Healthcare Industry News:  Balloon catheter 

Devices Neurology Interventional FDA

 News Release - December 13, 2006

CoAxia(TM) Announces FDA Approval of Clinical Trial for Its Novel Stroke Treatment in Patients up to 24 Hours After Onset

NeuroFlo(TM) catheter feasibility study complements ongoing SENTIS 10 hour pivotal study

MINNEAPOLIS, Dec. 13 (HSMN NewsFeed) -- CoAxia, Inc. of Maple Grove, MN, today announced that the FDA has approved a safety and feasibility study of its NeuroFlo(TM) perfusion augmentation therapy in ischemic stroke patients who present for treatment as late as 24 hours after stroke onset. This is believed to be the first interventional device trial approved for this patient population. The study will enroll up to 25 patients and the results will determine future expansion to a pivotal study in late presenting stroke patients.

Dr. Souvik Sen, Director of the Stroke Service at the University of North Carolina commented, "This study represents another important step in applying medical devices to the treatment of acute stroke. There are no treatments currently approved to treat stroke patients in this 8-24 hour time window after symptom onset. If NeuroFlo can safely treat the large number of patients who present in this time window, it will have a major impact in stroke treatment."

The SafeFlo24 trial is an evaluation of the safety of the NeuroFlo perfusion augmentation catheter in stroke patients presenting for treatment between 8 and 24 hours after last known to be normal. The study was co- authored by Souvik Sen, MD, Lee Schwamm, MD from Massachusetts General Hospital, Maxim Hammer, MD from University of Pittsburgh Medical Center and David Liebeskind, MD from UCLA Medical Center. In addition to these four centers, the University of Rochester, New York, the University of Alberta, Edmonton and the University of Calgary, Calgary, will participate in the study. CoAxia anticipates that patient enrollment will begin in the first quarter of 2007.

In addition to the SafeFlo24 study, CoAxia is currently conducting a randomized, pivotal trial, SENTIS, which is evaluating the safety and efficacy of the same NeuroFlo treatment in patients less than 10 hours after the onset of their symptoms. The SENTIS trial began significant enrollment in early 2006 and now has over 30 leading North American stroke centers participating.

The NeuroFlo treatment is accomplished with a unique, dual-Balloon catheter placed in the descending aorta that works by increasing blood flow to the brain via restricting flow in the descending aorta. The increased cerebral blood flow is delivered to the stroke periphery (penumbra) via collateral circulation and may limit the size and damage of the stroke.

"CoAxia believes that our perfusion augmentation therapy has broad applicability across the hundreds of thousands of stroke patients. The SafeFlo24 study, together with our SENTIS trial and other studies in the planning stages, are intended to demonstrate that utility across a broad spectrum of stroke patients," commented Lori Austin, CoAxia Vice-President of Clinical Affairs.

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. The company closed an $11M Series C financing round in December of 2006 funded by its current investors.

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


Source: CoAxia, Inc

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