Nemaura Reports Positive Zero Finger-Stick Calibration Data for SugarBEAT® Continuous Glucose Monitor
September 25 2018 - 4:00AM
LOUGHBOROUGH, England. Nemaura Medical Inc. (NASDAQ: NMRD), a
medical technology company developing sugarBEAT® as a non-invasive
affordable and flexible Continuous Glucose Monitor (CGM) for use by
people with diabetes and pre-diabetics, today announced data
indicating sugarBEAT® could potentially be used as an adjunctive
CGM without the need for finger-stick calibration.
Nemaura retrospectively evaluated a portion of previously
completed clinical data for 75 patients (337 in-clinic patient
days), using a refined factory calibration constant, based upon
newly developed algorithms. 66% of patches worn by 92% of the
patients generating 9,863 paired data points were evaluated, with
58% of these paired data points giving a MARD of 13.61%. Nemaura
further noted 73% of these paired data points gave a MARD of
17.83%.1
Nemaura is currently undertaking additional data analysis, to
potentially allow sugarBEAT® to be used with zero or reduced
frequency finger-stick calibration.
Nemaura previously published an interim data set on September
12, 2018, from an in-clinic portion of a FDA study which indicated
a MARD of 12.19% (at 30% / 30mg / gL) was achievable (on 80% of all
data) with a single finger-stick calibration, and a MARD of 10.65%
was achievable (on 88% of data) with two finger-stick calibrations,
over a 14 hour wear period.1
Current CGM adoption is minimal and growing rapidly amongst
people with diabetes, with the global total addressable market
estimated at $82Bn annually. The U.S. is the largest single market,
with CGM being used by an estimated 2.6% (630,000 users) of all
diagnosed diabetics in 2018, representing annualized growth of
117%.2
SugarBEAT® is anticipated to launch in the UK in the coming
months, and is intended to be marketed to all categories of
diabetics, including Type 1, Type 2 and pre-diabetics.
1 Further detailed summary of the results are available on the
publications page of the company’s website.
2 PiperJaffray Company Note DXCM Sep 5, 2018
About Nemaura Medical Inc.
Nemaura Medical (NASDAQ:NMRD) is a medical technology company
developing sugarBEAT® as a non-invasive, affordable and flexible
Continuous Glucose Monitor (CGM) designed to provide people with
diabetes and pre-diabetics with an Ambulatory Glucose Profile (AGP)
as a superior metric to better manage their glucose levels as
compared to an HbA1c reading. Insulin users can adjunctively use
sugarBEAT® when calibrated with a finger-stick glucose reading.
SugarBEAT® consists of a daily disposable adhesive skin-patch
connected to a rechargeable transmitter, with an app displaying
glucose readings at five minute intervals for periods up to 24
hours.
For more information
visit:www.NemauraMedical.comwww.SugarBEAT.com
Cautionary Statement Regarding Forward Looking
Statements
The statements in this press release that are not historical
facts, and 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, risks related to
regulatory approvals and the success of Nemaura Medical’s ongoing
studies, including the safety and efficacy of Nemaura Medical’s
sugarBEAT® system, the failure of future development and
preliminary marketing efforts, Nemaura Medical’s ability to secure
additional commercial partnering arrangements, risks and
uncertainties relating to Nemaura Medical 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®. These and other risks
and uncertainties are identified and described in more detail in
Nemaura Medical’s filings with the Securities and Exchange
Commission, including, without limitation, its Annual Report on
Form 10-K for the current year, its Quarterly Reports on Form 10-Q,
and its Current Reports on Form 8-K. Nemaura Medical undertakes no
obligation to publicly update or revise any forward-looking
statements.
Contact
Nemaura Medical Inc.Bashir TimolChief Business
Officerbashir.timol@nemauramedical.com
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