The Germantown, Maryland-based company said the FDA review of its next-generation, 365-day, once-per-week calibration Eversense implantable continuous glucose monitor (CGM) is advancing as planned. It expects the progress to enable 510(k) clearance in the near future and a fourth-quarter 2024 launch.
In April, the company received FDA integrated CGM (iCGM) designation, allowing the long-term implantable CGM to connect with insulin pumps as part of an automated insulin delivery system. Senseonics then submitted the 365-day sensor to the FDA for 510(k) clearance with that iCGM designation in May.
The company shared this latest update in the midst of the American Diabetes Association Scientific Sessions in Orlando, Florida.
A look at Senseonics’ full-year outlook
On top of that progress, the company expects significant year-over-year sales growth in 2024. It reaffirmed its expectation for $10 million in global revenue for the first half of the year, marking approximately 21% growth compared to the same period in 2023.
Senseonics said it also generated more than 200% new patient starts in the first half of this year compared to 2023 in the U.S. The company also began provider training and patient identification for its health system partnership with Mercy Health. It targets insertions in the third quarter of 2024 and acceleration in the fourth quarter.
For the full year, Senseonics expects revenue between $22 million and $24 million. It anticipates more than doubling U.S. new patient starts and an increase in the global installed base by about 50% compared to 2023. The company also expects inventory dynamics associated with the 365-day CGM launch impacting third-quarter sales. However, it anticipates accelerated fourth-quarter sales based on that launch.
President and CEO Tim Goodnow says the company continues executing on its business plan this year.
“The Eversense platform now sits in its strongest position of all time,” he said in a news release. “We are working diligently to convert two significant growth opportunities—the anticipated launch of our 365-day product together with the new leadership at Ascensia Diabetes Care and the Mercy collaboration. We believe the prospect of delivering a CGM system to patients that can last for one year, with just one calibration per week, and the potential to make Eversense CGM + RPM a systemic solution with a health system the scale of Mercy both present the opportunity to enable transformative growth for Senseonics.”
