In October 2016, Ultradian completed a 35-subject, 5-day (100 hr) clinical study at SUNY Upstate Medical University under the direction of our collaborator Dr. Ruth Weinstock. The data from our Biologue CGM was compared to the reference consisting of the Nova Biomedical Stat Strip Xpress blood glucose meter. The data from the Clarke Error Grid showed that 100% of the data points fell within the A (84.1%) and B (15.9%) zones of the error grid.
The next phase of our CGM development will focus on the development and manufacture of our Gen 3 go-to-market CGM. This will include CE Mark and FDA regulatory compliance. We anticipate launching in Europe in 2021 followed by the US in 2022.