PLYMOUTH, MA -- (MARKET WIRE) -- May 29, 2007 -- Harvest Technologies Corp. (www.harvesttech.com) announced today that the Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to commence a 48-patient ‘feasibility’ clinical trial using the company’s BMAC System to treat patients with Critical Limb Ischemia (CLI). The BMAC System is a point-of-care device for concentrating a patient’s own (autologous) bone marrow stem cells in approximately 15 minutes. The study’s design provides for injecting these cells into the affected limb to reduce the potential for limb amputation. It is believed that the injection of stem cells will arrest and possibly reverse the effects of CLI, a late-stage form of Peripheral Arterial Disease (PAD). Patients who will be enrolled in this study have exhausted all other surgical options and are at extreme risk for major amputation.
