Nemaura Medical, Inc.(NASDAQ: NMRD) (“Nemaura” or the “Company”), a
medical technology company focused on developing and
commercialising non-invasive wearable diagnostic devices and
supporting personalized lifestyle coaching programs, today
announced interim results from its metabolic health program.
The primary objective of the study was to
establish whether a metabolic program with a daily wear CGM worn
twice a month resulted in greater engagement levels and sustainable
weight reduction, and how this compared to other programs. The
multi-centered study was run in collaboration with the UK’s
National Health Service.
Known as Miboko (Mind, Body, Konnect), the
program is the first to integrate a daily-wear and non-invasive
glucose sensor with the Company’s bespoke app, educational content
and AI driven analytics platform.
Users were invited to participate by their
primary care practice, based on a BMI over 25. None of those
invited to participate had expressed a willingness to join a
metabolic weight loss program or had previously heard of the Miboko
program. Participants used the Miboko app, and were given access to
relevant education modules relating to aspects of metabolic health
and weight loss. Diet and lifestyle were entered daily into the
app, and weight was recorded weekly. Every two weeks, users wore
the daily wear continuous glucose sensor, which tracked and
displayed real-time glucose. At the end of the day, participants
were provided with a Metascore® and measure of glucose
variability.
In addition, users were presented with a video
report which analysed their glucose trends and made diet and
lifestyle recommendations. The Metascore® is derived from a number
of factors including BMI, insulin sensitivity and lifestyle.
The study tracked 83 participants, with a mean
age of 54 years old. The cohort was made up of 67% female (F), and
33% male (M), and 88% of participants recorded their ethnicity as
‘White’. After 20 weeks of enrolment, 59 people (16M/43F) had
recorded weight loss, with 21 participants losing over 5KG (11
pounds). On an average basis, weight loss was 2.9KG (6.3 pounds)
(1.9M/3.2F), with the rate of change increasing after week 8.
Qualitative feedback from users demonstrated
substantially increased levels of understanding and empowerment on
their weight loss goals, correlating to long-term behavioural
changes that are pivotal to sustained weight loss. Of particular
note is that users derived considerable benefit from their
personalised insights, based on their Metascore® and response to
diet and exercise. Verbatims from users confirmed that CGM sensor
use increased user participation, better understanding of food
choices and portion size.
After 20 weeks of use, the program had a
retention rate of 32.5%. When active participants were asked
whether they would continue with the program, 64% of respondents
stated they were likely or very likely to continue to use the
program. This far exceeds retention rates for health and wellbeing
apps of 16.7% at 13 weeks and 6.9% at 26 weeks.1
Published studies report that affordability is a
key barrier to CGM adoption, and the Company aims to price its
CGM-embedded program significantly lower than any presently
available comparable program.
The integration of Nemaura’s CGM sensor means
that for the first time, a low-cost metabolic health improvement
prevention program will soon be commercially available. The Company
has the advantage of its own proprietary non-invasive sensor
technology, which significantly reduces sensor costs, as the
sensors are only worn a few days each month.
The Company plans to publish more detailed
results in due course. A link to the Miboko website can be found
here: https://miboko.com
About Nemaura Medical, Inc.
Nemaura Medical Inc. is a medical technology
company developing and commercialising non-invasive wearable
diagnostic devices. The Company is currently also commercialising
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 prediabetes to better manage, reverse, and
prevent the onset of diabetes. Nemaura has submitted a PMA
(Premarket Approval Application) for sugarBEAT® to the U.S. Food
and Drug Administration (the “FDA”). proBEAT™ combines non-invasive
glucose data processed using artificial intelligence as part of a
lifestyle program that is being refined for commercial launch.
The Company sits at the intersection of the
global Type 2 diabetes market that is expected to reach nearly $59
billion by 2025, the $50+ billion pre-diabetic market, and the
wearable health-tech sector for weight loss and wellness
applications that is estimated to reach $60 billion by 2023.
For more information, please 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 U.S., 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’s 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 its 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, as the same may be amended from time
to time. Nemaura undertakes no obligation to publicly update or
revise any forward-looking statements.
Investor Relations:
IR@NemauraMedical.Com
1. https://mhealth.jmir.org/2022/10/e35896
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