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

CLEVELAND, April 6, 2012 /PRNewswire/ -- Arteriocyte, a leading biotechnology company with offices in Cleveland, Ohio and Hopkinton, Massachusetts announced today approval from the Food and Drug Administration (FDA) to initiate a Phase I clinical trial using its Magellan MAR01™ technology in the treatment of Compartment Syndrome. The FDA Investigational Device Exemption (IDE 15013) allows Arteriocyte and its clinical partners to initiate evaluation of concentrated marrow injections (using the Magellan MAR01™ technology) to mitigate ischemic damage due to Compartment Syndrome in extremity trauma patients. This treatment has been developed in partnership with the United States Army Institute of Surgical Research (ISR) and San Antonio Military Medical Center (SAMMC) at Fort Sam Houston, and The Ohio State University as part of Arteriocyte's Cellular Therapies for Battlefield Wounds Program.

The Magellan® system is an FDA 510(k) cleared medical device for the rapid production of platelet rich plasma from blood and bone marrow that can be applied to a surgical site as surgeons deem necessary for their clinical use requirements. Magellan MAR01™ technology enables the rapid Operating Room based "closed system" concentration of aspirated bone marrow, yielding an injectable tissue rich in platelets, hematopoietic stem cells and mesenchymal stem cells in as little as fifteen minutes. The self contained Magellan unit provides critical ease-of-use and operator-independent consistency necessary for deployment in military medical operations. Arteriocyte has partnered with the U.S. Military to develop Magellan MAR01™ in clinical use across three trauma platforms: Extremity Trauma, Burn Wounds and Infection Prevention. The company is already actively enrolling patients in a separate clinical trial for MAR01™ treatment in Critical Limb Ischemia under an FDA approved Investigational Device Exemption (IDE-14522).

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SOURCE Arteriocyte
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