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 a favorable outcome of the U.S. Food and Drug Administration (FDA) Clinical Chemistry and Clinical Toxicology Devices meeting on the Eversense system. The panel, comprised of independent medical experts, voted unanimously, 8 to 0, that the benefits outweigh the risks, voted unanimously, 8 to 0, that the system is safe, and voted unanimously, 8 to 0, that the system is effective.
“We are pleased that the advisory panel believes in the benefits of the Eversense system. We are confident that the benefits of the system – longest life sensor, sustained accuracy, predictive glucose alerts, removable smart transmitter, gentle-on-skin adhesive – can be life changing for people with diabetes, and this is another step toward offering these benefits to patients in the U.S.,” stated Tim Goodnow, President and Chief Executive Officer of Senseonics. “We thank the panel members, the participants in today’s meeting, the clinical trial participants and the FDA, and are eager to continue the positive dialogue with FDA in pursuit of approval for Eversense.”
The Eversense system is a first of its kind implantable continuous glucose monitoring system utilizing a sensor that lasts for up to 90 days. The company demonstrated safety, efficacy and a favorable risk benefit profile for Eversense through real world data from patients currently using the system in Europe and data from the U.S. PRECISE II study. The study is considered one of the largest studies of a CGM system in the world, including over 2 million sensor glucose readings, from 90 participants at eight clinical centers.
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 FDA review 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 recommendation of the panel with respect to the PMA, the ultimate decision by the FDA with respect to the PMA, timing of any such decision 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, 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.