Senseonics Obtains CE Mark for 6-Month CGM Implant, Prefiguring Third Quarter Launch in Europe

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Diving brief:

  • senseonics has received a CE mark for its six-month Eversense E3 continuous glucose monitoring implant, positioning its business partner to begin selling the device in the third quarter.
  • Ascensia Diabetes Care, which sign to sell Eversense in 2020, will distribute the diabetes device in countries including Germany, Italy and Spain, where it has been lay the foundation launch through trade conferences and the evolution of its distribution model.
  • After seeing the number of patients on its three-month-old device drop to 3,200 by the end of 2021, Senseonics is looking to its more enduring successor to reinvigorate its fight for a market dominated by bigger companies such as Abbott Laboratories and Dexcom.

Overview of the dive:

Senseonics has endured a difficult few years, with changes to his agreement with Roche ceasing sales of the device and running the company at consider strategic alternatives in 2020. An attempt to turn the company around began earlier this year when FDA approved the six-month version of the CGM implant, only for a 2022 sales forecast that was about half of what analysts expected to immediately eclipse the benchmark.

In the first trimester, Senseonics reported sales of $2.5 million. The company still expects revenue of $14 million to $18 million for the year. A launch in Europe in the third quarter could help accelerate sales.

Markets outside the United States have traditionally been major contributors to Senseonics sales. Last year, the United States taken into account 19% of total company revenue, a percentage in line with Senseonics results in 2020 and 2019. Ascensia, a blood glucose monitoring company that paid $80 million for a distribution deal, will lead device marketing and sales.

“Ascensia is implementing significant strategic changes and investments to provide patients and [healthcare provider] experience required for the commercialization of CGM”,senseonics CEO Timothy Goodnow said on an investor call last month. “Another important aspect of serving the European market is the success of competitive bidding in the various countries, and Ascensia continues to optimize its bidding process based on Eversense’s experience. .”

For example, the CEO said Ascensia traveled to national sales conferences to prepare for the launch and design targeting initiatives. Ascensia is also moving away from an indirect distribution model in Germany and establishing a team of inside sales specialists to support patients. The goal is to have “better control and visibility of the sales process,” Goodnow said.

A quick start in Europe could add to the momentum Senseonics has begun to build in the US

“Commercial payer coverage is progressing smoothly, with some early gains already and management now expects the majority of coverage to pass over the next two quarters. Medicare coverage may also be secured in the coming months. BTIG analysts wrote in a May 10 note.

Ascensia managing the launch, Senseonics is now turning its sights to a next-gen device. The company shared data on Eversense use for up to a year at the American Diabetes Association’s 82nd Scientific Sessions before the planned start of a pivotal trial in the fourth quarter.

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