Senseonics Initiates First-in-Human Study of Freedom, Designed to be the World’s First CGM System with No On-body Component

The early feasibility study is intended to inform a planned pivotal study that Senseonics expects to initiate in 2027.

Rhea-AI Summary

Senseonics Holdings (NASDAQ: SENS) initiated its first-in-human clinical study of Freedom, an investigational continuous glucose monitoring system designed without an on-body transmitter.

The early feasibility study will evaluate clinical safety and device functionality, including direct Bluetooth communication with a mobile device. Freedom is designed for one-year sensing. Senseonics expects to initiate a pivotal study in 2027 and targets a potential commercial launch in 2028. Preclinical studies completed in the second quarter of 2026 identified a preferred antenna configuration and implantation approach for human evaluation.

Positive

• Minor pointFirst-in-human Freedom study initiated, advancing the system into clinical evaluation.
• Minor point. Forward-looking: it has not happened yet and may not happen.2027 pivotal study expected; Senseonics targets a potential commercial launch in 2028.
• Minor pointPreclinical preferred design demonstrated 100% communication success within the target distance across approximately seven weeks and more than 18,500 communication data points.

Negative

• None.

Key Figures

Preclinical communication success: 100% Communication data points: More than 18,500 Preclinical testing duration: Approximately seven weeks +3 more

Preclinical communication success

100%

Preferred design within the target distance

Communication data points

More than 18,500

Preclinical testing

Preclinical testing duration

Approximately seven weeks

Bluetooth antenna designs and implantation locations

Planned pivotal study initiation

2027

Company expectation

Potential commercial launch

2028

Company target for Freedom

Sensor duration

One year

Designed duration for the Freedom CGM sensor

Key Terms

first-in-human, early feasibility study, pivotal study, bluetooth low energy

4 terms

first-in-human medical

"initiation of its first-in-human clinical study"

A first-in-human study is the initial test of a new drug, medical device, or therapy in people to check safety, side effects and appropriate dosing. It matters to investors because it marks a major development milestone: successful early human testing can reduce scientific and regulatory uncertainty, much like moving a prototype from the workshop to a real-world test drive, and often affects a company’s valuation and funding prospects.

early feasibility study medical

"It is an early feasibility study to evaluate the device design concept"

A small, first-in-human clinical study that tests whether a medical device or treatment is safe enough and shows enough promise to justify larger trials. Think of it as a short test drive for a new product: it helps investors gauge early safety, likely effectiveness, development costs and regulatory hurdles, so results can meaningfully change a program’s risk profile and timeline for potential revenue.

pivotal study medical

"inform a planned pivotal study that Senseonics expects to initiate in 2027"

A pivotal study is a large, definitive clinical trial designed to show whether a medical product works and is safe enough for regulators to approve and for doctors to use. Think of it as the final exam that determines whether a drug or device moves from testing into the market; its results can dramatically change a company’s approval chances, future sales prospects, and therefore its stock value.

bluetooth low energy technical

"multiple Bluetooth® Low Energy (BLE) antenna designs"

Bluetooth Low Energy is a wireless communication standard that lets small devices exchange short bursts of data over short distances while using very little battery power. For investors it matters because it enables products like fitness trackers, smart-home sensors and wireless accessories to run longer on small batteries and connect seamlessly, affecting product appeal, component demand, licensing and overall market growth—like a whisper that makes many gadgets practical.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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First clinical evaluation of investigational, transmitter-free one-year CGM marks an important milestone on Senseonics’ innovation roadmap, with potential launch in 2028

Built on the proven sensing technology behind Eversense 365 and supported by encouraging preclinical data to reduce development risk

GERMANTOWN, Md., Oct. 26, 2026 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NASDAQ: SENS), a diabetes company redefining continuous glucose monitoring (CGM) with long-term implantable sensing technology, today announced the initiation of its first-in-human clinical study evaluating Freedom, an investigational next-generation CGM system designed to communicate directly with a mobile device without the need for an external on-body transmitter.

Freedom represents an important step in Senseonics' innovation pipeline and is being developed with a vision to make diabetes technology less visible and burdensome. It is an evolution of the same fundamental sensing technology as the Eversense^® 365 system, with the addition of an integrated battery and embedded Bluetooth communication capability. It is designed to have no requirement for an on-body component, while maintaining the benefits people already value with Eversense 365, providing exceptional accuracy over a full year with a single sensor.

"Now being tested in humans for the first time, the Freedom CGM represents our vison to eliminate the requirement for an on-body component, effectively making continuous glucose monitoring invisible. We believe this represents an extremely attractive proposition for millions of people with diabetes and we are proudly leading the race to get there,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. "At Senseonics, we are not interested in incremental innovation. Our mission is to transform lives in the diabetes community and push the boundaries of sensing technology to improve health and wellbeing. 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 initiation of this first-in-human clinical study is a key milestone for Senseonics as the Company continues to invest in its innovation pipeline. It is an early feasibility study to evaluate the device design concept with respect to clinical safety and device functionality, including the sensor’s direct Bluetooth communication capabilities. The study’s purpose is to demonstrate safety and generate insights to inform a planned pivotal study that Senseonics expects to initiate in 2027, with the company targeting a potential commercial launch in 2028.

The initiation of the first-in-human study follows encouraging results from preclinical studies completed during the second quarter of 2026, which evaluated multiple Bluetooth® Low Energy (BLE) antenna designs and implantation locations to optimize communication performance and guide configuration selection. Across approximately seven weeks of testing and more than 18,500 communication data points, the preferred design demonstrated 100% communication success within our target distance. As a result, the study identified a preferred antenna configuration and implantation approach for human evaluation.

“Freedom exemplifies our approach to innovation at Senseonics. We are focused on developing game-changing advances that simplify life with diabetes and help make diabetes technology less visible,” Mukul Jain, PhD, Chief Operating Officer of Senseonics, commented. “This R&D approach leverages validated technologies wherever possible to reduce risk and accelerate innovation. Supported by encouraging preclinical communication data, we are excited to begin evaluating Freedom in humans. This program is being driven by what we consistently hear from people living with diabetes and it is what Senseonics was founded to deliver – a one-year CGM sensor with nothing required on-body.”

About Senseonics
Senseonics Holdings, Inc. ("Senseonics") is a diabetes company redefining continuous glucose monitoring (CGM) with long-term implantable sensing technology. Driven by a mission to transform lives in the diabetes community, Senseonics is the maker of Eversense^® 365, the world's first and only one-year CGM system, and is advancing a differentiated pipeline of innovation.

By commercializing Eversense 365 and pushing the boundaries of sensing technology, Senseonics is empowering better diabetes management, reducing the device burden, expanding patient choice, and shaping the future of diabetes care.

For more information, visit www.senseonics.com.

About Eversense^® 365
Eversense^® 365 is the only long-term continuous glucose monitoring (CGM) system available, offering people with diabetes a truly differentiated CGM experience. Designed for people with diabetes who demand more, Eversense 365 combines a small sensor inserted under the skin by a healthcare provider with a removable smart transmitter that delivers real-time glucose data to a mobile app or an integrated Automated Insulin Delivery (AID) system. With a single sensor designed to last a full year, Eversense 365 provides a unique approach to CGM that supports health outcomes, enhances patient confidence, and minimizes the burden associated with short-term devices.

Eversense 365 is cleared in the U.S. and approved in Europe for people with diabetes aged 18 years and older, and is available by prescription only. The system is indicated for continually measuring glucose levels for up to 365 days, and for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions (fingerstick BG measurements are still required for calibration primarily one time per week after day 14, and when symptoms do not match CGM information or when taking medications of the tetracycline class). It is available in the U.S. and in select European markets. Patients should talk to their health care provider to learn more. For important safety information, visit https://www.eversensecgm.com/safety-information/.

Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for Senseonics, including any statements regarding the development of the Freedom product, the potential results of the first-in-human study of Freedom, the timing of any pivotal study of the Freedom product, the timing of any potential commercial launch of the Freedom product and the potential benefits of Freedom product, other statements regarding the progress, results or benefits of the Freedom development program, and other statements containing the words “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “projects,” and “will,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the design, development and registration of new technology, uncertainties related to the results of the first-in-human study or pivotal study, and whether such data will support a regulatory submission to the FDA or other regulatory bodies, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties resulting from the Company’s dependence on third parties within the Company’s development program and supply chain, and other uncertainties inherent in the commercialization of new technology, including uncertainties relating to the current economic environment and relating to user decisions and preferences, and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year ended December 31, 2025, the Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 and Senseonics’ other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.

Senseonics Media Contact

Tim Stamper
FTI Consulting
Tim.Stamper@senseonics.com / Senseonics@fticonsulting.com

Senseonics Investor Contact

Jeremy Feffer
LifeSci Advisors
investors@senseonics.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Senseonics testing in the first human study of Freedom?

The early feasibility study evaluates Freedom’s clinical safety and device functionality, including direct Bluetooth communication. It is intended to demonstrate safety and generate insights to inform a planned pivotal study.

When could Senseonics launch the Freedom glucose monitoring system?

Senseonics targets a potential commercial launch in 2028 and expects to initiate a pivotal study in 2027. The first-in-human early feasibility study has begun.