WaveForm Technologies has completed four human clinical trials for its proprietary continuous glucose monitoring (CGM) system.
The WaveForm CGM system, which is designed to be worn by patients for a 14-day period, consists of several proprietary components: a novel sensor insertion tool and method, a small sensor wire, a specialized polymer coating and a small on-body transmitter. The WaveForm CGM will be compatible with all of the leading smartphone platforms, and will connect via Bluetooth to provide continuous glucose data directly to a patient's smartphone without the need for an additional receiver.
The WaveForm CGM system was acquired in December 2016 from Bayer Healthcare and iSense CGM and is based on several patented innovations, including pioneering sensor technology. The WaveForm CGM system offers rapid, easy and painless on-body sensor insertion, limited interferences (for example, for patients taking acetaminophen), rapid "warm up" time (one hour or less), more frequent glucose measurements (one measure every minute), limited calibrations (average of one per day) and the potential for significantly longer wear life (14 days and longer). The competitive manufacturing cost profile, combined with the longer potential wear life, provides the opportunity to offer CGM to patients at a very attractive per day cost.
A total of four human clinical trials were completed by WaveForm for its CGM system in 2017, building upon eight human clinical trials in 292 patients previously conducted by Bayer Healthcare. The studies, one of which included a performance comparison to the Dexcom G5 CGM, enrolled a total of 57 patients across three clinical sites. The study results indicate the current WaveForm CGM system, using an early phase CGM calibration algorithm that will be improved based upon data collected from these preliminary studies, demonstrates accuracy that is consistent with the Dexcom G5.
In the first two clinical studies, sensors were worn for 7 and 10 days respectively. The WaveForm CGM sensor demonstrated a mean absolute relative deviation, or MARD, as compared to a lab reference measurement of blood glucose, of 13.9% and 13.3%, respectively. In the third study, which included 10 subjects who utilized a WaveForm CGM and a Dexcom G5 Platinum Sensor CGM simultaneously, worn for a period of seven days, the WaveForm CGM demonstrated an MARD of 11.1%, as compared to 12.2% for the Dexcom G5. There were no reported safety issues in any of the four clinical trials. Results from the first two clinical trials were recently reported at the Diabetes Technology Meeting in November 2017.
"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," said Mihailo Rebec, Ph.D., Chief Technical Officer of WaveForm. "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."
WaveForm currently expects to receive CE mark approval for its CGM product candidate in the European Union in 2018, and is planning human clinical trials to support a PMA submission to seek approval to market and sell the system in the United States, potentially as early as 2019.