Senseonics, a medical device company focused on the development and commercialization of the first fully implantable, long-term continuous glucose monitoring (CGM) system, announced that it has raised an additional $20 million of private equity financing.
Current investors Anthem Capital, Delphi Ventures, Greenspring Associates, Healthcare Ventures, New Enterprise Associates and other strategic partners all participated in the financing round.
Senseonics (formerly known as Sensors for Medicine and Science) is developing an implantable continuous glucose sensor designed for highly accurate, long-term wear. The Continuous Glucose Monitoring System (CGMS) includes a miniaturized sensor, transmitter and mobile medical application.
Based on fluorescence sensing technology, the sensor is designed to be inserted into the subcutaneous space of the upper arm and communicate with the transmitter to wirelessly transmit glucose levels to a smartphone.
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After insertion, the sensor functions automatically and continuously, and the system is intended to enable people with diabetes to more confidently live their lives with more ease.
Senseonics has recently begun its European pivotal trials and expect to complete site initiation of all seven European sites before the end of summer, according to the company.
"We’re very happy of the continued support from our investors as we near the completion of the product development efforts for our first generation long-term CGM system," Tim Goodnow, CEO and president of Senseonics, said in a statement.
Continuous glucose monitoring has the potential to further help diabetes patients examine how their glucose level reacts to insulin, exercise, food and other factors. Recent studies have shown that CGM is effective at improving glucose control while minimizing severe hypoglycemia.
In addition, accurate continuous glucose monitors are a key component of the promising artificial pancreas ongoing studies that could potentially offer additional freedom in the management of diabetes.
Senseonics also announced that Mirasol Panlilio, formerly of Abbott Diabetes Care and LifeScan, has joined the company as vice president of global sales and marketing.
"We are excited that Mirasol has agreed to join Senseonics. She brings a wealth of first-hand experience and creative energy in delivering novel diabetes devices to market," Goodnow said. "Having Mirasol join us at this time shows our focus will begin to shift towards commercialization."
Last year, the company was granted ISO 13485:2003 certification of its quality management system, which represents the requirements for comprehensive quality management system for design and manufacture of medical devices.
The scope of certification includes the design, development, manufacturing, servicing and distribution of active implantable glucose sensors and accessories for continuous glucose monitoring.
The European Union, Canada and Australia recognize ISO 13485 certification as a means of meeting regulatory requirements for conformity assessment, and U.S. FDA’s Quality System Regulations (21CFR820) is harmonized with ISO 13485.
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