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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act 1934
Date of Report (Date of earliest event
reported): September 11,
2023
NEMAURA MEDICAL INC.
(Exact name of registrant as specified in charter)
Nevada
(State or other jurisdiction of incorporation)
001-38355 |
|
46-5027260 |
(Commission File Number) |
|
(IRS Employer Identification No.) |
57 West 57th Street
Manhattan, NY |
10019 |
(Address of principal executive offices) |
(Zip Code) |
|
|
|
Registrant’s telephone number, including area code: |
+1 (646) 416-8000 |
N/A
(Former name or former
address, if changed since last report) |
|
|
|
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12(b) under the Exchange
Act (17 CFR 240.14a-12(b))
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock |
NMRD |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR
§240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation
FD Disclosure.
On September 11, 2023, Nemaura
Medical Inc. issued a press release announcing completion of a 100-patient study for sugarBEAT® and providing interim results. A copy
of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
The information included
in this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall
such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act,
except as shall be expressly set forth by specific reference in such a filing. The information set forth under this Item 7.01 shall not
be deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is required to be disclosed solely
to satisfy the requirements of Regulation FD.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
SIGNATURE
Pursuant to the requirements of
the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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NEMAURA MEDICAL INC. |
|
|
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By: |
/s/ Dewan F.H. Chowdhury |
|
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Dewan F.H. Chowdhury Chief Executive Officer |
Date:
September 11, 2023
Exhibit 99.1
Nemaura Medical
Completes 100 Patient Study for sugarBEATÒ 24-hour
Wear and Reports Interim Results
LOUGHBOROUGH, September 11, 2023 (GLOBE NEWSWIRE) — Nemaura
Medical, Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing
and commercializing non-invasive wearable sensors and supporting personalized diabetes management and metabolic health programs, today
announced it has recently completed a 100-patient study across 4 cohorts of 25 diabetic patients for sugarBEAT® and provided interim
results.
The Company has previously received CE approval in Europe, and SFDA (Saudi
Food and Drug Authority) approval for its sugarBEAT® glucose sensor for a wear period of 14 hours. This study was designed to evaluate
several factors, including the possibility of increasing the wear period to up to 24 hours, evaluating the possibility of auto-calibration,
and different methods of application of the device to the skin. The new sensors have been designed to improve the user experience by reducing
the number of steps involved in the application of the sensor to the skin to a peel and place method. The study was conducted in the Middle
East on 100 adult patients aged 18 to 75 comprising 20 persons with Type 1 diabetes and 80 persons with Type 2 diabetes, with an approximately
equal split between male and female. The Company reports interim data from a first cohort comprising 25 patients, on a single day sensor
wear. Over a 12-hour period using a retrospectively applied algorithm, the results indicated an overall mean absolute relative difference
(“MARD”) of 9.8% with 86% of the paired points within 20/20 of the reference value based on 1,037 paired points and two calibrations,
(the proportion of the CGM system values that are within ±20% of relative difference of reference value at glucose levels >80
mg/dL and ±20 mg/dL of absolute difference at glucose level ≤ 80 mg/dL (referred to as % 20/20). A further calibration indicated
an overall MARD of 12.8% over a 24-hour sensor wear period based on 1,379 paired points, and 76% of the paired points within 20/20 of
the reference blood serum glucose value.
The results indicate that a 24-hour sensor wear period using a single sensor
is possible, which is expected to allow users to monitor their glucose fluctuations overnight. The Company is currently further evaluating
the remaining cohorts and variables with a view to establishing the extent to which auto-calibration may be feasible, and to also determine
the optimal sensor application method. The Company intends to publish findings of the study in forthcoming conferences, as well as to
use the data to supplement product registration applications for an increased sensor wear period of up to 24 hours for a second-generation
sensor as it progresses commercialization of the 14-hour wear sensor.
About Nemaura Medical, Inc.
Nemaura Medical Inc. is a medical technology company developing and commercialising
non-invasive wearable diagnostic devices. The Company is currently in the process of 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
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
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