Nemaura reports positive data from early head-to-head comparison with a major incumbent CGM Device
May 11 2020 - 6:04AM
Business Wire
sugarBEAT® was developed as a viable, flexible,
and cost-effective alternative to invasive continuous glucose
monitors (“CGM”), and the company plans to seek reimbursement in
key territories.
Nemaura Medical Inc. (NASDAQ: NMRD) (“Nemaura” or the
“Company”), a medical technology company focused on developing
micro-systems-based wearable diagnostic devices and digital
solutions for the medical and consumer markets, announced positive
initial user-volunteer data from its head-to-head comparison with a
major incumbent CGM device.
Earlier this year Nemaura announced that following discussions
with various healthcare insurers, it was planning head-to-head
comparisons with one or more major incumbent CGM devices. The aim
of these studies was to position sugarBEAT® as a cost-effective,
flexible alternative to marketed invasive CGM, allowing continuous
glucose monitoring on days the user chooses, and therefore, we
believe, reducing the overall cost burden to users and healthcare
insurers alike. Today, the Company reported early results comparing
data between sugarBEAT® and a major incumbent CGM device,
demonstrating sugarBEAT® accuracy comparable to the incumbent CGM
device, using a single finger stick calibration. Further details
can be viewed on a report published on the company’s website at:
https://nemauramedical.com/publications/
Dr Faz Chowdhury, CEO of Nemaura, stated: “The primary objective
of these user studies comparing sugarBEAT® with marketed CGMs was
to demonstrate that similar long term clinical outcomes can be
achieved irrespective of whether CGM is used every day of the month
or only on a few days of the week or month. We believe that the
implications of this would be that the annual cost per user would
dramatically fall, making it affordable for the 90% of the diabetic
population that are Type 2, the majority of whom do not require
continuous daily monitoring, and those persons with Type 1 diabetes
who are not currently using any CGM for whom having an occasional
daily glucose profile would provide a powerful insight into the
control over their blood sugar levels and Time-in-Range profiles.
Our overall goal is to empower users with data that helps them
develop control over their glucose fluctuations and guide them
towards improved Time-in-Range profiles to reduce the long term
complications of diabetes and help potentially reverse Type 2
diabetes, and also help those with pre-diabetes from developing
diabetes. We believe that sugarBEAT is uniquely positioned to be
able to achieve these goals, given that existing invasive CGMs are
costly and do not have the flexibility of wear and resulting
cost-advantage that we believe sugarBEAT provides.”
Dr Chowdhury discussed the commercial rollout and unique
positioning of sugarBEAT® in an exclusive interview with Redchip,
which can be viewed here:
https://youtu.be/7Mujq9_wDOw
Nemaura also plans to launch proBEAT™ in the USA later this
year, which is expected to help users improve their knowledge of
how a range of lifestyle, dietary and health and wellbeing factors
impact their sugar levels by deploying sugarBEAT® to act like a
black box flight recorder. It is planned that big data about the
multitude of factors that affect glucose levels will be gathered
from all users and employed in developing and subsequently
“fine-tuning” predictive algorithms and artificial intelligence
based feedback and prompts. We believe that these will then be able
to both educate and provide motivational tools to the user to
encourage them to lead a healthier lifestyle, targeting over 85
million people that are pre-diabetic and over 24 million people who
have Type 2 diabetes in the US. Nemaura is intending to pursue
reimbursement from healthcare insurers in the US for proBEAT™.
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 proBEAT™. sugarBEAT®, a
CE mark approved Class IIb medical device, 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 may help people with diabetes and
pre-diabetes to better manage, reverse and prevent the onset of
diabetes. Nemaura is planning to submit a PMA application for
sugarBEAT® during the second quarter of 2020 for FDA review of this
device under medical device regulations. proBEAT™ comprises a
non-invasive glucose monitor and a digital healthcare subscription
service and is due to be launched in the US as a general wellness
product.
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
proBEAT® in the US, risks related to regulatory status and 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 proBEAT®, 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 both
proBEAT® digital health, and 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 proBEAT® qualifies as
a general wellness product should it become aware of any issues
such as skin irritation or other adverse events from the device, as
well as any misuse impacting patient safety, and any other reason
as the FDA may see fit at its discretion to determine the product
does not fit the definition of a general wellness product. 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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version on businesswire.com: https://www.businesswire.com/news/home/20200511005423/en/
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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