Harvest Technologies to Present at Medtech Insight and Windhover Information's 'In3 East' Investor Conference in Boston, Oct. 18-20, 2006.Company Has Developed World's First Product (BMAC BMAC Brattleboro Museum & Art Center BMAC Biomedical Monitoring And Countermeasures BMAC Boeing Military Airplane Co. BMAC Beijing Municipal Administration Committee [TM] System) That Makes Possible the Collection and Concentration of Cellular Compositions from Autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. Bone Marrow, Including Adult Stem Cells, Derived from the Patient, at the Point-of-Care, in Just 15 Minutes BMAC Now Being Used in Europe to Treat Vascular, Orthopedic and Cardiovascular Diseases PLYMOUTH, Mass. -- Harvest Technologies Corp. (www.harvesttech.com) announced today that its General Manager of Strategic Business Relations, P. Kevin Benoit, will present at Medtech Insight and Windhover Information's 'In3 East' investor conference, Oct. 18-20, 2006, at The Westin Hotel, Copley Place, Boston. The BMAC[TM] (Bone Marrow Aspirate as·pi·rate v. To take in or remove by aspiration. n. A substance removed by aspiration. Aspirate The removal by suction of a fluid from a body cavity using a needle. Concentrate) System is currently being used in Europe to treat vascular, orthopedic and cardiovascular diseases. It is the world's first and only product that makes possible the use of a clinically effective quantity of cellular compositions from a small aspirate of autologous bone marrow, including a large quantity of adult stem cells, derived from a patient at the point-of-care, in just 15 minutes. It is well-established in the scientific literature that a concentrate of autologous adult stem cells from bone marrow is clinically effective in achieving tissue regeneration in cardiovascular and vascular diseases. A concentrate of these cells contains "not only stem cells and precursor cells as a source of regeneration tissue, but also accessory cells that support angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. and vasculogenesis by producing several growth factors and cytokines Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. ." (Saigawa et al; Circulation Journal; vol. 68, December 2004; 68:1189-1193). Until now, it has been difficult to process and concentrate a clinically significant dose of adult stem cells from a patient's bone marrow at the point-of-care. "Adult stem cells derived from autologous bone marrow have been documented in the scientific literature to be clinically effective, with no reported adverse eventsCobut until now, the procurement of these cells has been a laborious and tedious process," said Gary D. Tureski, President of Harvest Technologies. "Our clinical experiences in Europe have demonstrated that our novel BMAC technology now makes it possible to easily and quickly process and concentrate cellular compositions from bone marrow, including a large quantity of adult stem cells, safely and rapidly to aid in point-of-care treatment of difficult-to-treat diseases." In Europe, Harvest's BMAC System is a breakthrough because it can process and concentrate cellular components, including the adult stem cells, from autologous bone marrow (a) at the point-of-care (b) in just 15 minutes. The concentrate produced by the BMAC System has been documented to be significantly easier to implement and requires one-third-less bone marrow aspirate from the patient compared to concentrations obtained by using other, laborious laboratory methods used in successful clinical studies1. There are 20 published clinical studies involving 1,483 patients at 36 sites around the world demonstrating that this approach (adult stem cells derived from autologous bone marrow) enables clinicians to offer new therapies for a variety of serious diseases, with no reported adverse events. In the U.S., the BMAC System is currently marketed for use in "...the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of...a cell concentrate from bone marrow." As the safety and effectiveness of the BMAC System for in vivo use has not been established in the U.S., Harvest is actively in discussions with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to commence a multicenter clinical trial of this treatment modality. Harvest intends to conduct a six-site DE clinical trial using the BMAC System for the treatment of patients with Critical Limb Ischemia (CLI (1) (Call Level Interface) A database programming interface from the SQL Access Group (SAG), an SQL membership organization. SAG's CLI is an attempt to standardize the SQL language for database access. ), which is the later stage of Peripheral Arterial Occlusive occlusive /oc·clu·sive/ (o-kloo´siv) pertaining to or causing occlusion. oc·clu·sive adj. 1. Occluding or tending to occlude. 2. Disease (PAOD PAOD Peripheral Arterial Occlusive Disease )Coclogged arteries, particularly in the lower legs. Patients with CLI are at extreme risk for amputation amputation (ăm'pyətā`shən), removal of all or part of a limb or other body part. Although amputation has been practiced for centuries, the development of sophisticated techniques for treatment and prevention of infection has greatly . Approximately 500,000 people worldwide suffer from CLI, and about 160,000 amputations are performed each year in the U.S. as a result of this condition (source: The Sage Group). A recent pilot study conducted in Berlin, Germany, using the BMAC System to treat CLI showed a 60 percent reduction in amputations. An additional randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. prospective clinical trial for the treatment of CLI is planned to commence this fall in the EC. Harvest Technologies is a privately held company privately held company A firm whose shares are held within a relatively small circle of owners and are not traded publicly. based in Plymouth, Mass. 1Data on file. |
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