Eversense 365, an implantable continuous glucose monitor (CGM), becomes the world’s first 365-day CGM system, according to the company. Its indications cover people with type 1 and type 2 diabetes aged 18 years and older.
The system also received clearance as an integrated CGM (iCGM) system, meaning it can work with compatible medical devices. Those include insulin pumps as part of automated insulin delivery systems. Senseonics and its global commercial partner Ascensia Diabetes Care have discussions ongoing with various pump manufacturers.
Ascensia expects to begin the U.S. launch of the Senseonics Eversense 365 in the fourth quarter of this year. The companies have work underway to transition coverage availability to facilitate immediate access to as many users as possible.
Senseonics said last month that the FDA review for the 510(k) submission for the next-generation 365-day Eversense remained on track for the now-confirmed fourth-quarter launch. Brian Hansen, Ascensia and Senseonics’ president of CGM, explained the company’s future plans at ADA 2024.
“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, president and CEO of Senseonics. “Eversense 365 was ‘designed for real life’ and is optimally suited to help people with diabetes increase time in range of desired glucose levels and lower A1c. The delivery of the world’s first 365-day sensor is a seminal event for Senseonics and we’re excited to bring it to people with diabetes.”
More about the Senseonics Eversense 365
Eversense 365 is the only CGM offering a year-long wear time, with market-leading, non-implanted CGMs like Abbott’s and Dexcom’s worn for around two weeks. For Eversense 365 users, this means no frequent sensor changes and only one insertion and one “Day 1” every year.
The company says its sensor survivability across 12 months reduces the burden of data interruptions from frequent short-term CGM failures or changes. With the sensor resting under the skin, it can not be knocked off, minimizing inconveniences and replacement costs. On the comfort front, users can change its gentle, silicone-based adhesive daily with almost no skin reactions.
Senseonics says its sensor delivers consistent accuracy across one year, with almost zero false alerts from compression lows during the night. It offers the freedom to remove the transmitter device without wasting a sensor or adding a warm-up period. Eversense 365 also has on-body vibration alerts for improved discretion, alerting patients even when their mobile phone is out of sight.
“Managing diabetes can be stressful, and it is important for technology to disrupt life as little as possible to limit this burden,” said Hansen. “Eversense 365 allows people with diabetes to focus on living their lives rather than managing the limitations that many experience with short-term CGMs. We are very excited about Senseonics’ ability to once again bring true innovation to the CGM space and are working closely with our partner to make Eversense 365 commercially available as soon as possible.
“In parallel, our partnership discussions with various pump manufacturers continue to progress, as we look to leverage Eversense 365’s unique potential to simplify life with integrated automated insulin delivery (AID) systems.”
The analysts’ view
BTIG analysts Marie Thibault and Sam Eiber maintained a “Neutral” rating for Senseonics following this announcement.
They note that timelines presented by the company fall in line with prior commentary. The analysts also point out that the company already began preparations for its commercial launch through consumer and professional marketing initiatives to build awareness in addition to its efforts on transitioning coverage availability.
Additionally, the analysts say that Senseonics expects inventory transition dynamics to impact its third-quarter sales. However, they anticipate a rise in Senseonics shares today in response to the news.
Shares of SENS ticked up nearly 4% to 41¢ apiece before the market opened today.
