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Arteriocyte Receives FDA Approval to Initiate Compartment Syndrome Trial for Amputation Prevention Focused on Wounded Warriors
Date:4/6/2012

protocol will evaluate the Magellan MAR01™ technology's role in treating wounded warriors at risk for long-term complications due to Compartment Syndrome, an acute condition that results from a rapid build up of fluid pressure in soft tissue compartments following trauma or severe inflammatory events. The elevated pressure collapses the blood vessels that perfuse muscle and bone, which can result in permanent tissue death, disability and amputation of the affected limb.

"We've been thrilled to partner with Arteriocyte in development of point-of-care cellular therapies," said Joseph Wenke, PhD, Manager of ISR's Extremity Trauma and Regenerative Medicine Task Area and the Orthopaedic Extremity Trauma Research Program. "This program is another example of the Institute for Surgical Research's efforts to improve stabilization, retention and readiness for thousands of our Wounded Warriors. We're pleased that Arteriocyte is ready to take this treatment into the clinic."

Retired Army Col., Dr. John Kragh, Orthopaedic Surgeon and researcher at the ISR, and Arteriocyte's Program Officer added, "Compartment Syndrome and the associated complications are a major challenge in Combat Casualty Care, resulting in elevated rates of amputations. This treatment represents an important potential tool to improve success of limb salvage for these patients."

Enrollment into the Compartment Syndrome clinical trial is anticipated to commence immediately following final approval by the Army's Human Research Protections Office. The study will be performed at The Ohio State University Wexner Medical Center, led by Dr. Jason Calhoun, Chair, Department of Orthopaedics, and Frank J. Kloenne, Chair in Orthopaedic Surgery.

Arteriocyte CEO Don Brown said, "We consider it our responsibility to help focus on improving care delivery for our men and women in uniform. During the past five years, we have worked hard to make Arteriocyte's technologies available to those me
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