The maker of the Eversense 365 year-long implantable CGM hosted an analyst event during the American Diabetes Association’s 85th Scientific Sessions in Chicago this past weekend. At that event, the company touched on the commercial strategy for Eversense 365, plus potential timelines for the coming Gemini and Freedom systems.
Senseonics launched Eversense 365 with its global distribution partner, Ascensia Diabetes Care, in October 2024. It now plans to accelerate the system’s commercial ramp, thanks to recent fundraising efforts. Those include a public offering and private placement with fellow CGM maker Abbott.
The Germantown, Maryland-based company plans to invest more in direct-to-consumer and marketing initiatives. It hopes to build broader patient awareness, while increased marketing investments can supplement Ascensia’s 200-person CGM business. The company also recently inked its first automated insulin delivery integration partnership with Sequel Med Tech, potentially further expanding its reach. It expects to continue adding pump partners down the line, too.
“It’s a very exciting time for the company,” said Senseonics President and CEO Tim Goodnow said during the analyst event. “We really feel that we’re now at the point where we have the technology on Eversense 365 that enables us [to drive shareholder value].”
Funds also support the product pipeline, the company says. It anticipates the proceeds to help its cash runway extend through the development and commercialization of next-generation platforms in fiscal 2027.
The company has its Gemini system on track to begin an FDA investigational device exemption study later this year. It aims to launch that system by the fourth quarter of 2026. Freedom remains in prototype testing, with a functional system earmarked for the fourth quarter of this year. Senseonics targets a pivotal study in the fourth quarter of 2026 and a commercial launch in the fourth quarter of 2027.
A look at the upcoming Gemini system from Senseonics
COO Mukul Jain said that Eversense 365 achieved two of three long-term Senseonics goals. It reached the one-year length threshold and the weekly calibration threshold. Next, the company has its eyes on removing any on-body components.
The current system’s transmitter powers the device and provides communication. With Gemini, the company wants to eliminate the transmitter aspect completely. So, Jain says it added a battery that allows the sensor to collect data without an on-body component — the transmitter.
Senseonics designed the Gemini system with existing near-field technology, allowing users to scan their smartphone over the sensor — which remains the same as with the Eversense system — to access their data.
“When somebody has the transmitter on, you are getting the data,” Jain explaiend. ‘It’s working just like the real-time CGM that we currently have. Without the transmitter, you are still collecting data every five minutes, storing the data on the sensor, and you just need to do some communication to get it out.”
The company has transitioned all the tech for Gemini into development as it prepares for an IDE trial this year. It completed battery development this year and even overshot expectations on capacity, reaching, on average, about five months extra. Through human and feasibility testing, the company is nearing completion.
A few differences include size, as the device grew longer with the incorporation of the battery. Jain says the insertion experience and tools still worked, as has the scanning testing.
We’ve been very excited about where Gemini is currently,” Jain concluded. “This will be an exciting product.”
What about Freedom?
Jain said it was easy to pick the name for the technology that follows Gemini — “Freedom,” reflecting freedom from anything on the body.
Following the development of Gemini, Senseonics looked to Freedom to enhance communication capabilities through Bluetooth.
“Bluetooth is low-energy and present in a lot of implantable devices today,” Jain said. “It’s well-proven in implantable devices, pacemakers, defibrillators. They’re all using it right now… For us, it was an easy choice.”
Freedom, soon to transition into development, features little change from Gemini in terms of the sensor, with no changes on the battery. The company wanted to maintain the same size, which posed a challenge with extra power and capacity needed for Bluetooth. Modifications in the hardware of the battery allow for more capacity, Jain explained, as prototypes are in testing and the company plans to verify its design by the end of the year.
Senseonics incorporated an off-the-shelf Bluetooth chip with the Freedom system and expects it to only communicate via that method. A challenge came in the form of fitting it in a four-millimeter sensor, as Bluetooth in pacemakers and other device often has room for a larger antenna, Jain explained.
“We’ve made a lot of progress there,” he said. “We have made the sensors used in animal testing. On the Freedom side, we expect it to lag just a year from Gemini.”
