Nemaura Medical Stock

Nemaura Medical Inc. operates as a medical technology company.

The company develops sugarBEAT, a non-invasive, flexible, continuous glucose monitoring system, for adjunctive use by persons with diabetes, and any person focusing to determine factors influencing their blood glucose profiles. SugarBEAT consists of a disposable adhesive skin-patch containing a sensor, which is connected to a rechargeable wireless transmitter. The sensor takes a measurement of the glucose reading every 5 minutes and sends the data by low energy blue tooth to a smart device, such as mobile phone (both android and iOS). An app on the smart device uses a proprietary algorithm to display true glucose values, after the data is calibrated using a minimum of one finger stick calibration.

SugarBEAT works by extracting glucose from the skin into a chamber in the patch that is in direct contact with an electrode-based sensor. The data is recorded on the app and could be viewed in real time, as well as storing all historic data for later evaluation as desired. sugarBEAT might be adopted by persons with diabetes, whether Type 1 or Type 2 and also by persons focusing to determine factors affecting their blood glucose profiles, and therefore their state of metabolic health in terms of insulin resistance.

The company announced in May 2019 that it had been awarded CE approval to allow sugarBEAT to be legally sold in the European Union. CE approval is disclosed by the use of the CE mark, a manufacturers' declaration that the product meets the requirements of the applicable European laws. CE approval is the process to achieve a mandatory conformity marking for the sugarBEAT device to allow it to be legally sold in the European Union. It is a manufacturers' declaration that the product meets the requirements of the applicable European laws. The company also submitted a PMA (Premarket Approval) application to the U.S. Food and Drug Administration (the FDA) with the same label claim as achieved for CE approval, an adjunct device for glucose trending for persons with diabetes. The PMA is under review.

The company focuses there are additional applications for sugarBEAT and the underlying BEAT technology platform, which might include a web-server accessible by physicians and diabetes professionals to track the condition remotely, thereby reducing healthcare costs and managing the condition; a virtual doctor or coach that monitors a diabetic person's glucose fluctuations and provides advice; and other patches using the BEAT technology platform to measure alternative analytes, including lactate, uric acid, alcohol, lithium, and drugs. Lactate monitoring is used to determine the relative fitness of professional athletes and the company completed preliminary studies demonstrating the application of the BEAT technology for continuous lactate monitoring.

In July 2020, the company submitted a PMA application to the FDA for the sugarBEAT device for glucose profiling as an adjunct to a finger-stick measurement, following which it initiated plans to develop its go-to-market capabilities in the U.S. market, which included appointing an a commercial lead to head up the development of the commercial operations team with an expectation that its business development program would continue to build and accelerate through 2021 and 2022. The company would continue to seek to partner with organizations that might facilitate the further development and distribution of its products at various stages of this process.

In addition to this, the company continues to explore commercialization opportunities in other key geographic markets, which includes engaging with the German regulatory authority (GBA) to proceed with achieving reimbursement for sugarBEAT in Germany.

Strategy

The key elements of the company's strategy include to commercialize sugarBEAT in the United Kingdom and Republic of Ireland with Dallas Burston Ethitronix Limited, with whom it has an exclusive marketing rights agreement for these two countries; establish licensing or joint venture agreements with other parties to market sugarBEAT in other geographies; seek FDA PMA approval of sugarBEAT; expand the indications for which the sugarBEAT device might be used; and expand its product pipeline through its proprietary platform technologies, acquisitions and strategic licensing arrangements.

Intellectual Property

The sugarBEAT technology is protected by the company’s portfolio of intellectual property, including issued and pending patents and trade secrets covering a range of claims, including the methods and apparatus for measuring glucose extracted from human skin in a non-invasive manner, devices for extracting glucose from the skin is a stable manner, devices for reducing background noise signals, algorithm for converting raw data in to glucose values to calibrate the device, and the formulation and process for preparation of the enzyme solution used in the sensor.

The trademarks BEAT and sugarBEAT have been registered in various key global territories. Accordingly, various intellectual property essential to the sugarBEAT product is owned by the company, and not subject to royalty payments.

Research and Development

The company spent $1,554,603 during the year ended March 31, 2021 on research and development.

Regulation

The company’s device has undergone the applicable electrical safety testing and biocompatibility has been demonstrated against the relevant European Directives, Regulations and Standards. The manufacture and sale of CE certified medical devices are controlled and governed by guidelines stipulated in the International Organization for Standardization, primarily ISO13485.

History

Nemaura Medical Inc. was founded in 2009. The company was incorporated in 2013 under the laws of the state of Nevada. In December 2013, the company was re-domiciled as a domestic corporation in the United States.