Senseonics Reports Topline Accuracy Results from U.S. Pivotal Study of Eversense CGM System.
9.8.2016 20:05 | 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.
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.
Senseonics Holdings, Inc.
R. Don Elsey
Chief Financial Officer
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