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Market

Intensive Care Unit

Emergency Departments

Ambulances

Indication Vasospasm Ischemic Stroke Ischemic Stroke
Annual Patients 21,000 (U.S.) 8000,000 (Stroke / U.s.)
1,100,000 (Stroke / E.U.)
8000,000 (Stroke / U.s.)
1,100,000 (Stroke / E.U.)
Facilities (U.S.) 450 Hospitals 16,500 Hospitals 158,000 Ambulances
Customer Neurosurgery Departments Emergency Medical Departments Ambulance Owners / Operators / Manufacturers
Regulatory Pathway Humanitarian Device Exemption Expedited Access PMA
( Class IIa in E.U.)
Expedited Access PMA
( Class IIa in E.U.)

 

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Disclaimer: 1c0, emergency department, or amourance “CAUTION – Investigational device. Not yet approved by US FDA for sale. Limited by United States law to investigational use.”