Arteriocyte has received the Food and Drug Administration (FDA) approval, to initiate a Phase I clinical trial using its Magellan MAR01 technology in the treatment of Critical Limb Ischemia (CLI).
The FDA Investigational Device Exemption (IDE 14522) approval allows the company and its partners to initiate evaluation of concentrated marrow injections, using the Magellan MAR01 technology, to improve perfusion in ischemic tissue in affected limbs of patients with CLI who are not eligible for revascularization surgery.
The FDA approved Magellan technology combines a rapid bedside tissue concentration device and sterile surgical disposables that produce platelet rich plasma from blood and bone marrow aspirations in approximately 15 minutes, for use as deemed appropriate by surgeons.
The Magellan MAR01 technology enables the rapid ‘closed system’ concentration of aspirated bone marrow, yielding an injectable tissue rich in platelets, hematopoietic stem cells and mesenchymal stem cells, in tissue repair.
Arteriocyte is developing MAR01 for use as a clinical treatment for CLI, and plans to initiate additional clinical trials evaluating MAR01 in cardiovascular disease, and the clinical setting of orthopedics and tissue repair during 2011.