8-K

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): May 11, 2020

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 May 11, 2020, Nemaura Medical Inc. (the “Company”) issued a press release providing certain business updates. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. On May 11, 2020, the Company released a presentation titled Better Diagnostics for Life Management of Type 2 Diabetes using non-invasive CGM. A copy of the presentation is attached to this Current Report on Form 8-K as Exhibit 99.2.

The information included in this Current Report on Form 8-K, including Exhibit 99.1 and Exhibit 99.2, 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.

Exhibit No.	Description of Exhibit
99.1 99.2	Press release of the registrant dated May 11, 2020. Nemaura Medical Inc. Presentation.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: May 11, 2020	Nemaura Medical Inc.
	By:	/s/ Dewan F. H. Chowdhury
	Name: Title:	Dewan F. H. Chowdhury Chief Executive Officer

EX-99.1

Exhibit 99.1

May 11, 2020

Nemaura reports positive data from early head-to-head comparison with a major incumbent CGM Device

sugarBEATÒ 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.

Loughborough, England, May 11, 2020 — 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 sugarBEATÒ 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 sugarBEATÒ and a major incumbent CGM device, demonstrating sugarBEATÒ 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 sugarBEATÒ 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 sugarBEATÒ 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 sugarBEATÒ 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.

Investor Contact:

Dave Gentry, CEO

RedChip Companies

Office: 1.800.RED.CHIP (733.2447)

Cell: 407.491.4498

dave@redchip.com

EX-99.2

Exhibit 99.2

Better Diagnostics for Life Management of Type 2 Diabetes using non - invasive CGM 11 th May 2020

2 Authors Dr R K Ibrahim Head of data analytics Mr Steve Willmor Head of Regulatory

3 Summary of Presentation There is compelling evidence suggesting Type 2 diabetes may be managed by use of a Continuous Glucose Monitor (CGM) on non - consecutive days, leading to clinically significant outcomes. Invasive CGMs are generally designed for wear periods of up to 14 consecutive days, with the associated cost. The additional costs are not justified where significant clinical outcomes can potentially be achieved by substantially reduced CGM usage frequency e.g. monitoring on non - consecutive days a or a few (3 to 4) consecutive days per month. sugarBEAT ® is ideally positioned to cater for the Type 2 Diabetic population given it allows monitoring on any day the user chooses, making it an affordable solution. sugarBEAT ® accuracy appears comparable to at least one major incumbent invasive CGM.

4 Volunteer User Feedback Objectives Primary objective: To establish whether use of continuous glucose monitoring (CGM) a few days a week or month could lead to the same long term clinical outcome in terms of reduction in HbA1C and improved quality of life, as continuous wear of a CGM for up to 14 consecutive days at a time. The study would verify anecdotal evidence in literature based on intensive but intermittent glucose monitoring using finger prick testing. [Outcome from this portion will be reported periodically over the course of the next 12 months]. Secondary objective: To determine sugarBEAT® accuracy in real - life settings compared to the incumbent invasive CGMs such as the Dexcom® and Abbott Libre® which are known to exhibit high levels of accuracy. [Preliminary outcome reported in this presentation]. Rationale: If we can achieve the same long term clinical outcome using a CGM on non - consecutive days, we can dramatically reduce the cost of managing Type 2 diabetes, as well as increasing the number of people that can be treated and managed.

5 The Benefits of using CGM in Type 2 Diabetes on intermittent or non - consecutive days Currently there are no known devices other than sugarBEAT® that allow non - consecutive day use of a CGM. Invasive CGMs such as the Abbott Libre® and Dexcom® can be used by persons with Type 2 diabetes though the sensor wear time is up to 14 days and therefore the costs are currently commensurate with the 10 - 14 day sensor life. sugarBEAT® is a daily wear sensor and so the cost per use is limited to the cost of a single day sensor. The use of intensive finger - stick testing on non - consecutive days is considered to resemble the use of a CGM on non - consecutive days. It is on this basis that it is postulated that sugarBEAT® has the potential to provide a superior mode of measurement, and tool with which to manage Type 2 diabetes, a condition which constitutes approximately 90% of the total population with diabetes. The market opportunity is therefore substantial and use of CGM on non - consecutive days will potentially lead to a dramatic reduction in the costs associated with CGM usage in this population. Furthermore users need not suffer the inconvenience of piercing their arm with a sensor filament, nor be troubled with having to keep a device on their body for long periods of up to 2 weeks at a time.

6 Evidence for intensive Finger stick testing in Type 2 diabetes leading to positive long term outcomes 1. 6 - point glucose profiles two days per week. Counselling provided on diet and exercise [1] . Outcome: Significantly greater reduction in HbA1c. Marked improvement in general well - being, with significant improvements in depression and those with a lack of well - being. 2. 4 - point glucose profiles every 2 weeks. All patients instructed on lifestyle interventions [2] . Outcome: Significantly higher rates of regression and remission in experimental subjects. Significantly greater reductions in median HbA1c and BMI. Significantly improved lifestyle score. Treatment changes occurred earlier and more frequently. 3. 7 - point glucose profiles every 4 weeks. Patients received guidance for diet and exercise adjustments based on Self Monitoring Blood Glucose (SMBG) [3] . Outcome: Significant reductions in HbA1c, weight, BMI, systolic BP, diastolic BP, and LDL Cholesterol

7 Evidence for intensive Finger stick testing in Type 2 leading to positive long term outcomes cnt’d 4. 7 - point glucose profiles over 3 consecutive days per month. Education on device use and data collection using a paper tool. Basic education on use of SMBG to alter diet and physical activity [4] . Outcome: Significant reductions in HbA1c and mean, fasting, and postprandial glucose. 5. 7 - point glucose profiles over 3 consecutive days per month. Treatment adjustments made by clinicians based on SMBG [5] Outcome: Significant reductions in HbA1c. 6. 7 - point glucose profiles over 3 consecutive days, every 3 months [6] . Outcome: Significantly improved HbA1c. Treatment changes occurred earlier and more frequently.

8 Evidence for intensive Finger stick testing in Type 2 leading to positive long term outcomes cnt’d The above independent study outcomes provide compelling evidence for the use of a CGM on non - consecutive days or a few consecutive days per month, to provide clinically significant outcomes in the management and / or reversal of Type 2 diabetes. sugarBEAT® is ideally positioned to cater for this market over and above the incumbent invasive CGMs which have wear periods of up to 14 consecutive days with associated costs. With sugarBEAT ® it may be possible to provide a CGM to the majority of persons with Type 2 diabetes at an affordable cost point. This has the potential to change the paradigm for the management of Type 2 diabetes on a global scale.

9 Synopsis of accuracy of sugarBEAT® in a real - life setting Comparison of accuracy in terms of %MARD shown over 10 - 14 hours use per day. Finger prick taken with Accu - chek ® blood glucose meter, on a minimum of 8 times and maximum 12 times per wear period / day. Results indicate accuracy of sugarBEAT ® comparable to one of the major incumbent CGMs. Calibration sugarBEAT®: Calibrated once each day using a single finger stick measurement. Invasive CGM: Factory calibrated * Total 12 days of wear of sugarBEAT ® and an invasive CGM on the same day, over a period of 6 weeks.

10 Conclusions There is compelling evidence from a number of studies suggesting Type 2 diabetes may be managed by CGM usage on non - consecutive days, leading to clinically significant outcomes. sugarBEAT ® is ideally positioned to cater for the Type 2 Diabetic population given it allows monitoring on non - consecutive days, making it an affordable solution. sugarBEAT ® accuracy is comparable to at least one major incumbent invasive CGM.

11 Examples of sugarBEAT ® profiles sugarBEAT MARD: 16.43% Invasive CGM MARD: 17.28% sugarBEAT MARD: 10.71% Invasive CGM MARD: 8.18%

12 Examples of sugarBEAT ® profiles sugarBEAT MARD: 9.69% Invasive CGM MARD: 9.24% sugarBEAT MARD: 12.18% Invasive CGM MARD: 13.59%

13 References 1. Schwedes U, Siebolds M, Mertes G: Meal - related structured self - monitoring of blood glucose: effect on diabetes control in non - insulin - treated type 2 diabetic patients. Diabetes Care 2002;25:1928 – 1932 2. Durán A, Martín P, Runkle I, Pérez N, Abad R, Fernández M, Del Valle L, Sanz MF, Calle - Pascual AL: Benefits of self - monitoring blood glucose in the management of new - onset type 2 diabetes mellitus: the St Carlos Study, a prospective randomized clinic - based interventional study with parallel groups. J Diabetes 2010;2:203 – 211 3. Kempf K, Kruse J, Martin S: ROSSO - in - praxi : a self - monitoring of blood glucose - structured 12 - week lifestyle intervention significantly improves glucometabolic control of patients with type 2 diabetes mellitus. Diabetes Technol Ther 2010;12:547 – 553 4. Khamseh ME, Ansari M, Malek M, Shafiee G, Baradaran H: Effects of a structured self - monitoring of blood glucose method on patient self - management behavior and metabolic outcomes in type 2 diabetes mellitus. J Diabetes Sci Technol 2011;5:388 – 393 5. Kato NK, Kato M: Use of structured SMBG helps reduce A1c levels in insulin - treated diabetic patients [abstract]. Diabetes 2011;6 0( Suppl 1):A239 6. Polonsky WH, Fisher L, Schikman CH, Hinnen DA, Parkin CG, Jelsovsky Z, Axel - Schweitzer M, Petersen B, Wagner RS: A structured self - monitoring of blood glucose approach in type 2 diabetes encourages more frequent, intensive, and effective physician interven tio ns: results from the STeP study. Diabetes Technol Ther 2011;13:797 – 802