubbed the “Uber for birth control” — has launched a direct-to-consumer Human papillomavirus (HPV) testing kit. The addition means its customers can test for the most common sexually transmitted infection in the U.S. and a cause of genital warts and cervical cancer in the comfort of their own homes.

The Y-Combinator graduate is backed with about $42 million in venture capital funding from Kleiner Perkins, Union Square Ventures, Lowercase Capital and others. It launched in 2015 to facilitate women’s access to birth control across the U.S. with a HIPAA-compliant web platform and mobile application that delivers contraceptives directly to customer’s doorsteps. Nurx’s telemedicine platform ensure its users can communicate with doctors and are provided the resources necessary in choosing the correct method of birth control.

The HPV test is free with insurance, aside from the $15 shipping and lab processing fee, and $69 for those without insurance. Beginning today, the kit is available to all current Nurx users and will be fully rolled out to new customers in 2019.

In addition to birth control and the HPV test, the company also ships PrEp, a once-daily pill that reduces the risk of getting HIV. Nurx’s expansion beyond birth control is part of the company’s goal of helping people take control of their health, especially the millions in the U.S. who live in “contraceptive deserts,” or areas where there is no reasonable access to a public clinic.

“Our mission here is to leverage telemedicine to change public healthcare,” Nurx co-founder and chief executive officer Hans Gangeskar told TechCrunch. “We are building a full-stack primary care telemedicine platform at an unparalleled cost.”

The HPV testing kit is only approved for women over 30 and is not a replacement for a Pap smear, which collects a sample of cells from the cervix to check for abnormalities. Still, the kit, which requires only a vaginal swab, is able to assess for 14 high-risks of HPV that lead to cervical cancer. The company says the test will be a game-changer for women who are not regularly able to get Pap smears or who have not had access to the HPV vaccine, like women who live in rural areas and those without health insurance.

Nurx raised a $36 million round with support from the Clinton Foundation in July. As part of the deal, Chelsea Clinton joined its board of directors. The company has used that investment to incorporate the HPV testing kit, as well as to expand into several new markets in 2018. 

Nurx is currently available in 22 states, including the District of Columbia.

Natural Cycles contraception app told to clarify pregnancy risks

A multi-month investigation by Sweden’s Medical Products Agency into a number of unwanted pregnancies among users of ‘digital contraception’ app Natural Cycles has been closed after the startup agreed to clarify the risk of the product failing.

But, on the self-reported data front, the agency said it was satisfied the number of unwanted pregnancies is in line with Natural Cycles’ own clinical evaluations which are included in the certification documentation for the product.

In its marketing and on its website Natural Cycles describes the app-based system as “93% effective under typical use” — a finding that’s based on a clinical study it conducted of more than 22,000 of its users.

The investigation by Sweden’s MPA began around eight months ago, after a number of users in Natural Cycle’s home market had reported unwanted pregnancies to a local hospital — which then reported the app to the regulator.

The Natural Cycles app uses an algorithm to track fertility by monitoring the user’s menstrual cycle. The process requires women take their body temperature at least several times a week, and do so first thing in the morning, inputting the data into the app which is designed to adapts its ‘fertile’ or ‘not fertile’ predictions to each user’s cycle.

Several users have reported falling pregnant while using the app. But the proportion of women who have done so (at least in Sweden) is in line with efficacy rates reported by Natural Cycles, according to the regulator’s assessment.

Earlier this year the MPA said it had received “approximately 50 complaints” related to unwanted pregnancies in users of the app. But late last week it announced it had concluded its assessment of the app — which it said focused on “product safety, instructions for use and post market surveillance documentation in order to confirm if the product is in compliance with regulations”.

As well as looking at parts of the certification documentation for Natural Cycles, the agency says it assessed monthly reports of unwanted pregnancies among active app users in Sweden, covering a six-month period — with pregnancy data supplied by the company itself on a month by month basis during the first half of 2018.

The agency found the number of reported unwanted pregnancies reported by users to be in line with Natural Cycles’ certification documents for the product, finding a failure rate in typical use of 6.9%.

But it also asked the company to clarify the risk of unwanted pregnancies in instructions for the app.

“Our conclusion is that the number of unwanted pregnancies during the assessed time period is consistent with data shown in the clinical evaluation included in the certification documentation. Since it is important that a contraception app is correctly used, we requested the manufacturer to clarify the risk of unwanted pregnancies in the instructions for use and in the app. These issues have been addressed by Natural Cycles and thereby our review is completed,” said Mats Artursson, investigator at the agency in a statement.

As we reported earlier this year, the startup has lent heavily on aggressive social media marketing of its novel ‘digital contraception’ method — which has sometimes appeared to downplay the risk of failure for what is undoubtedly a relatively complex contraception option, given it requires users to consistently self-monitor (and accurately measure their body temperature) as well as use alternative contraception on days when the app informs them they are fertile.

Natural Cycles admits that factors such as illness, disrupted sleep, drinking alcohol and having an irregular menstrual cycle can have a negative impact on the accuracy of its algorithmic fertility predictions. And says itself that the method is not a suitable contraception choice for every individual.

Nor does the app offer any protection against STDs — unless users combine it with additional barrier methods of contraception.

But despite that, until very recently on its website (and in some of its marketing) Natural Cycles has been making the misleading claim that its contraception app is “99% effective” if used “perfectly”. (Perfect use implying, well, superhuman use.)

And just last month the company was wrapped on the knuckles by the UK’s Advertising Standards Authority — which banned one of its social media ads for being misleading, also warning the company against exaggerating the efficacy of the app in preventing pregnancies.

The assessment by the Swedish MPA looks to have reached similar conclusions about certain aspects of the claims Natural Cycles’ has been making for the app.

When we covered the ASA’s ruling last month Natural Cycle’s website still included the misleading 99% ‘perfect use’ claim — within this confusingly worded paragraph: “With using the app perfectly, i.e. if you never have unprotected intercourse on red days, Natural Cycles is 99% effective, which means 1 woman out of 100 get pregnant during one year of use.”

It’s since scrubbed the paragraph from its website, focusing solely on the 93% effective stat — on which it now writes: “Natural Cycles is 93% effective under typical use, which means that 7 women out of 100 get pregnant during 1 year of use. Typical use effectiveness takes into account all possible reasons for becoming pregnant while using the app: from having unprotected sex on a red day, to the app wrongly attributing a green day or the chosen method of contraception on a red day having failed.”

It’s not clear whether Natural Cycles removed the 99% ‘perfect use’ claim as a result of the ASA ruling — or following the Swedish MPA’s assessment. (We’ve asked the company to clarify the exact changes it made related to the MPA’s findings, which the regulator also says relate to software versioning, and will update this story with any response.)

Its app gained certification as a contraception in the EU in February 2017, and went on to gain FDA clearance (via a De Novo classification request) this summer — giving the product a major credibility boost, even as regulatory clearances still come with plenty of caveats. (In the FDA‘s case it warns that: “Users must be aware that even with consistent use of the device, there is still a possibility of unintended pregnancy.”)

It’s also worth noting that it’s still the case that Natural Cycles has not carried out a randomized control trial to more robustly prove out the efficacy of the product, i.e. by using standard scientific methods.

Instead, users must rely on the findings of its self-selecting clinical study of its own users — which may have its own weaknesses, given that, for example, any user who fails to report an unwanted pregnancy to Natural Cycles would not be reflected in the data it’s providing to regulators.

Commenting on the conclusion of the Swedish MPA’s investigation in a statement, Natural Cycles CEO Raoul Scherwitzl said: “We are pleased that the MPA has concluded its investigation, following a review of our real-world effectiveness data. There has been a lot of discussion about this investigation, and we hope that it will provide some reassurance to women to see eminent bodies like the Swedish MPA and the US FDA in alignment based on the strength of our clinical evidence. We never doubted the effectiveness of our product since the number of reported pregnancies is monitored closely on a monthly basis — this is an ongoing responsibility that we commit to as part of operating in a regulated environment.”

The FDA OK’d an app as a form of birth control

Don’t want to get pregnant? There’s a Food and Drug Administration approved app for that. The FDA has just given the go ahead for Swedish app Natural Cycles to market itself as a form of birth control in the U.S.

Natural Cycles was already in use as a way to prevent pregnancy in certain European countries. However, this is the first time a so-called ‘digital contraceptive’ has been approved in America.

The app works using an algorithm based on data given by women using the app such as daily body temperature and monthly menstrual cycles. It then calculates the exact window of days each month a woman is most fertile and therefore likely to conceive. Women can then see which days the app recommends they should avoid having sex or use protection to avoid getting pregnant.

Tracking your cycle to determine a fertile window has long been used to either become pregnant or avoid conceiving. However, Natural Cycles put a scientific spin on the age-old method by evaluating over 15,000 women to determine its algorithm had an effectiveness rate with a margin of error of 1.8 percent for “perfect use” and a 6 percent failure rate for “typical use.”

What that means is almost two in every 100 women could likely conceive on a different date than the calculated fertile window. That’s not exactly fool-proof but it is higher than many other contraceptive methods. A condom, for instance, has an 18 percent margin of error rate, according to the Centers for Disease Control (CDC).

And though the app makers were able to convince the FDA of its effectiveness, at least one hospital in Stockholm has opened an investigation with Sweden’s Medical Products Agency (MPA) after it recorded 37 unwanted pregnancies among women who said they had been using the app as their contraception method.

“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” assistant director for the health of women in the FDA’s Center for Devices and Radiological Health Terri Cornelison said in a statement.

However, she also acknowledged there was a margin of error in the app’s algorithm and other contraceptive methods. “Women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device,” she said.

Nurx raises $36 million and adds Chelsea Clinton to its board of directors

Telemedicine startup Nurx recently closed a $36 million funding round led by Kleiner Perkins. As part of the investment, Kleiner Perkins General Partner Noah Knauf is joining the startup’s board of directors, along with and Chelsea Clinton .

With this new funding, CEO and co-founder Hans Gangeskar told TechCrunch that the startup plans to scale its clinical teams, pharmacies and geographic reach in the coming year.

“We have a new site in Miami where we have a team of nurses being on-boarded, [we’re] building out our engineering and design teams and really just [working to] increase the pace of everything that we’re doing” Gangeskar said.

The startup launched in 2014 with the goal to make reliable access to contraceptives as easy as opening your web browser. After plugging your information into its online app, users are connected with physicians, given a prescription and Nurx prepares their product for delivery.

Since its launch, this California-based startup now operates in 17 states, and has expanded its products to include not only contraceptives (such as pills, patches, injectables and products like Nuva Ring) but the anti-HIV medication PrEP as well. Gangesker says the company is also preparing to launch an at-home lab kit soon for HIV testing.

For Gangeskar, creating affordable access to contraceptives is a first step to changing how patients interact and receive medication from their physicians.

“Birth control is one of the fundamental functions of any health care system [so] for us its a natural place to start,” said Gangeskar.

To help advance its plans to redefine this space, Gangeskar says Nurx is excited to welcome public health veteran Chelsea Clinton to its board.

“Her experience in public health and global health from the Clinton Global Initiative has been really valuable, [particularly learning about] rolling out preventative services in large scales, because really that’s the potential of our platform — [to reach] populations that can’t be reached by the conventional medical system.”

While Washington looks to make cuts to American’s health care access, startups like Nurx offer a fresh perspective on this critical space.