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2014

Harvest Receives FDA Clearance for Preparation of a Cell Concentrate from a Small Sample of Bone Marrow Aspirate

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    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
     gtureski@harvesttech.com
 
 

SOURCE Harvest Technologies Corporation

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