Senseonics Announces First Eversense E3 CGM System Patient Implant in the United States | News

GERMANTOWN, Md.–(BUSINESS WIRE)–April 6, 2022–

Senseonics Holdings, Inc. (NYSE-American: SENS), a medical technology company focused on developing and manufacturing long-term implantable continuous glucose monitoring (CGM) systems for people with diabetes, and Ascensia Diabetes Care , its commercialization partner, announced that the first commercial patient was implanted with Eversense® E3, kicking off the launch of the next-generation CGM system in the United States. The Eversense E3 sensor was approved by the FDA in February and is the most durable CGM available in the United States.

“The precision, duration and implantable form of Eversense E3 combine to provide diabetes patients with confidence and convenience never before available,” said Bantwal S. Baliga, MD: MRCP (UK), Director of East Alabama Endocrinology and first physician to insert the extended life sensor now that it is commercially available. “This next-generation implantable system was designed with patients in mind by offering a 6-month sensor life. It also offers unique benefits such as discreet on-body vibration alerts via a detachable transmitter that gives patients wear-time flexibility without ever having to waste a sensor. It’s an important offering for patients looking for precision, protection and convenience.

The Eversense E3 CGM system, developed by Senseonics and offered to people with diabetes by Ascensia Diabetes Care, offers:

  • Longest lasting CGM available, with 6 month sensor wear life, with essentially two sensor insertion and removal procedures per year
  • Exceptional accuracy, with a mean absolute relative difference (MARD) of 8.5% demonstrated in the PROMISE study for sensor wear time
  • A fully implantable fluorescence-based sensor, with a removable smart transmitter that provides discreet vibration alerts on the body and transmits the data to a mobile app
  • Reduced calibrations compared to previous generation Eversense CGM systems

“We are thrilled with the enthusiasm of patients and healthcare providers surrounding the launch of Eversense E3,” said Tim Goodnow, President and CEO. “Today marks an important milestone in the history of diabetes care, advancing our Eversense CGM offering so that patients with diabetes can live more freely. We are thrilled that Eversense E3 is now available to millions of diabetes patients across the United States.”

Patients interested in getting started with Eversense can now register at www.eversensediabetes.com/get-started-today. Physicians, nurse practitioners and physician assistants interested in offering the Eversense CGM System can register at https://www.ascensiadiabetes.com/eversense/become-a-provider/. You can also contact 844-SENSE4U (844-736-7348) to learn more about the first and only long-term implantable CGM system.

About Eversense

The Eversense® E3 Continuous Glucose Monitoring (CGM) System is indicated for continuously measuring glucose levels for up to 6 months in people with diabetes 18 years of age and older. The system is indicated for use as an alternative to fingertip blood glucose (glycemia) measurements for diabetes treatment decisions. Fingerstick blood glucose readings are still needed for calibration and when symptoms do not match CGM information or when taking tetracycline class medications. Sensor insertion and removal procedures are performed by a trained and certified healthcare provider. The Eversense CGM system is a prescription device; patients should speak to their healthcare provider to learn more.

For important safety information, see https://www.ascensiadiabetes.com/eversense/safety-info/.

About Senseonics

Senseonics Holdings, Inc. is a medical technology company focused on developing and manufacturing blood glucose monitoring products designed to transform the lives of the global diabetes community through differentiated and implantable long-term blood glucose management technology. term. CGM systems from Senseonics, Eversense®, Eversense® XL and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn on the sensor. Glucose data is automatically sent every 5 minutes to a mobile app on the user’s smartphone.

Forward-looking statements

All statements in this press release regarding Senseonics’ future expectations, plans and outlook, including the perception and benefits that patients will receive and the number of patients Eversense will be available to, and other statements containing the words ” believe”, “expect”, “intend”, “could”, “plan”, “will”, “plan” and other 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 these forward-looking statements due to a variety of important factors, including: the uncertainties inherent in the commercial launch of the Eversense E3 CGM System and the commercial expansion of the Eversense product, the inherent uncertainties the transfer of commercialization responsibilities to Ascensia and its commercial initiatives, uncertainties in the processes and decisions insurer, regulatory and administrative uncertainties in the duration and severity of the COVID-19 pandemic, and any other factors as set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and other documents filed by Senseonics with the SEC under the heading “Risk Factors.” In addition, forward-looking statements included in this press release represent the views of Senseonics as of the date of the present. Senseonics anticipates that subsequent events and developments will cause Senseonics to change its mind. However, while Senseonics may choose to update these forward-looking statements at some time in the future, Senseonics expressly disclaims any obligation to do so, except as required by law. These forward-looking statements should not be taken to represent the views of Senseonics as of any date subsequent to the date hereof.

Show source version on businesswire.com:https://www.businesswire.com/news/home/20220406006010/en/

CONTACT: INVESTOR CONTACT

Philip Taylor

Investor Relations

415-937-5406

[email protected]

KEYWORD: UNITED STATES NORTH AMERICA MARYLAND

INDUSTRY KEYWORD: DIABETES HEALTH MEDICAL DEVICES

SOURCE: Senseonics Holdings, Inc.

Copyright BusinessWire 2022.

PUBLISHED: 04/06/2022 16:34 / DISK: 04/06/2022 16:34

http://www.businesswire.com/news/home/20220406006010/en

Copyright BusinessWire 2022.

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