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
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
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
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.
Harvest Technologies Corp
President & Co-founder
SOURCE Harvest Technologies Corporation