Senseonics Announces Date for FDA Advisory Panel
Published: Mar 01, 2018
GERMANTOWN, Md.--(BUSINESS WIRE)-- Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of Eversense®, a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced the U.S. Food and Drug Administration (FDA) Clinical Chemistry and Clinical Toxicology Devices Panel is scheduled to review the premarket approval application (PMA) for Eversense on Thursday, March 29, 2018.
The Eversense PMA application contains data from Senseonics’ U.S. PRECISE II study. The study, considered one of the largest studies of a CGM system in the world, includes over 2 million sensor glucose readings, from 90 patients at eight clinical centers during the full 90-day study duration.
“The scheduling of the advisory panel represents a meaningful milestone toward offering patients in the U.S. a long term, implantable CGM system,” stated Tim Goodnow, President and Chief Executive Officer of Senseonics. “We are excited for the opportunity to discuss the data in support of the Eversense PMA with the panel. We believe the Eversense system’s value to people with diabetes will resonate with the panel as it has with users in Europe.”
Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of transformational glucose monitoring products designed to help people with diabetes confidently live their lives with ease. 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.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements about the timing of the advisory panel and the potential U.S. launch of Eversense and other statements containing the words “expect,” “intend,” “may,” “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: the uncertainties related to the panel being held as scheduled, the recommendation of the panel with respect to the PMA, the ultimate decision by the FDA with respect to the PMA 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, 2016, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 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 Holdings, Inc.
R. Don Elsey, 301.556.1602
Chief Financial Officer
Source: Senseonics Holdings, Inc.