Senseonics (NYSE:SENS) said yesterday that it won CE Mark approval in the European Union for its Eversense XL continuous glucose monitor.
The Eversense XL includes a glucose sensor designed to be implanted for 180 days and a removable smart transmitter that links with a mobile app for real-time glucose monitoring. Germantown, Md.-based Senseonics touts the sensor as the world’s longest lasting compared with others that require weekly insertions.
“We are pleased to announce the CE Mark approval of the Eversense XL System, representing another significant milestone for Senseonics. When we introduced the Eversense System last year, we were providing the longest-wear sensor with up to 90-day wear for people with diabetes. Now with the new Eversense XL System’s even longer sensor duration, patients can extend a single sensor wear over 3 seasons – inserting a new sensor in the Fall which will continue through the Winter to be replaced in Spring,” president & CEO Tim Goodnow said in prepared remarks. “As we continue to advance our product portfolio with extended long-term sensor capabilities, we are offering added convenience to support patients’ continuous glucose management. We are excited to bring this product to market in Europe in the fourth quarter of 2017.”
“We are all aware of the advantages of continuous glucose monitoring seen now in many studies, including improvements in glycemic control, quality of life and reduction in hypoglycemia,” added Dr. Pratik Choudhary of King’s College London. “The benefits have been linked with long-term usage, which for many requires changing sensors every week. Eversense now offers a unique option for people who want to use CGM long term, with a long-lasting sensor that has demonstrated accuracy.”
The news sent SENS shares, which closed up 0.3% at $3 even yesterday, to jump 7.0% to $3.21 apiece in after-hours trading.
“Now with the 180-day sensor, we believe SENS will further widen the differentiation gap, attracting even more patients with 2x per year insertion/removal vs. 4x per year,” Leerink Partners analyst Danielle Antalffy wrote in a note to investors this morning. “While CE Mark is certainly not a definitive harbinger of eventual FDA approval, we believe this approval does validate Eversense’s clinical data.”
The 180-day sensor is slated to hit the market in the U.K. during the fourth quarter and expand to the rest of Europe during the first quarter of 2018, Antalffy wrote. FDA approval depends on the results of an investigational device exemption study planned for the fourth quarter that could have data available for the federal safety watchdog by the end of next year, according to the analyst.
