Senseonics submits PMA to FDA for implantable Eversense CGM system – October 28, 2016

Yesterday, Senseonics announced the FDA PMA submission of its implantable 90-day Eversense CGM sensor, on-body transmitter, and mobile app. The news is right on par with the August projection for a submission in the “next few months.” Assuming a 12-month PMA process (the 1Q16 expectation), launch could occur in late 2017. This submission happened remarkably quickly, as the US pivotal trial only started in 1Q16 and wrapped up in July – great to see the team moving fast. The system performed well in the 90-day study (Precise II), demonstrating a MARD of 8.8% vs. YSI (over 16,000 paired CGM-YSI points). CEO Dr. Tim Goodnow suggested in 2Q16 that an insulin-dosing claim for the device is a possibility, though it was not mentioned in today’s announcement (more in silico data might be necessary, and given the fast submission turnaround, we’re not sure there was time to include this). The Eversense system already has a CE mark and has been available in Sweden since June, and launches in five more European countries (Germany, Italy, the Netherlands, Denmark, and Norway) were anticipated this quarter (per the 2Q16 call). The press release says it is currently available in “select European countries,” meaning at least one more has already launched. Management previously expected EU revenue of <$1 million for the year, implying a controlled rollout in these early days. We’ll hear more on the sensor’s performance at next month’s Diabetes Technology Meeting, for which you can our preview here. We’ll also be interested to hear patients’ perceptions on the implant and on-body form factor of this product relative to competitors.

-- by Brian Levine, Adam Brown, and Kelly Close