RANCHO CORDOVA, Calif., April 5 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. announced today that it has received notice from the U.S. Patent Office of the allowance of 20 new patent claims for the Company’s Thrombin Processing Device(TM) (“TPD(TM)”). TPD is a small, handheld, disposable device that produces thrombin, from a patient’s own blood or plasma in less than 30 minutes. Thrombin is an enzyme essential for blood clotting and releasing growth factors from platelets. The current thrombin market, estimated at $180 million/year, is currently dominated by King Pharmaceutical’s JMI Thrombin, sourced from bovine blood.
“This is the Company’s third patent on the preparation of autologous thrombin, bringing the Company’s total to 157 proprietary device, method and composition claims. This additional patent raises the technological barriers for potential competitors in the thrombin market and, along with the CryoSeal(R) Fibrin Sealant System, establishes ThermoGenesis as the leader in the autologous wound care market. ThermoGenesis is committed to being the leading innovator in this field and providing surgeons and their patients with safer and more convenient autologous products,” said Kevin Simpson, President & COO of ThermoGenesis Corp.
Many surgeons in Europe and Japan consider the use of bovine thrombin to be an unacceptable health risk to patients because a single exposure can increase the risk of adverse bleeding or autoimmune events in patients exposed to a second dose of bovine thrombin in a subsequent medical procedure(1). An additional concern about bovine products was further demonstrated in 2000 when the government of Japan announced a ban on drugs containing bovine materials over fears that ‘mad cow disease’ would be transmitted to patients.
The TPD is now being used by European surgeons to produce platelet gels from a patient’s own blood to help control surgical bleeding and accelerate wound healing. It is currently being marketed in Europe by Biomet, Inc. subsidiary Cell Factor Technologies, Inc., and Medtronic, Inc. in conjunction with their platelet gel products.
Regulatory Status of TPD
ThermoGenesis Corp. has been granted the right to affix to the TPD the CE Mark. From a marketing perspective, the CE Mark is the European equivalent to an FDA approval, in that it allows the Company to sell the TPD throughout the European community. The TPD will require approval of a PMA by the FDA before it can be sold in the U.S.
About ThermoGenesis Corp.
ThermoGenesis Corp. is a leader in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products. These products include:
* The BioArchive(R) System, an automated cryogenic device, is used by cord blood stem cell banks in 26 countries for cryopreserving and archiving cord blood stem cell units for transplant. * The AutoXpress(R) System, is a newly developed semi-automated device and companion sterile closed blood processing disposable, to harvest stem cells from cord blood. * The CryoSeal FS System, an automated device and companion sterile blood processing disposable, is used to prepare hemostatic and adhesive surgical sealants from the patient’s blood in about an hour. Enrollment in a 150 patient U.S. pivotal clinical trial has been completed and a PMA is being reviewed by the FDA. * The Thrombin Processing Device (TPD) is a sterile blood processing disposable that prepares activated thrombin from a small aliquot of patient blood, or blood plasma in less than 30 minutes. The TPD market launch is underway in Europe.
This press release, including statements regarding financial information for future periods, contain forward-looking statements, and such statements are made pursuant to the safe harbour provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. Several factors, including timing of FDA approvals, changes in customer forecasts, our failure to meet customers’ purchase order and quality requirements, supply shortages, production delays, changes in the markets for customers’ products, introduction timing and acceptance of our new products scheduled for fiscal year 2006, and introduction of competitive products and other factors beyond our control, could result in a materially different revenue outcome and/or in our failure to achieve the revenue levels we expect for fiscal 2006. A more complete description of these and other risks that could cause actual events to differ from the outcomes predicted by our forward looking statements is set forth under the caption “Risk Factors” in our annual report on Form 10-K and other reports we file with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward looking statements.
For More Information, visit the web site at www.thermogenesis.com
(1) Ortel et al. “Immunologic impact and clinical outcomes after surgical exposure to bovine thrombin.” Ann Surg. 2001 Jan; 233(1): 88-96.
ThermoGenesis Corp.
CONTACT: Lazar Partners for ThermoGenesis Corp., +1-212-867-1762
Web site: http://www.thermogenesis.com//
