WaveForm Technologies Gets CE Mark Approval for CGM System

WaveForm Technologies Inc. announced it received CE Mark (Conformité Européenne) approval for its Cascade Continuous Glucose Monitoring (CGM) system.

The commercialization of the product for the European market is anticipated to begin in select countries.

The WaveForm Technologies Cascade CGM system is based on several pioneering, patented innovations in glucose sensor technology offering users a convenient way to view up-to-the-minute glucose readings on a smartphone.

This innovative system continuously monitors glucose levels in interstitial fluid through a small, disposable sensor that can be worn on the body for up to 14 days.

Together, the sensor and Bluetooth^® transmitter accurately measure and transmit glucose data to the mobile app every minute, without the need for an additional receiver device.

“This is a substantial milestone for our company and marks our commercial entrance into the transformative and rapidly growing CGM marketplace,” said John Alberico, CEO of AgaMatrix Holdings LLC, the company owns WaveForm.

“The CE approval of the WaveForm CGM system allows us to reach a broader patient base and provide a powerful new tool in diabetes management. This achievement is shared with all our employees, and I want to take this opportunity to thank them for their tireless efforts and dedication,” Alberico added.

Who Can Use The Technology?

Real-time glucose data provided by the WaveForm CGM facilitates blood glucose control through informative glucose trends, predictive and customizable alerts, and personalized glucose reports.

Persons ages 2 years and older, including pregnant women and those requiring dialysis treatment, can use the WaveForm CGM in making diabetes treatment decisions.

Unlike similar systems on the market which use a needle to apply the glucose sensor, the novel sensor and applicator design for the WaveForm CGM enables a needle-free, virtually pain-free experience.

“We have demonstrated the performance of our system in extensive clinical testing, and the introduction of the WaveForm CGM system to the market represents another step forward in helping persons with diabetes maintain control of their lives,” stated Mihailo Rebec, CTO for WaveForm Technologies.

“The user experience has always been foremost in our minds during the development of this system and by delivering glucose results every minute, the WaveForm CGM will allow users to make real-time diabetes management decisions,” Rebec added.

How Does the CGM Work?

The WaveForm CGM system consists of a thin filament (sensor) that collects glucose data from just below the skin which is processed and wirelessly transferred to a mobile app through a small transmitter.

The rechargeable transmitter lasts an entire 14-day session on one complete charge and uses Bluetooth^® wireless technology to transfer data to an Android and iOS compatible mobile app.

WaveForm Technologies is also conducting clinical trials for extended sensor wear time and preparing for clinical studies in the U.S.

WaveForm anticipates filing an application with the FDA for the clearance of their CGM system in 2020, with U.S. commercialization anticipated in 2021.

Featured image: WaveForm Technologies Cascade Continuous Glucose Monitoring System, courtesy of WaveForm Technologies Inc.