Nemaura Reports Positive Interim Data from Clinic Portion of SugarBEAT® FDA Clinical Trial
September 12 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
persons with diabetes and pre-diabetics, today reported data from
an interim analysis of the first of a number of planned studies in
support of a submission to the U.S Food & Drug Administration
(“FDA”) for approval of its sugarBEAT® product.
The interim results consisted of 25 patients, split
approximately equally between Type I and Type II diabetics1. The
study was conducted in a clinic setting, and blood samples were
taken via a catheter every 15 minutes over a 12 hour period for 3
non-consecutive days, for a total of 75 patient days. Blood samples
were measured using an Architect c8000 Laboratory Instrument.
9,371 data points were analysed in total, consisting of 4,630
and 4,741 paired data points analysed using 1-point and 2-point
calibration respectively. The MARD (Mean Absolute Relative
Deviation, @ 30%/30mg/dL) for the 1-point calibration was 12.19%
(80% of all data), and for the 2-point calibration the MARD was
10.65% (88% of all data)). The results are in line with the
company’s expectations, and compare favorably with competitor
products.
SugarBEAT® is expected to launch in the UK in the coming months,
and is expected to be marketed to all categories of diabetics,
including Type 1, Type 2 and pre-diabetics. Continuous Glucose
Monitoring (CGM) is estimated to have a global total addressable
market worth $82Bn. The U.S. has the largest number of CGM users,
where 2018 usage numbers are estimated at 630,000 insulin users,
representing 2.6% of 24.6 million people who have been diagnosed
with diabetes.2
Nemaura previously reported data from the home-use portion of
the same study, whereby 121 matched pair points between the Blood
Glucose Meter and sugarBEAT® were evaluated, which indicated 84.3%
of the data points had an overall MARD of 10.63%, and an
overall nominal MARD of 16.3% (compared with 14.8%, 16.3% and 18%
for Eversense, Dexcom G5 and Abbott Libre Pro respectively1).
Completion of U.S. study and FDA submission is anticipated in Q1
2019, alongside poster presentation at the Advanced Technologies
& Treatment for Diabetes (ATTD) conference in Berlin in
February 2019 for the full in-clinic portion, which is designed to
record approximately 16,000 matched data
points. 1Further detailed summary of the results are
available on the publications page of the company’s website.
2As stated in PiperJaffray DXCM Company Note Sep 5th 2018
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NASDAQ: NMRD), is a medical technology
company developing sugarBEAT® as a non-invasive, affordable and
flexible Continuous Glucose Monitor (CGM) for use by persons with
diabetes and pre-diabetics. Insulin users can adjunctively use
sugarBEAT® when calibrated by a finger stick 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 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.
Contacts
Nemaura Medical Inc.Bashir TimolChief Business
Officerbashir.timol@nemauramedical.comorThe Ruth GroupLee
Roth646-536-7012
lroth@theruthgroup.com
Nemaura Medical (NASDAQ:NMRD)
Historical Stock Chart
From Jun 2024 to Jul 2024
Nemaura Medical (NASDAQ:NMRD)
Historical Stock Chart
From Jul 2023 to Jul 2024