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.
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SOURCE Natural Cycles