Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing and commercializing non-invasive wearable diagnostic devices and supporting personalized lifestyle coaching programs, today announced progress with the German regulatory authority (GBA) to achieve reimbursement for its sugarBEAT® device.
After initial review, the GBA has determined that sugarBEAT does not require GBA review and will go directly to the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) for a listing on the durable medical catalog. The Company is now completing the application for this listing, which is expected to be faster than where a GBA review is required.
“The availability of SugarBEAT® in Germany would be an important milestone for Nemaura and we are actively collaborating with the appropriate agencies to ensure timely availability there,” said Nemaura CEO Dr. Faz Chowdhury. “In the meantime, we are actively negotiating to identify the right partner to market and distribute the product and our program in this very important market. We will continue to provide updates as appropriate on our progress.”
About Nemaura Medical, Inc.
Nemaura Medical Inc. is a medical technology company developing and commercializing non-invasive 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 PMA (Premarket Approval Application) for sugarBEAT® to the U.S. FDA. proBEAT™ combines non-invasive glucose data processed using artificial intelligence and a digital healthcare subscription service and has been launched in the U.S. as a general wellness product as part of its BEAT®diabetes program.
The Company believes that it 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.