Senseonics Holdings, Inc. (NYSE: SENS) saw its stock soar by over 6% in premarket trading on Monday after the company announced a major breakthrough in diabetes technology - the U.S. Food and Drug Administration (FDA) clearance for its next-generation Eversense 365 continuous glucose monitoring (CGM) system.
The Eversense 365 is being hailed as a groundbreaking innovation, as it is the world's first CGM system to offer a sensor that can last for one full year. This is a significant improvement over currently available short-term CGM sensors that need to be replaced every 10-14 days, providing people with diabetes an uninterrupted year of glucose monitoring with just a single sensor insertion.
"The approval of Eversense 365 represents a significant leap in CGM innovation. Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides both freedom and peace of mind to patients living with diabetes," said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics.
In addition to its long-lasting sensor, the Eversense 365 system offers several other user-friendly features, including a tiny implantable sensor that cannot be knocked off, on-body vibration alerts for discreet notifications, and a removable transmitter that can be taken on and off without wasting the sensor or adding a warm-up period.
Senseonics' partner, Ascensia Diabetes Care, expects to initiate the U.S. launch of Eversense 365 in the fourth quarter of 2024, with plans to transition coverage availability to facilitate immediate access for as many users as possible.
Analysts are optimistic about the product's potential impact, with Guotai Junan International analyst Li Muhua stating, "Autonomous driving will turn into a key trade in the coming three months, aided by Senseonics' launch of its robotaxi next month."
The FDA clearance and anticipated launch have sparked excitement among investors, with Senseonics' stock surging in premarket trading as the company enters a new era in the CGM market, currently dominated by players like Medtronic, Abbott Laboratories, and Dexcom.
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