ThermoGenesis Corp. to Present at SunTrust Robinson Humphrey's Annual Conference.
Mr. Coelho will discuss how the Company's Blood Bank and Hospital divisions are addressing an approximately $1 billion market opportunity in 2007 with Blood Processing Systems that "enable" the production of therapeutic doses of cord blood stem cells, autologous protein surgical sealant, hemostatic agents or platelet-derived growth factors from single units of blood.
Blood Bank Division Products - $400 million market opportunity
The BioArchive(R) System, a computer controlled robotic device utilized to cryopreserve, archive and retrieve 3626 units of cord blood stem cells by cord blood banks within liquid nitrogen without exposing the samples to detrimental transient warming events (TWE), which can reduce cell viability. Fifty-five (55) cord blood banks in 23 countries are utilizing the Company's BioArchive System as a critical enabling technology for the harvesting, processing and cryogenic archiving of units of cord blood stem cells.
The Automated Cell Separation System, a small compact robotic device and proprietary blood processing disposable that enables the separation and harvest of the cellular components of blood.
Hospital Division Products - $600 million market opportunity
The CryoSeal(R) FS System combines a floor standing robotic device and a proprietary blood processing disposable to enable the production of cryoprecipitate and thrombin, the two components of fibrin sealant, from a single unit of patient plasma in about an hour. Fibrin sealants are used for surgical hemostasis and tissue adhesion in a wide variety of surgical procedures.
The Thrombin Processing Device ("TPD") is a small, hand-held single use, sterile disposable device that enables the production of 8.5 ml of activated thrombin from 10 ml of the patient's plasma in about 15 minutes. Thrombin is used to clot limited oozing bleeding during surgery and to release growth factors from platelets to assist tissue regeneration.
Regulatory Status -- The BioArchive System is a Class II blood and 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, that may include stem cells, dendritic cells, T-cells, cell lines, sperm cells, eggs, heart valves, corneas, virus samples, biopsy samples and other blood, tissue and saliva samples. The BioArchive System is currently intended for storage of blood and blood components. Additional indications for use would require U.S. FDA clearance or approval. -- The Automated Cell Separation System is currently under development. -- In Japan, the pivotal clinical trial of the CryoSeal System has recently been completed by the exclusive distributor, Asahi Medical Ltd. who is expected to file a pre-market approval (PMA) to the Japanese Ministry of Health in the near future. The CryoSeal FS System has also received CE Mark approval from the European Union Competent Authorities and is being tested in European clinical trials by Dideco S.p.A, of Mirandola, Italy. Additional field trials are underway in Canada and Brazil. The CryoSeal FS System is not yet available in the United States and will require completion of a Phase III clinical trial, currently underway at seven (7) clinical sites, and the submission of PMA to the U.S. FDA before sales can commence in the U.S. -- The TPD has not been submitted to the FDA.
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.
CONTACT: Phil Coelho of ThermoGenesis Corp., +1-916-858-5100
Web site: http://www.thermogenesis.com/
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|Date:||May 20, 2004|
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