Natural Cycles receives approval from Health Canada for its birth control app

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Jan 09, 2024, 08:45 ET

The company's latest regulatory clearance comes after receiving an additional FDA Clearance to integrate with Apple Watch

NEW YORK, Jan. 9, 2024 /PRNewswire/ -- Natural Cycles, the leading women's digital health company, announced it has received approval from Health Canada to market and sell the Natural Cycles app as a form of birth control. Previously sold in Canada as a fertility tracker, the Natural Cycles app is the first app of its kind to obtain a Class II Medical Device License from Health Canada and remains the only digital form of birth control on the market cleared by regulators in the United States (FDA), Europe (TÜV SÜD), Australia (TGA), Singapore (HSA), and South Korea (MFDS).

The Natural Cycles app is used to prevent and plan pregnancy naturally without hormones. There are six days in each cycle a woman can become pregnant, and the app is powered by an algorithm that analyzes daily hormone-driven temperature changes to confirm if the user is fertile that day or not. To receive their temperature-powered daily fertility status, users can manually take their body temperature with a thermometer or sync temperature data from an integrated wearable device when they wake up.

"Our mission has always been to reach as many women as possible and with our latest regulatory clearance from Health Canada, the Natural Cycles app is now accessible to more than 380 million women globally," said Natural Cycles co-founder and CEO Dr. Elina Berglund Scherwitzl. "We hear from our users every day that Natural Cycles has changed their lives, and we are excited to bring another birth control option to Canada and help more Canadians prevent or plan pregnancy naturally."

Natural Cycles currently has over three million registered users worldwide and the demand for its natural birth control option continues to increase, with many seeking an alternative to hormonal birth control or less effective fertility awareness methods. In 2023, Natural Cycles saw 50% year-over-year growth in new user sales, with 80% of users looking to actively prevent pregnancy.

"As the need for more contraceptive options increases worldwide, we will continue to obtain the proper regulatory approvals in new markets while also improving our product and making Natural Cycles more accessible in existing markets," said Natural Cycles co-founder and CEO Dr. Raoul Scherwitzl. "While our team was submitting for the Health Canada license, we were simultaneously working with US and European regulators to get clearance on our Apple Watch integration and with American insurance companies to help them comply with federal mandates to cover Natural Cycles in full."

In September 2023, Natural Cycles received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its use of wrist temperature data from Apple Watch. The integration allows the Natural Cycles app to use overnight wrist temperature data from Apple Watch (Series 8 and later and all models of Apple Watch Ultra) for users consenting to share this information. Apple Watch joined Oura Ring as Natural Cycles' second integrated wearable device, both of which have also been cleared by regulators in Europe and registered for use in Australia. Canadian Natural Cycles users can measure with a basal thermometer, Apple Watch, or Oura Ring.

By the end of 2023, Natural Cycles estimated that approximately 5% of its American users had submitted their subscription to their insurance company for reimbursement. While the company is working to increase this number in 2024, progress has expedited since the Department of Labor issued guidance outlining that plans and issuers are required to cover, at no cost, at least one form of contraception within each of the contraceptive categories identified by the FDA. As Natural Cycles is the only FDA Cleared birth control app on the market, it should be covered by all plans and issuers.

A dedicated team at Natural Cycles has been working with payers to establish guidance on how to get reimbursed for Natural Cycles, while also working with users directly, guiding them through the process of submitting for reimbursement. In the coming months Natural Cycles will continue to build out this team and has recently hired its first on-staff OB-GYN, Dr. Kerry Krauss, FACOG who will help educate healthcare providers and their patients on how to get Natural Cycles reimbursed.

To learn more about Natural Cycles, go here: https://www.naturalcycles.com/

About Natural Cycles°
Founded in 2013 by Dr. Elina Berglund and Dr. Raoul Scherwitzl, Natural Cycles is a leading women's health company that developed the world's first birth control app. As a Class II medical device, the NC° app is cleared by the FDA in the United States and certified to be used as a contraceptive in Europe, Canada, Australia, Singapore, and South Korea. The NC° app is powered by an algorithm that uses body temperature to determine each user's daily fertility status. Users can manually take their body temperature with a thermometer or sync temperature data from an Oura Ring or Apple Watch when they wake up. Natural Cycles also offers fertility-as-a-service to third-party partners, including Samsung. While not to be used as birth control, Samsung Galaxy Watch users with temperature sensors can access advanced cycle tracking through the Cycle Tracking feature, which is powered by Natural Cycles. For more information on the company, its scientific research, or how the NC° app works, visit naturalcycles.com.

SOURCE Natural Cycles