News Commentary

New York, NY (10/13/2022) – The medical device industry is growing steadily thanks to new technologies as well as an emerging medical infrastructure around the world. Some of the fastest growing segments in the medical device market by application include diagnostic devices like patient-monitoring systems, MRI machines, diagnostic imaging equipment (including X-ray devices and other diagnostic imaging), and ultrasonic scanning devices. Remote patient-monitoring devices have become more popular due to the pandemic and social distancing measures which were implemented at the time. Most commonly, medical wearable devices designed to collect data and measure vital signs such as heart rate, blood pressure, blood oxygen saturation, blood glucose levels and more. Remote medical monitoring is a complex sector. Herman Bonner, communication specialist at Firstbeat, which powers stress tracking features in a host of wearables from the likes of Garmin, Huawei and Suunto, explained in an article by Wareable that “it takes a lot of specialized expertise in mathematics, signal processing, pattern recognition, and programming to get to the point where you are providing useful information to people.” Nemaura Medical Inc. (NASDAQ: NMRD), DexCom, Inc. (NASDAQ: DXCM), Senseonics Holdings, Inc. (NYSE: SENS), Medtronic plc (NYSE:MDT), Abbott Laboratories (NYSE: ABT)

The healthcare industry is a key factor in the projected growth of wearable technology. Recent advances in sensors and artificial intelligence (AI) are helping millions detect and manage chronic health conditions and avoid serious illness on devices small enough to be worn on a wrist or a penny-sized patch. A report by Deloitte predicts that 320 million consumer health and wellness wearable devices will ship worldwide this year, and by 2024, that figure will likely reach nearly 440 million units as new offerings hit the market and more health care providers become comfortable with using them.

Nemaura Medical Inc. (NASDAQ: NMRD) announced yesterday breaking news that, “it has received a provisional purchase order from TPMENA, its MENA (Middle East/North Africa) licensee for the Company’s sugarBEAT® system.

TPMENA issued the provisional purchase order with Nemaura following its regulatory registration submission for sugarBEAT® in the Kingdom of Saudi Arabia (KSA). Registration in KSA is anticipated in the first quarter of 2023. The provisional purchase order is for 17,500 devices, and 1.7 million sensors, with 7,500 devices and 700,000 sensors in the first year following launch in KSA and 10,000 units and 1 million sensors in the second year. The purchase order is contingent on receipt of KSA registration.

‘We believe the Middle East, and Saudi Arabia in particular, represents a significant opportunity for Nemaura and its partner TPMENA, given the high rates of Type II diabetes in the region,’ said Nemaura CEO, Dr. Faz Chowdhury. ‘We have worked closely with TPMENA over the past year to get all language translations and packaging ready and are eager to launch our affordable and patient-friendly monitoring solution for diabetes in the region.’

Based in Dubai, TPMENA is a full-service distributor that markets premium international brands in the Middle East region and brings significant expertise in logistics, marketing, distribution, and sales. Founded in 2011, it has built a reputation as a reliable partner in growing brands across a number of categories. According to the International Diabetes Federation there were over 4.1 million people with diabetes in Saudi Arabia alone in 2021, a number predicted to grow to 5.6 Million by 2030.”

DexCom, Inc. (NASDAQ: DXCM) announced on October 4th, that the Dexcom G7 Continuous Glucose Monitoring (CGM) System is now available for people with diabetes age two years and older in the UK, Ireland, Germany, Austria and Hong Kong – marking the first major milestone in the availability of the revolutionary new technology. The company is also working quickly to introduce G7 in New Zealand and South Africa in the weeks ahead, with additional markets planned soon after. “Since Dexcom G6 came to market, we’ve eliminated over 15 billion fingerpricks‡ and helped improve the lives of more than 1.25 million people with diabetes around the world. We’re thrilled to begin the global rollout of Dexcom G7, our next-generation CGM technology, that vastly improves upon what everyone loves about G6,” said Kevin Sayer, chairman, president and CEO of Dexcom. “Dexcom CGM has become the gold standard of care for diabetes, and bringing our technology to more and more people around the world continues to be a top priority. With this initial launch behind us, we look forward to introducing G7 in additional markets and bringing this life-changing technology to as many people as we can.”

Senseonics Holdings, Inc. (NYSE: SENS) announced on June 16th, that it has received CE Mark approval for the next-generation Eversense® E3 CGM System, the longest-lasting system available, with exceptional accuracy. The CE Mark approval confirms that the Eversense E3 meets the requirements of the European Medical Device Regulation (MDR), and enables the commercialization of Eversense E3 in European Union (EU) member countries. Senseonics’ commercial partner, Ascensia Diabetes Care, will make the improved system, which can be used for up to 6 months, available from the third quarter of 2022. “The CE Mark approval for E3 is another demonstration of our commitment to advancing implantable CGM to improve the lives of more diabetes patients worldwide. Not only does E3 strengthen our position in the market, but it enables increased operational efficiency as Senseonics will now commercialize the same product iteration globally for the first time,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “We are excited for Ascensia to continue to build on the momentum of the E3 launch in the U.S. as they commercialize the improved system in European markets in the coming months.”

Medtronic plc (NYSE:MDT) announced on September 20th, the LINQ II™ Insertable Cardiac Monitor (ICM) system is the first-and-only ICM to receive 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use in pediatric patients over the age of 2 who have heart rhythm abnormalities and require long-term, continuous monitoring. “For pediatric cardiologists who see many young patients needing continuous, long-term monitoring for infrequent or unknown heart rhythm conditions, this expanded indication for the LINQ II ICM is critically important,” said Jennifer Silva, M.D., director of pediatric cardiac electrophysiology at Washington University in St. Louis and St. Louis Children’s Hospital. “The data generated from these small monitors can help us better tailor treatment decisions and ongoing management for our patients.”

Abbott Laboratories (NYSE: ABT) announced on September 20th, new data from the Real World Evidence of FreeStyle Libre (RELIEF) study showing the use of FreeStyle Libre, a continuous glucose monitoring system (CGM) significantly reduced the rate of hospitalizations due to acute diabetes events (ADEs) for people living with Type 2 diabetes on once-daily (basal) insulin therapy.1 These findings were published in the Journal of Diabetes Technology & Therapeutics and presented at the 58th Annual European Association for the Study of Diabetes (EASD) meeting. “The results of the RELIEF study highlight the value of FreeStyle Libre system in reducing serious diabetes-related events and hospitalizations among patients with Type 2 diabetes on basal-only therapy,” says Professor Jean-Pierre Riveline, Centre Universitaire du Diabète et de ses Complications, Hôpital Lariboisière. “The reductions are similar to the results seen among the larger cohort of people with Type 2 diabetes who were receiving multiple daily injections, suggesting that FreeStyle Libre technology therapy should be proposed as part of individualized care for patients with Type 2 diabetes on basal-only insulin, not just people on intensive insulin therapy.”

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