FDA grants IDE approval for Arteriocyte's Magellan MAR01 Phase I Compartment Syndrome clinical trial

ArteriocyteApr 7 2012

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).

The current clinical 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 men and women who serve our country. We continue to be humbled by the extraordinary vision and commitment of our partners at ISR and SAMMC to develop and deliver the best care possible for our combat wounded soldiers."