Market Opportunity

Comatose Monitoring
Brainstem Death Diagnosis
Market Statistics
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

Market Opportunity

Brainstem Death Diagnosis

A subset of comatose patients will not survive the NICU.  Brain Death diagnosis policies vary from facility to facility, country to country.  It is generally declared after several preconditions regarding hypothermia, drugs, and/or other abnormalities are ruled-out and then one, often two doctors conduct a clinical exam based upon standard, subjective tests of the patient’s 5 senses.

These tests generally include:

(1)    Eye movement when head is rotated,

(2)    Pupillary response to light,

(3)    Response to corneal stimulation,

(4)    Vistibular-ocular reflex,

(5)    Gag reflex,

(6)    Cough reflex following bronchial stimulation,

(7)    Motor responses to pain stimuli, and

(8)    Spontaneous ventilation (apnea test)

Often facilities require these tests to be repeated after a certain period of time, sometimes up to 24 hours apart.  Once a clinical diagnosis has been made, confirming studies are often used, especially in the U.S., including angiography, neuro-flow study, electroencephalogram, evoked potentials and transcranial doppler.  Often, such confirmatory tests require the patient to be transported to a separate testing station, which is costly, inconvenient, and detrimental to the patient’s state.  Furthermore, since these tests are measuring secondary conditions of the brain and they all report a high incidence of false positives, none of these tests can be a primary diagnostic tool. 

This prolonged and problematic process is necessary in the current setting, but costly in terms of valuable time, labor, and equipment resources – not to mention the emotional toll it takes on the caregivers and the family.  Further, organ donation opportunities are often jeopardized since the window for harvesting much-needed organs is small and often surpassed for patients who have actually expired but are not through the diagnosis process yet.

The TMU has the potential to supersede these secondary tests and become a primary clinical evaluative tool because it directly measures the activity in the brainstem.  Studies have shown that OMT frequencies are absent when brainstem death has been diagnosed using the standard procedures listed above.  And because the TMU displays OMT activity instantaneously, right at the bedside, a more timely diagnosis could result in lower costs and improved opportunities for organ donation.

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