09 maj 2017

Latest news on Eversense®

  • Broadening commercial launch in Germany and Sweden with distributors planning to be in eight European countries by mid-year 2017.
  • Received CE Mark for the second generation Eversense® Smart Transmitter in February 2017. This redesigned transmitter is slimmer, lighter and water-resistant for added convenience and comfort in use.
  • Initial preparations underway for U.S. commercial infrastructure through addition of industry veteran Mike Gill as Vice President of Sales. Mr. Gill previously built and managed commercial efforts for Medtronic Diabetes Americas Region to sales of over $1 billion in insulin pump and CGM sensors.
  • Anticipate Eversense XL CGM System approval in Europe in the coming months, which would extend the sensor life label for up to 180-day use, as the CE Mark amendment for this version is under review.

“We are excited about our strong start in 2017, building and expanding our commercial presence in Europe. With CE mark approval for our second generation smart transmitter, we are also moving forward on clinical and regulatory milestones,” said Tim Goodnow, President and Chief Executive Officer of Senseonics. “We continue to work closely with the FDA towards the approval of our PMA for Eversense, and we are pleased to begin building the infrastructure for initial commercial launch preparation in the United States. We look to accelerate this positive momentum throughout the rest of the year.”