Elsewhere in Europe, BioArchive Systems have been placed at the major Cord Blood Stem Cell Banks in Finland, France, Germany, Spain, and the United Kingdom. In North America, BioArchive Systems are placed at the New York Blood Center, Duke University Medical Center, San Diego Blood Bank, NuStem Technologies Inc., Coriell Institute for Medical Research pursuant to IND regulations, and the National Transfusion Service Cord Blood Bank in Mexico. Additionally in Asia, BioArchive Systems have been chosen in Japan, China, Taiwan, Vietnam, South Korea, Malaysia, and India.
The company estimates that more than 70 percent of the cord blood stem cell transplants performed to date are from Cord Blood Banks that are now using the BioArchive System, which demonstrates that the BioArchive System is the international choice for collecting, processing, and archiving cryopreserved hematopoietic stem cells sourced from PCB. PCB stem cells are used to restore immune systems of patients who have undergone high-dose chemotherapy and radiation to combat diseases such as leukemias, lymphomas, diverse inherited anemias, such as sickle cell anemia and thalassemia, and other genetic diseases.
Dr. James Godsey, President and COO of Thermogenesis Corp. commented: "We are pleased that the Catholic University of Louvain and the MDA Central Blood Bank have chosen to use the BioArchive System for their cord blood processing and banking programme. The Magen David Adom Institute is the first in Israel to install the BioArchive System. The implementation of our system at this premier stem cell bank in Israel moves Thermogenesis one country closer to its goal of establishing a global network of national cord blood bank programmes which have adopted the BioArchive System as their standard."
Dr. James Godsey further noted: "Indeed, we continue to carry out our strategic plan of installing a worldwide base of BioArchive systems. We derive both additional disposable product and equipment revenue as our customers continue to grow their PCB cell therapy programmes. Since many of these programmes are government funded, gaining entry puts us in the favourable position of securing the customers because of the desire for standardisation." Thermogenesis has been a pioneer in designing, manufacturing, and distributing equipment to collect, cryopreserve, and archive highly sensitive blood products and biological tissue for more than ten years.
"Recent research has suggested that there are stem cells in a unit of cord blood which have the potential to produce other cells outside the hematopoietic system such as neural, liver, and bone cells. This holds the promise of an ever growing demand for stem cell and regenerative medicine therapies which may be served by our growing base of installations. Since there are serious ethical issues with sourcing stem cells from an embryo or foetus, we believe scientists may begin to focus on cord blood as a superior, non-controversial source for these multi-potential stem cells", stated Philip Coelho, chairman and CEO of Thermogenesis Corp.
The BioArchive System uses Thermogenesis Corp.'s proprietary computer-driven liquid nitrogen robotic system to cryopreserve and archive up to 3626 units that have been collected, processed, and cryopreserved in proprietary sterile plastic bag sets. The BioArchive System performs robotic insertion and retrieval of each unique barcode identified stem cell unit. The unit subsequently can be delivered worldwide for transplant. The BioArchive System operates to freeze, place, and retrieve samples without exposing other archived samples to the Transient Warming Events (TWEs), which can significantly reduce cell viability.
The BioArchive System is a Class II blood component freezer exempt from the pre-market notification procedures. The BioArchive System has potential applications involving archiving, storing, managing, and retrieving other kinds of biological specimens, which may include stem cells, dendritic cells, T-cells, cell lines, male sperm cells, female eggs, heart valves, corneas, virus samples, biopsy samples, and other blood, tissue, and saliva samples. The BioArchive System is currently intended for the preservation of blood components and blood products and would require FDA 510(k) clearance for additional indications for use.