Nemaura To Prepare for Launch of sugarBEAT® CGM In the U.S. Following FDA Feedback
March 18 2020 - 6:00AM
Business Wire
Nemaura Medical Inc. (NASDAQ: NMRD) (“Nemaura” or the
“Company”), a medical technology company focused on developing
micro-systems-based wearable diagnostic devices and currently
commercializing sugarBEAT®, its non-invasive and flexible
continuous glucose monitor (“CGM”), together with BEAT®diabetes, a
planned health subscription service designed to help people with
Type 2 diabetes and pre-diabetes through personalized lifestyle
coaching, announced it is preparing for the launch of sugarBEAT® in
the U.S. under the wellness category following recent feedback from
the U.S. Food and Drug Administration (the “FDA”). The Company is
prioritizing launch plans in the U.S. and is considering various
options to expedite the launch, including potential partnering in
continuation of its on-going discussions with multi-national
companies.
“Under the FDA’s wellness category, the Company intends to make
sugarBEAT® available to any adult wishing to be empowered with
knowledge of how different lifestyle, dietary and health and
wellbeing factors impact their sugar levels and is potentially
appropriate to the pre-diabetic and diabetic market. This gives us
access into the US market, which we believe is the world’s largest
diabetic market by value. As sugarBEAT® is adopted, we believe we
will have the benefit of gathering data on a large scale, and from
a diverse patient demographic, that we believe has never previously
been achieved using CGM. Nemaura intends to use this data to
develop artificial intelligence-based predictive algorithms that in
the future potentially enable us to open up a number of new
opportunities for the prevention and management of diabetes in an
affordable and scalable manner. To the best of our knowledge, no
other CGM has yet been allowed under the wellness category by the
FDA, and this is one of the most important milestones for us thus
far,” stated Dr. Faz Chowdhury, Nemaura’s CEO.
The FDA general wellness category use is defined as: (1) An
intended use that relates to maintaining or encouraging a general
state of health or a healthy activity, or (2) an intended use that
relates the role of healthy lifestyle with helping to reduce the
risk or impact of certain chronic diseases or disease conditions
and where it is well understood and accepted that healthy lifestyle
choices may play an important role in health outcomes for the
disease or condition.
The first phase of the commercial launch of sugarBEAT® began in
the U.K. after the Company received CE Mark approval in 2019. In
this initial phase, devices were supplied to a limited cohort of
users while the Company focused on scaling up its manufacturing
operations. The U.K. licensee of sugarBEAT®, DB Ethitronix, is
currently in the process finalizing the launch of online sales of
sugarBEAT®.
The Company is also currently planning a user study comparing
sugarBEAT® directly against a highly successful major incumbent CGM
sensor, with the goal of positioning sugarBEAT® as a non-invasive,
daily/flexible, cost-effective alternative to traditional,
expensive and invasive CGM.
The total global addressable market for CGM is estimated at
$82.0 billion per annum, consisting of $12.7 billion for Type 1
insulin users (5% of diabetics), $38.0 billion for Type 2 insulin
users (15% of diabetics) and $31.4 billion for Type 2 non-insulin
users (80% of diabetics) . These numbers exclude the pre-diabetes
population, which is estimated at nearly three times as large as
the diabetes population.
About Nemaura Medical, Inc.:
Nemaura Medical Inc. (NMRD) is a medical technology company
developing micro-systems-based wearable diagnostic devices and
currently commercializing sugarBEAT® and BEAT®diabetes. sugarBEAT®
is a non-invasive and flexible continuous glucose monitor (CGM)
providing actionable insights derived from real time glucose
measurements and daily glucose trend data, which help people with
diabetes and pre-diabetes to better manage, reverse and prevent the
onset of diabetes. BEAT®diabetes is a planned health subscription
service providing 1-on-1 lifestyle coaching and behavior change
recommendations driven by personalized data provided by sugarBEAT®.
People with diabetes who take insulin can also adjunctively use
sugarBEAT® for insulin dosage purposes when calibrated by a finger
stick reading.
For more information visit: www.NemauraMedical.com.
Cautionary Statement Regarding Forward-Looking
Statements:
The statements in this press release that are not historical
facts may constitute forward-looking statements that are based on
current expectations and are subject to risks and uncertainties
that could cause actual future results to differ materially from
those expressed or implied by such statements. Those risks and
uncertainties include, but are not limited to, the launch of
sugarBEAT® in the US, risks related to regulatory approvals and the
success of Nemaura’s ongoing studies, including the safety and
efficacy of Nemaura’s sugarBEAT® system, the failure of future
development and preliminary marketing efforts, Nemaura’s ability to
secure additional commercial partnering arrangements, risks and
uncertainties relating to Nemaura and its partners’ ability to
develop, market and sell sugarBEAT®, the availability of
substantial additional equity or debt capital to support its
research, development and product commercialization activities, and
the success of its research, development, regulatory approval,
marketing and distribution plans and strategies, including those
plans and strategies related to sugarBEAT®. There can be no
assurance that the company will be able to reach a part of or any
of the global market for CGM with its products/services. The FDA
reserves the right to re-evaluate their decision that sugarBEAT
qualifies under the wellness category should it become aware of any
skin irritation or other adverse events from the device, as well as
any misuse impacting patient safety. These and other risks and
uncertainties are identified and described in more detail in
Nemaura’s filings with the United States Securities and Exchange
Commission, including, without limitation, its Annual Report on
Form 10-K for the most recently completed fiscal year, its
Quarterly Reports on Form 10-Q, and its Current Reports on Form
8-K. Nemaura undertakes no obligation to publicly update or revise
any forward-looking statements.
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Investor Contact: Dave Gentry, CEO RedChip Companies
Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498
dave@redchip.com
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