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SENS • CIK 0001616543
Overview We are a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (“CGM”) system to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy. Our implantable CGM system (“Eversense”), including Eversense E3 and Eversense 365 CGM systems are designed to continually and accurately measure glucose levels in people with diabetes via an under-the-skin sensor, a removable and rechargeable smart transmitter, and a convenient app for real-time diabetes monitoring and management for a period of up to twelve months in the case of Eversense 365 and six months in the case of Eversense E3, as compared to seven to 15 days for non-implantable CGM systems. In September 2024, the 365-day extended life Eversense E3 CGM system was approved by the FDA and, through Ascensia Diabetes Care Holdings AG (“Ascensia”), we began commercializing Eversense 365 in the fourth quarter of 2024. In January 2026, we took over full commercial responsibility for Eversense 365 in the United States and began marketing and distributing the product with our own sales force. In June 2022, we affixed the CE Mark to the Eversense E3 CGM system and Ascensia began commercialization in select markets in Europe during the third quarter of 2022. In January 2026, the Company obtained CE Mark approval for Eversense 365 and expects to launch Eversense 365 in the European Territories by the second half of 2026. Prior to the commercialization of the current Eversense systems, we sold Eversense system measuring glucose levels for up to 180 days in the United States and prior to that 90 days in both the United States and select European markets. In September 2017, we affixed the CE Mark to the Eversense XL CGM system to be sold in select markets in Europe and the Middle East. In June 2018, we obtained FDA approval for the 90-day Eversense CGM system for distribution throughout the United States. In June 2019, we received FDA approval for the non-adjunctive indication (dosing claim) for the 90-day Eversense system. With this approval and the availability of a new app in December 2019, the Eversense system can be used as a therapeutic CGM in the United States to replace fingerstick blood glucose measurement to make treatment decisions, including insulin dosing. We are in the early commercialization stages of the Eversense brand and are focused on driving awareness of our CGM system amongst people with diabetes and their healthcare providers. In both the United States and our overseas markets, we have entered into strategic partnerships and distribution agreements that allow third party collaborators with direct sales forces and established distribution systems to market and promote Senseonics’ various Eversense systems and future generation products, including our “Gemini” product variation to allow for a 2-in-1 glucose monitoring system combining the functionality of CGM and flash glucose monitoring, in an implantable sensor with battery that may be utilized with a smart transmitter to get continuous glucose readings and alerts, or be utilized through a swipe over 4 the sensor with a smart phone to get on-demand glucose reading without a smart transmitter and our “Freedom” product variation which would include Bluetooth in the sensor eliminating the on-body component. As described in detail below, in August 2020, we entered into a collaboration and commercialization agreement (“Commercialization Agreement”), with Ascensia pursuant to which we granted Ascensia the exclusive right to distribute Eversense worldwide, with certain initial exceptions. On September 3, 2025, the Company and Ascensia signed a memorandum of understanding (“MOU”) related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company. On December 31, 2025, the parties entered into a master asset purchase agreement (the “Master Asset Purchase Agreement”) formalizing this transfer and subsequently entered into an Amended and Restated Collaboration and Commercialization Agreement (the “A&R Commercialization Agreement”), which terminated Ascensia’s right to market Eversense products in the U.S. and rendered Ascensia’s right to market Eversense products in Italy, Germany, Spain and Sweden (the “European Territories”) non-exclusive.…
Directors who filed Form 4s in the last 2 years (not a full DEF 14A board roster)