Nemaura Medical Announces SFDA Approval of sugarBEAT®
2023年8月17日 - 9:30PM
Nemaura Medical, Inc. (Nasdaq: NMRD) (“Nemaura” or the “Company”),
a medical technology company focused on developing and
commercializing a daily disposable, wearable glucose sensor and
supporting personalized lifestyle coaching programs, today
announced SFDA (Saudi Food and Drug Authority) approval of
sugarBEAT®, its non-invasive wearable glucose sensor.
The news comes following over a year of liaisons
with the SFDA through TPMENA, the Company’s licensee in the Middle
East, and is seen as a major breakthrough in product
commercialisation in the largest territory in the Middle East, and
a region with one of the world’s highest diabetes prevalence
rates.
In 2021, the Economist Intelligence Unit
published a report titled ‘Telemedicine and Diabetes Care in Saudi
Arabia and the UAE’, which examined the diverse government
subsidised initiatives being taken to manage and reverse the
diabetes epidemic in the region. The report states that nearly 4.5
million people, or 18.3% of the adult population in Saudi Arabia,
have diabetes, compared to a global average of 9.3%. Mordor
Intelligence has reported that the market size for diabetes related
care devices in Saudi Arabia is expected to grow from USD637
million in 2023 to USD788 million in 2028.
Furthermore, it is estimated that 39% of adults
with diabetes in Saudi Arabia are unaware that they have the
condition, leaving them at higher risk of complications without
management. This segment of nearly 9 million people is ideally
placed to benefit from sugarBEAT® sensors within a general
metabolic health improvement program. Such a program specifically
addresses obesity to avoid diabetes and other complications and has
shown efficacy within trials with the UK’s National Health
Service.
The Company previously announced the receipt of
a provisional purchase order for 1.7 million sensors and 17,000
devices from TPMENA. The Company will now work with its licensee to
commence fulfilling this purchase order.
Nemaura Medical is in advanced discussions to
play a pivotal role in the region with its superior sensor
technology, and diabetes and metabolic health management programs.
Diabetes care has been in dire need of enhancement: all countries
in the region have a high prevalence of Type 2 diabetes and have
projected increased rates of diabetes among their populations. The
resulting healthcare costs from digital management programs are
significant. It has become imperative to national health, as well
as healthcare budgets, that better, more innovative and sustainable
management and prevention tools are explored to their fullest. The
Company believes that SFDA approval places Nemaura Medical in an
unparalleled position to gain approval across the Gulf and other
regions, and to commercialise its digital programs.
About Nemaura Medical,
Inc.
Nemaura Medical, Inc. is a medical technology
company developing and commercializing non-invasive wearable
diagnostic devices. The Company is 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 has submitted a PMA
(Premarket Approval Application) for sugarBEAT® to the U.S. FDA.
proBEAT™ combines non-invasive glucose data processed using
artificial intelligence and a digital healthcare subscription
service as a general wellness product as part of its BEAT® diabetes
program that is currently undergoing pilot studies.
Additionally, Nemaura has launched a beta trial
of Miboko, a metabolic health and well-being program using a
non-invasive glucose sensor along with an AI mobile application
that helps a user understand how certain foods and lifestyle habits
can impact one’s overall metabolic health and well-being. Nemaura
believes that up to half the population could benefit from a sensor
and program that monitors metabolic health and well-being.
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 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 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 U.S.
Food and Drug Administration (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 Medical’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 Medical undertakes no obligation to publicly update or
revise any forward-looking statements.
Investor Relations Contact:
IR@NemauraMedical.com
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