ORLANDO, Fla.--(BUSINESS WIRE)--Senseonics Holdings, Inc. (NYSE-American: SENS), a medical technology company focused on the development and commercialization of transformative glucose monitoring products, today announced the presentation by third party researchers of new data from a clinical study evaluating the performance of the Eversense® XL Continuous Glucose Monitoring (CGM) system for up to 180 days in pediatrics and adults with diabetes. Findings were presented on June 22, 2018 at the American Diabetes Association’s (ADA) 78th Scientific Sessions.
“This is the first study to examine any CGM system in a pediatric population for a period of continuous wear for more than 14 days,” said Dr. Ronnie Aronson, MD, FRCPC, FACE, primary investigator, endocrinologist and chief medical officer of LMC Diabetes & Endocrinology, Toronto, Canada. “The Eversense System was observed to be a safe and durable alternative to currently available CGM systems and demonstrated excellent accuracy. The sensor insertion and removal procedures for the device were also well-tolerated in subjects studied. Further, patients in the study expressed a high degree of likeability for the Eversense system as relates to its features, which could make it a valuable tool for improved diabetes management.”
In this prospective, unblinded, single-arm, single-center study, pediatrics (n=30) and adults (n=6) with diabetes were evaluated on the accuracy and safety of the Eversense XL CGM System through the 180-day study duration. When referenced against a lab analyzer, the findings demonstrated the accuracy of Eversense XL (MARD of 9.4%, 15/15% metric of 83%, and 99.6% of consensus error grid data in zones A and B). Study participants also expressed an overall favorable rating of the system (long sensor life, implantable wear and vibratory alerts). No serious adverse events related to the insertion/removal of the sensor or device were reported.
In another third party study presented on June 22, 2018 at the ADA meeting, results of the CGM Comparative Accuracy Study conducted by the MGH Bionic Pancreas Monitoring Study group were reported. In the study, each of Eversense, Dexcom G5 and Libre Pro were worn simultaneously by 23 subjects and evaluated using blood glucose meter as the reference method.. In the 3-way comparison study, Eversense achieved the lowest nominal MARD (14.8%) followed by Dexcom G5 (16.3%) and Libre Pro (18.0%) “We found that the point accuracy of the Eversense was significantly better than two other CGM systems,” the study’s authors said. “The Eversense CGM system may be useful to provide glucose values to artificial pancreas devices.”
On June 21, 2018, the U.S. Food and Drug Administration approved Senseonics’ Pre-market Approval (PMA) application to market the Eversense® CGM System in the United States to people age 18 and older with diabetes for up to 90 days.
“On the heels of the U.S. FDA approval of the Eversense CGM System, we are pleased to see these new data evaluating the long-term safety and accuracy of the device be presented at the ADA’s 78th Scientific Session,” said Tim Goodnow, President and CEO of Senseonics. “We look forward to further advancing the science of CGM research, which includes demonstrating clinical support for new product indications for wider populations with an even longer sensor life. In particular, we believe the results of the pediatric study will potentially help inform the design of our future pediatric clinical trials.”
The Eversense System is the first and only CGM system approved by the FDA to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months.
The Eversense® Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 90 days. It is intended to complement, not replace, fingerstick blood glucose monitoring. The sensor insertion and removal is performed by a physician. The Eversense CGM System is a prescription device; patients should talk to their doctor to learn more. For important safety information, see https://eversensediabetes.com/safety-info/.
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 potential U.S. launch of Eversense, potential future development of Eversense, including its potential development for pediatric patients with diabetes 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 development of the market for CGM products generally, and Eversense in particular, people with diabetes' perceptions of the benefits of the Eversense System, patient use of the system, the need to conduct pivotal clinical trials to establish the safety and effectiveness of Eversense in pediatric patients, the uncertain regulatory approval process, 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, Senseonics' Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, 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.