The first-in-human trial of its Freedom system will evaluate a one-year, under-the-skin sensor that links directly with the user’s smartphone, doing away with the need for additional on-body hardware and making a CGM as discreet as possible.
The early feasibility study will explore the device’s design, safety and Bluetooth communication capabilities, ahead of Senseonics’ plans to launch a pivotal trial in people with diabetes next year. If all goes well, the company said it is eyeing a potential commercial launch in 2028.
“We believe this represents an extremely attractive proposition for millions of people with diabetes and we are proudly leading the race to get there,” Senseonics President and CEO Dr. Tim Goodnow said in a statement. “Eversense 365 redefined what a CGM could be by becoming the world’s first and only one-year system and we are just getting started.”
The company described Freedom as employing the same sensor technology as the Eversense 365, with its small capsule placed under the skin of the upper arm, but with its own added battery. Currently its removable transmitter patch needs to be recharged with adhesive reapplied daily.
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Senseonics said preclinical studies earlier this year explored multiple Bluetooth Low Energy antenna designs and implantation locations to optimize communication performance within a targeted distance.
The company pitched the project as a key investment in its innovation pipeline, after earlier this year posting what it called the strongest financial quarter in its history. It reported $14.5 million in revenue for the second quarter — up 120% over last year, following the end of its Eversense distribution agreement with Ascensia Diabetes Care — however, Senseonics still claimed a net loss of $36.7 million. Its third-quarter earnings report is scheduled for Nov. 9.
