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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 announced it has submitted its PMA application for sugarBEAT® to the United States Food and Drug Administration (FDA) through the eCopy (electronic copy) program submission process.
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.
Wearable devices have now become one of the fastest developing segments of the technology and medical technology industries. Wearable devices were designed to track real time data on various activities of its user and can be worn on the body with ease. Generally, these devices include analog-watches, smartwatches, glasses, fitness trackers and others. More recently, synchronization of such devices with smartphones has become an evolving technology with a numerous new features being incorporated into the devices. This increase of diverse applications is a major driver for this market’s growth. Furthermore, the implementation of the Internet of Things (IoT) that is used for the development of new features among smartwatches has created an essential transformation in the watch industry. Overall, according to Knowledge Sourcing Intelligence LLP, the wearable devices market is projected to grow at a CAGR of 21.63% to reach USD 80.438 Billion by 2025, from USD 24.486 Billion in 2019.
In the medical field, growing health awareness at the global level is expected help the medical wearable device segment reach new highs. Medical wearables are built to track vital signs and other health indicators, including calorie intake, cholesterol levels, heartbeat rate, blood pressure, glucose levels, sleeping patterns and more. Now, the rising occurrence of chronic diseases, along with increasing mortality rates, is a major area of concern among people as well as government organizations. Therefore, healthcare providers are offering personalized care including continuous and remote patient monitoring. These medical devices can be worn 24 hours without affecting the user’s routine life. Hence, the demand for wearable devices is projected to witness a rise over the forecast period. “The therapeutic device segment is anticipated to expand at the fastest CAGR throughout the forecast period owing to the increasing influx of these products. Moreover, a strong pipeline of therapeutic devices such as intelligent asthma management devices, wearable pain reliever devices, and insulin management devices is anticipated to assist market growth,” a report by Grand View Research, Inc. indicates.
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