Nemaura Announces Positive Results for its SugarBEAT® European Clinical Program
January 31 2018 - 1:20PM
Business Wire
Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology
company developing the wireless sugarBEAT® non-invasive glucose
monitoring system for adjunctive use by persons with diabetes today
announced positive summary data for its sugarBEAT® European
clinical trial program.
The summary results were taken from a 25 patient cohort of the
previously reported European three-stage 75 patient Clinical study,
consisting of 80% Type 1 and 20% Type 2 Diabetics. The study was
designed as a single centre open-label, single arm, within-subject
comparison of sugarBEAT®, with blood samples drawn from a venous
catheter at corresponding time points, with glucose concentration
measured using a Laboratory blood glucose analyser, ARCHITECT
C8000. Each patient continuously wore sugarBEAT® for 14 hours on
seven consecutive days. Three of the seven days were in-clinic
where venous blood samples were taken at 15 minute intervals over a
continuous 12 hour period.
Results indicate an overall MARD (Mean Absolute Relative
Difference) of 13.76% over a broad dynamic glucose concentration
range. However, up to 70% of the data from the study paired between
sugarBEAT® and the venous blood glucose concentration achieved an
average MARD of 10.28%, denoting even greater accuracy. A MARD of
10% is deemed to be sufficient for making therapeutic decisions. No
serious or major device related adverse events were noted.
CEO, Dr Faz Chowdhury commented, “these results are a
significant milestone towards commercialization of sugarBEAT®. We
anticipate our miniature wireless device format, which is directly
adhered to the body using a non-irritant soft silicone gel,
together with our improved sensor performance, will prove to be a
formidable tool in helping persons with diabetes globally to better
manage their blood sugar levels. We also believe the non-invasive
nature of sugarBEAT® will lend itself well to the rapidly growing
consumer wellbeing market, for lifestyle glucose management by
non-diabetic and pre-diabetic persons.”
SugarBEAT® consists of a disposable skin-patch connected to
a rechargeable transmitter, with a mobile app displaying glucose
readings at regular five minute intervals. Unlike the Dexcom
or Abbott Libre devices, sugarBEAT® is non-invasive and does
not require the insertion of a needle-like sensor into the
skin.
SugarBEAT® is expected to launch in the UK, followed
by other territories upon achieving CE approval, which is
anticipated in the coming months. Additional clinical studies
are planned for sugarBEAT® for FDA approval in the US, and for
use of sugarBEAT® in critical care settings.
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NASDAQ: NMRD), is a medical technology
company developing sugarBEAT® as a non-invasive, affordable
and flexible glucose monitoring system for adjunctive use by
persons with diabetes. SugarBEAT® consists of a disposable
adhesive skin-patch connected to a rechargeable transmitter, with
an app displaying glucose readings. For more
information, please
visit www.NemauraMedical.com and www.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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180131006030/en/
Nemaura MedicalBashir TimolDirector of Strategy &
Corporate Developmentbashir.timol@nemauramedical.com
Nemaura Medical (NASDAQ:NMRD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Nemaura Medical (NASDAQ:NMRD)
Historical Stock Chart
From Apr 2023 to Apr 2024