[October 27, 2016]

Senseonics submits Eversense® Continuous Glucose Monitoring system PMA to FDA

Senseonics Holdings, Inc. (NYSE-MKT:SENS), a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) a Premarket Approval (PMA) application for its Eversense® CGM system.

"The submission of our PMA marks a significant milestone toward meeting our goal of bringing an accurate, reliable and long-lasting CGM system to people with diabetes in the United States," said Tim Goodnow, PhD., CEO and President of Senseonics. "We look forward to working with the FDA to receive approval as quickly as possible."

As previously reported, the PRECISE II U.S. pivotal trial enrolled 90 adults with Type 1 or Type 2 diabetes at eight clinical centers. The objective of the study was to demonstrate the safety and effectiveness of the Eversense CGM system over 90 days of continuous glucose sensor wear. Participants in the study used the system's smart transmitter and mobile app at home for the next 90 days. Calibration was performed twice a day, and Sensor glucose readings were calculated prospectively, but real-time glucose readings and trends were not made available to participants. Clinic visits were scheduled at approximately 30-day intervals in order to obtain lab reference glucose values for comparison with the sensor values and to evaluate hyperglycemic and hypoglycemic challenges in a controlled setting.

Results of the PRECISE II study will be presented at this year's Diabetes Technology Meeting in Bethesda, Maryland on November 10, 2016.

Upon receiving FDA regulatory approval, Senseonics plans to initiate sales in the United States. The company received its CE mark in May 2016 and is currently marketing the Eversense CGM System in select European countries.

Eversese CGM System is an Investigational Device and is limited by United States law to investigational use.

About Senseonics

Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics' first generation continuous glucose monitoring (CGM) system, Eversense®, includes a small sensor, smart transmitter and mobile application. Based on fluorescence sensing technology, the sensor is designed to be inserted subcutaneously and communicate with the smart transmitter to wirelessly transmit glucose levels to a mobile device. After insertion, the sensor is designed to continually and accurately measure glucose levels. For more information on Senseonics, please visit www.senseonics.com.

SAFE HARBOR STATEMENT

Certain statements contained in this press release, other than statements of fact that are independently verifiable at the date hereof, may constitute "forward-looking statements." These forward-looking statements reflect Senseonics' current views about its plans, intentions, expectations, strategies and prospects, including statements concerning the FDA review, and potential approval, of the PMA, and the United States commercial launch of Eversense, which are based on the information currently available to Senseonics and on assumptions Senseonics has made. Although Senseonics believes that its plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, Senseonics can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond Senseonics' control, including those risks and uncertainties more fully described in the section entitled "Risk Factors" in Senseonics' Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC (News - Alert)) on February 19, 2016, the Quarterly Report on Form 10-Q filed with the SEC on August 9, 2016 and its other SEC filings. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cause Senseonics' expectations and beliefs to change. While Senseonics may elect to update these forward-looking statements publicly at some point in the future, Senseonics specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161027006909/en/

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