• Final Critical Care Feasibility Study Data Strong with MARD of 9.0%
• Experts See Demand for CGM in Hospitals – Echo’s Transdermal CGM Favored
• Ferndale Pharma Expands License for Prelude® to Additional Countries
Download Full 8-Page Note with Important Disclosures: Morning Note 08-01-12 ECTE
Echo Therapeutics announced very strong results for their Symphony® tCGM (transdermal continuous glucose monitoring) system from the Feasibility 3B study in Critical Care patients (their lead indication) conducted at Thomas Jefferson University. The results of all the feasibility studies are highly supportive for the initiation of late-stage clinical trials for European registration.
Investors should note three key takeaways from the Feasibility 3B (Thomas Jefferson) results:
1.) The Feasibility 3B data indicates that the new Symphony® tCGM System can successfully monitor Critical Care patients, which is their lead indication. The low MARD of 9.0% was the best seen thus far during feasibility testing. The CG-EGA was 98.9% clinically accurate with 0.3% benign errors for a combined A+B of 99.2%.
2.) The Feasibility 3B data agreed with the data seen in the previous Feasibility studies in both healthy and diabetic patients using Prelude® microabrasion. The Symphony tCGM results appear to be accurate and consistent. 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 |
CG-EGA |
SkinPrep |
Patients |
# of |
|
Feasibility 3B |
9.0% |
98.9% |
99.2% |
Prelude® |
15 Critical Care |
1,200 |
|
Feasibility 3A (Tufts) |
12.3% |
99.6% |
99.6% |
Prelude® |
15 Critical Care |
540 |
|
Feasibility 2 |
12.6% |
94.4% |
96.9% |
Prelude® |
20 Diabetic |
2,600 |
|
Feasibility 1 |
10.5% |
98.3% |
99.5% |
Prelude® |
12 Healthy |
1,600 |
|
Prototype Pilot 3 |
12.9% |
n/r |
97% |
Prelude® |
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 |
SkinPrep |
|
Echo Symphony® tCGM |
9.0%-12.6% |
96.9%-99.6% |
Prelude® |
|
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 |
|||
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 3B (Thomas Jefferson)
Study Design: The study was performed at Thomas Jefferson University Hospital and enrolled 15 adult patients. The skin of each patient was prepared using Prelude and a Symphony tCGM biosensor was applied to the skin site after transfer to critical care. Reference blood samples were taken from arterial line catheters at 30-minute intervals and measured on a YSI 2300 STAT Plus Glucose Analyzer. The data collected by Symphony was blinded to study subjects and Jefferson clinical staff. At the conclusion of the study period, the test sites were inspected for redness or other undesirable effects.
Study Results: Using over 1,200 Symphony tCGM glucose readings from 15 study subjects paired with reference blood glucose measurements, CG-EGA showed that 98.9% of the readings were clinically accurate and 0.3% were benign errors with a combined A+B of 99.2%. The MARD for the study was 9.0%. There were no adverse events reported from the Prelude skin preparation or the Symphony tCGM biosensor.
FEASIBILITY 3A (Tufts)
Study Design: The study was performed at Tufts Medical Center and enrolled 15 adult patients scheduled for elective cardiac surgery. The skin of each patient was prepared using Prelude and a Symphony tCGM biosensor was applied to the skin site prior to surgery. Reference blood samples were taken from arterial line catheters at 30-minute intervals and measured on a YSI 2300 STAT Plus Glucose Analyzer. The data collected by Symphony was blinded to study subjects and Tufts clinical staff. At the conclusion of the study period, the test skin sites were inspected for redness or other undesirable effects.
Study Results: Using over 540 Symphony tCGM glucose readings from 15 study subjects paired with reference blood glucose measurements, CG-EGA showed that 99.6% of the readings were clinically accurate and 0% were benign errors with a combined A+B of 99.6%. The MARD for the study was 12.3%. There were no adverse events reported from the Prelude skin preparation or the Symphony tCGM biosensor.
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 8-Page Note with Important Disclosures: Morning Note 08-01-12 ECTE
