<b>July 25 2003</b> – RANCHO CORDOVA, Calif., July 25 /PRNewswire-FirstCall/ — ThermoGenesis Corp. announced today that HR 2852 titled "Cord Blood Stem Cell Act of 2003" was introduced in the House of Representatives "to establish a National Cord Blood Stem Cell Bank network to prepare, store and distribute human umbilical cord blood stem cells for the treatment of patients and to support peer-reviewed research using such cells." The lead sponsors were Congressmen Chris Smith (R, NJ), Richard Burr (R, NC), Artur Davis (D, AL), Edolphus Towns (D, NY) and Congresswoman Anna Eshoo (D, CA). According to Philip Coelho, CEO, this landmark legislation was in response to the June 12th Senate Hearing presentations of clinical data from Dr.'s Pablo Rubinstein (New York Blood Center (NYBC)) and Joanne Kurtzberg (Duke University Medical Center) who pioneered this form of cell therapy. Neonatal cord blood stem cells were used in the treatment of genetic, metabolic and blood diseases, such as leukemia, lymphoma, sickle cell anemia, and immunodefeciencies ("boy in the bubble"). Cord blood as a source of stem cells is available faster than bone marrow and provides survival rates for patients with uniformly fatal diseases that can be as good as those following adult donor bone marrow donations through the registries.
Philip Coelho further commented, "The federal financing of this large inventory of cord blood stem cell units provided by this legislation will complete the evolution of this unique cell therapy from pure research to routine clinical practice and is an excellent demonstration of U.S. medical research functioning well — with both federal health agencies and academic research institutions each fulfilling their roles in promoting promising research through to tangible health benefits for U.S. citizens."
Kevin Simpson, President and COO of ThermoGenesis, noted that, "Cord blood transplants are currently curing hundreds of U.S. patients from these otherwise lethal diseases each year. However, the 150,000-unit inventory which will be collected pursuant to this legislation should provide life saving stem cell transplant for the thousands of patients each year who need them and cannot currently get them from the 'walking donor' bone marrow registries (as disclosed in the GAO Report, October 2002). This inventory will be a National treasure."
The role of ThermoGenesis has been the development of the BioArchive® System — an advanced robotic method of cryopreservation and long-term storage used by the major Cord Blood Banks in 21 countries. Following the first sibling-donor cord blood transplant in 1988, the NIH approved Dr. Rubinstein's grant proposal to develop the world's first cord blood program at the NYBC, in order to establish the inventory of stem cell units necessary to provide unrelated, matched grafts for patients (1992). In 1993, Dr. Joanne Kurtzberg performed the first two successful cord blood transplants, in the unrelated setting, one of which cured a patient with acute lymphoblastic leukemia (ALL). By 1996, with more than 300 unrelated transplants accomplished, the FDA accepted the NYBC's request for an Investigational New Drug (IND) Exemption which allowed the expansion of the clinical use of cord blood under conditions that documented the critical processing protocols and the clinical outcome data which would allow the FDA to understand how best to regulate this promising cell therapy. Today, the FDA, with these clinical outcome data in hand, is considering the licensing of this cell therapy product. The Agency's involvement will assure that cord blood stem cell units to be utilized in routine patient treatment will be in compliance with the necessary standards.
Simpson further noted, "We believe the best way to rally public support for stem cell research is to publicize the wonderful results already obtained with the clinical application of cord blood stem cells to the dreaded diseases mentioned above."
The BioArchive System plays a key role in the emerging world cord blood standards that are being adopted for the processing and storage of blood components. A computer-driven robotic system to allow users to cryopreserve and archive up to 3,626 units of blood components in -196 degrees C liquid nitrogen. The BioArchive System can cryopreserve, archive and retrieve samples within liquid nitrogen without exposing the samples to detrimental transient warming events (TWE), which can reduce cell viability.
About ThermoGenesis Corp.
After extensive research, ThermoGenesis Corp.'s newly introduced technology platforms lead the world in their ability to produce biological products from single units of blood. Umbilical cord blood banks are utilizing the Company's BioArchive System as a critical enabling technology for the harvesting, processing and cryogenic archiving of stem cells for transplant. The CryoSeal® FS System is used to prepare hemostatic and adhesive surgical sealants from patient blood in about an hour. ThermoGenesis Corp. has been a leading supplier of state-of-the-art Ultra-Rapid Blood Plasma Freezers and Thawers to hospitals and blood banks since 1992.
The statements contained in this release which are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, including, but not limited to, certain delays beyond the company's control with respect to market acceptance of new technologies and products, delays in testing and evaluation of products, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission.
