NeurOs

Clinical Validation of Mespere NeurOs against Invasive Blood Sample Analysis By Co-Oximeter

Methods

A peripheral IV was placed in the patient’s hand or arm vein. An ultrasound-guided small diameter catheter was then inserted in the right upper internal jugular vein. A radial arterial line was inserted into a radial artery on the left arm. Two standard pulse oximeters were attached to the patient’s fingers to help guide the hypoxia state plateau levels. The Mespere Cerebral Oximetry sensor was placed on the forehead. Blood gas analysis to determine oxyhemoglobin saturation was performed using a Co-Oximeter. Each subject had control data taken at the beginning of each experiment, with two control blood samples drawn while breathing room air. Hypoxia was induced to different levels of oxyhemoglobin saturation (between 70-100% SpO2) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. Once a steady state level of hypoxia is achieved, a 1.0ml sample of blood are obtained simultaneously from the jugular line and radial arterial line. A second blood pair of samples, at the same steady-state saturation, is taken 30 seconds later. The VO200 - NeurOs Cerebral Oximetry samples were recorded simultaneously to the blood samples. The blood samples were immediately analyzed by the Co-Oximeter. Up to 27 paired samples were obtained on the plateaus across this span for each subject.

Results

A total of 284 paired venous and arterial blood sample readings, and 284 Mespere VO 200- NeurOs Cerebral Oximetry System readings were used to perform the comparison and statistical analysis.

The calculated statistical results from the study are as follows:

Absolute Trending Accuracy	± 1.5%
Pearson Coefficient	0.973

Scenario

Number of Cases Per Year:	500
Cost of ICU Stay Per Day:	$3592
Cost of Non-ICU Stay Per Day:	$1135

Mespere vs. Competitors Sensor Savings

	COMPETITOR	MESPERE
Comparison cost per patient:	$300	$50
Total cost per year:	$150,000	$25,000

Net Savings by Mespere: $125,000

Hospital Savings

SAVINGS	TOTAL
Number of Cases per year:	500
Number of Cases at risk of cerebral desaturation (20%):	100
Decrease in ICU days using Cerebral Oximeter per patient:	3
Total Decrease in ICU days using Cerebral Oximeter per year:	300
Cost of ICU stay per day:	$3,592
Total Savings - ICU Stay:	$1,077,600
Decrease in Non- ICU days using Cerebral Oximeter per patient:	1
Total Decrease in ICU days using Cerebral Oximeter per year:	100
Cost of Non-ICU stay per day:	$1,350
Total Savings - ICU Stay:	$135,000
Cost of Mespere sensors per patient:	$50
Cost per year	$25,000

Net Savings to hospital: $1,187,600