Nemaura Announces Successful Completion of Summative Human Factors Usability Study for SugarBEAT®
April 23 2019 - 8:00AM
Nemaura Medical, Inc. (NASDAQ: NMRD), a medical technology company
focused on the development of SugarBEAT® as a non-invasive,
affordable and flexible Continuous Glucose Monitor (CGM) for use by
diabetics and pre-diabetics, today announced that it has
successfully completed two summative human factors usability
studies for SugarBEAT®. The usability studies were conducted
according to the U.S. Food and Drug Administration (FDA) guidance
on ‘Applying Human Factors and Engineering to Medical Devices,’ in
preparation for submission of its medical device application to the
FDA for SugarBEAT®.
The two studies consisted of 16 participants each, including
both Type I and Type II diabetics. Participants in the first
and second study ranged from ages 18-50 and 51-70, respectively.
The studies were designed to ensure adequate information was
captured for the diverse age groups expected to use SugarBEAT®.
The objective of the two studies was to confirm that the user
interface aspects of SugarBEAT® met the FDA guidelines for medical
devices.
Dr. Faz Chowdhury, CEO of Nemaura, commented, “We are pleased to
have successfully completed these important studies and we are
preparing our FDA filing at this time. We anticipate broader
adoption of SugarBEAT® as compared with competitive offerings given
SugarBEAT® is non-invasive with flexible wear time, and will be
attractively priced.”
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) designed to help people
with diabetes and pre-diabetics better manage their glucose levels
by spending more time in range. 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
small form factor rechargeable transmitter, connected via Bluetooth
to a specially designed mobile application, which displays glucose
readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
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’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®. These and other risks and uncertainties are identified
and described in more detail in Nemaura’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
undertakes no obligation to publicly update or revise any
forward-looking statements.
Contact:
Crescendo Communications, LLC 212-671-1021
NMRD@crescendo-ir.com
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