This is to be brought to notice that WaveForm Technologies has successfully completed its four clinical Trials for its proprietary continuous glucose monitoring system.
Patients are supposed to sport the WaveForm CGM System for a period of 14- days. The system comprises of a novel sensor insertion tool and method, a small sensor wire, a specialized polymer coating and a small on-body transmitter. Patients will be intimated daily of their glucose data routing out the requirement for an additional receiver. The WaveForm CGM System pioneered in sensor technology offering umpteen benefits like seamless body sensor insertion restricting interferences providing ample and quick “warm up” time, sporadic glucose measurements, constricted calibrations paving way for longevity.
WaveForm also endeavors to curate an artificial pancreas or “closed loop” system to utilize the WaveForm’s possession of CGM sensor permitting “vertically integrated” AP system, differentiating the WaveForm system from virtually all AP systems currently under development. Development of the WaveForm AP system is likely to commence in 2018.As far as the clinical trials were concerned, 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. 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.
Mihailo Rebec, Ph.D., Chief Technical Officer of WaveForm stated “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.”