Senseonics Holdings Inc. has secured an integrated continuous glucose monitoring (iCGM) designation from the FDA for its Eversense® device. This designation shows the device’s high standards and reliability and allows Eversense to be marketed as a fully implantable system capable of integrating seamlessly with insulin pumps as part of automated insulin delivery (AID) systems. This development represents an advancement in diabetes management technology, particularly for patients seeking a more integrated approach to managing their condition. Unlike traditional CGM systems which often require frequent sensor changes, Eversense offers a unique value proposition with its long-lasting implant, which is effective for up to 180 days compared to the more typical 14-day lifespan of patches from competitors like Abbott and Dexcom. This extended duration minimizes the physical and psychological problems of frequent sensor replacements and reduces the cost and inconvenience associated with diabetes care, improving adherence and outcomes.
The FDA’s iCGM designation enables Eversense to be used in conjunction with other medical devices, particularly insulin pumps, allowing a more automated and precise management of blood glucose levels. This interoperability is necessary for the effectiveness of automated insulin delivery systems, which rely on accurate and real-time data to adjust insulin doses appropriately. The integration capability of Eversense is a step forward in enhancing the autonomy of diabetes patients, simplifying the management of the disease, and ensuring that daily life is less interrupted by diabetes care routines. Eversense stands out with its high accuracy in critical low glucose ranges and features such as minimal compression lows and dependable alert detection for real-time corrections. The system’s removable transmitter, which can be detached without requiring sensor disposal or a restart period, offers flexibility and convenience, addressing one of the common limitations in existing CGM technologies.
In anticipation of evolving patient needs and technological advancements, Senseonics is actively developing the next generation of its CGM systems, namely the Gemini and Freedom versions. These versions aim to eliminate the need for an on-body transmitter, enhancing user comfort and wearability. The company plans to initiate first-in-human trials for the Gemini model in the second half of 2024, demonstrating its commitment to innovation and continuous improvement of its products. By eliminating the external transmitter, these new models will offer an even less invasive option for glucose monitoring, which could greatly enhance user satisfaction and widen the appeal of the Eversense system. The focus of Senseonics is to expand the integration capabilities of Eversense with leading insulin delivery devices, leveraging the iCGM designation to capture a larger share of the diabetes management market and to provide benefits to a greater number of patients.
Despite its innovative technology and the recent regulatory advancements, Senseonics remains a relatively minor entity in the CGM market, which is dominated by larger companies like Dexcom and Abbott. The company reported revenues of $22.4 million last year and is optimistic about its growth prospects, especially with the impending submission of a 365-day sensor that promises to further reduce the frequency of sensor replacements. This longer-duration sensor is expected to be particularly appealing to both patients and healthcare providers by minimizing the invasiveness and upkeep required for diabetes management. The promise of a year-long sensor places Senseonics in a potentially competitive position to challenge the market leaders by addressing one of the major barriers to CGM adoption—sensor longevity. With the iCGM designation enabling broader integration within AID systems, Senseonics aims to enhance its market presence, appeal to a larger patient population, and increase its competitive stance against established industry giants.
