Digital Apps and Wearables: Can They Become a New Contraceptive Method?
Swiss-based Ava markets the Ava bracelet, what it calls a cycle-tracking sensor bracelet. Similar to Fitbit, Garmin or the Apple Watch, it is a wearable bracelet that tracks various metrics, such as body temperature, resting heart rate, breathing rate, sleep, movement, heart rate variability, heat loss, perfusion, and bioimpedance. It is being sold as a way to track a woman’s fertile period, although the company suggests it plans to see if it can be used as a type of birth control.
On May 30, the company raised $30 million in a strategic Series B financing round. Most of the new funds came from existing investors, with European VC company btov and SVC Ltd. joining in.
At the same time, the company announced a peculiar milestone, 10,000 pregnancies among users since its July 2006 launch. No sales numbers were provided as to percentages or context.
The company is investing in clinical trials with the University Hospital of Zurich to gain further knowledge about women attempting to get pregnant, and to understand infertility and pregnancy complications.
“Ava’s long-term vision is to accompany women through all stages of their reproductive life by providing data-driven, clinically proven technology that will make a woman’s life easier, healthier and better—be it when they just want to understand their body, while they are trying to prevent pregnancy, trying to get pregnant, are pregnant or entering menopause, company co-founder and chief executive officer Pascal Koenig said in a statement.
The company is working on research into using the bracelet for contraception and into pregnancy monitoring. It’s not without its critics and skeptics.
Nathaniel DeNicola, an obstetrician-gynecologist with George Washington University and co-chair of the American College of Obstetrics and Gynecology Telehealth Taskforce, told Forbes that the biomarkers the company promotes “haven’t been validated as part of fertility awareness methods conception programs,” although he concludes it’s reasonable to think subtle changes might provide information, but “these things are different than many of the traditional [fertility] markers.”
Ava appears to be taking a more technical approach to what is dubbed the Temperature Method for tracking fertility. It has been used for a long time to help women determine the best period in their menstrual cycle to get pregnant, because body temperature generally increases a degree or two shortly after ovulation.
DeNicola points out that women using a “fertility awareness method” have about a 25 percent chance of becoming pregnant. “Reasonably,” he told Forbes, “we don’t expect a dramatic change in risk of pregnancy [using fertility awareness methods] based on only more monitoring or use of an app.”
However, the company’s new chief medical officer, Maureen Cronin, who was formerly global head of Medical Affairs at Vifor Pharma from 2010 and before that, from 1998 to 2010, was vice president and head Global Medical Affairs Women’s Healthcare for Bayer Schering Pharma, bristles at the criticism. She told Forbes, “I would have been skeptical had I not really understood it.”
Forbes, however, writes, “Ava’s marketing materials say the bracelet is an FDA class one medical device. That may sound like it’s passed some sort of regulatory sniff test. It hasn’t. Koenig says the bracelet is exempt from the standard requirements many devices must meet to be sold—a submission making the case it’s ‘substantially equivalent’ to something already on the market. That means tampon-makers do more paperwork to introduce a new product than Ava—or many other fertility apps—has yet.”
Fertility apps are a big business, but a study by the Medical College of New York showed that 81 percent of period trackers are inaccurate. And further, three out of 33 apps were only able to provide an accurate prediction of the best time to get pregnant.
Many have also been criticized for their access to patient data, including the number of times a user logs on to Google, Amazon, or Facebook from their phone, as well as the selling of personal data.
There are numerous other studies ongoing. Victoria Jennings with Georgetown University’s Institute of Reproductive Health told Digital Health Age in late 2017, “That’s always the case with anything new, that because it is new there isn’t any regulation. Our primary concern at the Institute for Reproductive Health, in general, is that it’s a very confusing space and there is very little guidance for women regarding which apps are appropriate for pregnancy prevention, which ones are appropriate just for tracking cycles, which ones are appropriate for what. There are more than 1,000 of those apps out there and it’s very easy to put a fertility app into the app store.”
It’s easy to see why companies would be interested, however. According to the U.S. Centers for Disease Control and Prevention (CDC), about 6.9 million women between the ages of 15 and 44 use infertility testing services in the U.S. Ovulation test kits are considered the most effective, with about 97 percent reliability.
And according to a 2017 market research report, the Global Wearable Medical Devices Market is expected to hit $23.8 billion by 2025, and is growing at around a 17.4 percent CAGR.
Still, it’s a difficult jump to go from health monitoring, even improved fertility monitoring, to using a wearable device to reliably avoid pregnancy. Forbes notes that European regulators certified the Natural Cycles app (but the FDA has not), but the Swedish Medicines Agency has opened an investigation into it because of its unreliability.
Jennings also described two broad categories of digital platforms for fertility and contraception, and said, “It seems to be that there are basically zero of them that have undergone the kind of quality, prospective, efficacy trials that all recommended methods of birth control or family planning need to be subjected to. There is one that has undergone a post-marketing study on which they are basing efficacy claims. We are doing a prospective trial that follows the gold standard guidelines for a contraceptive study. I believe that other algorithm apps would need to undergo the same kind of rigorous study to qualify as a bona fide method.”
The Temperature Tracking and other not terribly reliable methods of pregnancy prevention have been dubbed “Vatican Roulette” because they were touted by the Catholic Church as the only acceptable method of birth control. Unless they are proven reliable, these digital tracking systems may find themselves called “Silicon Valley Roulette.”