Harvest Receives FDA Clearance for Preparation of a Cell Concentrate from a Small Sample of Bone Marrow Aspirate
PLYMOUTH, Mass., Feb. 2 /PRNewswire-FirstCall/ -- Harvest(R) Technologies Corporation, announced today that it had received an additional FDA clearance for the point of care, safe and rapid preparation of a cell concentrate from bone marrow. Harvest plans to market the system under the BMAC(TM) (Bone Marrow Aspirate Concentrate) name. The BMAC System produces a cell concentration from a small 60ml sample of bone marrow in 15 minutes. Laboratory and clinical results have documented the bone marrow concentrate contains approximately 823 million total cells, comprised of 190 million mononuclear cells with about 1800 colony forming units. The BMAC System was approved in the EC approximately six months ago. Since that approval Harvest has been sponsoring clinical studies, documenting the effectiveness of its cell concentrate in orthopedic and ischemic tissue procedures. Physicians in Europe have been using cell concentrates from bone marrow for over ten years for various orthopedic procedures. The published literature has documented that the safe and effective use of autologous bone marrow concentrate on thousands of patients. These studies point to the use of a bone marrow concentrate for treating peripheral arterial disease, improving cardiac function, following debilitating cardiac events, and for the successful treatment in orthopedic applications of non-healing non-unions, reversing stage 1 and 2 osteonecrosis, and for numerous bone fusion procedures, Mr. Gary Tureski, Harvest's President states: We are extremely excited to offer a safe, easy to use point of care preparation of a cell concentrate from bone marrow. In Europe, we are aggressively supporting several studies intending to document the efficacy for orthopedic and ischemic tissue applications. We are looking forward to initiating similar multi-center IDE studies in the US and working with the FDA to secure additional appropriate clearances and approvals. Harvest plans on introducing the BMAC System at the AAOS in Chicago. Harvest will also be participating on March 21, at the "Stem Cell Summit" sponsored by the Robin Young Consultant Group. CONTACT: Harvest Technologies Corp Gary Tureski, President & Co-founder 508-732-7500 email@example.com
SOURCE Harvest Technologies Corporation
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