Market Overview

Positive Results for Ultradian Diagnostics 5-Day Clinical Study of Biologue CGM


Ultradian Diagnostics LLC, based in Rensselaer, New York, announced the
results of a 5-day clinical study of their Biologue minimally invasive
continuous glucose monitoring (CGM) system. The study was completed at
SUNY Upstate Medical University in Syracuse, NY under the direction of
Ruth Weinstock, MD, PhD.

The study was funded by a $1.3 million, Phase 2 SBIR grant from the
National Institutes of Diabetes, Digestive & Kidney Disease. The study
included 35 subjects: 20 with type 1 diabetes, 10 with type 2 diabetes,
and 5 with normal glycemia. Subjects wore the Gen 2 Biologue CGM for a
period of 5-days while in the clinic and at home. The Nova Biomedical
StatStrip Xpress glucose meter served as the reference method. A total
of 2,038 paired data points were obtained from 33 of 35 subjects.
Statistical analysis yielded a mean absolute relative difference (MARD)
of 11.3 % and a mean absolute difference (MAD) of 20.0 mg/dl. Continuous
glucose error grid analysis (CG-EGA) showed the point accuracy was 84.1
% in zone A, 15.9 % in zone B (100.0% A+B).

The study demonstrated proof of concept for Ultradian's single-point
calibration method and proprietary technology for extracting glucose
frequency and amplitude data for the purpose of factory calibration and
developing insulin pump control algorithms. "The data from this study
represents a significant milestone on our path to develop a user
calibration-free CGM capable of interfacing with an insulin pump to form
a closed-loop artificial pancreas", said Dr. John Willis, CEO of
Ultradian Diagnostics.

About Ultradian Diagnostics

Ultradian is a medical device company developing wireless, wearable
biosensors for monitoring chronic illnesses. The Company was founded to
improve the accuracy of minimally invasive biosensors so they may be
used at the bedside in hospitals and by people for self-monitoring of
chronic illnesses. Ultradian's initial product, called Biologue, is a
minimally invasive biosensor system that continuously measures glucose
within the dermis of the skin. Biologue is a platform technology whereby
components of the core system can be leveraged into other product
opportunities. Ultradian is actively seeking strategic partners to
accelerate commercial introduction of their continuous monitoring
technologies. For more information about Ultradian Diagnostics, please

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