For over a year Sweden based nuclear physicistElina Berglund has been fighting authorities and malicious headlines. Now her app will be the first in the world to be approved as a contraceptive.
“It feels incredibly exciting that there is now an approved alternative to conventional pregnancy prevention methods, and that it’s possible to replace medication with technology,” says a more than satisfied Elina Berglund, who founded Natural Cycles together with her husband Raoul Scherwizl.
The approval comes from the German inspection and certification organization Tüv Süd, which has classified the app in the medicinal category of IIb. That means Natural Cycles officially offers a new, clinically tested alternative to birth control methods such as contraceptive pills, contraceptive implants and condoms.
2015 was a turbulent year for the founding couple. The difficulties peaked November 25 when the ruling of the Swedish Medicinal Products Agency reached their inbox. It demanded that all talk of contraceptive should be done away with in ten days, while the agency continued to investigate the matter. The app’s users were informed two days before Christmas.
“At that point it felt tough. Really tough. After all, the app had been developed for birth control,” Elina Berglund told Veckans Affärer in an interview during the summer of 2016.
On top of that, the information that the Medicinal Products Agency was investigating Natural Cycles leaked, and from the peak revenue of $280,000 in October 2015 they experienced a dramatic decline.
”By December our revenues were $120,000.”
The storm continued: Frightening headlines about Natural Cycles attempting to trick young women who lack the discipline to protect themselves, along with strict monitoring from the Medicinal Products Agency.
Now, more than a year later, Elina Berglund and her husband finally get their long-awaited vindication. The previous prognosis of doubled revenues for 2016 was lost in the time pending approval, but now it’s time to strive onward again.
“We barely grew at all last year, so now we’ll have to double up this year instead and go from revenues of about SEK 18 million to SEK 36 million.”
The plans of a big scale launch in the US will have to wait pending approval from the American regulatory agency, FDA. Instead, Natural Cycles will go ’all in’ into the UK, which is already one of the biggest markets for the company.
Natural Cycles calculates daily fertility with an algorithm.
To use the app, women measure the temperature underneath their tongues every morning and enter the measurement into the app. An algorithm developed uniquely for the app then determines whether you’re fertile or not that day, so that you know if you risk pregnancy by having unprotected sex.
Natural Cycles has over 150,000 users in 161 countries and a clinical study has proved that using the app is as effective as a method of birth control as being on the pill.
This article was originally published on Business Insider, read it here.