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Coaxia Inc. Announces First Patient Enrolled In Pivotal Trial Evaluating NeuroFlo(TM) Cerebral Perfusion Augmentation For Ischemic Stroke


11/1/2005 1:00:19 PM

MINNEAPOLIS, Nov. 1 /PRNewswire/ -- CoAxia, Inc. of Maple Grove, MN, today announced that Central DuPage Hospital in Winfield, IL enrolled the first patient in its multi-center trial evaluating the safety and efficacy of its unique cerebral perfusion augmentation therapy for ischemic stroke.

Dr. Harish Shownkeen, Director of Endovascular Surgical Neuroradiology at Central DuPage Hospital treated the patient with the NeuroFlo catheter approximately eight and a half hours after symptoms were first reported. Dr. Shownkeen commented, "This patient had no proven acute treatment options, due to the relatively long time from the onset of symptoms to treatment. The NeuroFlo catheter was deployed easily and treatment occurred with no issues. We are pleased to have enrolled the first patient in this unique and important trial."

The CoAxia SENTIS trial (Safety and Efficacy of NeuroFlo Treatment for Ischemic Stroke) is an FDA-approved, randomized evaluation of NeuroFlo that will be enrolling approximately 400 patients at more than 40 sites in the US and Canada. Patients will be treated up to 10 hours after stroke onset and be evaluated neurologically at 90 days. If successful, NeuroFlo may become an important treatment option for the many thousands of patients that arrive at hospitals beyond the time limit for delivery of present treatments.

"We are excited to begin enrollment for this important trial. Our goal is to provide a new treatment option for acute stroke -- one that minimizes the disability of this devastating condition and can be safely and easily delivered up to 10 hours after onset," says Lorinda Austin, Vice-President of Clinical Affairs for CoAxia.

The NeuroFlo catheter works by increasing blood flow to the brain through restriction of blood flow in the descending aorta. The increased cerebral blood flow is designed to provide enhanced perfusion to the stroke penumbra and thus limits the size and damage of the stroke. The NeuroFlo catheter is inserted in the femoral artery and advanced to the abdominal aorta where its unique dual balloon design provides the therapy.

CoAxia, Inc. is a venture-backed, privately held, development stage company focused on providing perfusion augmentation therapies that improve outcomes for patients with cerebral ischemia resulting from vasospasm, stroke and other conditions. In addition to the SENTIS trial for ischemic stroke, CoAxia's NeuroFlo system has been approved by the US FDA via Humanitarian Device Exemption for the treatment of refractory cerebral ischemia following repair of a subarachnoid hemorrhage.

CoAxia, Inc.

CONTACT: Rick Schallhorn, Vice President, Marketing & BusinessDevelopment, +1-763-315-8396, rschallhorn@coaxia.com , or Andrew M. Weiss,President & CEO, +1-763-315-8393, aweiss@coaxia.com , both of CoAxia, Inc.



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