January 4, 2022 – GERMANTOWN, Md.–(BUSINESS WIRE)–Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced operational and financial business updates.

Operational and Financial Updates

• Substantive review with the FDA for the PMA supplement for the next generation Eversense 180-day CGM system is nearing completion, all queries raised have been answered and a decision regarding approval is expected in the coming weeks

• Designing plans with Ascensia Diabetes Care for a smooth transition to the 180-day system in the U.S., pending FDA approval, including:
  • Marketing campaigns to highlight the availability of system upgrade programs for patients and to increase overall patient awareness
  • Payor engagement regarding reimbursement and coverage transitions
    These plans are being designed with a goal of minimizing the impact to patients, providers and sales, taking into account the expected use of existing inventory in Q1 2022 and initiating transition to the new product in Q2 2022

• Reiterating 2021 financial outlook expectation for full year 2021 global net revenue to be in the middle of the revenue guidance range of $12.0 million to $15.0 million

“We understand that the FDA is at full capacity managing the backlog of COVID-19 related filings creating longer than expected review timelines. We are confident a decision regarding approval of the 180-day system will be made in the coming weeks as the FDA continues to clear out the backlog,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “In 2021 we integrated operations and coordination activities with our commercial collaborator Ascensia Diabetes Care. A thoughtful go-to-market strategy is being designed to target a smooth transition to the 180-day system while providing uninterrupted service for patients, providers and payors. We are excited to advance long-term solutions for people with diabetes as we continue to aim to make the new 180-day system available in the U.S..”

About Senseonics

Senseonics Holdings, Inc. is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics’ CGM systems, Eversense® and Eversense® XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user’s smartphone.