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 has announced that the Eversense® Continuous Glucose Monitoring (CGM) System has received FDA approval for qualified health care providers to be trained and certified to provide patients with the highly accurate sensor that lasts up to three months. Previously, the sensor insertion and removal procedure could only be performed by trained physicians.
“We are pleased with this FDA approval, we can now include nurse practitioners and physician assistants in the growing list of diabetes care professionals who can be certified to place the Eversense CGM System,” said Tim Goodnow, President and CEO of Senseonics. “We believe that allowing additional health care providers to perform the in-office placement procedure for Eversense CGM will enable broader access to patients for this compelling long-term diabetes management technology.”
The Eversense CGM 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. In addition to featuring the first long-term and first implantable CGM sensor, the system is also first to feature a smart transmitter that provides wearers with discreet on-body vibratory alerts for high and low glucose and that can be removed, recharged and re-adhered without discarding the sensor. The sensor can now be inserted subcutaneously in the upper arm by a physician, physician assistant* or nurse practitioner* via a brief in-office procedure.
"As a nurse practitioner, I appreciate that the FDA is recognizing the importance of advanced practitioners in a physician practice and in the care continuum," said KC Arnold, ANP, from The Diabetes Center in Ocean Springs, MS. “Many health care providers are ready and willing to learn and perfect these types of in-office procedures with the goal of helping more patients in their practice manage their diabetes with the latest technology available on the market.”
In addition to medical doctors, physician assistants and nurse practitioners will be able to file claims with health insurance plans under established CPT codes. Depending on the health plan contracts and state-by-state regulation, physician assistants and nurse practitioners may receive a percentage of the typical reimbursement provided to a medical doctor. Once physician assistants and nurse practitioners are trained on sensor placement, the Eversense CGM system will be more widely available across the U.S. market for patients with diabetes.
Patients who are interested in getting started on Eversense can sign up at www.eversensediabetes.com/get-started-today. Physicians, nurse practitioners or physician assistants interested in offering the Eversense CGM System for their patients can contact 844-SENSE4U (844-736-7348).
*Scope of practice may vary by state.
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 health care provider. 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 expanded commercialization, use and reimbursement of Eversense, label expansion, additional regulatory approvals, and other statements containing the words “expect,” “intend,” “may,” “projects,” “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: uncertainties inherent in the commercial launch of Eversense 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 June 30, 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.