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ORGANIZATION AND PRINCIPAL ACTIVITIES
9 Months Ended
Dec. 31, 2020
Disclosure Text Block [Abstract]  
Organization and principal activities

NOTE 1 – ORGANIZATION AND PRINCIPAL ACTIVITIES

 

Nemaura Medical Inc. (“Nemaura” or the “Company”), through its operating subsidiaries, performs medical device research and manufacturing of a continuous glucose monitoring system (“CGM”), named sugarBEAT®. The sugarBEAT® device is a non-invasive, wireless device for use by persons with Type I and Type II diabetes and may also be used to screen pre-diabetic patients. The sugarBEAT® device extracts analytes, such as glucose, to the surface of the skin in a non-invasive manner where it is measured using unique sensors and interpreted using a unique algorithm.

Nemaura is a Nevada holding company organized in 2013. Nemaura owns 100% of Region Green Limited, a British Virgin Islands corporation (“RGL”) formed on December 12, 2013. RGL owns 100% of the stock in Dermal Diagnostic (Holdings) Limited, an England and Wales corporation (“DDHL”) formed on December 11, 2013, which in turn owns 100% of Dermal Diagnostics Limited, an England and Wales corporation formed on January 20, 2009 (“DDL”), and 100% of Trial Clinic Limited, an England and Wales corporation formed on January 12, 2011 (“TCL”).

DDL is a diagnostic medical device company headquartered in Loughborough, Leicestershire, England, and is engaged in the discovery, development and commercialization of diagnostic medical devices. The Company’s initial focus has been on the development of the sugarBEAT® device, which consists of a disposable patch containing a sensor, and a non-disposable miniature wireless transmitter with a re-chargeable power source, which is designed to enable trending or tracking of blood glucose levels. While the Company’s key operations and assets are located in England, the Company has recently commenced commercial operations in the United States.

The following diagram illustrates Nemaura’s corporate structure as of December 31, 2020:

 

 

The Company was incorporated in 2013 and has reported recurring losses from operations to date and an accumulated deficit of $21,714,045 as of December 31, 2020. These operations have resulted in the successful completion of clinical programs to support approval of a CE mark (European Union approval of the product) which is managed via an ISO 13485 accredited Quality Management System that is subject to annual audit by the accreditation body (“BSI”); this accreditation was successfully renewed during November 2020. In addition to this, a medical device Premarket Approval (“PMA”) application was submitted to the U.S. Food and Drug Administration (“FDA”) in July 2020; however, we, along with other applicants, have been informed by the FDA that the approval process is currently subject to delays as a result of the FDA’s Center for Devices and Radiological Health (“CDRH”) being actively engaged in responding to the current pandemic caused by COVID-19. According to recent notifications received from the FDA, this has resulted in staff being reallocated to other approval requests associated with COVID-19.  As such, the timeline for other, non-COVID-19 related, approvals continues to be adversely impacted. Current guidance provided by the FDA indicates that this staff reallocation is likely to last at least through mid-April, 2021.

 

The Company expects to continue to incur losses from operations until revenues are generated through licensing fees or product sales. However, given the completion of the requisite clinical programs, these losses are expected to be reduced over time. Management has entered into licensing agreements with unrelated third parties relating to the United Kingdom, Europe, Qatar and all countries in the Gulf Cooperation Council.

 

Management has evaluated the expected expenses to be incurred along with its available cash and has determined that the Company has the ability to continue as a going concern for at least one year after the date of issuance of these unaudited condensed consolidated financial statements.

 

On April 15, 2020, the Company entered into a note purchase agreement resulting in net cash proceeds of $4,675,000, as further described in Note 6. The Company had $14,959,785 of cash at December 31, 2020. The Company believes the cash position as of December 31, 2020, is adequate for our current level of operations through at least February 2022, and for the achievement of certain of our product development milestones. Our plan is to utilize the cash to continue establishing commercial manufacturing operations for the commercial supply of the sugarBEAT® device and patches now that CE mark approval has been received.