Senseonics Announces Start of PRECISE II U.S. Trial of Long-Term CGM
Study of the Eversense(R) CGM System, a 90-Day Implantable Glucose Sensor
GERMANTOWN, MD--(Marketwired - January 20, 2016) - Senseonics, Incorporated today announced the start of the PRECISE II (A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor) Study in people with diabetes in the United States.Â The PRECISE II study will evaluate the long-term safety and effectiveness of the company's EversenseÂ® Continuous Glucose Monitoring (CGM) System, which is expected to be the first fully implantable, long-term CGM system in the world.Â
"The start of the PRECISE II study is an important milestone for the company.Â We have completed the original PRECISE multi-site European pivotal study demonstrating very strong results including meeting all primary endpoints.Â We believe this U.S. based PRECISE II study will continue to demonstrate the system's safety and effectiveness enabling us to submit necessary data to the U.S. Food and Drug Administration for our PMA approval," said Dr. Tim Goodnow, CEO and President of Senseonics.
"CGM systems allow people with diabetes to continuously monitor their glucose 24/7, to see glucose trends and patterns, and be alerted to clinically significant high and low glucose levels," said Dr Ronald Brazg, Clinical Investigator at Rainier Clinical Research Center, Seattle, Washington.Â "What is different about the Eversense system is that it is implanted in the upper arm for continuous 90 day use, versus the transcutaneous 7-day sensors used by current CGM systems. We began enrolling subjects last week, and yesterday we had the very first PRECISE II subject successfully inserted with the sensor.Â We're excited to follow this subject, and all the other study subjects, for 90 days to evaluate the system's performance."
The primary objectives of the PRECISE II study are to determine the accuracy, and to demonstrate the safety, of the Eversense system through 90 days post-insertion. The PRECISE II is a non-randomized, blinded, prospective, single-arm, multi-center study, enrolling adult subjects with diabetes at up to 10 U.S. sites. The investigation will include both clinic visits and home use of the system.Â The CGM glucose results and all glucose related alarms and alerts will be blinded to the study subject for the duration of the study.
Senseonics Holdings, Inc. is developing the first fully implantable continuous glucose sensor designed for accurate, long-term wear. The EversenseÂ® CGM system includes a miniaturized sensor, smart transmitter and mobile app. Based on proprietary 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 functions automatically and continuously. The system is intended to enable people with diabetes to confidently live their lives with ease. For more information on Senseonics, please visit us at www.senseonics.com .
Forward Looking Statements
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 our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we 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 our control.
Other risks and uncertainties are more fully described in the section entitled "Risk Factors" in the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on December 10, 2015. 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 our expectations and beliefs to change. Unless otherwise required by applicable securities laws, we do not intend, nor do we 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 we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim 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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