0001079973-23-001566.txt : 20231114 0001079973-23-001566.hdr.sgml : 20231114 20231114080007 ACCESSION NUMBER: 0001079973-23-001566 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20231114 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231114 DATE AS OF CHANGE: 20231114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Nemaura Medical Inc. CENTRAL INDEX KEY: 0001602078 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 465027260 FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38355 FILM NUMBER: 231401638 BUSINESS ADDRESS: STREET 1: 57 WEST 57TH STREET CITY: MANHATTAN STATE: NY ZIP: 10019 BUSINESS PHONE: 44-1509-222-912 MAIL ADDRESS: STREET 1: 57 WEST 57TH STREET CITY: MANHATTAN STATE: NY ZIP: 10019 8-K 1 nmra_8k.htm FORM 8-K
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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): November 14, 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 November 14, 2023, Nemaura Medical Inc. issued a press release announcing the launch of the direct to consumer offering of its metabolic health program in combination with GLP-1 weight loss drugs. 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

     
Exhibit No.      

Description

   
99.1 Press release of the registrant issued on November 14, 2023.
104 Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document

 

 

 

 

 
 

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. 

 

  NEMAURA MEDICAL INC.
   
  By: /s/ Dewan F.H. Chowdhury
    Dewan F.H. Chowdhury
Chief Executive Officer

 

Date: November 14, 2023 

 

  

 EX-99.1 2 ex99x1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

Nemaura Launches Direct to Consumer Offering of Metabolic Health Program in Combination with GLP-1 Weight Loss Drugs

Company CEO to discuss development at 1pm EST on 15th November 2023, at the Sidoti Virtual Investor Conference

Loughborough, UK, 14th November 2023. Nemaura Medical, developer of a daily wear non-invasive glucose sensor, and digital healthcare programs today announced the UK launch of its ground-breaking approach to metabolic health and weight management by integrating continuous glucose monitoring (CGM) with its behavioral change program, Miboko, complemented by pharmaceutical interventions using GLP-1 agonists such as Ozempic, Wegovy and Mounjaro. This innovative offering, featuring education, lifestyle modifications, dietary guidance, exercise goals, and cutting-edge glucose monitoring, represents a significant advancement in personalized weight loss strategies addressing the metabolic health, obesity and diabetes markets.

Nemaura's program leverages the power of its world-first daily wear non-invasive CGM technology, allowing individuals to gain insights into how their body deals with glucose. By using CGM for just two days per month, participants can access real-time data on how the drugs, lifestyle, diet, and exercise are impacting their blood glucose profiles, empowering them to make informed choices for sustainable improvements to quality of life.

In pilot studies with the UK's National Health Service (NHS), Nemaura's program has demonstrated encouraging outcomes. Early results indicate positive responses to the integrated approach even in the absence of drug therapy using GLP-1’s, showcasing the program's potential to reshape the landscape of personalized health solutions.

The integration of behaviour change programs, encompassing education on nutrition, personalized exercise regimens, and lifestyle adjustments, complements the data-driven approach of CGM. The goal is to provide individuals with the tools they need to make lasting changes that support their overall well-being. The incorporation of GLP-1 agonists like Ozempic, Wegovy and Mounjaro adds a powerful layer of support for individuals seeking effective and sustainable weight loss.

"The launch of this integrated program is a turning point in the Company’s history. Leveraging off positive outcomes observed thus far from the NHS studies, and the profound impact of GLP-1 therapy globally leads us to believe we have an optimal offering, with the goal of enabling the drugs to help kick start weight loss initiatives and then sustain this through education and sustainable behavioural change," said Dr Faz Chowdhury, CEO of Nemaura. Users may now subscribe directly via the Miboko website at www.Miboko.com

Dr Faz Chowdhury, CEO, will be presenting at, and host one-on-one meetings with investors, at the Sidoti November Virtual Investor Conference. Dr Chowdhury’s presentation will begin at 1:00 pm ET on Wednesday, November 15, 2023 and can be accessed live here:  https://sidoti.zoom.us/webinar/register/WN_rT_4pTouREiUuM862xQkLA. Nemaura will also host virtual one-on-ones with investors on Wednesday and Thursday, November 15-16, 2023. To register for the presentation or one-on-ones, visit www.sidoti.com/events. Registration is free.

 

 

 
 

 

About Nemaura Medical, Inc.

Nemaura Medical, Inc. is a medical technology company developing and 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 proposal for a Modular PMA (Premarket Approval Application) application for sugarBEAT® to the U.S. FDA, for its generation II, 24 hour sensor. proBEAT™ is a non-regulated version of sugarBEAT which 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.

Additionally, Nemaura 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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