SOURCE: Harvest Technologies, Inc.

December 06, 2006 10:05 ET

Study Reports That Harvest Technologies' BMAC™ Point-of-Care System for Concentrating Autologous Adult Bone Marrow Stem Cells Gives New Hope to Patients With End-Stage Critical Limb Ischemia

Facing Leg Amputation

Data Presented at the VEITH Symposium™

PLYMOUTH, MA -- (MARKET WIRE) -- December 6, 2006 -- "I believe the Harvest technology may do for regenerative medicine what 'PCR' has done for cloning genes and discovering drugs... It is a 'changing' technology." -- Berthold Amann, MD, Vascular Medicine Specialist, Berlin Vasculature Center

Harvest Technologies Corp. ( announced today that Berthold Amann, MD, a specialist in vascular medicine, has reported data from his pilot study with autologous bone marrow transplantation in patients with end-stage Critical Limb Ischemia (CLI). CLI is the later stage of Peripheral Arterial Disease (PAD) -- 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).

In Dr. Amann's study, ischemic legs that were threatened by amputation were injected with the patients' own bone-marrow stem cells. Sixteen of the 23 end-stage patients included in the pilot study, who were treated at the Berlin Vascular Center of Franziskus Hospital, Berlin, Germany, were able to have their limbs salvaged as a result of the stem cell therapy, according to Dr. Amann.

Dr. Amann also reported that his stem cell therapy procedure was made "safe and simple" because of Harvest Technologies' BMAC™ (Bone Marrow Autologous Concentrate) System, a point-of-care device for concentrating autologous adult stem cells from bone marrow. With the harvest BMAC System, Dr. Amannn and other European clinicians can now offer stem cell therapies for vascular, cardiac and orthopedic diseases.

"Autologous adult stem cells derived from bone marrow offer profound potential as therapies -- but they are extremely difficult to process outside the human body -- until now," said Gary Tureski, President of Harvest Technologies. "Our novel BMAC technology is making it possible to harvest and concentrate them easily and rapidly -- at the point of care, in about 15 minutes -- thereby empowering European physicians to develop non-surgical approaches for difficult-to-treat diseases, today."

"Harvest's BMAC technology could be a significant step forward for medicine, in general, and for treating CLI, in particular, because it is fast and easy to use," said Dr. Amann. "The concentrate produced by the BMAC System requires a lower volume of bone marrow aspirate compared to traditional methods, is less painful, and does not require general anesthesia. In summary, I believe the Harvest technology may do for regenerative medicine, and especially for therapeutic angiogenesis, what 'PCR' has done for cloning genes and discovering drugs... It is a 'changing' technology."

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. The BMAC™ System is the world's first and only technique that produces clinically effective amounts of stem and precursor cells from a small aspirate of autologous bone marrow in just 15 minutes. Several studies have established the beneficial effect of injected bone marrow cell concentrates in cardiovascular and orthopedic diseases. 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." Harvest is now actively in discussions with the FDA to commence a multicenter clinical trial using the BMAC System to induce the growth of new blood vessels in patients with CLI.

Now entering its fourth decade, the VEITH Symposium, sponsored by The Cleveland Clinic, is a highly regarded annual meeting of leading vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists. It focuses on new and important treatment modalities for vascular disease.

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

Contact Information

  • Ronald C. Trahan
    Ronald Trahan Associates, Inc.
    508-359-4005 x108