SOURCE: Harvest Technologies, Inc.

November 16, 2006 12:13 ET

French and U.S. Physicians Say a Simple, Point-of-Care System for Concentrating Autologous Adult Stem Cells From Bone Marrow Is Enabling European Clinicians to Offer New Therapies for a Variety

of Serious Diseases, With No Reported Side Effects

Data Presented at Harvest Technologies-Sponsored Symposium: "The Potential for Concentrated Bone Marrow Stem Cells in Orthopedic Surgery: The European Experience"

PLYMOUTH, MA -- (MARKET WIRE) -- November 16, 2006 -- Harvest Technologies Corp. (www.harvesttech.com) announced today that a French and a U.S. physician told an audience of other physicians, medical industry executives and patients about a simple, point-of-care device for concentrating autologous adult stem cells from bone marrow that is enabling European clinicians to offer stem cell therapies for orthopedic and other diseases, with no reported side effects.

Phillipe Hernigou, M.D. (Henri Mondor Hospital, Creteil, France) and Sherwin Kevy, M.D. (Associate Professor of Pediatrics, Harvard Medical School, and Director of the Transfusion Services Emeritus at Children's Hospital (Boston) and an Investigator at CBR Institute for Biomedical Research (Boston) presented data related to the clinical experiences in Europe using Harvest's BMAC System. "Harvest's technology is an important advance for medicine because it can process and concentrate cellular components, including the adult stem cells, from autologous bone marrow not only at the point-of-care, but also in just 15 minutes," said Dr. Hernigou. "And, 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 studies," added Dr. Kevy. He also noted that there are 20 published clinical studies involving 1,483 patients at 36 sites around the world demonstrating that this approach (concentrating 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.

The BMAC™ 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, orthopedic 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 and vasculogenesis by producing several growth factors and cytokines." (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.

"I wish this BMAC technology were available to doctors here in the United States," said Don Freeman, 54, of Belchertown, Mass., a former hospital administrator who suffers from osteonecrosis of the shoulders, ankles and knees, has had two hip replacements because of osteonecrosis and has been disabled as a result of his osteonecrosis for seven years. "The clinical experiences in Europe are showing that Harvest's BMAC System is making it easy and quick for clinicians to process and concentrate cellular compositions from bone marrow that include a significant amount of adult stem cells. This is being done safely and rapidly in Europe to aid in point-of-care treatment of osteonecrosis and other hard-to-treat diseases, so why not here in the United States?"

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 to commence a multicenter clinical trial of this treatment modality. Harvest intends to conduct a six-site IDE clinical trial using the BMAC System for the treatment of patients with Critical Limb Ischemia (CLI), which is the later stage of Peripheral Arterial Occlusive Disease (PAOD) -- clogged arteries, particularly in the lower legs. Patients with CLI are at extreme risk for amputation. Reportedly, 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 patients showed a 60 percent reduction in amputations. An additional randomized prospective clinical trial for the treatment of CLI is planned to commence in Europe.

Harvest Technologies is a privately held company based in Plymouth, Mass.

Contact Information

  • Contact:
    Ronald C. Trahan, APR
    President
    Ronald Trahan Associates Inc.
    508-359-4005, x108