Senseonics Reports Topline Accuracy Results from U.S. Pivotal Study of Eversense CGM System.
Topline Accuracy of 8.8% MARD (Mean Absolute Relative Difference)
over 90 Days.
GERMANTOWN, Md.--(BUSINESS WIRE)--
Senseonics Holdings, Inc. (NYSE-MKT: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 topline results of the PRECISE II (A Prospective,
Multicenter Evaluation of the Accuracy
of a Novel Continuous Implanted
Glucose Sensor) Clinical Investigation.
Results from the 90 adults with diabetes generated over 16,000
comparative glucose data points and demonstrated strong accuracy for the
90-day continuous wear period with a mean absolute relative difference
(MARD) of 8.8% across the 40-400 mg/dL range when compared to YSI blood
reference values.
According to the Principle Investigator, Dr. Mark Christiansen of Diablo
Clinical Research, “The accuracy result is quite significant with the
device. This was an important study and we are thankful to all the
patients and clinics who participated. The early result shows that this
system can be an important treatment option for our patients. Having a
long lasting, 90-day CGM sensor that is safe and accurate will be a
welcome addition to the diabetes community, as it will offer greater
freedom of choice.”
The PRECISE II U.S. investigational device exemption trial enrolled 90
participants at eight clinical centers. The objective of the study was
to determine the safety and effectiveness of the Eversense® CGM system
over 90 days of continuous glucose sensor wear.
Participants in the study underwent unilateral (n=75) or bilateral
sensor (n=15) insertions in the clinic and used the system’s smart
transmitter and mobile app at home for the next 90 days. Sensor glucose
readings were calculated prospectively. Calibration with a standard home
blood glucose meter was performed twice a day but real-time glucose
readings and trends were not made available to participants. Clinic
visits were scheduled at approximately 30-day intervals in order to
obtain lab reference glucose values for comparison with the sensor
values and to evaluate hyperglycemic and hypoglycemic challenges in a
controlled setting.
“The promising results and compelling accuracy data shown in the PRECISE
II study represent a major milestone for the company,” said Tim Goodnow,
PhD., CEO and President of Senseonics. “We are quite excited to complete
the full analysis and report on other outcomes in the coming months.
Pending FDA review and approval, we look forward to bringing this
exciting technology to the U.S. market and to people with diabetes.”
Senseonics expects to submit its Pre-Marketing Approval (PMA) package to
the U.S. Food and Drug Administration in the next few months. Subject to
receiving FDA regulatory approval, Senseonics plans to initiate sales in
the United States. The company currently markets the system under the
brand name Eversense in select European countries.
Eversense CGM System is an Investigational Device and is limited by
United States law to investigational use.
About Senseonics
Senseonics
Holdings, Inc. is a medical technology company focused on the
design, development and commercialization of glucose monitoring products
designed to help people with diabetes confidently live their lives with
ease. Senseonics’ first generation continuous glucose monitoring (CGM)
system, Eversense®, includes a small sensor, smart transmitter and
mobile application. Based on fluorescence sensing technology, the sensor
is designed to be inserted subcutaneously and communicate with the smart
transmitter to wirelessly transmit glucose levels to a mobile device.
After insertion, the sensor is designed to continually and accurately
measure glucose levels. For more information on Senseonics, please visit www.senseonics.com.
SAFE HARBOR STATEMENT
Certain statements contained in this press release, other than
statements of fact that are independently verifiable at the date hereof,
may constitute “forward-looking statements.” These forward-looking
statements reflect Senseonics’ current views about its plans,
intentions, expectations, strategies and prospects, including statements
concerning the United States commercial launch of Eversense and future
regulatory filings, which are based on the information currently
available to Senseonics and on assumptions Senseonics has made. Although
Senseonics believes that its plans, intentions, expectations, strategies
and prospects as reflected in or suggested by those forward-looking
statements are reasonable, Senseonics can give no assurance that the
plans, intentions, expectations or strategies will be attained or
achieved. Furthermore, actual results may differ materially from those
described in the forward-looking statements and will be affected by a
variety of risks and factors that are beyond Senseonics’ control. Other
risks and uncertainties are more fully described in the section entitled
“Risk Factors” in Senseonics’ Annual Report on Form 10-K filed with the
Securities and Exchange Commission (SEC) on February 19, 2016, the
Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission on May 12, 2016 and its other SEC filings. Existing and
prospective investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. The
statements made in this press release speak only as of the date stated
herein, and subsequent events and developments may cause Senseonics’
expectations and beliefs to change. Unless otherwise required by
applicable securities laws, Senseonics does not intend, nor does
Senseonics undertake any obligation, to update or revise any
forward-looking statements contained in this news release to reflect
subsequent information, events, results or circumstances or otherwise.
While Senseonics may elect to update these forward-looking statements
publicly at some point in the future, Senseonics specifically disclaims
any obligation to do so, whether as a result of new information, future
events or otherwise, except as required by law.

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Senseonics Holdings, Inc.
INVESTOR CONTACT
R. Don Elsey
Chief
Financial Officer
301.556.1602
[email protected]
Source: Senseonics Holdings, Inc.