After more than a yearlong wait at the FDA due to the COVID-19 pandemic, Senseonics’ continuous glucose monitoring system that lasts up to six months is finally headed to users with diabetes in the U.S.
Through a commercialization partnership with Ascensia Diabetes Care, which serves as the exclusive worldwide distributor of Senseonics’ Eversense implanted CGM sensors, the latest E3 system will be made available under an introductory payment program that aims to increase access to the device.
The Eversense Payment Assistance and Simple Savings program, or PASS, allows eligible users to pay $99 out-of-pocket for their first sensor and transmitter and then $100 per month for the six months of wear.
“Eversense E3’s offering is truly differentiated, and we believe it is important to make the system as affordable as possible,” Ascensia President Robert Schumm said in a statement, adding that the company has been working with payers to secure insurance coverage for the system.
The E3’s 180-day sensor obtained an approval from the FDA this past February, doubling the amount of time users with diabetes could go between appointments to have the device removed and replaced compared with Eversense’s previous 90-day versions.
The device includes a small fluorescence-based sensor, about the size of a grain of rice, which is fully embedded in the upper arm. A transmitter stuck to the skin over the sensor reads the data, transmits the information to a smartphone and provides vibration alerts for changes in blood sugar.
According to Ascensia, primarily one calibration with a fingerstick blood draw is needed per day after three weeks of use, while the 90-day sensor required two fingersticks per day for the entire duration.
After receiving the FDA approval and outlining its plans for a commercial launch this year, Senseonics said it expects the company’s global net revenue for 2022 to fall between $14 million and $18 million. Meanwhile, its main expenses are slated to come from R&D spending, including the planned launch of a pivotal trial of a new 365-day sensor, pending an FDA green light for the study.
Review of the 180-day sensor was put on the FDA’s back burner in late 2020 as the agency’s workforce was tasked with a deluge of emergency applications for diagnostics and products aimed at COVID-19. In October of that year, the head of the FDA’s device center, Jeff Shuren, M.D., described how the agency received a surge of over 1,200 submissions for tests, ventilators, digital tech and more during the first months of the pandemic.