HAGAR’s GWave RF Non-Invasive CGM Wins Breakthrough Status

Following $11.7 million series B funding earlier this year, Hagar recently earned FDA breakthrough status for GWave, a non-invasive continuous glucose monitoring (CGM) device that uses radiofrequency (RF) waves to measure glucose levels in blood.
 
GWave is about the size of a smartphone involves less RF exposure than one. It measures blood glucose without pricking the skin, enabling early glucose elevation detection and encouraging good diet and exercise.
 
“The GWave technology is impressive. I believe it has the potential to significantly improve the management of diabetes,” Roy Beck, MD, Ph.D., Medical Director of the JAEB Center for Health Research in Tampa, Fla. told the press.
 
A pilot study found that GWave blood glucose levels were accurate compated to measurements from a hexinokase core lab assay during an oral glucose tolerance test. The company intends to publish further studies in the coming months.
 
“Receiving FDA Breakthrough Designation reflects our commitment to deliver innovative technology targeting one of the world’s most significant chronic diseases, one which affects more than 422 million people, 8.5 percent of the world’s population,” Dr. Gerry Waintraub, CTO and co-founder of HAGAR told the press. “Our mission at HAGAR is to materially improve the health and quality of life of people impacted by diabetes.”
 
HAGAR also plans to begin a study before the end of the year on adults with diabetes at Israel’s Schneider Children’s Medical Center.
 
“The study will involve 250 patients with type 1 and type 2 diabetes and will test the accuracy of GWave on a diverse group of individuals across a range of demographic criteria,” Dr. Irl Hirsch, Medical Advisor to HAGAR and Professor of Medicine and the Diabetes Treatment and Teaching Chair in the Division of Metabolism, Endocrinology, and Nutrition at the University of Washington told the press. “We also have a second study due to start this winter, which will test the device’s accuracy during conditions of rapidly changing glucose levels.”
 
HAGAR is also developing a second-gen sensor that can be integrated into common available smartwatches.