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Senseonics Announces the First Patient Implant of the Eversense E3 CGM System in the U.S.
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Rhea-AI Summary
Senseonics Holdings, Inc. (AMEX: SENS) has announced the successful implantation of the first patient with the Eversense® E3 Continuous Glucose Monitoring (CGM) System in the U.S. This system, which received FDA approval in February, offers a 6-month sensor life, making it the longest-lasting CGM available. It features exceptional accuracy with a mean absolute relative difference (MARD) of 8.5%, reduced calibration frequency, and discreet on-body alerts. The Eversense E3 marks a significant advancement in diabetes care, enabling patients to manage their condition with improved confidence and convenience.
Positive
First patient implanted with Eversense E3, marking a successful launch.
Eversense E3 is FDA-approved and offers a 6-month sensor wear duration.
Achieves high accuracy with a MARD of 8.5% from clinical studies.
Features discrete alerts and reduced calibration for user convenience.
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None.
GERMANTOWN, Md.--(BUSINESS WIRE)--
Senseonics Holdings, Inc. (NYSE-American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, and Ascensia Diabetes Care, its commercialization partner, have announced the first commercial patient has been implanted with Eversense® E3, kicking off the launch of the next-generation CGM System in the U.S. The Eversense E3 Sensor was approved by the FDA in February and is the longest lasting CGM available in the U.S.
“The accuracy, duration and implantable form of Eversense E3 combine to provide diabetes patients confidence and convenience never available previously,” said Bantwal S. Baliga, MD: MRCP (U.K.), Director of East Alabama Endocrinology, and the first physician to insert the extended life sensor now that it is commercially available. “This next-generation implantable system has been designed with patients in mind by offering 6-months of sensor life. It also offers unique benefits like discrete on-body vibratory alerts through a removable transmitter that provides patients wear time flexibility without ever having to waste a sensor. It is an important offering for patients wanting accuracy, protection, and convenience.”
The Eversense E3 CGM System, developed by Senseonics and brought to people with diabetes by Ascensia Diabetes Care, offers:
The longest lasting CGM available, with a 6-month sensor wear duration, 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 the duration of sensor wear
A fully implantable fluorescence-based sensor, with a removable smart transmitter that provides discreet on-body vibratory alerts and transmits data to a mobile app
Reduced calibrations compared to the previous generation Eversense CGM Systems
“We are pleased with the patient and health care provider excitement surrounding the Eversense E3 launch,” said Tim Goodnow, President and Chief Executive Officer. “Today marks a major milestone in the history of diabetes care, advancing our Eversense CGM offering so that patients with diabetes can live more freely. We are excited the Eversense E3 is now available to millions of diabetes patients across the U.S.”
Patients who are interested in getting started with Eversense now can sign up at www.eversensediabetes.com/get-started-today. Physicians, nurse practitioners and physician assistants who are interested in offering the Eversense CGM System can sign up at https://www.ascensiadiabetes.com/eversense/become-a-provider/. Alternatively, 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 continually measuring glucose levels for up to 6 months in persons with diabetes age 18 and older. The system is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a trained and certified health care provider. The Eversense CGM System is a prescription device; patients should talk to their health care 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 the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM systems, Eversense®, Eversense® XL and Eversense® E3 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 the perception of and benefits to be received by patients and the number of patients to whom Eversense will be available, and other statements containing the words “believe,” “expect,” “intend,” “may,” “projects,” “will,” “planned,” 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 E3 CGM system and commercial expansion of the Eversense product, uncertainties inherent in the transition of commercialization responsibilities to Ascensia and its commercial initiatives, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties in the duration and severity of the COVID-19 pandemic, 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, 2020 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.
What is the significance of the Eversense E3 launch for Senseonics?
The Eversense E3 launch represents a major milestone for Senseonics as it introduces the longest-lasting CGM system in the U.S., enhancing diabetes management.
How long can the Eversense E3 sensor be worn?
The Eversense E3 sensor can be worn for up to 6 months, representing a significant advancement in continuous glucose monitoring.
What is the mean absolute relative difference (MARD) for Eversense E3?
The Eversense E3 CGM System demonstrates a mean absolute relative difference (MARD) of 8.5%, indicating high accuracy.
How does the Eversense E3 improve user experience?
The Eversense E3 features discrete on-body alerts and reduced calibration frequency, enhancing user convenience and experience.
When was the Eversense E3 FDA approved?
The Eversense E3 was approved by the FDA in February, prior to the first commercial implantation.
