Healthcare Industry News:  Balloon catheter 

Devices Neurology Interventional

 News Release - July 24, 2007

CoAxia(TM) Announces First Use of NeuroFlo(TM) Technology in Study for Stroke Patients After Attempted Thrombolysis

MINNEAPOLIS, July 24 (HSMN NewsFeed) -- CoAxia(TM), Inc. of Maple Grove, MN, today announced that investigation of its NeuroFlo(TM) perfusion augmentation technology has been extended to patients who do not respond to thrombolysis with the drug tissue plasminogen activator (tPA), the only stroke therapy currently approved by the US FDA. Already being evaluated as a stand alone treatment for patients that are outside the three hour tPA treatment window, NeuroFlo cerebral perfusion augmentation was successfully performed for the first time on a patient who had previously received tPA by the stroke team at University of Alberta Hospital in Edmonton, Canada.

The procedure was performed by Dr. Rob Ashforth on a 35 year old stroke victim whose symptoms and cerebral imaging showed no improvement following administration of tPA. Following NeuroFlo treatment, the patient had a significant improvement in blood flow to the brain and in motor and speech function, with no adverse events. Co-principal investigators, Drs. Ken Butcher, Derek Emery and Ashfaq Shuaib are leading this 20 patient feasibility study to investigate the safety of using cerebral perfusion augmentation in patients who receive tPA but do not respond clinically. While thrombolysis is the only stroke treatment proven safe and effective in a randomized trial, only a minority of patients benefit from a near complete recovery. There remains significant need for adjunctive treatments in this important patient group.

Dr. Ashfaq Shuaib, Director of Stroke Services at the University of Alberta said, "CoAxia is already conducting studies to demonstrate that NeuroFlo treatment may be effective as a stand alone treatment, and we are excited to extend this work to patients who do not respond to pharmaceutical interventions. This feasibility study is an important step to show that NeuroFlo treatment is a good adjunct to tPA therapy."

Lori Austin, Vice President Clinical Affairs commented, "The NeuroFlo technology may be an ideal adjunct to tPA therapy by providing global perfusion augmentation before, during, or after thrombolytics. With the help of the team in Edmonton, we have taken our first step in the clinical evaluation for this large group of patients".

The NeuroFlo treatment is intended to deliver increased blood flow to the affected, but still salvageable, area of the brain in stroke patients by increasing flow via collateral pathways "around" a blocked artery. The therapy is accomplished with a unique, dual-Balloon catheter that creates a partial occlusion of the descending aorta and redirects blood flow to the brain.

In addition to this feasibility study, CoAxia has two additional stroke studies underway -- the SENTIS randomized pivotal trial of patients up to 10 hours after stroke onset, and the Flo24 safety and feasibility study of patients as late as 24 hours after stroke.

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 stroke, vasospasm and other conditions.

For further information contact Andrew M. Weiss, President & CEO (763-315- 8393 or or Rick Schallhorn, Vice President, Marketing & Business Development (763-315-8396 or

Source: CoAxia

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