WaveForm Technologies said today that it has finished four clinical trials of its continuous glucose monitoring system and that it expects to win CE Mark clearance for the device this year.
The WaveForm CGM system is designed to be worn for 14 days and includes a sensor insertion tool, a small sensor wire, a polymer coating and an on-body transmitter.
The company, which was formed after AgaMatrix split last year, noted that its CGM will connect directly with a patient’s smartphone using Bluetooth, eliminating the need for an extra receiver.
WaveForm’s CGM boasts several advantages compared to currently-available products, the company suggested, including fast and painless on-body sensor insertion and the ability to take one glucose measurement every minute. The system also needs just one calibration each day and features longer wear-time than traditional devices.
In one study conducted last year, 10 patients wore a WaveForm CGM and one of Dexcom‘s (NSDQ:DXCM) G5 Platinum Sensor CGM at the same time for seven days. The WaveForm device had a mean absolute relative deviation of 11.1%, compared to 12.2% for Dexcom’s product.
“We believe these clinical trial results support the safety, efficacy and potential of WaveForm’s CGM technology, and the commencement of pivotal studies designed to secure commercial approval,” chief technical officer Mihailo Rebec said in prepared remarks.
“We look forward to commencing additional studies using our improved sensor algorithm in early 2018, which we expect will indicate continued improvements in system accuracy, and to completing pivotal studies that will serve as the basis for seeking approval to market the WaveForm CGM in the European Union.”
The company is also planning to begin development for a closed-loop insulin delivery system integrated with its CGM this year.
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