Senseonics' Eversense wins FDA approval and real-world accuracy study
Senseonics, a medtech company focused on continuous glucose monitoring, has been busy this month as they've seen an FDA approval for Eversense, won a real-world accuracy study and priced a $130 million stock offering.
Last week, Eversense became the first FDA-approved CGM system with a fully implantable sensor. The approval is for adults with diabetes and the device can be worn for 90 days and paired with a mobile app to take measurements every five minutes, and alert users if glucose levels are too high or too low.
"We're very pleased to receive this FDA approval that allows us to make Eversense available in the United States, as it is in many European markets. With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way," said Tim Goodnow, President and CEO of Senseonics. "More importantly, we believe the unique features Eversense offers will help open up CGM to millions of people with diabetes who, up to this point, have been hesitant to try CGM despite the clear health benefits it provides."
What is Eversense?
"Research has repeatedly demonstrated the clinical benefits patients experience with regular CGM use, including improved glucose control and protection against severe hypoglycemia," said Steven Edelman, MD, Professor of Medicine at University of California San Diego, Founder & Director of Taking Control of Your Diabetes, and Senseonics Board member. "Despite these benefits, a significant number of people with diabetes do not use, or have access to, continuous glucose monitoring. Furthermore, the data shows that many people who've tried traditional CGM in the past either don't wear it as often as they should or don't stick with it for a variety of reasons, including concerns surrounding sensor accuracy, sensor insertion, and sensor discomfort. So, it's important that patients have choices and that medical device companies continue to advance the field of CGM with innovations that make it easier for the end user."
Three Way Comparison
A recent study published in the American Diabetes Association’s journal, Diabetes, found that Eversense was significantly more accurate than the Dexcom G5 and the Abbott Freestyle Libre Pro.
23 adults with Type 1 diabetes wore all three CGMs over a 6-week period with the primary outcome being the mean absolute relative difference (MARD) vs. plasma glucose (PG) values. The values were measured with the Nova Biomedical StatStrip Xpress meter that was also used for calibrations according to the manufacturer's instruction (except for Libre Pro that is not calibrated).
Accordging to the study, Eversense achieved the lowest nominal MARD (14.8%) followed by Dexcom G5 (16.3%) and Libre Pro (18.0%) (Eversense vs. Libre Pro p=0.004, other comparisons p=NS). In the 2-way comparison the MARD difference between Eversense (15.1%) and G5 (16.9%) was statistically significant (p=0.008).
The authors of the study also concluded that the Eversense CGM system may be useful in providing glucose values to artificial pancreas devices.
In addition to the FDA approval and successful study, Senseonics announced the public offering of stock in an effort to raise $130 million, which will be used to commercialize its Eversense implantable continuous glucose monitor in the United States as well as funding ongoing research and development of future Eversense configurations and for working capital and general corporate purposes. It also may use a portion of the net proceeds to invest in or acquire complementary businesses or technologies, although Senseonics said it has no prospective deals in the works at this time.
Based on the investor deck below, the company anticipates the first patients at the end of July and they will start with between 20 and 30 sales reps.