Senseonics Begins U.S. Commercialization of Eversense Continuous Glucose Monitoring System With First Shipment, First Users and First Policy Coverage
Trained and authorized U.S. diabetes clinics begin providing the first-ever 90-day, long-term CGM system to people with diabetes
GERMANTOWN, Md.--(BUSINESS WIRE)-- Senseonics Holdings, Inc. (NYSE-American: 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 the Eversense® CGM System is now available at trained clinics across the U.S. and physicians have begun sensor placements with patients. Concurrently, the company reported that its first commercial payer, Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, has added coverage of the Eversense System to its Medical Policy.
Today’s milestone announcements mark the company’s rapid entry into the U.S. commercial market, with the product available to U.S. patients just six weeks since the FDA approval of the product in late June.
“Since receiving FDA approval for the Eversense System, we have experienced tremendous support and interest from physicians and their patients,” said Tim Goodnow, President and CEO of Senseonics. “We are thrilled that clinics and users can now benefit from Eversense, and we’re also pleased to receive our first medical policy coverage, clearing the way so more people with diabetes can access this important tool for helping ease the burden of managing diabetes.”
The Horizon BCBSNJ coverage decision is significant not only because of the promptness with which it followed the FDA’s product approval, but also because Horizon serves nearly 4 million covered lives primarily in New Jersey but also in adjacent states.1
Product shipments began the last week of July to diabetes clinics across the United States. Physicians and staff have been subsequently trained and authorized on the Eversense System and have started their first patients on the system.
"We are pleased to be one of the first clinics to offer Eversense to our patients after our onboard training," said Bruce Bode, MD, FACE, Atlanta Diabetes Associates and Clinical Associate Professor, Department of Medicine Emory University. "I have seen the benefits of CGM in my own practice, and it’s important to me to offer the latest technology to my patients. With an implantable long-term sensor, patients with diabetes can have discretion when they want it, the convenience of vibratory alerts from the transmitter, and the comfort of knowing where their glucose is headed."
To recognize patients receiving their first Eversense sensor insertion, Senseonics recently initiated Freedom Week, sponsored by Eversense®, to help patients mark the day they were freed from the weekly and biweekly self-insertions required by traditional CGM systems.
While the glucose sensors of traditional CGM systems last 7 to 14 days, the Eversense System is the world’s first and only long-term CGM system, with a highly accurate implantable sensor that lasts up to three months. The Eversense System also features a smart transmitter that is the first that can be removed and re-adhered without discarding the sensor and the first to provide discreet on-body vibratory alerts signaling high and low glucose levels.
Patients who are interested in getting started on Eversense can sign up at www.eversensediabetes.com/get-started-today. Physicians interested in becoming an authorized practice can contact 844-SENSE4U (844-736-7348).
1 “The 20 Largest Health Insurance Companies,” Nerdwallet.com, Aug. 26, 2016 (https://www.nerdwallet.com/blog/health/largest-health-insurance-companies/)
Senseonics Holdings, Inc. (NYSE American: SENS) is a medical technology company focused on the design, development and commercialization of transformative glucose monitoring products designed to help people with diabetes confidently live their lives with ease. From its inception, Senseonics has been advancing the integration of novel, fluorescence sensor technology with smart wearable devices. The Eversense® CGM System received FDA PMA approval for up to 90 days of continuous use and is available in the United States. The Eversense® CGM XL System received CE mark for up to 180 days of continuous use and is available in Europe. For more information on Senseonics, please visit www.senseonics.com.
The Eversense System consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. Light, discreet, and comfortable to wear, the system's smart transmitter interprets glucose data from the sensor and sends it to the system's mobile application via Bluetooth, so patients can review their glucose data to help them make daily diabetes decisions.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements about physician and patient adoption of the Eversense System 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, 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.
Source: Senseonics Holdings, Inc.