UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): July 14, 2020

 

NEMAURA MEDICAL INC.

(Exact name of registrant as specified in its charter)

 

Nevada   001-38355   46-5027260

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

 

57 West 57th Street

Manhattan, NY

  10019
(Address of principal executive offices)   (Zip Code)
     
Registrant’s telephone number, including area code:   (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 the 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 under the Exchange Act (17 CFR 240.14a-12)
   
[  ] 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 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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 pursuant to Section 13(a) of the Exchange Act. [  ]

 

 
 
 

 

 

Item 7.01. Regulation FD Disclosure.

 

On July 14, 2020, Nemaura Medical Inc. (the “Company”) issued a press release and presentation outlining potential new applications for monitoring disease progression in COVID-19 patients using continuous lactate monitoring (CLM). Copies of the press release and presentation are attached as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.

 

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

 

 DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS

 

Certain statements contained in this Current Report on Form 8-K, including on Exhibits 99.1 and 99.2 hereto, that are not historical facts constitute forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Reliance should not be placed on forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which may cause actual results, performance, or achievements to differ materially from those expressed or implied. Any forward-looking statement speaks only as of the date made. We undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date on which they are made.

 

The words "believe," "anticipate," "design," "estimate," "plan," "predict," "seek," "expect," "intend," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are not guarantees of the future as there are a number of meaningful factors that could cause the Company’s actual results to vary materially from those indicated by such forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors the Company believes are appropriate in the circumstances. Factors which could cause actual results to differ from expectations, many of which are beyond the Company’s control, include, but are not limited to, obtaining regulatory approval for our sugarBEAT device, conducting successful clinical trials, executing agreements required to successfully advance the Company's objectives; retaining the management and scientific team to advance the product; overcoming adverse changes in market conditions and the regulatory environment; obtaining and enforcing intellectual property rights; obtaining adequate financing in the future through product licensing, public or private equity or debt financing or otherwise; dealing with general business conditions and competition; and other factors referenced in the Company’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2020. Except as required by law, we do not assume any obligation to update any forward-looking statement. We disclaim any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
99.1   Press release issued by the registrant on July 14, 2020.
99.2   Presentation of the registrant dated July 14, 2020.

 

 
 
 

 

SIGNATURES

 

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

 

Dated: July 14, 2020 NEMAURA MEDICAL INC.
   
  By:  /s/ Dewan F. H. Chowdhury
 

Name:

Title:

Dewan F. H. Chowdhury
Chief Executive Officer

 

Exhibit 99.1

 

 

 

 

JULY 14, 2020

Nemaura Medical Evaluates New Applications for Continuous Lactate Monitoring using its BEAT™ platform

 

Loughborough, England, July 14, 2020 – Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT®, its non-invasive and flexible continuous glucose monitor (“CGM”), together with BEAT™diabetes, a planned health subscription service designed to help people with Type 2 diabetes and prediabetes through personalized lifestyle coaching, today issued a presentation outlining potential new applications for monitoring disease progression in Covid-19 patients using Continuous Lactate Monitoring (CLM).

The Company has previously discussed the market for athletic performance monitoring using its non-invasive continuous lactate monitor (CLM), and based on recently published independent clinical evaluations, the measurement of blood lactic acid has been established as an indicator for disease progression in Covid-19 patients. The company has issued a presentation on this subject, which can be found here: https://nemauramedical.com/wp-content/uploads/2020/07/BEAT-CLM-in-Covid19-July-2020-1.pdf

 

 

Both the CGM and CLM products are based on Nemaura’s BEAT™ platform, which is designed to non-invasively extract a number of analytes through the skin. By adapting the sensor chemistry, algorithm and mobile app interface initially developed for sugarBEAT®, the BEAT™ platform has the potential to be utilized for several markets beyond glucose monitoring and diabetes. Nemaura is evaluating the timelines for bringing the CLM to market as a Class 2 approved Medical Device.

 

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 has also submitted a PMA application for sugarBEAT® to the U.S. FDA. 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 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 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.

Contacts

Investor Contact:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
dave@redchip.com

 

Exhibit 99.2

 

 

Better Diagnostics for Life BEAT™ Continuous non - invasive Lactate Monitoring In Critical Care and Monitoring Disease Progression in Covid - 19 July 2020

 
 

2 Author Dr Moiz Khan, Pharm.D , MBA

 
 

3 Overview Continuous Lactate monitoring has Potential in Medical and non Medical Applications. Medical Field - Recent reports of elevated Lactate levels in Covid - 19 patients - Critical Care monitoring Non - Medical Field - Athletic performance monitoring/endurance training This presentation highlights the potential applications of Continuous Lactate Monitoring in Critical Care, and monitoring disease progression in Covid - 19 patients Nemaura’s CLM (Continuous Lactate Monitoring) device is based on the BEAT™ platform used in sugarBEAT®, with appropriate adaptations to the sensor chemistry, the algorithm and the mobile app interface. Nemaura is evaluating the timelines for bringing this product to market as a Class 2 approved medical device.

 
 

4 Increased blood lactate levels: a marker of critical disease states Normal blood lactate levels are 1.3 mmol /L . Lactate metabolism mainly occurs in the liver and kidney. Increased lactate levels have been consistently associated with morbidity and mortality in a wide range of disease states for many years. Increased blood lactate levels, in combination with acidosis, should urge the clinician to restore a probable imbalance between oxygen demand. Increased blood lactate levels should prompt the clinician to initiate both diagnostic and immediate therapeutic actions and intensive care admission should be considered. https://acutecaretesting.org/en/articles/increased - blood - lactate - levels - a - marker - of

 
 

5 Clinical use of lactate monitoring in critically ill patients Increased blood lactate levels ( hyperlactataemia ) is common in critically ill patients. Lactate levels are frequently used to diagnose inadequate tissue oxygenation, and other processes not related to tissue oxygenation may also increase lactate levels. Increased lactate levels usually reflect increased morbidity and high mortality. Two multicentre trials suggest that the use of lactate levels in goal - directed therapy may improve clinical outcome. Findings confirm that lactate monitoring is a valuable parameter in the early resuscitation of critically ill patients. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3654944/

 
 

6 Clinical applications of lactate testing in patients with sepsis and septic shock Hyperlactatemia is very common in patients with sepsis and septic shock and is closely associated with poor prognosis. The third international consensus definition for sepsis and septic shock recently revised the definition of septic shock. Serum lactate concentration >2 mmol /L was added as a key component in the definition of septic shock. The Surviving Sepsis Campaign (SSC)recommended lactate normalization in patients with elevated lactate levels as a marker of tissue hypoperfusion http://jeccm.amegroups.com/article/view/4083/4694

 
 

7 Covid - 19: A retrospective review of medical records in a single medical centre, Wuhan, China https://www.sciencedirect.com/science/article/pii/S1201971220301867

 
 

8 Covid - 19: A retrospective review of medical records in a single medical centre, Wuhan, China https://www.sciencedirect.com/science/article/pii/S1201971220301867

 
 

9 Lymphopenia predicts disease severity of COVID - 19: a descriptive and predictive study Analysis of possible reasons for lymphopenia in COVID - 19 patients - Hyperlactic acidemia / lactic acidosis inhibit lymphocytes - The severe type of COVID - 19 patients had elevated blood lactic acid levels, which suppress the proliferation of lymphocytes. https://www.nature.com/articles/s41392 - 020 - 0148 - 4?fbclid=IwAR0oNmxwN2RaKh4N7xSNizHOJCBwTfWwRoZLV942Hq9OreoT0 - E4wmrtFC8

 
 

10 Epidemiologic and clinical characteristics of 91 hospitalized patients with COVID - 19 in Zhejiang, China: a retrospective, multi - centre case series https://academic.oup.com/qjmed/article/113/7/474/5809152

 
 

11 Conclusions Increase in blood lactate levels is a marker of critical disease states. Recent publications have indicated the presence of elevated lactate levels in patients with Covid - 19 infection. Continuous Lactate Monitoring therefore has applications in disease states including the monitoring of disease progression in Covid - 19 infections.