Promising Results for Symphony® tCGM in Diabetics – Critical Care Next
Non-Invasive Symphony® tCGM Equivalent to Existing Invasive Wire Systems
Echo Raises Approximately $5.4M to Fund Symphony® tCGM Development
Download Full 6-Page Note with Important Disclosures: Morning Note 12-06-11 ECTE
Echo Therapeutics announced successful results from the clinical trial of their Symphony® tCGM System in both Type I and Type II diabetic patients (see Feasibility 2 below). Echo now plans to conduct a study in critical care patients.
Echo also announced a registered direct equity financing with current, institutional and strategic investors of approximately $5.4M by issuing 2.4M units at a price of $2.25 per unit. The unit consists of 1 share of common stock and a 3-year warrant to purchase 0.4 of a share of common stock at an exercise price of $3.00 (exercisable 6 months after issuance). The offering is expected to close on or about December 7, 2011.
Investors should note three key takeaways from the Feasibility 2 results:
1.) The Feasibility 2 data indicates that the new Symphony® tCGM System can monitor a broader range of blood glucose values found in diabetic patients (from 38 to 399 mg/dL) whereas the previous Feasibility 1 study in healthy patients had a narrower range from (64 to 212 mg/dL).
2.) The Feasibility 2 data agreed with the data seen in their Prototype Pilot 3 trial in diabetic patients using Prelude® microabrasion. The data also indicates that Echo’s non-invasive transdermal biosensor and skin microabrasion technology is equivalent to the competition’s invasive sensor wire systems.
3.) The Symphony® tCGM System appears safe as there were no adverse events reported.
|
Study
|
MARD
|
CG-EGA
A
|
CG-EGA
A+B
|
SkinPrep
|
Patients
|
# of
Glucose Readings
|
|
Feasibility 2
|
12.6%
|
94.4%
|
96.9%
|
Prelude®
Microabrasion
|
Diabetic
(Type I & II)
|
2,600
|
|
Feasibility 1
|
10.5%
|
98.3%
|
99.5%
|
Prelude®
Microabrasion
|
12 Healthy
|
1,600
|
|
Prototype Pilot 3
|
12.9%
|
n/r
|
97%
|
Prelude®
Microabrasion
|
Diabetic
|
900
|
|
Prototype Pilot 2
|
11.6%
|
86.4%
|
100%
|
Ultrasound
|
8 Critical Care
|
147
|
|
Prototype Pilot 1
|
12.5%
|
89.6%
|
98.7%
|
Ultrasound
|
10 Diabetic
|
220
|
|
Source: Echo Therapeutics
|
|
Competition / Product
|
MARD
|
CG-EGA
A+B
|
SkinPrep
|
|
Echo Symphony® tCGM
|
10.5%-12.6%
|
96.9%-99.5%
|
Prelude®
Microabrasion
|
|
Abbott Freestyle Navigator
|
9.3%-12.3%
|
98.0%
|
None
|
|
DexCom SEVEN PLUS
|
13.0% -15.9%
|
97.0%
|
None
|
|
Medtronic Guardian RT
|
15.6%-19.7%
|
98.9%
|
None
|
|
Source: Echo Therapeutics and LifeTech Capital
|
Definitions
MARD: Mean Absolute Relative Difference – Error calculated as the average relative difference between Symphony and the reference measurements
CG-EGA A: Continuous Glucose-Error Grid Analysis A – the clinically accurate A zone of the Clarke error grid
CG-EGA A+B: includes the clinically relevant B zone benign errors of the Clarke error grid
FEASIBILITY 2
Study Design: 20 adult subjects with Type 1 or Type 2 diabetes were evaluated. The skin of each subject was prepared using Prelude and a Symphony tCGM biosensor was applied to the skin site. Venous reference blood samples were taken from intravenous lines at 15-minute intervals for 24 hours and measured on a YSI 2300 STAT Plus Glucose Analyzer. The study data was blinded to study subjects and study personnel. At the conclusion of the 24-hour study period, the test skin sites were inspected for redness or other undesirable effects.
Study Results: Using over 2,600 Symphony tCGM glucose readings from the 20 study subjects paired with reference blood glucose measurements, CG-EGA showed that 94.4% of the readings were clinically accurate and 2.5% were benign errors with a combined A+B of 96.9%. The MARD for the study was 12.6%. Values for blood glucose measurements ranged from 38 to 399 mg/dL. There were no adverse events reported from the Prelude skin permeation or the Symphony tCGM biosensor.
FEASIBILITY 1
Study Design: 12 adult subjects without a history of diabetes were evaluated. The skin of each subject was prepared using Prelude and a Symphony tCGM biosensor was applied to the skin site. Venous reference blood samples were taken from intravenous lines at 15-minute intervals for 24 hours and measured on a YSI 2300 STAT Plus Glucose Analyzer and a commercially available, professional-use glucometer. The study data was blinded to study subjects and study personnel. At the conclusion of the 24-hour study period, the test skin sites were inspected for redness or other undesirable effects.
Study Results: Using over 1,600 Symphony tCGM glucose readings from the 12 study subjects paired with reference blood glucose measurements, CG-EGA showed that 98.3% of the readings were clinically accurate and 1.2% were benign errors with a combined A+B of 99.5%. The MARD for the study was 10.5%. Values for blood glucose measurements ranged from 64 to 212 mg/dL. There were no adverse events reported from the Prelude skin permeation or the Symphony tCGM biosensor.
Download Full 6-Page Note with Important Disclosures: Morning Note 12-06-11 ECTE
